We are seeking an experienced and motivated Senior Scientist for T cell process development and GMP manufacturing for a personalized neoantigen-based T-cell therapy product. The successful candidate will focus on the day-to-day process development and clinical manufacturing activities with Contract Development and Manufacturing Organizations (CDMO). The candidate should be detail oriented and have strong understanding and technical knowledge of T cell process development activities, including sorting, activation, expansion, cryopreservation, and associated analytics including multicolor flowcytometry for cell phenotyping. Additionally, the candidate will play a major role for tech transfer for GMP manufacturing and writing of SOPs, batch records and CMC sections for the IND, as well as in ensuring clinical supply of the cell therapy product.
The ideal candidate must have experience in T cell therapy development in industrial settings with hands-on T cell culture process development with GMP understanding. Experience with cell therapy analytical assay development would be recommended but not required. This is an exciting opportunity to change people’s life by developing novel life-saving cancer therapy with opportunity for professional growth, and company success.
Develop plan for day-to-day technical CMC development activities including T cell sorting, activation, expansion, harvest/cryopreservation.
Experience with flow cytometry and analytical assays development of relevant technologies would be recommended.
Under the guidance of Director, Cell Therapy and Manufacturing act as technical lead and provide oversight for technical interactions with CDMO and analytical vendors.
Work closely with other members and groups of Pharm Sci & Mfg team to advance CMC activities. Work closely with supply chain and others for supply chain development.
Develop plan with superiors for for manufacturing development, GMP readiness, technology transfer, capacity planning and clinical/commercial manufacturing.
Draft, CMC sections and participate in quality and regulatory meetings.
Provide technical expertise to ensure successful clinical supply.
Clear understanding and experience of aseptic techniques for primary human cell cultures, process development/qualification and GMP manufacturing.
Experience with single use technologies, tools for cell culture, current understanding of multi-color flow cytometry, ELISAs, cell-based assays.
Knowledge of CMC regulatory framework for advanced cell therapy regulations.
The candidate should have high planning skills for day-to-day activities and excellent communication and interpersonal skills.
A strong work ethic and sense of purpose with a demonstrated ability to identify, analyze and solve problems.
Willingness for up to 20% travel.
Education and Experience Required
BS in Biology, Chemical engineering or Biomedical engineering with 10+ years of experience or MS in Biology or equivalent with 7+ years of experience or Ph.D. in Biology or equivalent with 5+ years of experience.
At least 3 years of hands-on experience with T cell process development with understanding of GMP manufacturing activities in industry/ academia.