Careers

Come join our growing Tonix Team!

Tonix Pharmaceuticals is a clinical-stage biopharmaceutical company that invents, licenses, acquires and develops innovative medicines to help patients manage immunology and central nervous system (CNS) conditions.

We are a team of passionate professionals dedicated to advancing science to improve patient care and public health.

We are committed to offering a flexible working environment where we value the input and ideas of our diversified employee base. We work collaboratively and with a team-oriented mindset, understanding that every employee brings differing views to the table that will continue Tonix’s growth and development.

We are continuing our growth by building a new facility in North Dartmouth, Massachusetts that is expected to open in early 2022, and by planning for further expansion in Hamilton, Montana.

Our competitive benefits include:

  • Medical, Dental, and Vision Insurance
  • Basic Life / AD&D, Voluntary Life / AD&D
  • Short Term Disability and Long Term Disability
  • Health Care and Dependent Care Flexible Spending Accounts
  • Commuter Benefits
  • Paid time off
  • 13 US Company Paid Holidays
  • Parental leave
  • 401(k) Plan – 6% match with an additional 3% safe harbor contribution
  • 529 Plan
  • Employee Stock Purchase Plan (ESPP)
  • Option Awards
  • Summer Fridays
  • Educational Assistance Program
  • Employee Referral Program

Openings

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Based on the expansion of it its R&D platform, Tonix is looking for an Analytical Development Subject Matter Expert (SME) to supplement its internal and external team.

The Analytical Development SME will be responsible for developing methods designed at characterizing and/or measuring the critical quality attributes (CQAs) of viral vaccine products. The individual in this position will be responsible for independently designing and executing laboratory experiments, compiling relevant findings into reports, and presenting results to internal and external stakeholders across the portfolio of Tonix viral vaccine products.

The individual in this position will be highly motivated with experience and interest in working with CDMOs and on-site role, in a dynamic, cross-functional, entrepreneurial environment with broad responsibilities and opportunities.

Tonix is currently constructing its own Advanced Development Centre (ADC) facility which will be ready for commissioning in North Dartmouth, MA in Q1, 2022. The position will be based in this ADC facility once open and operational. Remote work arrangements will be in place until such time. The earlier the individual can start will allow them take part in the set-up of the laboratory along with the design team.

Essential Duties

  • Lead projects associated with establishing robust and compliant analytical methods at Tonix
  • Own and maintain the knowledge and history of Tonix method development and qualification throughout the method and product lifecycle
  • Prepare and review technical documents such as test method SOPs, product specifications, qualification and test protocols, technical reports, sampling plans, risk assessments, and/or relevant sections for regulatory submission files
  • Provide first line technical support to QC and development testing laboratories in compliance with relevant instructions and quality requirements
  • Design new analytical methods or refine existing methods
  • Lead method transfers from Internal (Discovery) or external (CDMO) laboratories, method optimization and qualification
  • Develop and support HPLC/UPLC methods (Agilent and Thermo HPLCs/UPLCs; SEC, IEX, and RP using UV, FLR, CAD, and MALS) to measure the CQAs of viral vaccine products
  • Develop and support LC-MS/MS methods to characterize the nucleic acid, protein, and/or lipid components of viral vaccine products
  • Lead the transfer of developed methods and acquired knowledge to the Quality Control team
  • Author and reviewing analytical test methods, data summaries, protocols, and technical reports
  • Engaging with internal and external stakeholders and customers to set strategic goals, generate workplans, and discuss findings
  • Use scientifically sound rational and statistical tools for data analysis, contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
  • Support change review and implementation, quality investigations, CAPAs in cross-functional teams
  • Participate in the definition and selection of analytical instruments by providing input to User Requirement Specifications (URS) and creating associated procedures
  • Support instrument qualification activities
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Advanced degree in biochemistry, analytical chemistry, or related discipline with five+ years of industry experience or Bachelor’s in biochemistry, analytical chemistry, or related discipline with seven years of industry experience or equivalent combination of education and experience
  • Experience with biochemical, physicochemical and/or biologic activity methods
  • Project management experience
  • Experience in experimental design and statistical analysis methodology
  • Experience with projects in clinical development e.g., Phase 1 through Phase 3
  • Experience in the area of viral vaccines, viral vector or monoclonal antibodies strongly preferred
  • Experience with cGMP manufacturing and regulatory submissions is a plus
  • Ability to identify and resolve critical issues
  • Good interpersonal and stakeholder management skills to collaborate with and direct the work of others on assigned projects, including both internal teams and external collaborators.
  • Demonstrated ability to develop methods to characterize or measure the CQAs of in-process and release samples
  • Experience developing methods for viral vaccines or gene therapy products strongly preferred
  • Experience with the following techniques: ELISA, gel electrophoresis, DLS, DSC, AUC, and capillary electrophoresis (CE-SDS, cLIF, cIEF)
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written, organizational, and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.

Please click Scientist, Analytical Development to apply. 

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix is looking for a full-time Animal Technician II to effectively provide in vivo study support in ABSL-2 and ABSL-3 environments. The individual in this position would be responsible for handling and working with a variety of animal species.  The individual in this position would also be responsible for executing key activities on in vivo studies following appropriate procedures.  The Animal Technician II has a strong understanding of the principles involved in providing documenting quality animal study support, is proficient in applying these principles, and has a proven ability to work well in a team environment.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Manager, In Vivo Laboratories and will be based at the Frederick, MD office.

Essential Duties

  • Administer test and control materials by various routes, including (but not limited to) gavage, intravenous, intramuscular, intraperitoneal, and subcutaneous
  • Collect samples and specimens (blood, cerebrospinal fluid, urine, feces, etc.)
  • Administer analgesia and anesthesia to all species of animals in the facility and monitor their recovery
  • Administer treatments to animals with active clinical cases
  • Gather experimental data by measuring and recording body weights and temperatures, qualitative and quantitative food and water consumption, and observation of physical condition
  • Observe animals daily and report abnormal findings to the appropriate individual(s)
  • Handle and restrain rodents, rabbits, ferrets, and nonhuman primates
  • Perform animal identification procedures (ear tag, transponder implantation, tattoo, etc.)
  • Assist in surgeries (animal preparation, perioperative and postoperative animal monitoring)
  • Sterilize surgical instruments, equipment, and supplies
  • Perform animal necropsies and harvest various tissues as directed per study protocol
  • Learn new techniques required to provide adequate research study support
  • Observe appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), Good Laboratory Practices (GLP), Animal Care and Use Protocols (ACUP) and study protocols
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Associates or Bachelor’s degree in Animal or Biological Sciences plus two (2) years of experience working in a laboratory animal research environment or a High School Diploma plus five (5) years of experience working in a laboratory animal research environment
  • Must like working with animals and demonstrate a commitment to quality animal care
  • AALAS Certification at the ALAT or LAT level preferred
  • Knowledge of GLP regulations preferred
  • Ability to work overtime including nights, weekends, and holidays, on a rotating schedule
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written, organizational, and verbal communication skills are essential
  • Strong attention to detail and organizational skills
  • Comfortable independently with minimal supervision
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please click Animal Technician II to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix is looking for a full-time Manufacturing Associate I focused on the manufacturing of clinical materials in support of Phase I-III human clinical trials at Tonix’s brand new Advanced Development Center (ADC) facility. Duties include processing in upstream and downstream operations while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply.

Due to the production schedule, the work schedule for this position varies month to month.  Typical schedule demands are weekly Monday – Friday as well as night, weekend, overtime, and shift coverage when necessary.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Director of Manufacturing and will be based at the Tonix ADC facility in North Dartmouth, MA.

Essential Duties

  • Learn to operate manufacturing process equipment to perform various cell culture and purification production steps, and train co-workers on the operation of the equipment
  • Operate inside of a BSC, sample, and perform with aseptic techniques
  • Monitor and record batch parameters, including computer data entry
  • Complete relevant paperwork following GDP/GMP guidelines including performing mathematical calculations related to production processes
  • to operate cleaning and sanitization systems including glasswasher and autoclave systems, manually clean portable equipment and small parts, and train co-workers on the operation of the systems
  • Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion
  • Troubleshoot process problems and respond appropriately
  • Provide information for unplanned events, including entering data into event management software
  • Perform daily routine environmental monitoring
  • Order, receive, and distribute supplies into production area
  • Schedule department or process activities and demonstrate procedures as a part of training sessions for team members
  • Participate in and lead team meetings as well as facilitate multidepartment discussions
  • Participate on continuous improvement teams Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Bachelor’s degree in life science or engineering or Associates degree with two (2) years relevant experience preferred
  • Biotech certificate preferred
  • Demonstrated knowledge of cGMP manufacturing
  • a plus
  • Knowledge of laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, cell culture equipment, chromatography skids and columns, analytical equipment
  • Proficiency in a variety of mathematical disciplines and able to work with metric and USA standards of measurement, and military time
  • Solid verbal and written communication skills with the ability to read and follow detailed English written instructions
  • Ability to write legibly and grammatically correct entries on records and must be able to author technical procedures and create manufacturing forms
  • Familiar with standard troubleshooting approaches such as problem statement, root cause analysis, and corrections
  • Knowledge of basic chemical and biological safety procedures
  • Solid computer skills, knowledge of Microsoft Word and Excel
  • Good interpersonal skills and ability to work effectively and efficiently in a team environment
  • Ability to work during general business hours Monday – Friday as well as flexibility to work nights, weekends, holidays, overtime and shift work as dictated by the 365-day per year production schedule
  • Ability to work in a clean room environment and comply with hygiene standards and use of special garments, including wearing personal protective equipment as per safety requirements
  • Ability for minimal travel
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please click  Manufacturing Associate I to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

 

Position Overview

Tonix is looking for a full-time Manufacturing Associate II to effectively focused on the manufacturing of clinical materials in support of Phase I-III human clinical trials at Tonix’s brand new Advanced Development Center (ADC) facility. Duties include processing in upstream and downstream operations while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply.

