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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharm.com for specifics on the pipeline.

Position Overview:

Tonix is looking for a full-time Administrative Assistant to effectively provide quality support to the Tonix executives and management team and to manage the Tonix Chatham, NJ office. The candidate should have a bachelor’s degree and at least three years’ relevant experience supporting a corporate environment.  This is a fast-paced challenging position offers a competitive compensation and benefits package. The position would be based in the Tonix Chatham, NJ office.  

Reporting to the Head of HR, the Administrative Assistant is responsible for collaborating with our executive management team to effectively provide support and efficiencies for the company as well as manage the Tonix Chatham, NJ office.

Essential Duties

• Providing administrative assistance, such as writing and editing emails, drafting memos, preparing communications, and editing presentations
• Maintaining comprehensive and accurate corporate records, documents, and reports
• Organizing meetings, including scheduling, sending reminders, and organizing catering and AV when necessary
• Answering incoming phone calls in a polite and professional manner and accurately taking messages
• Welcoming visitors and identifying the purpose of their visit before directing them to the appropriate department
• Assist with coordination of travel arrangements as necessary
• Using various software, including word processing, spreadsheets, and presentation software to prepare reports and/or special projects
• Maintaining and ordering of office supplies
• Handling office mail and correspondence as well as outgoing / incoming packages as needed
• Upholding company mission and values through accountability, innovation, integrity, quality, and teamwork
• Performing other ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

• Bachelor’s degree preferred
• Three years of experience supporting a corporate office environment, pharma /biotech industry experience preferred
• Administrative Professional (CAP), or similar certification preferred
• Demonstrated ability to quickly develop and maintain strong relationships with internal customers and external vendors
• Superior time management skills with the ability to multitask and meet tight deadlines
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, decision maker, collaborator
• Ability to act as gatekeeper and escalate relevant information to executives as needed
• Ability to treat confidential information with appropriate discretion
• Exceptional attention to detail
• Dedicated team player who can withstand the high demands of a fast-paced environment
• Excellent written, organizational, and verbal communication skills
• Skilled in the use of standard office equipment (e.g., copiers, business telephone systems, projectors, fax machines).
• Proficient in MS Office Suite
• Ability to travel minimally as needed
• Available for client work and/or travel Monday through Friday on a general basis, including outside of normal business hours and weekends
• 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 human.resources@tonixpharma.com and include Executive Assistant 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

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 New Bedford, MA in Q1, 2022. The position will be based in this New Bedford 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 send your resume and cover letter to human.resources@tonixpharma.com and include Analytical Development Scientist in the subject of the email. 

Overall responsibilities of a Clinical Program Manager (CPM) at Tonix Pharmaceuticals include:

• Being the primary contact and leader of all clinical activities for a given study or program
• Working with the Tonix Director of Clinical Operations and Tonix’s internal departments – Medical, Statistics, Regulatory, Quality Assurance and CMC – to ensure projects are run on time and on budget yet maintaining high quality
• Managing CRO’s and other vendors to ensure all functions of a study or program are running as contracted.
• Reporting program and/or study progress to management at specified (weekly/monthly) time points.
• Attending general management meetings and on occasion attending industry conferences.
• Assisting with conference presentations or posters when needed

Specific responsibilities of the CPM include:

• Assisting with protocol and/or program design
• Identifying CRO’s/vendors, negotiating contracts and setting up expectations
• Preparing study plans and manuals for study start up
• Developing recruitment plans and working with recruitment vendors
• Organizing Investigator Meetings
• Communicate study procedures and methods in clear manner to all parties
• Assuring study supplies (labs, study medications, etc.) are delivered to sites on time
• Approve site regulatory packages for initial drug shipments
• Overseeing study progress, including recruitment, monitoring and data cleaning
• Managing vendor budgets and approving payments; ensuring work is being done on time
• Reviewing data on an ongoing basis to ensure database locks occur on time
• Assisting with final statistical table and listing reviews; preparing charts when needed 

Job Requirements

Specific requirements include:

• Bachelor’s degree in science and at least 10 years of experience in randomized clinical trials in central nervous system indications
• Advanced degree in health science, such as MA, MS, M.Pharm, RN, MPH, preferred
• Prior experience in the role of program or project manager for trial(s) of preventative (prophylactic) migraine small molecule or biologic therapeutics
• Good medical writing skills for study protocols, consent forms, clinical study reports, grant applications, etc.
• Highly organized with excellent communication skills
• Able to carry out CPM responsibilities in the migraine space with little supervision, yet works well with a multiple disciplinary internal clinical team as well in the management of CROs/vendors                                     

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

This position would be based out of a Tonix office location (Chatham, NJ; Sand Diego, CA; South Dartmouth, MA; New Bedford, MA).  

