Process Development

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.

Sr. Scientist, cGMP Cell Banks Direct Hire MA

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Job ID: 16186 Direct Hire MA

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Our client is a large, international biopharmaceutical company with two dozen global sites and a large portfolio of approved therapeutics and a robust pipeline.  

The main function of this role is to lead/or support technical transfer of projects to meet GMP Cell Bank production for clinical and commercial programs.

Responsibilities include but are not limited to;
•  Identification and implementation of technologies to ensure alignment of cell culture processes from Development to Cell Banking to Biologics Manufacturing and ensuring execution of method transfers across the global network. 
•  Supporting site selection and interacting with External Site Operations group for management of external CMO cell banking projects.
•  Ensure accurate and well managed transfer of process changes/improvements to floor operations. 
•  Integrate best practices, where appropriate, into manufacturing as part of the Global Cell Bank Network.
•  Design/conduct laboratory studies aimed at Cell Bank method transfer support for storage stability studies, increasing cell culture process knowledge, and improving process robustness.
•  Assemble and analyze manufacturing data aimed at both long-term trending and resolution of investigations. 
•  Act as the lead on on-the-floor technical issues and provide risk assessments if required.
•  Initiate deviations or investigations and work with cross-functional departments to identify root cause or reach closure.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher in a relevant discipline and several years of experience in a cGMP mammalian cell culture-based setting.  Previous experience in Cell Banking highly preferred.    

Must be authorized to work in the US indefinitely to be considered and must be commutable to the suburbs of Boston & Cambridge or able to relocate with very limited assistance.  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.