Due to the production schedule, the work schedule for this position varies month to month.  Typical schedule demands are weekly Monday through Friday as well as night, weekend, overtime, and shift coverage when necessary.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Manager of Manufacturing and will be based at the Tonix ADC facility in North Dartmouth, MA.

 

Essential Duties

  • Operate manufacturing process equipment to perform various cell culture and purification production steps such as: expansion of cells, automated and manual cell culture systems supporting cell growth, expansion and harvesting systems, and clarification systems
  • Strong knowledge and understanding operating manufacturing process equipment to perform various purification production steps such as: various filtration steps, chromatography process, and ultra-filtration
  • Ability to train employees on upstream and downstream activities
  • Proficient operation of BSC’s, chromatography skids, chromatography columns, autoclave and glass washers As well as the ability to train co-workers in these areas
  • Subject matter expert in operating production testing equipment, such as pH and conductivity meters
  • Monitor and record batch parameters, including computer data entry
  • Complete relevant paperwork following GDP/GMP guidelines including performing mathematical calculations related to production processes
  • Initiate new documents for procedures with the ability to make revisions to existing documents
  • Work with support teams on all necessary event investigations
  • Troubleshoot process problems and respond appropriately to alarms.
  • Provide information for unplanned events
  • Oversee training of new employees, as well as track training requirements for team members ensuring appropriate training is completed prior to process execution
  • Operate cleaning and sanitization systems including glasswasher and autoclavesystems, manually clean portable equipment and small parts
  • Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion
  • Operate inside of a BSC, sampling, and performing with aseptic techniques
  • Perform environmental monitoring as required
  • Order, receive, and distribute supplies into production area
  • Convey information to external stake holders
  • Lead continuous improvement teams
  • Schedule department or process activities and demonstrate procedures as a part of training sessions for team membersLead team meetings and facilitate multidepartment discussions
  • Provide knowledge and input into areas of training process improvements
  • Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Bachelor’s degree  5 years of experience or 8-10 years of relevant experience in lieu of Bachelor’s degree
  • Bachelor’s degree in the Life Sciences or Engineering field plus one(1) year of related experience or a high school degree with three (3)  years of related experience required
  • Biotech Certificate preferred
  • Demonstrated knowledge of cGMP manufacturing with particular skills in purification
  • Experience with upstream and downstream processing a plus
  • Knowledge of laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, chromatography skids and columns, and analytical equipment
  • Proficiency in a variety of mathematical disciplines and able to work with metric and USA standards of measurement, and military time
  • Solid verbal and written communication skills with the ability to read and follow detailed English written instructions Ability to write legibly and grammatically correct entries on recordsand ability to author technical procedures and create manufacturing forms
  • Familiar with standard troubleshooting approaches  such as problem statement, root cause analysis, and corrections
  • Knowledge of basic chemical and biological safety procedures
  • Solid computer skills, knowledge of Microsoft Word and Excel
  • Good interpersonal skills and ability to work effectively and efficiently in a team environment
  • Ability to work during general business hours Monday – Friday as well as flexibility to work nights,  weekends, holidays, overtime and shift work as dictated by the 365-day per year production schedule
  • Ability to work in a clean room environment and comply with hygiene standards and use of special garments, including wearing personal protective equipment as per safety requirements
  • Strong knowledge and understanding of operating manufacturing process equipment to perform various cell culture and purification production steps
  • Ability for minimal travel
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please send your resume and cover letter to careers@tonixpharma.com and include Manufacturing Associate II in the subject of the email.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview:

The Associate/Senior Associate, QA Operations and Compliance will support the Quality Assurance GMP Operations and Compliance function for the organization. The individual in this position will support the implementation of Quality standards and systems related to activities at the Tonix GMP manufacturing facility. The individual in this position will also execute day-to-day operations within the Quality Assurance function, including compliance oversight of internal GMP operations.  In addition, the individual in this position may also oversee aspects of external manufacturing related activities.

The individual in this position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  The individual in this position will also provide support for the reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Senior Manager of Quality Assurance Operations and Compliance and will be based at the Tonix Advanced Development Centre (ADC) facility in North Dartmouth, MA location.

Essential Duties:

  • Perform day-to-day operations of the Quality Assurance operations and compliance functions
  • Execute Quality System requirements in compliance with applicable quality standards and requirements, including but not limited to risk management, change control, deviations, CAPA, self-inspection, and complaints for internal programs
  • Perform lot release activities including review and approval of master and executed batch records and Certificates of Analyses
  • Prepare and monitor metrics to ensure control of systems and drive continuous improvements
  • Support internal audit program as well as participate in regulatory audits
  • Provide compliance support for external programs
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications:

  • Bachelor’s Degree in Science or other related discipline or equivalent work experience preferred
  • Two (2) years of combined experience in a biotechnology/cell and gene therapy environment, covering QA, QC and/or manufacturing preferred
  • Background in application of cGMP in a drug substance or drug product manufacturing environment
  • Demonstrated troubleshooting and problem-solving skills
  • Ability to analyze a wide variety of information and data to make decisions regarding potential risks associated with regulatory compliance
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Excellent written and verbal communication skills are essential
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to careers@tonixpharma.com and include Associate/Senior Associate, Quality Operations and Compliance in the subject of the email.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

The Associate, Quality Control Raw Materials will sample, inspect, and test incoming goods intended for use in the manufacturing area, according to Standard Operating Procedures (SOP) ensuring material meets acceptable quality attributes. In addition to testing, this role will assist in the implementation of general laboratory operational systems, method transfer, and qualification activities. The individual in this position will provide high-quality support and meet or exceed current company and GMP requirements.

The individual in this position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  The individual in this position will also provide support for the reporting/escalation of quality issues and/or risk mitigation activities.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Manager of Quality Control.

Tonix is currently constructing its own Advanced Development Centre (ADC) facility which will be ready for commissioning in North Dartmouth, MA in Q1, 2022.  The position will be based in Tonix’ ADC facility once open and operational.

Essential Duties

  • Execute day-to-day operations of the Quality Control Raw Material function
  • Perform sample receipt and inspection of incoming raw materials
  • Perform routine laboratory activities such as housekeeping, equipment maintenance, and glassware
  • Perform all testing and activities in accordance to standard operating procedures
  • Assist with and execute method validation plans
  • Perform daily equipment calibrations and performance checks
  • Document all activities in accordance with GMP guidance
  • Execute continuous improvement activities
  • Ensure document and data integrity is maintained at all times
  • Provide testing data and other required quality-related information needed to support clinical studies with minimal supervision
  • Assist in the development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements
  • Revise documents, including SOP’s and protocols as necessary
  • Provide support to audit teams for internal and vendor audits
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Bachelor’s degree in Chemistry or a relevant scientific discipline preferred
  • cGMP QC experience in the biotechnology/large molecule industry preferred
  • Basic understanding of QC principles, USP/Ph Eur compendia testing requirements, and various analytical and biochemical testing techniques
  • Basic understanding of GMP requirements
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Solid written and verbal communication skills are essential
  • Good planning and organizational skills
  • Highly organized, results driven, problem solver, and collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to careers@tonixpharma.com and include Senior Associate, Quality Control Raw Materials in the subject of the email.

 

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix is looking for a full-time Head of Clinical Manufacturing to lead start up and operation of a new state of the art manufacturing facility. This role will be responsible for supporting the commissioning of plant and process equipment, assuring cGMP compliant operational procedures are in place and followed, assuring all plant operations exceed safety requirements, recruiting and developing staff, transferring processes from development, and manufacturing investigational drug product for clinic.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Executive Director of CMC/Technical Operations and will be based at the Tonix Advanced Development Center (ADC) facility in North Dartmouth, MA.

Essential Duties

  • Recruit and train cohesive and efficient clinical manufacturing team
  • Lead facility startup, including facility qualification, equipment commissioning, qualification, and validation activities
  • Develop manufacturing execution and controls systems including SOPs, Master Batch Record, Bills of Material, and other documentation
  • Lead the manufacturing team in transfer of drug substance and drug product processes into the facility
  • Plan and execute strategic and day to day manufacturing activities to meet project timelines
  • Engage and effectively influence team members while prioritizing multiple projects and meeting deadlines
  • Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc projects as necessary to support Tonix on various business initiatives

Supervisory Responsibilities

  • Recruit and train new staff
  • Oversee the daily workflow of the department
  • Provide constructive and timely performance evaluations
  • If necessary, handle discipline and termination of employees in accordance with company policy
  • Contribute to performance and compensation decisions such as: merit raises, bonuses, and promotions

Minimum Qualifications

  • Bachelor’s degree in chemical, bio-engineering or related field, advanced degree preferred
  • Ten years of leadership experience in Manufacturing in an FDA regulated environment
  • Experience in manufacturing of biologics required
  • Experience in manufacturing vaccines and viral products in aseptic manufacturing preferred
  • Ability for minimal travel
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please click Director, Manufacturing to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix is looking for a full-time Director of Project Management (PM) to effectively shape and execute the project and development strategies for highly complex drug development programs. The Director of PM is accountable for the cross-functional planning and execution of multiple programs including management of timelines, cost, risk assessment, and mitigation. The Director of PM should strive to provide an independent voice to shape the overall project strategy and drive optimal strategic decisions for the broader portfolio value.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Company’s Chief Operating Officer and will be based at the Tonix Chatham, NJ office.