The Clinical Trial Associate (CTA) is involved in the conduct of the study and interfaces closely with the Program/Project Managers and the Clinical Team.

The CTA also supports the Clinical Team by creating and distributing study team materials, tools and documents and ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support. The CTA will work as a crucial team member with the Clinical Team in completing all required tasks to meet departmental and project goals.

Responsibilities will vary based on whether the study is insourced or outsourced, phase of the study lifecycle (start up, maintenance, close out).

Job Description (Functions and Responsibilities):

• Creating and/or reviewing study plans, specification documents, materials and tools.
• Oversight of documents (e.g. FDA 1572, CVs, FDF, etc.) required for Tonix Regulatory from site initiation to site close out.
• QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines.
• Be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.
• Assist in organizing, scheduling, and attending Tonix site visits, if required.
• Develop and maintain good working relationships with investigators and sites staff.
• Function as liaison between investigative sites and the Tonix Medical Monitors, and ensure follow up/closure of action items.
• Ensure trial sites carry out recruitment and screening procedures according to the study protocol and in accordance with ICH/GCP regulations and study-specific guidelines.
• Identify and monitor the progress and obstacles of assigned study(ies) by implementing follow up strategies on any potential action items identified on site visits or in communication with sites.
• Assist in the set-up, organization, and maintenance of project Share Point (folders, documents)
• Support submission of documents required for TMF from Sponsor study team.
• Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors.
• Generate, finalize and distribute study team agendas and meeting minutes, where required. Review CRO meeting minutes.
• Assist in the production of slides, as needed for projects.
• Attend (and contribute where required) to internal Tonix meetings and CRO/vendor project meetings.
• Ability to communicate clearly both verbally and written to sites, vendors, CROs, internal study team, etc.
• Be familiar with ICH GCP, appropriate regulations, relevant Tonix SOP’s and internal tracking systems.
• Tracking and reporting on progress of study including site activation, recruitment activities, patient enrollment, and CRO monitoring visits (where assigned).
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determining appropriate action in conjunction with Tonix study team.
• Other duties as assigned

Job Requirements

• Bachelor’s degree in science and at least 5 years of experience in randomized clinical trials in central nervous system indications
• Prior experience in role of CTA for randomized clinical trials
• Highly organized with excellent communication skills
• Versatile with MS Office applications (Word, Excel, PowerPoint) and SharePoint cloud services
• Works well with a multiple disciplinary internal clinical team as well as in interactions with CROs/vendors

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include “Clinical Trial Associate” in the subject line of the email. 

This position would be based out of a Tonix office location (Chatham, NJ; Sand Diego, CA; South Dartmouth, MA; New Bedford, MA).

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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharm.com for specifics on the pipeline.

Position Overview:

Tonix is looking for a full-time Executive Assistant to effectively provide quality support mainly to Tonix’ CEO. The candidate should have a bachelor’s degree and at least 3 years’ experience or equivalent in supporting C level executives.  This is a fast-paced challenging position offers a competitive compensation and benefits package. The position would be based in Tonix’ South Dartmouth, MA office.  

Reporting to the CEO, the Executive Assistant is responsible for collaborating with our CEO to effectively provide support and provide efficiencies for them in regard to travel and calendaring as well as general administrative support needed to successfully run the company.

Essential Duties

• Managing the executive's day-to-day calendar, including making appointments and prioritizing the most sensitive matters
• Organizing meetings, including scheduling, sending reminders, and organizing catering and AV when necessary
• Coordinating travel arrangements (both domestic and international) and create trip itineraries
• Assist with filtering, prioritizing and overall management of emails
• Providing administrative assistance, such as writing and editing emails, drafting memos, and preparing communications on the executive's behalf
• Maintaining comprehensive and accurate corporate records, documents, and reports
• Using various software, specifically MS Office Suite, including word, spreadsheets, and presentation software to prepare reports and/or special projects
• Ensuring the executive has any tools or supplies needed to perform their duties
• Upholding company mission and values through accountability, innovation, integrity, quality, and teamwork
• Performing other ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

