Careers

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), immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox and next-generation vaccines to prevent 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 EVP, Commercial Strategy to effectively provide leadership for the development of the required infrastructure and commercial strategy for products being introduced in the U.S. market. This position would also be responsible for financial results for the operating unit, direction and leadership of staff, and interaction with outside partners including manufacturing, distribution and managed care.

 

This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the CEO and will be remotely based but will require occasional travel to Tonix locations.

 

Essential Duties

• Develop necessary infrastructure to support commercial operations
• Identify key staff positions, define roles and responsibilities, and hire staff
• Develop, communicate, and execute the commercial strategy and align resources to ensure successful introduction of our first products marketed in the U.S. market
• Provide commercial analysis and direction for the development and management of the pipeline products
• Lead all commercial product launch preparation activities including brand strategy, product positioning, distribution, market access strategy, sales force strategy, and pricing
• Lead other functional areas in the commercial unit such as Supply Chain Management, Regulatory, Quality, and Finance
• Provide effective leadership to the commercial organization to ensure the development of the business and people
• 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 team members
• Oversees the daily workflow of the department
• 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

 

Minimum Qualifications

• Fifteen (15) years’ experience in pharma/biotech or relevant life sciences executive leadership
• Previous C-level experience in pharma preferred
• Ability for travel 10% 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. To apply, please click EVP, Commercial Strategy

 

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.

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), immunology and infectious disease product candidates.  Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer.  Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies 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 Accounts Payable Manager to effectively oversee and maintain  select accounts payable projects and processes related to  the disbursements cycle for a publicly traded, multi-national pharmaceutical company. The individual in this position is also responsible for ensuring that key accounts payable initiatives are completed in a timely and accurate manner.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Senior Manager, Accounting and will be based in the Tonix Chatham, New Jersey office.

Essential Duties

• Coordinate and validate the processing of invoices for US and international entities using the company’s accounting system and accounts payable automation software
• Ensure accurate approval and coding of all invoices
• Build and maintain effective relationships with vendors and ensure timely, accurate payments
• Track and ensure accurate currency conversions for international vendors and entities
• Assist in preparation of online wire payments, EFT, and ACH payments
• Ensure employee expense reports are received by set departmental deadlines and audit expenses for accuracy and timeliness in the company’s expense software platform
• Manage company’s corporate credit and purchase card programs
• Liaise with internal departments as required to resolve issues
• Assist with the compilation and preparation of tax reporting for US and international entities
• Oversee IRS 1099 compliance and year end filings
• Support the implementation of new technology, processes, and procedures in the department in order to guarantee higher efficiency from the team
• Assist with both internal and external audits by providing requested support documentation
• Investigate and resolve problems associated with processing of invoices and purchase orders
• Protects organization’s value by keeping information confidential
• Ensure all policies, processes and controls are compliant with the Sarbanes Oxley Act
• 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 team members
• Oversees the daily workflow of the department
• 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

Minimum Qualifications

• Bachelor’s degree in finance, accounting, or related field preferred
• Five years financial work experience including three years direct responsibility for accounts payable functions in a corporate environment
• Experience with Microsoft Dynamics Great Plains accounting system preferred
• Working knowledge of accrual accounting, general ledgers, and journal entries
• Strong computer skills and proficiency in all Microsoft Office applications
• Strong organizational aptitude and meticulous attention to detail and accuracy
• Familiarity with FX transactions
• Ability to display professionalism in written and oral communications, both internally and externally
• Ability to work in a small team environment
• Working knowledge of contracts, purchase orders and change orders
• Ability for minimal travel
• 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
• 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, Accounts Payable 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 Manager responsible for overseeing daily activities and personnel at Tonix’s brand new Advanced Development Center (ADC) facility. In addition to being fully trained in the production processes, the hands-on Manager ensures that manufacturing is done in strict compliance with current Good Manufacturing Practices (CGMP), environmental health and safety (EHS) guidelines, and any other regulations that may 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 weekend coverage when necessary.

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

Essential Duties

Hands-on supervision of manufacturing staff including hiring, coaching, goal setting, professional development, and overall performance management and assessment
Function as a resource and facilitator for all manufacturing employees
Complete the necessary training to be able to perform all manufacturing operations
Support multiple project initiatives, including driving business excellence and continuous improvement initiatives, using operational excellence tools and leading metrics
Work closely with other ADC teams to align overlapping processes including shared work areas, management of consumables, deviations, and corrective actions
Schedule and allocate department employees, materials, and equipment on a daily basis to support uninterrupted processing of high-quality products
Author, revise, and approve SOP’s, batch records, deviations, and other documentation as required to ensure compliance
Perform real-time review of completed manufacturing documentation, including batch records, and form
Communicate manufacturing process status with relevant critical data and details to manufacturing management, staff, and other internal departments
Continuously support and train employees on the safety and quality commitments of the manufacturing department as well as make decisions to ensure that safety and quality commitments are met
Facilitate and verify appropriate training for employees in manufacturing/the facility; including, but not limited to, GMP, job skills, and safety
Ensure compliance with all GMP rules, product documentation, specifications, SOPs, and regulatory requirements
Support the manufacturing team during internal and external 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