Essential Duties

  • Lead a cross-functional matrix team of experts in advancing programs/assets by developing detailed plans, pursuing approval, and executing on the project strategy
  • Create and maintain a cross-function development plan, timeline, and budget for each program and evaluate progress vs. plan
  • Facilitate effective, science-based business decisions including development of scenarios and strategic impact of decisions
  • Ensure all decisions are assessed as to their risks and impacts; accountable for communication to team and stakeholders in a transparent and timely manner
  • Act as an integrator within the project team and across the Company to ensure alignment and connect best practices
  • Develop and coordinate resource and budget planning across functions to assure adequate resources are applied to the project and any changes are highlighted appropriately
  • Provide leadership to the team and functional areas to anticipate and identify complex project issues which pose a challenge to achieving strategic goals; propose and implement plans to resolve such issues, and execute corrective actions
  • Provide updated project documents and information for regular budget reviews, Board updates, and portfolio reviews
  • Enable high-performing teams by ensuring good team dynamics within the project team
  • Ensure project work complies with established practices, policies, and processes
  • Upholds company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Performs ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Bachelor’s degree and minimum of ten (10) years of relevant project/portfolio management experience within the pharmaceutical / biotechnology industry; or a PhD in a scientific field or a PharmD, DVM or MD degree with six (6) years of relevant experience
  • Five (5) years of leading cross-functional project management activities within the pharmaceutical industry, building, managing, and articulating comprehensive, complex, cross-functional plans required
  • Scientific background preferred
  • PMP (Project Management Professional) or other PM certification or equivalent preferred
  • Line management supervisory experience is desirable
  • Extensive knowledge of the drug development process and deep understanding of and application of principles, concepts, practices, and standards of pharmaceutical project management
  • Expertise in developing and managing project scope, deliverables, risks, and resource requirements
  • Strong leadership presence with the ability to translate strategy into action
  • Excellent analytical skills with an ability to summarize and present complex information in a clear and concise manner
  • Outstanding verbal and written communications skills with the ability to effectively interact with all levels within the company
  • Must be able to understand and communicate scientific and business elements associated with the therapeutic area(s) of assigned projects
  • Advanced knowledge and skill with Microsoft Project, Microsoft Excel, and other reporting and tracking tools
  • Exceptional interpersonal skills and understanding of team dynamics
  • Ability to lead without authority, influence and motivate teams
  • Ability to help teams anticipate, plan, and adapt to an evolving environment
  • Ability to take accountability and empower individuals and teams to make effective decisions which are aligned with the company’s vision, values, and goals
  • Ability to create an inclusive environment and lead empowered teams who operate with high standards of alignment, trust, accountability, expertise, transparency, and collaboration
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Strong planning and organizational skills
  • Highly autonomous in daily work; comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please click Director, Project Management to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

 

Position Overview

Based on the expansion of its R&D platform and clinical pipeline, Tonix is looking for an Engineer, MSAT to supplement its internal and external teams. The MSAT Engineer will lead technology transfer and support of internal and external manufacturing, as well as contribute to overall technical development. This position will be located at the Tonix Advanced Development Center (ADC) facility in North Dartmouth, MA.

The ideal candidate will be a highly motivated individual with experience in viral products and biologics working in an entrepreneurial environment with broad responsibilities and opportunities.

This is a fast-paced challenging position offering a competitive compensation and benefits package. The position will report directly to the MSAT Manager.

Essential Duties

  • Lead technical transfer projects for establishing robust and compliant manufacturing processes and associated control strategy
  • Own and maintain the knowledge and history of manufacturing processes throughout the product lifecycle
  • Author, review, and approve technical documents such as batch records, sampling plans, SOPs, risk assessments, study protocols, technical reports, and sections for regulatory submissions
  • Provide first line technical support to manufacturing on the floor in compliance with relevant instructions and quality requirements
  • Lead process characterization, scale up, process optimization, and process validation
  • Use scientifically sound rational and statistical tools for data analysis and trending
  • Contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
  • Support change review and implementation, risk assessments, quality investigations, impact assessment, and CAPAs in cross-functional teams
  • Participate in the definition and selection of equipment by providing input to User Requirement Specifications (URS) and creating associated procedures
  • Support process equipment FAT, SAT, and on-site qualification activities
  • Plan and organize training for manufacturing personnel
  • Deliver robust, scalable, and cost-effective manufacturing processes for viral vaccine and biologics drug substance and drug product that meet or exceed the target product profile
  • Provide hands-on contribution in the Process Development lab during process scale up
  • Prepare technical reports, publications, and oral presentations
  • Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Leadership

  • Accountable for on-time project completion and achievement of compliance goals
  • Represent the CMC Development function in project team meetings

Minimum Qualifications

  • Bachelor’s Degree in Biochemistry, Chemical Engineering, Biotechnology, or related scientific discipline with three (3) years of experience in biotechnology industry
  • Biopharmaceutical development and manufacturing experience specifically in viral vaccines and viral-based products required; monoclonal antibodies development is an asset
  • Broad experience with upstream and purification technologies for viral products, drug substance formulation, and fill/finish
  • Experience with statistical analysis
  • Experience with cGMP manufacturing and regulatory submissions
  • Ability to identify and resolve critical issues
  • Available for minimal travel
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please click Engineer, Manufacturing Science and Technology (MSAT)to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix is searching for a strategic leader to build and lead the Quality Assurance (QA) function. This role is strategically important for the success of Tonix’s near term goals, ensuring continuous improvement and high-quality deliverables. The individual in this position will be a hands-on leader responsible for direct management of quality personnel, develop and oversight of the quality systems, vendor audits and regulatory inspections, and assuring the overall GCP, GLP and GMP compliance with current regulations and guidelines.

This is a highly visible role and can be either at the Executive Director or VP level based on candidate’s ability and experience. This role in collaboration with Tonix management will set the Quality vision for the company.

This fast-paced challenging position offers a competitive compensation and benefits package.  This position will report directly to the Company’s Chief Operating Officer and will be based at the Tonix Headquarters in Chatham, NJ or the Advanced Development Center (ADC) in North Dartmouth, MA.

Essential Duties

  • Develop and oversee implementation of GCP, GMP, and GLP Quality Management systems at appropriate Tonix locations and ensure GxP compliance for the organization
  • Collaborate with the Clinical Operations, GLP-Tox., Regulatory Affairs and Product Development (CMC) teams to provide QA oversight throughout the product lifecycle
  • Set the QA objectives in alignment with the overall corporate goals and objectives
  • Implement the quality strategy and culture through collaboration, training, metrics, and risk-based thinking
  • Ensure that regulated processes and systems at Tonix are phase appropriate and inspection-ready
  • Take leadership responsibility for execution of Tonix audit programs, including annual audit plans, and oversee the performance of internal and external audits
  • Lead, host, and manage regulatory inspections including follow-up activities
  • Lead the GxP training program at Tonix
  • Drive internal process improvement initiatives, such as, inspection readiness activities including mock inspections and interview preparations
  • Collaborate with and educate internal and external partners to implement a culture of Quality
  • Ensure all customer contracts, including Quality agreements, are effectively negotiated to meet the quality and regulatory requirements needs of Tonix in a cost-efficient manner
  • Organize Quality Governance Meetings to report Quality metrics, compliance trends, and any areas of risk with associated mitigation plans
  • Enhance policies and procedures and ensure compliance with applicable regulations
  • Provide QA oversight of investigations, associated CAPAs, and Effectiveness Checks
  • Identify, hire, manage and develop experienced Quality leaders and managers
  • Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Supervisory Responsibilities

  • Recruits, interviews, hires, and trains new staff
  • Oversees the daily workflow of the department
  • Provides constructive and timely performance evaluations
  • Handles discipline and termination of employees in accordance with company policy
  • Contributes to performance and compensation decisions such as: merit raises, bonuses, and promotions

Minimum Qualifications

  • Bachelor’s degree preferably in the life sciences
  • Twenty (20) years of Pharmaceutical Industry experience with fifteen (15) years of Quality Assurance experience in US/EU environment preferred
  • Ten (10) years in progressive Quality Leadership roles with proven ability to mentor and develop the QA teams through coaching and effective performance management
  • Extensive experience hosting regulatory inspections and interacting with regulators
  • Consistent track record of success in audit compliance
  • Excellent decision-making and strong communication skills and attention to detail
  • Knowledge of Risk Management systems and tools
  • Experience in Quality Systems Management and oversight
  • Strong knowledge of US-FDA, ISO, ICH, GxP principles, and other global regulations for drugs and medicinal products and their application
  • Demonstrated leadership experience in the vendor selection and management
  • Experience leading problem investigations, Root Cause Analysis (RCA), and CAPA
  • Experience with computer software validation (CSV) and implementation of systems.
  • Ability for travel up to 25% of the time
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please send your resume and cover letter to careers@tonixpharma.com and include Executive Director or VP, Quality Assurance in the subject of the email.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Based on the expansion of its R&D platform and clinical pipeline, Tonix is looking for an Analytical Development Subject Matter Expert and Leader to supplement its internal and external teams. The Head of Analytical Development will be responsible for developing methods designed at characterizing and/or measuring the critical quality attributes (CQAs) of viral vaccine products.  They will also be responsible for planning and execution of internal and external analytical development activities across the portfolio of Tonix viral products and leading a small team of scientists located at the Tonix’ Advanced Development Centre (ADC) facility.