• Bachelor’s degree with 3 years of experience or at least 5 years of relevant experience preferred
• Knowledge of the life sciences industry preferred
• IAAP Certified Administrative Professional (CAP), or similar certification preferred
• Demonstrated ability to quickly develop and maintain strong relationships with internal customers and external vendors
• Superior time management skills with the ability to multitask and meet tight deadlines
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, decision maker, collaborator
• Ability to act as gatekeeper and escalate relevant information to executives as needed
• Ability to treat confidential information with appropriate discretion
• Exceptional attention to detail
• Dedicated team player who can withstand the high demands of a fast-paced environment
• Excellent written, organizational, and verbal communication skills
• Skilled in the use of standard office equipment (e.g., copiers, business telephone systems, projectors, fax machines).
• Proficient in MS Office Suite
• Ability to travel minimally as needed
• Available for client work and/or travel Monday through Friday on a general basis, including outside of normal business hours and weekends
• 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 human.resources@tonixpharma.com and include Executive Assistant 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview:

The Director, Quality Systems & Operations will play a key leadership role in ensuring high quality/regulatory compliance during the cGMP manufacturing process for both internal and external programs. The external programs, in strategic partnership with our global service providers (e.g., CDMO’s). The internal programs at our newly created Advanced Development Center (ADC) in New Bedford, MA. The individual in this position will be overseeing the buildout, set-up and operation of the facility that has an expected opening in 2022. The individual in this position will have the unique opportunity to help grow and shape the Tonix QA and QC teams at the New Bedford MA site, evolving the company’s Quality Management System (QMS), and supporting CMC regulatory processes, globally.

This position will also provide QA oversight to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  In addition, this position will be responsible for the Quality Control functions at the site. The position will also provide strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and ensures a culture of quality and compliance.

The position will be based in Tonix’ New Bedford, MA facility once open and operational. Remote work arrangements will be in place until such time. 

Essential Duties

• Provide strategic leadership for Quality Systems & Operations at Tonix in support of Good Manufacturing Practices (GMPs) at our CDMO partners
• Provide strategic Quality buildout oversight (design, construction, and preparation) of Tonix new viral vaccine manufacturing site in New Bedford, Massachusetts opening in 2022
• Responsible for building the QA and QC teams responsible for providing Quality oversight of the PD/clinical operations at the New Bedford manufacturing site
• Responsible for site validation, equipment validation, and operations validation in the New Bedford facility in corporation with cross functional departments
• Provide independent oversight and compliance direction with authority for QA, Quality oversight and product disposition
• Recruit, hire, train and mentor future QA and QC staff; provide company-wide training as needed
• Drive process and product quality through effective virtual Quality systems, ensuring adequate supplier oversight/surveillance
• Approve Protocol and Reports, Master Batch Records and Executed Batch Records at the CDMO and the CROs for Filling and Packaging
• Ensure that all necessary steps are added to the Process Control Strategy
• Review and verify process data to assure compliance with data integrity and traceability regulatory requirements as appropriate
• Disposition (approve/reject) batches for release
• Responsible for all QC laboratory functions (raw materials, intermediates and final product testing and release)
• Ensure that Tonix and its partners are inspection-ready for health authority audits by regulatory agencies, lead engagements with health authorities
• Assist in preparation and review of regulatory filings and safety data (e.g., INDs, BLAs, Annual Reports); ensure compliance with regulatory procedures
• Oversee development and maintenance of internal manufacturing and operational SOPs related to GxP activities, with primary focus on cGMP regulations
• Ensure that all products manufactured meet the registration and cGMP requirements based on global regulatory requirements
• Responsible for driving efficiencies and supporting the overall manufacturing process including process development activities, drug substance formulation and drug product manufacturing (filling, labelling, packaging, and distribution)
• Utilize GMP-regulated quality management systems and eQMS, including document control, change control, deviations/complaints, DS/DP release and CAPAs
• Coordinate with other departments within Tonix to establish a robust QMS
• Provide direct oversight of activities related to participation in U.S. FDA (CBER) and other regulatory agency inspections
• Perform other quality-related responsibilities, as necessary
• 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, chemistry, engineering, or other related discipline or equivalent work experience required
• Ten (10) years of GxP leadership in Quality Assurance (QA) with substantial operational experience; cGMP large molecule expertise required
• Five (5) years in roles of increasing management responsibility in a biopharmaceutical environment
• Two (2) years managing Phase 1-3 clinical trials manufacturing; commercial experience optimal.
• Experience interacting with FDA and global regulatory bodies/health authorities; pre-approval readiness (PAI) for commercial manufacturing preferred
• Experience in viral vaccine CMC environment and BSL2 operations is strongly preferred
• Experience in leading and managing complex projects/teams within corporate objectives and project timelines and participating in cross-functional projects as a Quality expert and leader role
• 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 send your resume and cover letter to human.resources@tonixpharma.com and include Head of Quality 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview:

