Sr. Manager/Sr. Scientist, TCR/CAR-T Process Development Direct Hire MA
Job ID: 15781 Direct Hire MA
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.