The ideal candidate will be a highly motivated individual with experience in analytical development for viral products and interest in working in both a virtual and onsite role, in an entrepreneurial environment with broad responsibilities and opportunities.

This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Executive Director, CMC.

Tonix is currently constructing the Advanced Development Centre (ADC) facility which will be ready for commissioning in North Dartmouth, MA in Q1, 2022. The position will be based in the Tonix ADC facility once open and operational. Remote work arrangements will be in place until such time.

Essential Duties

  • Lead projects associated with establishing robust and compliant analytical test methods
  • Own and maintain the knowledge and history of method development and qualification throughout the method and product lifecycle
  • Prepare and review technical documents such as test method SOPs, product specifications, qualification and test protocols, technical reports, sampling plans, risk assessments, and/or relevant sections for regulatory submission files
  • Provide first line technical support to QC and development testing laboratories in compliance with relevant instructions and quality requirements
  • Design new analytical methods or refine existing ones
  • Lead method transfers from internal (discovery) or external (CDMO) laboratories, method optimization and qualification
  • Personally contribute and lead teams developing viral products release and characterisation methods including biophysical and cell-based assays; including, but not limited to HPLC/UPLC methods, LC-MS/MS methods, particle characterisation methods (AUC, DLS, NTA, Flow virometry), PCR, ddPCR, qPCR, NGS, ELISA, cell based potency assays
  • Lead the transfer of developed methods and acquired knowledge to the Quality Control team
  • Author and reviewing analytical test methods, data summaries, protocols, and technical reports
  • Engage with internal and external stakeholders/customers to set strategic goals, generate workplans, and discuss findings
  • Use scientifically sound rational and statistical tools for data analysis, contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
  • Support change review and implementation, quality investigations, CAPAs in cross-functional teams
  • Participate in the definition and selection of analytical instruments by providing input to User Requirement Specifications (URS) and creating associated procedures
  • Support instrument qualification activities
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Leadership Duites

  • Provide guidance and training to direct reports as relates to assigned projects and consistent with the quality governance
  • Develop work and project plans and execute per the plans
  • Provide input into development of budgets proposals, new capital expenditures, recruitment planning and external spending
  • Accountable for on-time project completion and achievement of compliance goals
  • Represent the CMC Development function in project team meetings

Minimum Qualifications

  • PhD in Biochemistry, Analytical Chemistry, or related discipline with eight (8) years of industry experience in Analytical Development
  • Experience developing methods for viral vaccines, viral products or gene therapy
  • Experience with Biochemical, Physicochemical and/or Biologic activity methods
  • Project management experience
  • Experience in experimental design and statistical analysis methodology
  • Experience with projects in clinical development (e.g. Phase 1 through Phase 3)
  • Experience with cGMP manufacturing and regulatory submissions
  • Ability to identify and resolve critical issues
  • Excellent written and verbal communication skills, good interpersonal and stakeholder management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
  • Demonstrated ability to develop methods to characterize or measure the CQAs of in-process and release samples
  • Experience with the following techniques: ELISA, gel electrophoresis, DLS, DSC, AUC, and capillary electrophoresis (CE-SDS, cLIF, cIEF)
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written, organizational, and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please click Associate Director, Analytical Development to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.   Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix is looking for a full-time Information Technology Specialist (System Administrator) to effectively provide system support for all hardware (PCs, Printers, Lab Systems, and Servers) and it’s associated software.  The individual in this position would be responsible for the planning, coordinating, modifying, implementing, and troubleshooting of equipment to meet business needs.  This position will support both the Corporate and GxP IT Infrastructure at our new Advanced Development Center (ADC) in North Dartmouth, MA. The Information Technology Specialist would also be responsible for assisting in equipment validation by supporting all aspects of this process including maintaining documentation and change control.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Associate Director, IT and will be based at the Tonix Advanced Development Center (ADC) facility located in North Dartmouth, MA.

Essential Duties

  • Helpdesk support (In-office and remote)
    1. Support onboarding of employees at the ADC facility
    2. Configure new workstations
    3. Relocate equipment for employees and laboratories
    4. Troubleshoot and address IT requests
    5. Support the AV technology in common areas, such as conference rooms, phone rooms
    6. Manage and inventory IT equipment and software licenses
  • Periodic maintenance and routine support activities for IT equipment
    1. Assist with network equipment and virtual infrastructure upgrades/patching
    2. Coordinate support calls with 3rd party vendors
    3. Trace and patch ethernet cables in MDF/IDF closets
  • GxP automation system support
    1. Interact with 3rd party partner to support activities on GxP network
    2. Support Computerized System Validation (CSV) activites as an IT representative
    3. Provide IT assistance for GxP equipment and automated systems
    4. Develop guidelines and Standard Operating Procedures (SOPs) for administration, operation, and management of GxP IT Systems
  • PD Laboratory and GxP equipment (QC and MFG) support
    1. Support CSV activities in alignment with CFR Part 11 compliance
    2. Support the execution of CQV supporting documentation and assessment
    3. Review all CQV documentation pre and post execution
    4. Support change management activities
  • Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Bachelors degree in Computer Science or 4 years of relevant experience preferred
  • Basic skills in the follow areas: PC/laptop hardware, software, telecommunication and networking
  • Lifting/moving of equipment up to 50 lbs is required
  • Ability for minimal travel
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  To apply to the Information Technology Specialist, click here.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Based on the expansion of its R&D platform and clinical pipeline, Tonix is looking for a Manager, MSAT to supplement its internal and external teams. The MSAT Manager will have one direct report and will lead technology transfer and support of internal and external manufacturing, as well as contribute to overall technical development. This position will be located at the Tonix Advanced Development Center (ADC) facility in North Dartmouth, MA.

The ideal candidate will be a highly motivated individual with experience in viral products and biologics working in an entrepreneurial environment with broad responsibilities and opportunities. This is a fast-paced challenging position offering a competitive compensation and benefits package. The position will report directly to the Executive Director, CMC.

Essential Duties

  • Lead technical transfer projects for establishing robust and compliant manufacturing processes and associated control strategy
  • Own and maintain the knowledge and history of manufacturing processes throughout the product lifecycle
  • Author, review, and approve technical documents such as batch records, sampling plans, SOPs, risk assessments, study protocols, technical reports, and sections for regulatory submissions
  • Provide first line technical support to manufacturing on the floor in compliance with relevant instructions and quality requirements
  • Lead process characterization, scale up, process optimization, and process validation
  • Use scientifically sound rational and statistical tools for data analysis and trending
  • Contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
  • Support change review and implementation, risk assessments, quality investigations, impact assessment, and CAPAs in cross-functional teams
  • Participate in the definition and selection of equipment by providing input to User Requirement Specifications (URS) and creating associated procedures
  • Support process equipment FAT, SAT, and on-site qualification activities
  • Plan and organize training for manufacturing personnel
  • Deliver robust, scalable, and cost-effective manufacturing processes for viral vaccine and biologics drug substance and drug product that meet or exceed the target product profile
  • Provide hands-on contribution in the Process Development lab during process scale up
  • Prepare technical reports, publications, and oral presentations
  • Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Leadership

  • Provide manufacturing science leadership and manage performance of direct reports
  • Provide guidance and training to direct reports and manufacturing personnel
  • Develop work and project plans and execute per the plans
  • Provide input into development of budgets proposals, new capital expenditures, recruitment planning and external spending
  • Accountable for on-time project completion and achievement of compliance goals
  • Represent the CMC Development function in project team meetings

Supervisory Responsibilities

  • Recruits, interviews, hires, and trains new staff
  • Oversees the daily workflow of the department
  • Provides constructive and timely performance evaluations
  • Handles discipline and termination of employees in accordance with company policy
  • Contributes to performance and compensation decisions such as: merit raises, bonuses, and promotions

Minimum Qualifications

  • Bachelor’s Degree in Biochemistry, Chemical Engineering, Biotechnology, or related scientific discipline with six (6) years of experience in biotechnology industry
  • Biopharmaceutical development and manufacturing experience specifically in viral vaccines and viral-based products required; monoclonal antibodies development is an asset
  • Broad experience with upstream and purification technologies for viral products, drug substance formulation, and fill/finish
  • Experience with statistical analysis
  • Experience with cGMP manufacturing and regulatory submissions
  • Ability to identify and resolve critical issues
  • Available for minimal travel
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please click Manager, Manufacturing Science and Technology (MSAT) to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix is looking for a full-time Quality Assurance Manager to effectively ensure GLP protocols, standard operating procedures (SOPs), and industry and regulatory standards are met or exceeded.  The individual in this position would be responsible for performing audits and inspections to confirm service and product compliance.  The individual in this position would also be responsible for being the quality point of contact for Food and Drug Administration inspections.  The Quality Assurance Manager has a strong understanding of the GLP Regulations (21 CFR Part 58) for Nonclinical Laboratory Studies, is proficient in applying these principles, and has a proven ability to work well in a team environment.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Executive Vice President, Strategic Development and will be based at the Tonix Research and Development Center (RDC) in Frederick, MD.