Based on the expansion of it its R&D platform, Tonix is looking for a Head of/Director to supplement its CMC internal and external team of Tonix viral vaccine products.  The individual in this position will be responsible for CMC-related activities across the portfolio, specifically for large molecules and viral vaccine platform including Upstream, Downstream, Formulation and Filling for supply of clinical trial materials, Phase I-III.

The individual in this position will be highly motivated with experience and interest in working in both virtual (CDMO) and onsite locations, as well as in an entrepreneurial environment with broad responsibilities and opportunities.

The position is one of the lead roles at Tonix’s new Advanced Development Centre (ADC) in New Bedford MA expected to open early 2022, will lead a team of discovery, development, and manufacturing on site. This facility will be the hub and main location for advancement going forward specifically for all viral vaccine development.

Essential Duties

• Identification, selection, and management of Contract Development Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs for all Tonix viral vaccine programs
• Develop and implement strategy with the team for the Design of Experimentation (DOE) for optimizing and controlling quality of bulk DS and DP using CROs and CDMOs
• Deliver robust, scalable, and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile
• Projection of DS and DP needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance team)
• Formulation design and development for clinical programs
• Manage supply chain and logistics in support of clinical studies
• In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
• Execute plans for the validation and registration of DS and DP as required by cGMP, ICH, and FDA regulations
• Write and review documents for INDs / regulatory section submissions
• Represent the company as the CMC expert before U.S. and European regulatory authorities
• Prepare, review, or edit cGMP batch records, CMC regulatory and Quality documents
• 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

Minimum Qualifications

• PhD or MS with 10+ years of experience; advanced degree in pharmaceutical chemistry, organic chemistry, pharmaceutics, pharmaceutical science, or related] scientific discipline or equivalent education/work experience required
• Experience in managing US and International CRO/CDMOs for the manufacture of cGMP DS and DPs
• Experience with projects in clinical development e.g., Phase 1 through Phase 3
• Biopharmaceutical development experience specifically in the area of viral vaccines and monoclonal antibodies development, upstream, downstream and filling strongly preferred
• Advanced expertise in mammalian cell /viral culture, bioreactor operations and related techniques strongly preferred
• Experience with cGMP manufacturing and IND, CTA, and NDA filings
• Thorough knowledge of relevant FDA and EMEA regulations
• Ten years relevant experience in a biotechnology CMC/cGMP environment
• Experience in supply chain management
• Able to identify and resolve critical issues
• Experience implementing technical, strategic, and operational plans
• Exceptional interpersonal and 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 send your resume and cover letter to human.resources@tonixpharma.com and include Director, CMC/Product Development/Tech Ops 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Tonix is looking for a temporary Legal Assistant to effectively provide administrative support services to Tonix’ COO in regard to contract administration. The Legal Assistant will support all aspects of the contracts process including tracking and record keeping, liaising with counsel, and templated document preparation and review.

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

Essential Duties

• Perform timely and accurate tracking and record keeping of all Tonix contracts including updating and maintaining the Tonix Document Status Charts and saving fully executed documents to the appropriate location on Tonix server
• Act as liaison with outside legal counsel and Tonix contracting parties to facilitate the drafting, negotiation and execution of legal contracts and ancillary documents
• Collaborate cross-functionally to proactively manage and address the contractual needs of internal stakeholders in each contract
• Ensure that R&D contracts, once fully executed, are sent to the CFO in a timely manner, in compliance with Sarbanes Oxley
• Assist with the drafting of templated routine legal documents including CDAs, and consulting agreements
• File and maintain all intellectual property correspondence as per Tonix SOPs
• Act as alliance manager on programs for which Tonix has a license agreement; ensure that reporting and financial milestones are being met, in line with the license agreement; liaise with the Licensor as needed
• Partner with finance by maintaining accurate upcoming payments as per executed agreements
• Assist with preparing agendas for group meetings and taking detailed minutes for distribution
• Assist with special projects as needed, including compliance initiatives, implementation of contract process changes, development of contracting standards and contract project management
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork

