Process Development

Sr Associate Sci, Oncology Cellular ProcDev Direct Hire MA

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Job ID: 16169 Direct Hire MA

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Associate Director, Late-Stage Upstream Development Direct Hire MA

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Job ID: 16067 Direct Hire MA

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Growing Gene Therapy Company here in the Waltham, MA area is expanding and looking to add an Associate Director, Cell Culture Process Development (late-stage development / process characterization) to their team!  This role will report into the Executive Director, Pharmaceutical Development and lead the R&D efforts of advanced cell culture and production methods AAV vectors.  The incumbent will also lead the establishment of systems and business processes required to facilitate late-stage BLA-enabling development campaigns.  Other responsibilities include but not limited to:

  • Provide program-specific leadership and subject matter expertise for late-stage upstream process and development activities.  Lead and mentor team members and direct laboratory activities to ensure that development milestones are aligned with program timelines.
  • Establish sound business processes and systems to structure the development activities and information management in order to ensure the efficient delivery of a well-organized data package for IND- and BLA-enabling development.
  • Provide hands-on leadership in the laboratory as needed, ensuring clear communication of experimental plans to ensure successful execution, leading analysis and documentation, requiring excellent writing skills and the flexibility to move between the management and execution as needed.
  • Define and drive the process development strategy for the production of AAV vectors from mammalian cell culture by applying unit operations that are robust, scalable and suitable for cGMP production.
  • Lead the team in efforts to apply engineering concepts to the screening, optimization and scale-up of mammalian cell culture system, incorporating advanced feeding strategies as necessary, as part of a comprehensive strategy to establish robust, scalable, and highly productive upstream processes and ensure technical success in manufacturing campaigns.
  • Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed. Write/revise SOPs as needed.
  • Apply cutting edge technologies in bioprocessing to AAV manufacturing, independently formulate new technology development initiatives and carry them to patent and public disclosure
  • Collaborate within a cross-functional department (Process Development, Analytical Development, Quality, and Manufacturing) to establish robust cross-functional planning to further advance the science.

Requirements

  • BS, MS or PhD in Biochemical Engineering, Biotechnology, Biochemistry or a related discipline AND 12+ years (BS/MS) or 5+ years (PhD) relevant industrial experience in bioprocessing.  
  • Demonstrated thought leader in the development and scale-up of mammalian cell culture processes for the production of biologics, biotechnology products, vaccines, or viral vector products for clinical or commercial disposition.
  • Recent experience with late-stage development of biologics or viral vector products, with familiarity in establishing a risk-based approach to BLA-enabling studies.
  • An in-depth understanding of engineering methodology required for implementing and scaling-up advanced feeding strategies of mammalian cell culture systems for the production of live viral vectors or vaccines, or large molecule biologics.
  • High level understanding of complex analytical methods used to support process development of viral vector products is required.

Head of Downstream Process Development Direct Hire MA

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Job ID: 16066 Direct Hire MA

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Growing Gene Therapy Company here in the Waltham, MA area is expanding and looking to add an Head of Downstream Process Development to their team!  This role will report into the Executive Director, Pharmaceutical Development and lead the R&D efforts of advanced purification methods and formulation development for AAV vectors.  The incumbent will also lead the establishment of systems and business processes required to facilitate late-stage BLA-enabling development campaigns.  Other responsibilities include but not limited to:

  • Provide leadership and subject matter expertise for all downstream process and formulation development activities.  Lead and mentor downstream team members and direct laboratory activities to ensure that development milestones are aligned with program timelines.
  • Establish sound business processes and systems to structure the development activities and information management in order to ensure the efficient delivery of a well-organized data package for IND- and BLA-enabling development.
  • Provide hands-on leadership in the laboratory as needed, ensuring clear communication of experimental plans to ensure successful execution, leading analysis and documentation, requiring excellent writing skills and the flexibility to move between the management and execution as needed.
  • Define and drive the process development strategy for the purification of AAV vectors from mammalian cell culture by applying unit operations that are robust, scalable and suitable for cGMP production.
  • Apply engineering concepts to the screening, optimization and scale-up of chromatography (affinity, ion exchange, size exclusion) and filtration processes including microfiltration, depth filtration, ultrafiltration, and sterile filtration.
  • Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed. Write/revise SOPs as needed.
  • Apply cutting edge technologies in bioprocessing to AAV manufacturing, independently formulate new technology development initiatives and carry them to patent and public disclosure.
  • Collaborate within a cross-functional department (Process Development, Analytical Development, Quality, and Manufacturing) to establish robust cross-functional planning to further advance the science.

Requirements

  • BS, MS or PhD in Biochemical Engineering, Biotechnology, Biochemistry or a related discipline AND 12+ years (BS/MS) or 7+ years (PhD) relevant industrial experience in bioprocessing.
  • Expertise with GE AKTA units, column chromatography, filtration and UF/DF (TFF) operations required to develop and manufacture high quality biologics, biotechnology, vaccine, or viral vector products for clinical or commercial disposition.
  • Recent experience with late-stage development of biologics or viral vector products, with familiarity in establishing a risk-based approach to BLA-enabling studies.
  • An in-depth understanding of purification of viral vectors, live viral vaccines, or large molecule biologics, including process scale-up and tech transfer.
  • Understanding of analytical methods used to support biologics purification process development is needed.
  • Experience in working with and managing outside vendors.