Essential Duties

  • Inspect each applicable study at intervals adequate to assure the integrity of the study and maintain written records of each inspection
  • Report study inspection results to the Study Director and RDC Management
  • Prepare a Quality Assurance Statement for each applicable study protocol
  • Maintain the master schedule
  • Review final study reports to assure that the results accurately reflect the raw data
  • Audit facility records and processes, provide findings to area management and maintain written records of each audit
  • Inspect equipment qualification and software validation packages
  • Serve as the quality point of contact for FDA inspections
  • Provide inspection responses to the FDA within set deadlines
  • Perform subcontractor inspections and vendor qualifications
  • Observe appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), Good Laboratory Practices (GLP), and study protocols
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Bachelor’s degree in Animal or Biological Sciences plus five (5) years of experience working in a GLP environment or High School Diploma plus ten (10) years of experience working in a GLP environment
  • Registered Quality Assurance Professional in GLP (RQAP-GLP) certification preferred
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written, organizational, and verbal communication skills are essential
  • Strong attention to detail and organizational skills
  • Comfortable working independently with minimal supervision
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to careers@tonixpharma.com and include Quality Assurance Manager in the subject of the email.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview:

The QC Manager/Sr Manager will oversee the Raw Material Testing function in support of QC drug substance and finished product testing for products produced at the Tonix manufacturing facility and affiliated contract organizations. In addition to incoming raw material and consumable receipt testing, this role will oversee the implementation of general laboratory operational systems and testing capabilities, related method transfer and qualification activities, investigations and assay/instrument troubleshooting.  Also, the individual will be supporting the buildout of the QC laboratories of a site specific GMP manufacturing facility in Dartmouth, MA opening in 2022. The individual in this position will have the unique opportunity to hire, train and oversee performance management, mentoring and career development.

This position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  Also, this role will also provide support for the appropriate QC strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and to ensure a culture of quality and compliance.

This position reports into the Associate Director of Quality Control and is a member of the Quality management team at the facility.  The role will be based out of the new facility in Dartmouth, MA once open and operational. Remote work arrangements will be in place until such time.

Essential Duties:

  • Oversee day-to-day operations of the Quality Control Raw Material testing function
  • Manage laboratory personnel and oversee their selection, performance management, mentoring, and career development
  • Direct the implementation of in-house testing capabilities in the QC laboratory, including ID, safety testing, compendial testing as well as routine testing
  • Assist and support the development of raw material specifications
  • Support raw material sampling and release testing both internally and at CMOs and contract laboratories
  • Provide testing data and other required quality-related information needed to support clinical studies
  • Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements
  • Troubleshoot issues related to laboratory procedures and assay performance
  • Manage laboratory investigations, change controls, and CAPAs for relevant QC operations
  • Provide support to audit teams for internal and vendor audits
  • Contribute to departmental budget and resource allocation
  • Prepare and monitor metrics to ensure control of systems and drive continuous improvements
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Execute special projects as necessary to support various business initiatives

Minimum Qualification

  • Bachelor’s degree in Chemistry or a relevant scientific discipline or equivalent experience preferred
  • Eight (8) years of cGMP QC experience in biotechnology/large molecule industry strongly preferred
  • Prior experience in Quality leadership in the pharmaceutical/biotechnology industries
  • Strong understanding of QC principles, USP/Ph Eur compendia testing requirements and various analytical and biochemical testing techniques
  • Experience in method transfer and qualification/validation activities
  • Demonstrated troubleshooting and problem-solving skills
  • Excellent written, and verbal communication skills
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please click Manager, Quality Control, Raw Materials to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview:

The Manager, Quality Control Microbiology will oversee the microbiology function in support of QC raw material, drug substance and finished product testing for products produced at the Tonix manufacturing facility and affiliated contract organizations. In addition to routine testing, this role will oversee the environmental monitoring program, implementation of general laboratory operational systems and microbiological testing capabilities, related method transfer and qualification activities, investigations, and assay/instrument troubleshooting.  Also, the individual will be supporting the buildout of the QC laboratories of a site specific GMP manufacturing facility in Dartmouth, MA opening in 2022. The individual in this position will have the unique opportunity to hire, train and oversee performance management, mentoring and career development.

This position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  Also, this role will also provide support for the appropriate QC strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and to ensure a culture of quality and compliance.

This position reports into the Associate Director of Quality Control and is a member of the Quality management team at the facility.  The role will be based out of the new facility in Dartmouth, MA once open and operational. Remote work arrangements will be in place until such time.

Essential Duties:

  • Oversee day-to-day operations of the Quality Control Microbiology function
  • Manage laboratory personnel and oversee their selection, performance management, mentoring, and career development
  • Direct the implementation of in-house testing capabilities in the QC laboratory, including bioburden, endotoxin, and sterility assays as well as microbial identifications as required
  • Develop and maintain the environmental monitoring program
  • Support routine testing for raw materials, drug substance and drug product internally and at CMOs and contract laboratories
  • Provide testing data and other required quality-related information needed to support clinical studies
  • Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements
  • Troubleshoot issues related to laboratory procedures and assay performance
  • Manage laboratory investigations, change controls, and CAPAs for relevant QC operations
  • Provide support to audit teams for internal and vendor audits
  • Contribute to departmental budget and resource allocation
  • Prepare and monitor metrics to ensure control of systems and drive continuous improvements
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Utilize data to risk assess recoveries in support of manufacturing
  • Execute special projects as necessary to support various business initiatives

Minimum Qualifications:

  • Bachelor’s degree in Microbiology or a relevant scientific discipline preferred
  • Eight (8) years of cGMP QC experience in biotechnology/large molecule industry strongly preferred
  • Prior experience in Quality leadership in the pharmaceutical/biotechnology industries
  • Strong understanding of QC principles, USP/Ph Eur compendia testing requirements and various microbiological testing techniques
  • Experience in method transfer and qualification/validation activities
  • Experience with risk assessment
  • Demonstrated troubleshooting and problem-solving skills
  • Excellent written, and verbal communication skills
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please click Manager, Quality Control, Microbiology to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview:

The Quality Control Manager/Senior Manager, Product Testing will oversee the product testing function in support of In-process, drug substance and finished product testing for products produced at the Tonix manufacturing facility and affiliated contract organizations. In addition to product testing, this role will oversee the implementation of general laboratory operational systems and testing capabilities, related method transfers and qualification activities, investigations and assay/instrument troubleshooting.  Also, the individual will be supporting the buildout of the QC laboratories of a site specific GMP manufacturing facility in Dartmouth, MA opening in 2022. The individual in this position will have the unique opportunity to hire, train and oversee performance management, mentoring and career development.

This position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  Also, this role will also provide support for the appropriate QC strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and to ensure a culture of quality and compliance.

This position reports into the Associate Director of Quality Control and is a member of the Quality management team at the facility.  The role will be based out of the new facility in Dartmouth, MA once open and operational. Remote work arrangements will be in place until such time.

Essential Duties:

  • Oversee day-to-day operations of the Quality Control Product Testing function
  • Manage laboratory personnel and oversee their selection, performance management, mentoring, and career development
  • Direct the implementation of in-house testing in the QC laboratory for in-process and product release testing, including (but not limited to) Chromatography, flow cytometry, ELISA, Bioassay, Plaque assay, and basic compendial product testing
  • Oversee outsourced testing of in-process, drug substance and finished drug product which may be at a contract or CMO lab
  • Support manufacturing and process development in the development and implementation of GMP manufacturing activities, including identification of in-process sampling and control strategy, development of product specifications
  • Provide testing data and other required quality-related information needed to support clinical studies
  • Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements
  • Troubleshoot issues related to laboratory procedures and assay performance
  • Maintain lab compliance, and ensure audit ready
  • Maintain lab data integrity and ensure all required attributes are met
  • Manage laboratory investigations, change controls, and CAPAs for relevant QC operations
  • Provide support to audit teams for internal and vendor audits
  • Contribute to departmental budget and resource allocation
  • Prepare and monitor metrics to ensure control of systems and drive continuous improvements
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Execute special projects as necessary to support various business initiatives

Minimum Qualifications:

  • Bachelor’s degree in Chemistry/ Biochemistry or a relevant scientific discipline preferred
  • Eight (8) years of cGMP QC experience in biotechnology/large molecule industry strongly preferred
  • Prior experience in Quality leadership in the pharmaceutical/biotechnology industries
  • Strong understanding of QC principles, USP/Ph Eur compendia testing requirements and various analytical and biochemical testing techniques
  • Experience in method transfer and qualification/validation activities
  • Demonstrated troubleshooting and problem-solving skills
  • Excellent written, and verbal communication skills
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please click Manager, Quality Control, Product Testing to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix Pharmaceuticals is searching for a Process Engineer to be a member of our Facilities and Engineering team. This position will support the engineering design, construction, and commissioning of a phase I/II cGMP manufacturing facility. Upon completion, this position will transition to an operational support role focused on day-to-day manufacturing and facilities equipment and automated system support. The individual in this position will be responsible for the system ownership and project execution of utilities equipment and automated system integration. Responsibilities include troubleshooting plant and process equipment, automated systems, managing project execution, executing commissioning and qualification activities, and optimizing process and utilities, equipment within a regulated cGMP facility. They will be involved in the project lifecycle (conceptual design, specification, design and verification, installation and acceptance, and maintenance) of process and utilities equipment for cGMP production equipment. They will be asked to develop solutions and best practices for a variety of problems with moderate scope and complexity. They must be able to work collaboratively with Quality, Manufacturing, Facilities, Product Development, external supply partners, and vendors.