Minimum Qualifications

• Bachelor’s degree or relevant work experience required
• Two (2) years of professional experience in similar role
• Familiarity with Adobe eSign and DocuSign is a plus
• Understanding of legal language and principles and other related matters
• Highly organized and detail oriented
• Results driven, problem solver and collaborator
• Excellent interpersonal and customer service skills.
• Excellent time management skills with a proven ability to meet deadlines.
• Ability to maintain confidentiality, and to exercise discretion and good judgment.
• Proficient with Microsoft Office Suite and 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
• Strong planning 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.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Legal Assistant 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Based on the expansion of it its Recombinant Pox Vaccine (HPV) Platform, Tonix is looking for a Manager, CMC Development to supplement its internal and external team. The individual in this position will be responsible for planning and execution of process and analytical 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 small virtual, 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 New Bedford MA in Q1, 2022. The position will be based in Tonix’ New Bedford, MA 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
• Prepare and review of technical documents such as batch records, sampling plans, process related and analytical method SOPs, risk assessments, study protocols, 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 and 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, through providing input to User Requirements Specifications (URS) and creating associated procedures
• Deliver robust, scalable, and cost-effective manufacturing processes and product formulations that meet or exceed the target product profile
• Project product needs for preclinical and clinical programs, working within associated budgets
• In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CROs and CDMOs are using systems and processes in compliance with all relevant regulatory standards
• Prepare and present 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 leadership, guidance, and direction consistent with the quality governance, to associates across sites and functions as relates to assigned projects
• Provide coaching, training, and mentoring of other associates as applicable, as well as seek and provide feedback
• Develop work and project plans, assign tasks, and oversee execution per the plans
• Review the progress of projects and outcomes to evaluate if changes are required in direction, scope, time, labor, or staff
• Ensure that projects are completed on schedule and within budget
• Provide input into development of budgets proposals, new capital expenditures, recruitment planning, and external spending
• Accountable for achievement of compliance goals
• Represent department in project team meetings
• Address or escalate compliance issues

Minimum Qualifications

• Bachelor’s degree in biochemistry, chemical engineering, microbiology, biotechnology, or related discipline with ten (10) years’ experience or Master’s/PhD with five years’ experience in the biotechnology industry preferred
• Advanced expertise in mammalian cell / viral culture, bioreactor operations, and related techniques
• Project management experience
• Experience in experimental design and statistical analysis methodology
• Experience with cell and gene therapy products and processes preferred
• Experience with projects in clinical development e.g., Phase 1 through Phase 3
• Biopharmaceutical development experience specifically in the area of viral vaccines and monoclonal antibodies development, upstream, downstream, and filling preferred
• Knowledge of analytical method development and qualification practices
• Experience with cGMP manufacturing and regulatory submissions preferred
• Ability to identify and resolve critical issues
• Experience implementing technical, strategic, and operational plans
• 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 send your resume and cover letter to human.resources@tonixpharma.com and include Manager, CMC, Viral Vaccine Development 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Based on the expanding portfolio of products in development, Tonix is looking for a Manager, CMC Development to supplement its external CMC development team. The individual in this position will be responsible for planning and execution of process and analytical development activities across the portfolio of Tonix products at various CDMOs globally.

The individual in this position will be highly motivated with experience and interest in working in a small virtual, entrepreneurial environment with broad responsibilities and opportunities.

