Manager - Manufacturing, Science & Technology

Company: Tonix Pharmaceuticals Inc
Location: New Bedford
Posted on: August 5, 2022

Job Description:

Job DescriptionAbout 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 OverviewBased on the expansion of its R&D platform and clinical pipeline, Tonix is looking for a Manager, MSAT to supplement its internal and external teams. The MSAT Manager will have one direct report and will lead technology transfer and support of internal and external manufacturing, as well as contribute to overall technical development. This position will be located at the Tonix Advanced Development Center (ADC) facility in North Dartmouth, MA.The ideal candidate will be a highly motivated individual with experience in viral products and biologics working in an entrepreneurial environment with broad responsibilities and opportunities. This is a fast-paced challenging position offering a competitive compensation and benefits package. The position will report directly to the Executive Director, CMC.Essential Duties

• Lead technical transfer projects for establishing robust and compliant manufacturing processes and associated control strategy
• Own and maintain the knowledge and history of manufacturing processes throughout the product lifecycle
• Author, review, and approve technical documents such as batch records, sampling plans, SOPs, risk assessments, study protocols, technical reports, and sections for regulatory submissions
• Provide first line technical support to manufacturing on the floor in compliance with relevant instructions and quality requirements
• Lead process characterization, scale up, process optimization, and process validation
• Use scientifically sound rational and statistical tools for data analysis and trending
• Contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
• Support change review and implementation, risk assessments, quality investigations, impact assessment, and CAPAs in cross-functional teams
• Participate in the definition and selection of equipment by providing input to User Requirement Specifications (URS) and creating associated procedures
• Support process equipment FAT, SAT, and on-site qualification activities
• Plan and organize training for manufacturing personnel
• Deliver robust, scalable, and cost-effective manufacturing processes for viral vaccine and biologics drug substance and drug product that meet or exceed the target product profile
• Provide hands-on contribution in the Process Development lab during process scale up
• Prepare technical reports, publications, and oral presentations
• Follow all established occupational health and safety procedures, good manufacturing practices (GMP's) and standard operating procedures (SOP's)
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiativesLeadership
  • Provide manufacturing science leadership and manage performance of direct reports
  • Provide guidance and training to direct reports and manufacturing personnel
  • Develop work and project plans and execute per the plans
  • Provide input into development of budgets proposals, new capital expenditures, recruitment planning and external spending
  • Accountable for on-time project completion and achievement of compliance goals
  • Represent the CMC Development function in project team meetingsSupervisory 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 promotionsMinimum Qualifications
      • Bachelor's Degree in Biochemistry, Chemical Engineering, Biotechnology, or related scientific discipline with six (6) years of experience in biotechnology industry
      • Biopharmaceutical development and manufacturing experience specifically in viral vaccines and viral-based products required; monoclonal antibodies development is an asset
      • Broad experience with upstream and purification technologies for viral products, drug substance formulation, and fill/finish
      • Experience with statistical analysis
      • Experience with cGMP manufacturing and regulatory submissions
      • Ability to identify and resolve critical issues
      • Available for minimal travel
      • Dedicated team player who is able to withstand the high demands of a fast-paced environment
      • Excellent written and verbal communication skills are essential
      • Strong planning and organizational skills
      • Comfortable working independently with minimal supervision
      • Highly organized, results driven, problem solver, and collaborator
      • Demonstrated ability to perform the essential duties of the position with or without accommodationTonix offers salary commensurate with experience and an excellent benefits package.

Keywords: Tonix Pharmaceuticals Inc, New Bedford , Manager - Manufacturing, Science & Technology, Executive , New Bedford, Massachusetts