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 a scientific or engineering discipline with previous biomanufacturing experience and demonstrated knowledge of GMP preferred
Previous supervisory or lead experience preferred
Demonstrated interpersonal and leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment
Strong understanding of GMPs and other regulatory guidelines applicable to commercial pharmaceutical manufacturing
Ability to manage multiple priorities in a fast-paced manufacturing plant setting
Strong written and verbal communication skills and ability to prepare technical reports
Strong problem assessment and troubleshooting skills
Demonstrated ability to interact with all levels of personnel to analyze and solve problems related to manufacturing, Quality, documentation, and personnel
Ability to analyze data and information to determine paths for process improvement and potential root cause/corrective actions in the case of exceptions
Ability to respond to detailed inquiries, and present information to groups with varying levels of scientific knowledge including senior management
Solid computer skills including Word, Excel, and PowerPoint
Ability to work during general business hours Monday – Friday as well as flexibility to work nights and weekends as needed to ensure adequate oversight and support for direct reports
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
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 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 central nervous system (CNS), immunology and infectious disease product candidates.  Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer.  Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies 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 SOX Compliance Manager who will be responsible for managing the company’s Sarbanes-Oxley (SOX) Compliance. The role includes leading the strategy, scoping, training, deficiency remediation, and reporting for the company’s SOX compliance program. The SOX Compliance Manager works with leadership to design effective and efficient controls over financial reporting, recommends process/controls/systems improvement changes for any gaps and deficiencies identified through SOX testing, and facilitates the remediation and monitoring strategy to comply with SOX. The individual in this position will also lead specific key SOX initiatives such as trainings, risk assessment, fraud risk assessment, and quarterly certification processes. The individual will also work with external consultants, and business leads in the design of internal control procedures for new processes.

This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Corporate Controller and will be based at the Tonix Chatham, NJ office.

Essential Duties

• Lead the annual SOX 404 financial statement mapping, risk assessment, and scoping process including identifying significant locations, business units, transaction cycles, and critical processes and accounts ensuring an adequate scope and testing of the Company’s financial statements
• Lead walkthroughs and risk assessments with process owners, review documentation, and assess results to ensure adequate control design and identification of “key” controls
• Assess the effectiveness of internal controls over key financial risks
• Work with process owners to ensure controls are operating effectively and evidenced appropriately
• Identify process/control deficiencies, recommend remediation plan, and monitor remediation progress
• Facilitate SOX Section 404 related tests of controls, including Accounting and IT controls testing and related documentation
• Serve as the main SOX contact for coordination with external auditors related to testing requests and issues
• Evaluate changes in process, people, and technology that may have an impact to internal control over financial reporting, including process changes, new accounting pronouncements, and system implementations
• Document SOX impact and provide controls guidance and training
• Assist process owners in the preparation and on-going maintenance of SOX process documentation and process flowcharts
• Review the quarterly SOX certification process
• Monitor segregation of duties review
• Make process improvement recommendations with regards to control design and audit procedures
• 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 team members
• Oversees the daily workflow of the department
• 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

Minimum Qualifications

• Bachelor’s degree with a major in accounting or finance required
• Professional certification a plus (CPA, CIA, CISA, CFE)
• Six (6) years of progressive experience in internal audit, accounting, and finance
• Big 4 public accounting experience strongly preferred
• Public company audit experience
• Detailed knowledge of COSO framework, US Generally Accepted Accounting Principles (GAAP), and PCAOB requirements
• Strong knowledge of Business Process, Internal controls, and Sarbanes Oxley requirements.
• Knowledge of Great Plains is a plus
• Proficient in Word, Excel, PowerPoint, Visio, and Outlook
• Ability for travel 30% 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 a salary commensurate with experience and an excellent benefits package. To apply, please click Manager, SOX Compliance.

Physical qualifications needed for this job:

Constantly-

• Remaining in a stationary position, often standing, or sitting for prolonged periods.
• Communicating with others to exchange information.
• Repeating motions that may include the wrists, hands and/or fingers.
• Assessing the accuracy, neatness and thoroughness of the work assigned.

Occasionally-

• Moving about to accomplish tasks or moving from one worksite to another.

Rarely-

• Ascending or descending ladders, stairs, scaffolding, ramps, poles, and the like.
• Moving self in different positions to accomplish tasks in various environments including tight and confined spaces.
• Adjusting or moving objects up to 50 pounds in all directions.
• Ability to travel via standard modes of transportation

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. To apply, please click  Associate, Manufacturing

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), immunology and infectious disease product candidates.  Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer.  Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies 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 Process Development Scientist II to effectively plan and execute 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 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 be based at the Tonix North Dartmouth, MA facility.