Essential Duties

• Identify and select suitable CDMOs for each project phase
• Establish robust and compliant manufacturing processes at the CDMOs through defining the manufacturing process and associated control strategy relevant to the phase of development
• Own and maintain the knowledge and history of Tonix manufacturing processes throughout the product lifecycle
• Prepare and review of technical documents such as batch records, sampling plans, process related and analytical method SOPs, risk assessments, study protocols, technical reports, and/or relevant sections for regulatory submission files
• 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 in collaboration with the CDMO team
• Support change review and implementation, quality investigations, and CAPAs in cross-functional teams with the CDMO
• Deliver robust, scalable, and cost-effective manufacturing processes and product formulations that meet or exceed the target product profile
• Project product needs for preclinical and clinical programs, working within associated budgets
• In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CROs and CDMOs are using systems and processes in compliance with all relevant regulatory standards
• Prepare and present 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 leadership, guidance, and direction consistent with the quality governance, to associates across sites and functions as relates to assigned projects
• Provide coaching, training, and mentoring of other associates as applicable, as well as seek and provide feedback
• Develop work and project plans in collaboration with CDMOs, assign tasks, and oversee execution per the plans
• Review the progress of projects and outcomes to evaluate if changes are required in direction, scope, time, labor, or staff or alternate CDMOs
• Ensure that projects are completed on schedule and within budget
• Provide input into development of budgets proposals, recruitment planning, and external spending
• Accountable for achievement of compliance goals
• Represent department in project team meetings
• Address or escalate compliance issues

Minimum Qualifications

• Bachelor’s degree in biochemistry, chemical engineering, microbiology, biotechnology, or related discipline with ten (10) years’ experience or Master’s/PhD with five years’ experience in the biotechnology industry preferred
• Project management experience
• Experience in experimental design and statistical analysis methodology
• Experience with projects in clinical development e.g., Phase 1 through Phase 3
• Knowledge of analytical method development and qualification practices
• Experience with cGMP manufacturing and regulatory submissions preferred
• Ability to identify and resolve critical issues
• Experience implementing technical, strategic, and operational plans
• 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 send your resume and cover letter to human.resources@tonixpharma.com and include Manager, CMC, Virtual Development 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Tonix is looking for a full-time Manager of Health, Safety and Environmental (HSE) to effectively provide oversight of their new Advanced Development Center to be located in the New Bedford Industrial Park, Dartmouth MA. The individual in this position would be responsible for ensuring the health, safety and wellbeing of all employees working in a BSL-2 compliant Vaccine Development facility.  The individual in this position will also be responsible for ensuring compliance with all state, federal, and local environmental codes, and regulations.  The Manager of HSE will support all aspects of this process including strategy development and all consulting and service contracts required to support operations.

This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Director of Facilities and Engineering with an indirect report to the Site Head.

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

Essential Duties

• Provide safety oversight during facility construction including review of Contractors Safety Plans and safety audits in the field
• Participate in the facility design review process including any Process Hazard Reviews (PHR’s)
• Lead site permitting activities for all state and local environmental permits (air emission, wastewater, etc.)
• Develop BSL-2+ compliance program in accordance with the CDC BMBL
• Develop a waste management program for regulated medical waste as well as chemical wastes

• Develop and implement inspection policies and procedures, and a schedule of routine inspections
• Develop health and safety procedures for all ADC operations.
• Prepare and schedule training to cover emergency procedures, workplace safety, and other relevant topics
• Monitor compliance with safety procedures
• Generate inspection reports to document inspection findings
• Ensure that material safety data sheets are maintained and readily accessible when needed
• Maintain records of discharge of employee exposure to hazardous waste and/or pollutants, as required
• 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 Environmental Safety, Occupational Safety and Health, or related field required, Master’s degree desirable
• Five years of life science or related industry experience preferred
• Experience with BSL -2 or greater laboratory safety programs
• Extensive knowledge of environmental regulations and policies
• Excellent analytical and problem-solving skills
• Excellent written and verbal communication skills
• Excellent organizational skills and attention to detail
• Proficient in technology and equipment used in environmental inspections
• Proficient in Microsoft Office Suite or similar software

• 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 send your resume and cover letter to human.resources@tonixpharma.com and include Manager of Health, Safety and Environmental 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview:

Tonix is looking for a full-time Manager, QA Compliance to effectively provide direction and leadership to the QA Compliance team. The individual in this position is responsible for providing strategic planning for QA Compliance, providing oversight and compliance to corporate standards and implementation and compliance to the Quality Management Systems within the Tonix facility. The individual will be overseeing the buildout of the QA Compliance department of a site specific GMP Manufacturing facility in New Bedford, Massachusetts opening in 2022. The individual in this position will have the unique opportunity to hire, train and supervise the QA Compliance staff.

The individual will also be responsible for aligning with the other Quality teams (QA Operations and QC) regarding accomplishing corporate goals/objectives and ensuring strategic planning of quality innovation.  They will provide the framework to operate with corporate standards and ensure the oversight and implementation of the Quality Management Systems within the Tonix facility. 

