Senior Scientist, Engineering- Cell Banking

Role: Support mid- to late-stage development and commercialization of cell bank processes for biologics and vaccines within the Biologics Drug Substance Commercialization (BDSC) organization. Responsibilities include process risk assessments, technology transfer, process characterization, qualification of new cell banks, and regulatory documentation in support of licensure and post-market manufacturing. The role involves designing experiments, analyzing data, preparing technical reports, and collaborating with research, manufacturing, and regulatory teams. Requirements: Bachelor's degree with 5+ years (or Master's with 3+ years) in Biochemistry, Bioengineering, or related field; hands-on experience in mammalian or microbial cell culture, cell line development, and upstream process development. Skills in DOE, statistical data analysis, and experience with GMP manufacturing and regulatory submissions are essential. Preferred: expertise in large molecule process development, regulatory knowledge (FDA, EMA), Quality by Design (QbD), and experience authoring IND/MAA/BLA filings. The position requires 25% travel, and work is primarily on-site. High-value biopharma specifics include focus on biologics/vaccines, cell bank process transfer, process validation, regulatory compliance, and supporting licensure activities for biologics and vaccines.