Essential Duties

Project Support

  • Responsible for managing automated system integration by working with external supply partners
  • Support equipment engineering testing, commissioning, and qualification activities
  • Assist in troubleshooting and remediating exceptions found during process operations and technology transfers
  • Define all aspects of project scope and project activities
  • Ensure all project documentation is accurate and up to date (P&lDs, mechanical system drawings, automation documentation, etc.)
  • Compile and review equipment Engineering Turnover Packages (EToPs) for executed projects
  • Work with a cross-functional groups to develop requirements and recommendations for system/equipment modifications
  • Organize and lead all aspects of a medium to large size operational projects including scope, schedule, and coordination of activities

Operational Support

  • Collaborate with manufacturing personnel regularly about standard practices and procedures for process and utilities equipment/automation design and operation
  • Provide technical input to Manufacturing team on SOP changes, Deviations, GMP Investigations and CAPAs
  • Regularly interact with process development, manufacturing, quality, facilities, and procurement to proactively address system challenges
  • Provide on-call support for all active automated systems, process equipment, and manufacturing activities
  • Responsible for addressing safety related design/equipment issues
  • Own all aspects of automated system design and process equipment for GMP manufacturing
  • Revise equipment designs to meet end-user’s needs
  • Responsible for troubleshooting activities, equipment design, and specifications for automated systems, equipment and instrumentation
  • Determine corrective maintenance actions, collaborates on preventative maintenance, work to identify spare parts for process and utility equipment
  • Provide guidance to maintenance personnel and actively participates in the decision making and project execution of process and/or design improvement
  • Own and ensure timely closure of equipment corrective and preventative actions

Documentation, Standards and Templates

  • Write, review, and approve equipment specifications, engineering procedures and protocols
  • Assist in the revision of manufacturing documentation (SOPs, BR, etc.)
  • Actively manage engineering documentation and drawing, as well as coordinating and executing redlines and revisions as applicable
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Bachelor’s degree in Chemical/Mechanical Engineering or other related discipline or ten (10) years related work experience required; alternatively, a Masters degree in Chemical/Mechanical Engineering or other related discipline plus one (1) year related work experience required
  • Minimum 3-5 years of experience in a cGMP engineering environment
  • Experience in engineering, facility design, automation, or related disciplines
  • Frequent use and general knowledge of industry practices, techniques, and standards
  • Able to accommodate rapidly changing priorities and deadlines
  • Must be a team player able to embrace a team-based culture
  • Proficiency with Microsoft Office products and ability to learn additional software applications, as needed
  • Hands-on expertise with bioprocess engineering and automated systems
  • Familiar with biotechnology process equipment
  • Competent with domestic and international GMP regulations
  • Demonstrates the ability to work independently to solve complex process and equipment problems
  • Capable of establishing working relationships with internal departments and external supply partners
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written, organizational, and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please click Process Engineer II to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

This position is responsible for the direct management of research and development projects involving teams with a broad range of cross-functional departments, potentially including numerous and diverse outside vendors. Projects managed can range in scope from medium scale/complexity to large scale/complexity managed domestically and / or internationally. This position is also responsible for overall project execution and ensuring team commitments (project contracts) are met and communicated in a timely manner.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Director of Project Management and will be based at the Tonix Frederick, MD office.

Essential Duties

  • Manages projects from initiation to delivery; driving project team to execute on tasks and deliverables
  • Develops project plan and integrated schedules, ensures plans address stage gate deliverables
  • Works with functional management to ensure sufficient and appropriate resources will be made available
  • Monitors progress on project deliverables, metrics, and technical output
  • Develops a sense of urgency when key deliverables are jeopardized
  • Facilitates problem solving and meetings to address obstacles
  • Proactively manages risks and employs strategies to address
  • Holds team members accountable to project commitments
  • Facilitates communication to key stakeholders on project performance
  • Fosters teamwork; strives to maintain an environment of openness and trust
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Bachelor’s degree in biology or other scientific discipline required
  • Four (4) years of relevant experience driving research and development projects with bachelor’s degree or two (2) years of relevant experience with an advanced degree required
  • Project management and/or technical leadership experience in a stage-gate system with at least one of the following: international teams, academic institutions, and/or contract research organizations required
  • Excellent project management and organization skills including clear goals/milestones setting, detailed planning/organizing teamwork, diligent monitoring/tracking progresses, and managing dynamic changes
  • Excellent interpersonal and influence skills including efficient collaboration, effective negotiation, timely conflict resolution, and creative problem solving of difficult situations such as resource constraints, ambiguous/conflicting requirements, and other road-blocks
  • Leadership skills and experience managing complex technology development projects and cross functional teams
  • Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of scientific disciplines and complex technical/logistical issues
  • Ability to manage risks
  • Skilled in using the tools and techniques of Project Management
  • Experience in successfully managing projects in FDA regulated industry is a plus
  • Ability to travel up to 10% of the time
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written, organizational, and verbal communication skills are essential including management of expectations, and relationships with stakeholders
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please click Project Manager to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix is hiring at various levels for both Quality Assurance and Quality Control overseeing our internal and external cGMP manufacturing and testing activities. Candidates should have 2 – 8 years of experience in the biopharmaceutical industry with relevant Quality Assurance or Quality Control experience. The below are our available opportunities:

  • Manager/Sr Manager, Quality Control, Chemistry
  • Associate/Sr Associate, Quality Control, Chemistry
  • Associate/Sr Associate, Quality Control, Raw Materials
  • Manager/Sr Manager, Quality Control, Microbiology
  • Associate/Sr Associate, Quality Control, Microbiology
  • Manager/Sr Manager, Quality Control, Bioassay
  • Associate/Sr Associate, Quality Control, Bioassay
  • Associate/Sr Associate, Quality Assurance Operations/Compliance
  • Associate/Sr Associate, Quality Assurance Validation

The individuals in these positions in the Quality functions will work to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  Also, the individuals will provide support for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and ensure a culture of quality and compliance. All positions will be based in Tonix’s new facility in Dartmouth, MA once open and operational, expected in 2022.  Remote work arrangements will be in place until such time.

Tonix offers salary commensurate with experience and an excellent benefits package. Please send your resume and cover letter to careers@tonixpharma.com and include the position title in the subject of the email.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix is looking for a Scientist / Senior Scientist, Bioinformatics to provide assistance with Genome Wide Association Studies (GWAS) for pharmacogenomics.  The individual will support all aspects of this process including writing code, analyzing data, and interpreting findings. The individual in this role will be responsible for designing modeling experiments and assessing the performance of integrated risk assessment tools that incorporate genetic and non-genetic risk factors to predict drug response.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Executive Director, Bioinformatics and Genomics and will be based at the Tonix Hackensack, NJ office.

Essential Duties

  • Drive projects that require expertise in GWAS, Omics, genetic profiling, and large data sets
  • Collaborate and partner closely with cross-functional leaders, scientists, and epidemiologists across research units to design and analyze large and complex data sets that inform disease drivers, health disparities and outcomes
  • Develop and apply innovative quantitative and statistical methods to help drive biomedical informatics and precision medicine programs
  • Perform polygenic risk score analyses
  • Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • PhD degree in Bioinformatics, Statistical Genetics, or related field required
  • Postdoctoral experience preferred
  • Experience with Genome Wide Association Studies (GWAS)
  • Familiarity with standard bioinformatics tools
  • Experience with cloud computing (AWS or Azure)
  • Broad range of experience in biology and precision medicine
  • Understanding of multiple-omics technologies such as: genomics, pharmacogenomics, transcriptomics, proteomics, and metabolomics
  • Ability to independently lead and conduct research, and to evaluate, interpret, and present complex genotype and phenotype data
  • Substantial experience in Python programming recommended
  • Ability for up to 20% travel
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Click Scientist, Bioinformatics to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Based on the expansion of it its R&D platform, Tonix is looking for a Process Development subject matter expert to supplement its internal and external teams.  The individual in this position will be responsible for planning and execution of process development activities across the portfolio of Tonix viral vaccine products.  The individual in this position will be highly motivated with experience and interest in working in a both a virtual and onsite role, in an entrepreneurial environment with broad responsibilities and opportunities.

Tonix is currently constructing its own Advanced Development Centre (ADC) facility which will be ready for commissioning in North Dartmouth, MA in Q1, 2022. The position will be based in Tonix’ ADC facility once open and operational. Remote work arrangements will be in place until such time.