Furthermore, this individual will ensure that every manufacturing step is performed in compliance with cGMPs and internal controls that satisfy approved specifications.

The individual will work with the other QA and QC staff to ensure safety and compliance with FDA and other applicable global health authority requirements as appropriate.

This individual reports into the Head of Quality and is a member of the Quality management team at the facility.   

The position will be based in Tonix’ New Bedford, MA facility once open and operational. Remote work arrangements will be in place until such time.  

Essential Duties

• Ensure that quality systems are applicable to operations, as well as build and maintain customized compliance standards as needed
• Ensure the compliance and oversight of key Quality systems, including but not limited to risk management, change control, deviations, CAPA, training, self-inspection, and complaints
• Provide and monitor quality metrics to ensure control of operations and drive continuous improvements.
• Propose solutions in collaboration with the operations department as needed
• Host the Site Quality council
• Approve site risk register
• Provide support to major and critical investigations
• Assess the impact of changes on cGMP and regulations
• Participate in regulatory inspections and clients’ 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 required
• A strong foundation in application of GMPSs in a drug substance or drug product manufacturing environment
• Minimum 10 years’ combined experience in biotechnology/cell and gene therapy environment, covering QA and/or manufacturing
• Strong GMP knowledge, covering FDA and Health Canada requirements

• Proven Aseptic experience and training in cGMP large molecule industry strongly preferred
• Demonstrated troubleshooting and problem-solving skills
• Ability to work in a fast-paced and agile environment

• Prior experience in quality leadership in the pharmaceutical industry is required
• Experience with cell therapy and/or gene therapy is 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 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 send your resume and cover letter to humanresources@tonixpharma.com and include Manager, QA 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview:

The Manager, QA Operations provides direction and leadership to the QA operations group.  The individual in this position also provides strategic planning for QA Operations, as well as oversight and compliance of manufacturing documentation (batch record review) and internal audits. The individual in this position will also be responsible for aligning with the other Quality teams regarding accomplishing corporate goals and objectives and ensuring strategic planning of quality innovation.

The individual in this position will oversee the buildout of the QA Operations department of a site specific GMP Manufacturing facility in New Bedford, MA opening in 2022. The individual in this position will have the unique opportunity to hire, train and supervise the QA Operations staff.

The individual in this position will work with the other QA and QC staff to ensure safety and compliance with FDA and other applicable global health authority requirements as appropriate.

This individual in this position reports into the Head of Quality and is a member of the Quality management team at the facility.  This position will be based out of the new facility in New Bedford, MA once open and operational. Remote work arrangements will be in place until such time. 

Essential Duties:

• Assist in the implementation of the overall quality strategy for the QA Operations group
• Develop, direct, and maintain quality systems in support of Tonix manufacturing in a manner consistent with global quality systems, Tonix’s requirements and standards and current regulatory requirements (primarily US FDA and European requirements), and other requirements as needed; quality systems include but are not limited to audits and inspections, documentation, and records management.
• Interface with site QA compliance / QC functions to support or develop appropriate interfaces with the site-based QA systems
• Develop working relationships with other site functions for support of equipment, facility, utility, cleaning services and computer validation/qualification
• Oversee all aspects of QA operations and act as first line of support for troubleshooting within the Tonix facility, including but not limited to executed batch record review, on the floor QA support, MODA data review, quality oversight for APSs
• Build and maintain expertise in the QA Operations team, including development of staff
• Apply aseptic manufacturing experience, including aseptic process validation, to ensure that manufacturing operations meet customer and regulatory expectations and requirements for aseptic manufacturing at all phases of product development
• 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 required
• A strong foundation in application of GMPSs in a drug substance or drug product manufacturing environment is critical,
• Ability to quickly assess facts and make the appropriate decisions
• Advanced experience in a biopharmaceutical manufacturing environment and/or quality operations or quality systems working in a GMP environment is strongly preferred
• Proven aseptic experience and training in cGMP large molecule industry is strongly preferred
• Demonstrated troubleshooting and problem-solving skills
• Prior experience in quality leadership in the pharmaceutical industry is strongly preferred
• Experience with cell therapy and/or gene therapy 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 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 send your resume and cover letter to human.resources@tonixpharma.com and include Manager, QA Operations 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview:

The QC Manager will be responsible for the coordination and supervision of all biochemical, microbiological, environmental monitoring, analytical and chemical techniques with regards to the testing of raw materials, in-process, bulk release, drug product release, stability product samples and facility and personnel monitoring.  The individual will be overseeing the buildout of the QC laboratories of a site specific GMP Manufacturing facility in New Bedford, MA opening in 2022. The individual in this position will have the unique opportunity to hire, train and supervise the QC staff.