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
• 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
• 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 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

• Bachelors in biochemistry, chemical engineering, microbiology, biotechnology, or related discipline with ten years of experience in the biotechnology industry; or Masters/PhD with five years of experience in the biotechnology industry or equivalent work experience preferred
• 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
• 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

Physical requirements:

• Must be able to be able to stand or sit for long periods of time.
• Must be able to communicate with others.
• Must be able to repeat motions that may include the wrists, hands, and or fingers.
• Must be able to assess the accuracy, neatness and thoroughness of the work assigned.
• Occasionally move about to accomplish tasks or moving from one worksite to another.
• Rarely will be on ladders, be in tight spaces, or traveling via standard modes of transportation.

Tonix offers a salary commensurate with experience and an excellent benefits package.  Please click Scientist II, 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 central nervous system (CNS), immunology and infectious disease product candidates.  Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer.  Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies 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 Research Associate in protein expression, purification, and characterization to join a rapidly growing and dynamic discovery and development team. The candidate will be contributing to the process of design, engineering, and production of cutting-edge new biologics.

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

Essential Duties

• Clone and express of recombinant proteins from various systems including bacterial and mammalian cell lines
• Purify proteins using affinity, ion exchange, and size exclusion chromatography
• Perform protein characterization using analytical techniques (SDS-PAGE, Western Blot, ELISA)

• Generate and maintain plasmid DNA stocks
• Maintain immortalized and primary human cell lines
• Coordinate ordering of laboratory supplies
• Document experiments in laboratory notebooks
• Communicate experimental data within internal meetings
• Participate in generating standard operating procedures (SOPs)
• Maintain organized and safe laboratory environment

• 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 biology, chemistry, biochemistry, microbiology, or related disciplines required
• Master’s degree in related disciplines preferred
• Extensive hands-on experience with protein purification methods, including batch purification techniques and operating automated FPLC equipment

• Experience with SPR/BLI and DLS techniques is preferred
• Experience with protein crystallization screening and optimization is a plus

• Experience with recombinant DNA such as cDNA cloning, plasmid amplification
• Experience with protein expression, purification techniques, and bioanalytical methods
• Experience with basic cell culture techniques
• 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

Physical requirements:

• Must be able to be able to stand or sit for long periods of time.
• Must be able to communicate with others.
• Must be able to repeat motions that may include the wrists, hands, and or fingers.
• Must be able to assess the accuracy, neatness and thoroughness of the work assigned.
• Occasionally move about to accomplish tasks or moving from one worksite to another.
• Rarely will be on ladders, be in tight spaces, or traveling via standard modes of transportation.

Tonix offers a salary commensurate with experience and an excellent benefits package. To apply, please click Senior Associate, Research

 

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), immunology and infectious disease product candidates.  Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer.  Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies 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, Tonix is looking for a Senior Director, CMC, to supplement its CMC team.  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 supporting both outsourced (CDMO) and in-house operations, as well as being in an entrepreneurial environment with broad responsibilities and opportunities.

The position is one of the lead roles at Tonix’s Advanced Development Centre (ADC) in North Dartmouth, MA, and will lead development and manufacturing on site. The ADC facility is the hub and main location for Tonix advancement going forward.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Executive Vice President of Product Development, and will be based at the Tonix North Dartmouth, MA facility.

Essential Duties

• Manage the Process Development, Analytical Development, and Clinical Manufacturing teams on site
• Introduce new projects to the site from other Tonix research locations, including Tonix’ Research and Development Center (RDC), University collaborations, and CDMOs
• Develop and implement strategy with the team for the Design of Experimentation (DOE) for optimizing and controlling quality of bulk DS and DP
• Deliver robust, scalable, and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile which are phase appropriate
• Projection of DS and DP needs for preclinical and clinical programs and associated budgets
• Manage internal & external supply chain and logistics in support of clinical studies
• In coordination with Quality Control, implement stage-appropriate analytical methods and protocols to ensure that all programs are in compliance with all relevant regulatory standards
• Execute phase appropriate 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, as well as CMC regulatory and Quality documents
• Prepare technical reports, publications, and oral presentations
• For external managed projects, identify, select, and manage 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 programs
• 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 team members
• Oversees the daily workflow of the department
• 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

Minimum Qualifications

• Twenty (20) years of industry experience; advanced degree in pharmaceutical chemistry, organic chemistry, bioengineering, pharmaceutics, pharmaceutical science, or related scientific discipline or equivalent education/work experience preferred
• 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
• 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
• 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 a salary commensurate with experience and an excellent benefits package.  To apply, please click Senior Director, CMC.

Physical qualifications needed for this job:

Constantly-

• Remaining in a stationary position, often standing, or sitting for prolonged periods.
• Communicating with others to exchange information.
• Repeating motions that may include the wrists, hands and/or fingers.
• Assessing the accuracy, neatness and thoroughness of the work assigned.

Occasionally-

• Moving about to accomplish tasks or moving from one worksite to another.

Rarely-

• Ascending or descending ladders, stairs, scaffolding, ramps, poles, and the like.
• Moving self in different positions to accomplish tasks in various environments including tight and confined spaces.
• Adjusting or moving objects up to 50 pounds in all directions.
• Ability to travel via standard modes of transportation