Process Development

Sr. Scientist, Upstream Process Development (AAV) Direct Hire MA

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Job ID: 16385 Direct Hire MA

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Gene Therapy start-up here in the Boston/Cambridge area is looking to bring on-board an AAV Specialist (Scientist/Sr. Scientist) to lead upstream process development for the manufacture of AAV-based gene therapies. The ideal candidate for this position is an experienced Scientist/Engineer with a strong background in AAV manufacturing technologies and an excellent track record in gene therapy upstream process development. The successful candidate would have experience in process scale-up, process optimization, and tech transfer for GMP manufacturing.

Responsibilities include but not limited to:

  • Implement and lead upstream process development of AAV production and technical transfer to GMP.
  • Implement and/or develop innovative vector production technologies based on QbD strategies.
  • Develop protocols for vector production in shake flasks, wave bioreactors, and stirred tank bioreactors.
  • Perform monitoring of cell viability/growth and cell culture metabolites from cultures.
  • Develop intellectual property, publishing scientific papers and other tasks related to the company’s scientific and business interests.
  • Provide scientific expertise and guidance in clinical AAV production, development and innovation.
  • Author and review appropriate CMC documents for regulatory filings.
  • Participate in project related teams as a subject matter expert.

Requirements:

  • Minimum PhD in chemical engineering, biology, biochemistry, chemistry, biotechnology, or a related field and a minimum of 3 years of relevant process development experience OR an MS degree in a related field with significant experience will also be considered.
  • Experience in developing HEK293 or similar mammalian cell-based manufacturing platforms is a must. Prior experience with AAV process development and manufacturing is preferred.
  • Proficient with aseptic techniques and the use of shake flasks, wave-based bioreactors, and stirred tank bioreactors at various scales.
  • A background in cGMP, cGLP, regulatory guidelines related to pharmaceutical development, aseptic processing and process validation is a plus.

Scientist I/II, Upstream Process Development Direct Hire MA

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Job ID: 16355 Direct Hire MA

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Our large Gene Therapy client is going and looking to add a Scientist I/II to their Upstream Process Development team!  This role will focus on late-stage upstream process development efforts.  Will lead the design and execution of experimental strategies aimed at defining robust bioreactor processes for the production of AAV vectors in HEK293 cells or an alternative production platform that is robust, scalable and suitable for cGMP production.  Other responsibilities include but not limited to:

  • Provide scientific leadership and define experimental strategy for addressing clinical development program objectives for the development and optimization of cell culture systems for the production of high quality AAV vector products.
  • Apply engineering concepts to develop and rationally 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.  Design and execute experiments and troubleshoot process and equipment when needed with associate scientists in the lab.
  • Lead/Conduct laboratory studies to enhance AAV manufacturing technologies, capabilities and processes (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).
  • Mentor associate scientists to 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:

  • PhD in Biochemical engineering, Virology, Biochemistry, or Biological Sciences with applicable academic or industrial experience in mammalian cell culture process development, or MS with 6+ 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 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.

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

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Job ID: 16240 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.

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. 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.