Associate Director, Drug Substance Development Direct Hire MA

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Job ID: 15806 Direct Hire MA

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Global biopharmaceutical company here in the Woburn MA area is looking to add a Small Molecule Associate Director to their Process Development team!  Company is known for their innovative medicines to treat chronic CNS diseases and has commercial products! This position will support the development of novel active compounds within the company’s pipeline.  Specifically, this position will provide strategic leadership for drug substance unit operations, scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation.  Specific areas of focus include reaction engineering, crystallization and process modeling.  The individual is expected to integrate QbD principles, guide experimental design with a focus on process understanding & robustness, interpret data, participate in cross-functional teams, write technical reports and mentor fellow engineers.  The candidate should have strong communication & interpersonal skills, be able to multi-task and have a commitment to continuous learning.  A solid background in chemical engineering is required.  Responsibilities include but are not limited to: 

  • Collaborate within cross-functional teams, specifically with Chemical and Analytical Development to define and execute development strategies that enable successful launch of products.
  • Implement scale-up strategies for drug substance synthesis and crystallization unit operations with a focus on process understanding, identification of critical process parameter and process optimization.
  • Apply reaction engineering and process modeling in development activities.  Identify and deploy new technologies as needed.
  • Design crystallization processes that deliver solids of desired attributes
  • Support technology transfer of drug substance unit operations and production at CMO(s)
  • Integrate Quality Risk Management (QRM) and Quality by Design (QbD) principles into project activities in accordance with ICH Q9 & Q11
  • Write technical reports and deliver presentations to technical, CMC and broader project groups.
  • Author & review CMC sections of regulatory filing documents
  • Mentor fellow engineers
Requirements:

  • MS in Chemical Engineering with 15+ years of experience OR PhD in Chemical Engineering with 10+ years of experience
  • Experience in introducing, implementing and/or executing new chemical processes in pilot, commercial plants and/or contract manufacturing facilities
  • Proven ability to apply scientific principles to design, execute and interpret experiments
  • Experience in drug substance crystallization
  • Pharmaceutical cGMP manufacturing experience
  • Statistical design of experiment experience

Sr. Manager/Sr. Scientist, TCR/CAR-T Process Development Direct Hire MA

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Job ID: 15781 Direct Hire MA

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Are you experienced in TCR/CAR-T Process Development and looking for your next career move?  Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area.  This role is with a mid-size company and they have a culture that can't be beat.  Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer. 

The main focus of this role is defining and driving the scientific strategy for engineered T cell process development efforts and to serve as technical liaison between the research immunology and manufacturing operations functions.

Responsibilities include but are not limited to;

•  Development, qualification and characterization of engineered T cell processes including the establishment of critical process parameters and controls for manufacturing using common cellular therapy equipment including but not limited to: Wave Bioreactors, Haemonetics Cell Saver 5, Elutra Cell Separator, Controlled rate freezers, LOVO cell washer, Multisizer 4 Coulter counters, CliniMACS, etc.
•  Serve as technical liaison between the research immunology and manufacturing operations functions.

•  Troubleshooting cell culture upstream productivity and product quality issues at clinical manufacturing scale.  The Hiring Manager can also consider those without at scale T-cell processing if experienced in CAR-T activation of T-cells or assessment of T-cell potency.

•  Support IND and BLA filings.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS and 10-15+ years or a PhD and 5-10+ years of industry experience in the development of cellular and gene therapies with a strong background in T cell biology and Immunology. Industry experience is welcome but not required to be considered.  A strong background in relevant assays such as FACS, ELISA, qPCR, Cytotoxicity, Proliferation, and Luminex is expected.  Experience with large scale, closed system manufacturing of therapeutic cell and/or gene therapy products from whole blood, apheresis, or bone marrow is preferred.    

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Sr. Research Associate/Scientist, Cell Culture Process Development Direct Hire MA

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Job ID: 15772 Direct Hire MA

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Mid-Size Gene Therapy company in the Waltham, MA area is expanding!  They are looking to bring on board Sr. Research Associate, Cell Culture Process Development!  This role will conduct experiments aimed at defining robust bioreactor processes for the production of gene therapy products in HEK293 cells or an alternative production platform that is robust, scalable and suitable for cGMP production.  Responsibilities include but not limited to: 

  • Apply engineering concepts to develop and scale the mammalian cell culture processes, including transient transfection, clarification of harvested material, and other upstream unit operations.
  • Design and apply DOE studies to develop, refine, optimize and characterize cell culture and vector production processes.
  • Conduct well-designed experiments and troubleshoot process and equipment when needed with associate scientists in the lab.
  • Contribute to development programs to enhance manufacturing technologies, capabilities and processes (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).
  • Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed. Write/revise SOPs as needed.
  • Must demonstrate a keen knowledge of experimental design, underlying scientific principles, and the ability to analyze and assess results.

Requirements:

  • BS in Biochemical engineering or Biological Sciences with 4+ years, or MS with 2+ year of industrial experience in mammalian cell culture process development.
  • Experience with small or large-scale single-use bioreactor operations, and technology transfer to pilot plant or cGMP manufacturing for clinical stage products is preferred.
  • Familiarity with development of viral vectors, live viral vaccines, producer cell lines, high throughput or disposable bioreactors, culture media development, or perfusion unit operations is preferred.
  • Should be highly motivated, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
  • Ability to execute and follow-through to completion and documentation.