Essential Duties

  • Lead projects associated with establishing robust and compliant manufacturing processes at Tonix through defining the manufacturing process and associated control strategy
  • Own and maintain the knowledge and history of Tonix manufacturing processes throughout the product lifecycle
  • Responsible for preparation and review of technical documents such as batch records, sampling plans, process related and analytical method SOPs, risk assessments, study protocols, and technical reports and/or relevant sections for regulatory submission files
  • Provide first line technical support to manufacturing in compliance with relevant instructions and quality requirements
  • Lead process characterization, scale up, process optimization, and process validation
  • Use scientifically sound rational and statistical tools for data analysis, contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
  • Support change review and implementation, quality investigations, and CAPAs in cross-functional teams
  • Participate in the definition and selection of equipment by providing input to User Requirement Specifications (URS) and creating associated procedures
  • Support process equipment FAT, SAT, and on-site qualification activities
  • Deliver robust, scalable, and cost-effective viral vaccine manufacturing processes and product formulations that meet or exceed the target product profile
  • Prepare technical reports, publications, and oral presentations
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Leadership Duties

  • Provide guidance and training to associates across sites and functions as relates to assigned projects and consistent with the quality governance
  • Develop work and project plans and execute per those plans
  • Provide input into development of budgets proposals, new capital expenditures, recruitment planning, and external spending
  • Complete projects on-time and achieve compliance goals
  • Represent the CMC Development function in project team meetings

Minimum Qualifications

  • Bachelor’s in biochemistry, chemical engineering, microbiology, biotechnology or related discipline with five years of experience in the biotechnology industry; or Masters/PhD with three years of experience in the biotechnology industry or equivalent work experience required
  • Experience with mammalian cell /viral culture, bioreactor operations, cell separation and virus purification techniques
  • Project management experience
  • Experience in experimental design and statistical analysis methodology
  • Experience with projects in clinical development e.g., Phase 1 through Phase 3
  • Biopharmaceutical development experience specifically in viral vaccines and/or monoclonal antibodies development, upstream, downstream, and filling strongly preferred
  • Experience with cGMP manufacturing and regulatory submissions preferred
  • Ability to identify and resolve critical issues
  • Good interpersonal and stakeholder management skills to collaborate with and direct the work of others on assigned projects, including both internal teams and external collaborators
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written, organizational, and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please click tScientist, Process Development to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix is looking for Scientists and Senior Scientists with extensive experience in antibody discovery and development responsible for developing therapeutics in oncology, infectious diseases, and other antibody or protein reachable targets. The positions are at Tonix’s Research and Development Center (RDC) which is the innovation and development arm of the Tonix pharmaceuticals.  RDC is responsible for providing efficient and cutting-edge treatment methods for various diseases including infectious diseases, oncology, and other indications.  These positions will involve working as part of the research team to deliver and optimize biological pipelines for clinical investigation. The individuals in this position will participate in many aspects of antibody design, engineering, production, optimization, and development.

We are searching for self-motivated, resourceful, and adaptive scientists with industry mindset to join the antibody discovery and development team.  The individuals in this position will have access to the state-of-the art technologies such as latest high-content imaging and Cytof. The individual will coordinate activities with other senior scientists and run an independent research program which may include development of novel informatic or computational program development.

These are fast-paced challenging positions offering a competitive compensation and benefits package.  This position will report directly to the EVP of Strategic Development and will be based at the Tonix Research and Development Center in Frederick, Maryland.

Essential Duties

  • Use robotic, and automation to support novel engineered proteins and antibody design, production, purification, and screening
  • Conceive and design novel scaffolds molecules, including immune modulator and protein complexes, single- and multi-domain antibodies, various antibody fragments and fusion proteins to achieve or improve on target specificity, activity, and desired biological outcomes
  • Manage and participate in hypothesis generation, production, and identifying of unique biologics with high specificity and affinity to allow Tonix Pharmaceuticals competitively advance biologics pipeline in immunology, oncology, infectious diseases, and related fields
  • Biophysically and biologically assess binding properties of the novel proteins and antibodies by using various technologies such as SPR, flow cytometry, epitope screening, Octet, novel reporter-based assays, and high content plate-based imaging
  • Perform antibody engineering to improve potency and use of affinity maturation
  • Participate or initiate clonal selection, process optimization, process characterization, and expansion of the protein or antibodies using systems such as Ambr ® 250
  • Lead specific project teams or participate in related project teams
  • Propose new discovery and optimization path with industry mindset
  • Use strong interpersonal skills to elicit, synthesize, and manage the cross-functional inputs required for a robust development plan.
  • Generate hypothesis to test ideas, use the data set to evaluate hypothesis and design new studies
  • Apply multiple cutting-edge selection techniques to synthetic and immune antibody libraries, such as application of novel display systems, flow cytometric sorting, plate-based screening
  • Supervise and mentor members of the team and communicate well with peers
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Ph.D., or equivalent doctoral degree preferred
  • Documented relevant research experience in antibody discovery, design, development with two years of post-graduation experience
  • Knowledge and use of AI to enhance design and target engagement preferred
  • Strong accomplishment record demonstrating the ability to perform independent, high-quality, creative, and impactful research in the field of antibody or protein design and discovery
  • Deep knowledge of B cell biology including B cell memory generation and responses, humoral immunity, immunoglobulin genetics, isolation of antigen specific B cells required
  • Experience in various expression systems to perform high-throughput analysis of sub-clones
  • Sound working experience in industry or biological context, and the ability to interrogate data set such as high throughput data, preferred
  • Domain knowledge in some major area within life science for Pharma (e.g. infectious diseases, oncology, biomarkers, or in connection with high throughput technologies and their applications and pitfalls) preferred
  • Working knowledge of systems such as multi-parameter flow cytometry, including acquisition and analysis, required
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written, organizational, and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please click Scientist, Antibody Development to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview:

The Senior Associate, QA Operations and Compliance (External Manufacturing) will support the Quality Assurance GMP Operations and Compliance function for the organization. The individual in this position will provide compliance oversight of external manufacturing and testing activities at various contract organizations. The role will also support day-to-day operations within the Quality Assurance function.  In addition, the role may also oversee aspects of internal manufacturing related activities.

The individual in this position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  The individual in this position will also provide support for the reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Senior Manager of Quality Assurance Operations and Compliance and will be based at the Tonix Advanced Development Centre (ADC) facility in North Dartmouth, MA location.

Essential Duties:

  • Provide quality and compliance support for external contract organizations
  • Perform external manufacturing lot release activities including review and approval of master and executed batch records and Certificates of Analyses
  • Provide assessment, guidance, and resolution on issues from a quality impact perspective
  • Support day-to-day operations of the Quality Assurance operations and compliance function
  • Execute Quality System requirements in compliance with applicable quality standards and requirements, including but not limited to risk management, change control, deviations, CAPA, self-inspection, and complaints
  • Prepare and monitor metrics to ensure control of systems and drive continuous improvements
  • Support internal and external audit program as well as participate in regulatory audits
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications:

  • Bachelor’s Degree in Science or other related discipline or equivalent work experience preferred
  • Five (5) years of combined external manufacturing quality oversight experience in a biotechnology/cell and gene therapy environment, covering QA, QC and/or manufacturing preferred
  • Strong foundation in application of cGMP in a drug substance or drug product manufacturing environment
  • Demonstrated troubleshooting and problem-solving skills
  • Ability to analyze a wide variety of information and data to make decisions regarding potential risks associated with regulatory compliance
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Excellent written and verbal communication skills are essential
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to careers@tonixpharma.com and include Senior Associate, Quality Operations and Compliance (External Manufacturing) in the subject of the email.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview:

The Senior Associate, Quality Assurance Validation will provide compliance oversight of site GMP qualification and validation activities. The individual in this position will review and approve validation documentation, participate in cross-functional planning, and execution meetings as well as provide support for issue resolution.

The individual in this position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  The individual in this position will also provide support for the reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Senior Manager of Quality Assurance Operations and Compliance.

Tonix is currently constructing its own Advanced Development Centre (ADC) facility which will be ready for commissioning in Dartmouth, MA in Q1, 2022.  The position will be based in Tonix’ ADC facility once open and operational.

Essential Duties:

  • Oversee site validation activities (e.g., equipment, utilities, processes, computer system validation) to ensure compliance with cGMP
  • Review and evaluate internal validation documentation (i.e., user requirement specifications, functional specifications, protocols, reports, etc.)
  • Perform review of vendor protocols and creation of in-house supporting documentation to deliver a complete package of qualification documentation
  • Develop and implement solutions to validation related discrepancies and deviations
  • Participate in cross-functional validation planning and execution meetings
  • Prepare and monitor metrics to ensure control of validation systems and drive continuous improvements
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications:

  • Bachelor’s Degree in Science, Engineering or other related discipline or equivalent work experience preferred
  • Five (5) years of combined validation experience within a biotechnology/pharmaceutical environment preferred
  • Ability to identify validation requirements, manage time effectively, handle multiple projects simultaneously and analyze and resolve unique situations within a manufacturing environment
  • Demonstrated troubleshooting and problem-solving skills
  • Strong foundation in application of cGMP in a drug substance or drug product manufacturing environment
  • Ability to analyze a wide variety of information and data to make decisions regarding potential risks associated with regulatory compliance
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Excellent written and verbal communication skills are essential
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please click Senior Associate Quality Assurance Validation to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

The Senior Associate, Quality Control, Microbiology will execute and conduct product testing on inprocess, drug substance, and finished product testing for products in accordance to Standard Operating Procedures ensuring product meets acceptable quality attributes. In addition to testing, this role will assist in the implementation of general laboratory operational systems, sample for environmental monitoring and utility monitoring.  These activities are conducted with limited supervisor interaction. The individual in this position will provide high-quality support and meet or exceed current company and GMP requirements.

The individual in this position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  The individual in this position will also provide support for the reporting/escalation of quality issues and/or risk mitigation activities.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Manager of Quality Control Microbioloy.

Tonix is currently constructing its own Advanced Development Centre (ADC) facility which will be ready for commissioning in Dartmouth, MA in Q1, 2022.  The position will be based in Tonix’ ADC facility once open and operational.