This position will work with the other Quality cross functional departments to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  This position will also provide 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 Head of Quality and is a member of the Quality management team at the facility.  This position will be based out of the new facility in New Bedford, MA once open and operational. Remote work arrangements will be in place until such time. 

Essential Duties:

• Management of facility’s QC laboratories
• Hire, train, and supervision of QC staff
• Supervise the review of all laboratory data (both internal and external) and the closeout of laboratory investigations and deviations
• Manage the scheduling of all QC testing, coordinating with the other departments delivering QC samples to ensure the timely delivery of results
• Supervise all testing techniques and ensure full regulatory compliance to all laboratory functions
• Ensure all QC personnel involved in testing and other laboratory functions are trained in basic and appropriate cGMP training principals and are receiving routine updates in cGMP information and training
• Develop, author, and review appropriate change controls, deviations/investigations as well as QC test methods, specifications, and SOPs
• Manage and supervise data and QC logbook(s) review
• Interact with and support customer and regulatory authorities
• Work interdepartmentally to enhance communications at all levels and ensure that work orders, preventative maintenance, compliance, and documentation issues are resolved in a timely manner
• Evaluate vendors via vendor audits, comprehensive testing, and review of quality performance
• Manage laboratory equipment qualification
• Perform annual performance evaluations of all direct reports
• Provide continued coaching and development of staff to help them meet both career and personal development goals, and to ensure a cohesive, productive, and highly motivated QC team
• 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 or master’s degree in Biology, Chemistry, or other related discipline or equivalent work experience required
• Ten (10) years of cGMP QC experience in biotechnology/large molecule expertise strongly preferred
• Five (5) years in roles of increasing supervisory responsibility in a QC biopharmaceutical environment
• Two (2) years’ experience supporting Phase 1-3 clinical trials manufacturing; commercial experience preferred
• Exceptionally good understanding of QC principles and the different QC techniques used for testing
• Demonstrated troubleshooting and problem-solving skills
• Experience of analytical method transfer and/or method validation 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 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 send your resume and cover letter to human.resources@tonixpharma.com and include Manager, QC 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

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 New Bedford MA in Q1, 2022. The position will be based in Tonix’ New Bedford, MA 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 send your resume and cover letter to human.resources@tonixpharma.com and include Process Development Scientist/Engineer 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

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 in New Bedford, MA. Upon completion, this position will transition to an operational support role focused on day-to-day manufacturing equipment and processes.  The individual in this position will be responsible for the system ownership and project execution of process and utilities equipment.  Responsibilities include troubleshooting process equipment, 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.

This position will be based out of the new facility in New Bedford, MA once open and operational. Remote work arrangements will be in place until such time. 

Essential Duties:

Project Support

• Responsible for managing single-use technology designs 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/facility 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 process and performance problems
• Provide on-call support for all active process equipment and manufacturing activities
• Responsible for addressing safety related design/equipment issues
• Own all aspects of process equipment and single-use technologies for GMP manufacturing
• Revise single-use and process equipment designs to meet end-user's needs
• Responsible for troubleshooting activities, equipment design, and specifications for equipment (including single-use technologies) 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 equivalent 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
• Demonstrates the ability to solve problems of moderate scope
• Proficiency with Microsoft Office products and ability to learn additional software applications, as needed
• Hands-on expertise with bioprocess engineering and knowledge of disposable applications in a biologics process
• Familiar with biotechnology single-use systems and stainless-steel 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 send your resume and cover letter to human.resources@tonixpharma.com and include Process Engineer 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 central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Tonix is looking for a full-time Purchasing Manager to effectively coordinate, organize, and oversee all activities involved in the identification and acquisition of the materials and equipment required for the Tonix Advanced Development Center (ADC). Tonix is currently constructing the ADC facility which will be ready for commissioning in New Bedford, MA in Q1, 2022.

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

Essential Duties

• Support the capital project and the buyout of up to $10M of owner’s equipment for lab and manufacturing
• 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 send your resume and cover letter to human.resources@tonixpharma.com and include Purchasing Manager in the subject of the email.