Process Development

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, 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. 

Sr. Manager/Sr. Scientist, Cell Culture Process Engineering Direct Hire MA

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Job ID: 15707 Direct Hire MA

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Are you an experienced Cell Culture Process Engineer looking to make the jump to cell & gene therapy?  Already in cell & gene therapy 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. 

Responsibilities include but are not limited to;
•  Cell culture upstream process scale up, tech transfer, manufacturing support, data compilation and analysis.
•  Bioreactor and/or platform selection and optimization (Perfusion systems, WAVE bags, single-use systems, etc.), characterizing mass transfer coefficient & mixing time for bioreactors, characterizing cell culture harvest.
•  Troubleshooting cell culture upstream productivity and product quality issues at clinical manufacturing scale.
•  Use of various "omics" tools (proteomics, transcriptomics, metabolomics, etc.) to advance process understanding mammalian cell-based processes and drive development, scale-up and technology transfer activities.   

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS and 10+ years of industry experience or a PhD and 5+ years of industry experience in a cell culture, process development environment and good understanding of bioprocess engineering concepts.  Cell therapy and/or gene therapy experience is welcome but not required to be considered.  Experience in statistical analysis or modeling is preferred.  

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