Essential Duties

  • Execute day-to-day operations of the Quality Control microbiology testing function
  • Assist EM monitoring and utility sampling
  • Perform routine laboratory activities such as housekeeping, equipment maintenance, and glassware
  • Perform all testing and activities in accordance to standard operating procedures
  • Execute daily equipment calibrations and performance checks
  • Perform assay qualification
  • Document all activities in accordance with GMP guidance
  • Execute continuous improvement activities
  • Ensure document and data integrity is maintained at all times
  • Provide testing data and other required quality-related information needed to support clinical studies with minimal supervision
  • Assist or lead in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements
  • Revise documents, including SOP’s and protocols as necessary
  • Provide support to audit teams for internal and vendor audits
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Bachelor’s degree in Microbiology or a relevant scientific discipline preferred
  • Four (4) years of cGMP QC experience in the biotechnology/large molecule industry
  • Strong understanding of QC principles, USP/Ph Eur compendia testing requirements, and various microbiological testing techniques
  • Strong understanding of GMP requirements, and demonstrated effective utilization of principles
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to careers@tonixpharma.com and include Senior Associate, Quality Control, Microbiology in the subject of the email.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix is looking for a Senior Scientist, Immunology to effectively lead immunology related programs such as vaccines and ImmunoTherapeutics in preclinical and advancing into clinical trials. The individual will coordinate activities with other senior scientists and run an independent research program which may include in vitro and in vivo studies with the goal of advancing knowledge and understanding of the vaccines and ImmunoTherapeutics.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the EVP of Strategic Development and will be based at the Tonix Research and Development Center in Frederick, Maryland.

Essential Duties

  • Address basic hypothesis-driven analyses of preclinical and clinical studies aiding in vaccine and immunotherapeutic discovery and development
  • Identify, implement, and develop immunological analyses that reflect various stages of discovery, preclinical, and clinical development
  • Use strong interpersonal skills to elicit, synthesize, and manage the cross-functional inputs required for a robust development plan
  • Supervise and mentor members of the team and be able to communicate well with peers
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • M.D., Ph.D., or equivalent doctoral degree highly desirable
  • Documented relevant research experience in immunology and two (2) years of post-graduation experience
  • Strong accomplishment record demonstrating an ability to perform independent, high-quality, creative, and impactful research in the fields such as basic understanding of innate and adaptive responses to pathogens, ImmunoTherapeutics, vaccines and viral immunology
  • Basic and translational understanding of innate immune functions, T-cell and B-cell memory, activation, functions, and profiling required
  • Expertise in infectious diseases with T-cell and B-cell immunology and assay development
  • Experience in elucidation and characterization of T-cell and B-cell responses associated with ImmunoTherapeutics, vaccines, and viral diseases
  • Experience with mass cytometry (CyTof) and high-content imaging are beneficial
  • Working knowledge of systems such as multi-parameter flow cytometry, including acquisition and analysis, required
  • Knowledge of immunological assay standardization, qualification, and validation for clinical translational research
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written, organizational, and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please click Sr Scientist, Immunology to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.  Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix is looking for a full-time Senior Manager, Purchasing to effectively coordinate, organize, and oversee all activities involved in the identification and acquisition of the materials and equipment required for the Tonix Research and Development Center (RDC) In Frederick, MD as well as oversee all purchasing for the Company’s other locations.

This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Controller and will preferably be based at the Tonix RDC facility. Remote work arrangements will be in place until such time.

Essential Duties

  • Collaborates with other departments and stakeholders to identify and maintain equipment and materials needed to keep the site functioning
  • Prepares and processes purchase orders and requisitions for materials, supplies, and equipment
  • Develops and maintains detailed inventories of materials and supplies
  • Maintains required quantity of supplies and materials to optimize production and testing
  • Analyzes current inventories and procedures; suggests improvements to increase profitability for the company
  • Negotiates prices for raw material and delivery with suppliers, vendors, and/or shipping companies
  • Participates as an advisory member of the product development team, providing information and guidance on availability and cost of supplies and materials
  • Monitors the performance of suppliers, assessing their ability to meet quality and delivery requirements; identifies and qualifies new suppliers in collaboration with other departments
  • Maintains and/or implements purchasing and recordkeeping systems
  • Acts as the company’s representative in negotiations with suppliers
  • Administers the departmental budget
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

  • Bachelor’s degree in business or related field or related work experience required
  • Three years of experience as a supervisor, manager, or similar relevant position strongly preferred, preferably in a pharma R&D organization
  • Excellent interpersonal and negotiation skills with a proven ability to create and maintain positive working relationships with vendors, suppliers, shippers, and customers
  • Excellent organizational skills and attention to detail
  • Strong analytical and problem-solving skills
  • Proficient with Microsoft Office Suite or related software
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written, organizational, and verbal communication skills are essential
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please click Senior Purchasing Manager to apply.

About Tonix*

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.   Tonix’s portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates.  Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.  Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix Pharmaceuticals is looking for a Scientist or Senior Scientist, Virologist with experience in vaccine or therapeutic research.  The position will be based at Tonix’s Research and Development Center (RDC) in Frederick, MD, which is the innovation and development arm of the Tonix Pharmaceuticals.

The individual in this position is expected to have a strong background in molecular virology with emphasis on vaccines or therapeutics. The individual in this position will work with the VP, Infectious Diseases and members of the Infectious Diseases Team to set goals and conceptualize projects. They will also have significant authority to determine how the research activities will be performed.

The Tonix RDC is responsible for providing efficient and cutting-edge treatment methods for various diseases including infectious diseases, oncology, and other indications.  The individual in this position will work as part of the research team to deliver and optimize biological pipelines or other therapeutics for clinical investigation.

Highlights:

  • Responsibilities as of day 1 – you will feel the ownership of your project from the beginning, and you will be given specific projects and responsibilities.
  • Continuous mentorship – you will work with passionate people and receive both formal training as well as day-to-day mentoring from your manager.
  • Work and be part of a dynamic and encouraging environment – working over a diverse array of interesting problems.
  • Promote agility and work/life balance for employees, we value every individual and support initiatives.
  • Experience true support for work/life effectiveness and your long-term well-being.

Strong technical and organizational skills are essential. Excellent communication skills are required as the candidate will participate in oral presentations and the preparation of written technical reports.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the VP, Infectious Diseases and will be based at the Tonix Research and Development Center (RDC) in Frederick, MD.

Essential Duties

  • Hands-on experience with molecular biology and virology techniques is required: recombinant DNA techniques, RNA isolation, RT-PCR, sequence analysis etc.
  • Perform standard cell culture and use transfection protocols to generate viral vectors and vaccine candidates
  • Operate standard laboratory and experimental equipment such as spectrophotometers, ultracentrifuges etc. as well as an ABI 3500XL DNA sequencer and organize the sequencing data generated
  • Help develop new approaches to design novel vaccines and to improve existing vaccine candidates and/or platforms
  • Routinely track and document results in laboratory notebooks and databases
  • Analyze, summarize, and present experimental results to other team members, supervisors and third parties
  • Employ specialized serological and molecular techniques in order to study viruses
  • Follow all established occupational health and safety, GLP, GMP, and standard operating procedures (SOP’s)
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Supervisory Responsibilities

  • Recruits, interviews, hires, and trains new staff
  • Provides constructive and timely performance evaluations
  • If necessary, handles discipline and termination of employees in accordance with company policy
  • Contributes to performance and compensation decisions such as: merit raises, bonuses, and promotions
  • Supervise the work of biological technicians and researchers and evaluate the accuracy of their results
  • Assist and support junior team members to accomplish project goals and milestones

Minimum Qualifications

  • Ph.D. in biology, cell biology, microbiology or related discipline preferred. Masters in biology, cell biology, microbiology or related discipline with 10 years of experience considered
  • Proficient in mammalian cell culture techniques such as microscopy, transfection, virus generation, and amplification.
  • An understanding and/or experience with reverse genetics for the generation of RNA viruses   preferred
  • Familiarity with diverse software packages for cloning, primer design, as well as sequence alignment and blasting
  • Must be highly motivated while also possessing excellent teamwork skills and clear and effective verbal and written communication skills
  • Good foundation in general scientific practice, principles, and concepts of discipline
  • Basic knowledge of GMP/GLP regulations in cGMP/cGLP manufacturing environment preferred
  • Good lab skills
  • Good problem-solving and critical thinking skills
  • Ability to execute tasks and studies based on the deliverable timeline
  • Ability to analyze and summarize routine scientific data
  • Ability to function in a rapidly changing environment
  • Strong background in molecular virology and vaccines with experience in recombinant DNA technologies
  • Have an in-depth knowledge of molecular tools and techniques (genomics/ multiplexing/ transcriptomics etc.)
  • Automate standard methods to drive efficiency and productivity
  • Be well connected to external capabilities and lead R&D to leverage skill set that does not exist internally
  • Create technical strategies to develop new methods to influence FDA
  • Experience in employing specialized serological and molecular techniques
  • Have the know-how to propagate various viruses on relevant cell lines and successfully maintain them
  • Develop viruses and cell line models and screening technologies
  • Good MS Excel and Word skills
  • Ability for minimal travel
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Excellent written and verbal communication skills are essential
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

 

Tonix offers salary commensurate with experience and an excellent benefits package. Please click Senior Virologist to apply.

Interested in joining? Please send your resume and cover letter to careers@tonixpharma.com and include the position title in the subject of the email.

Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.