Role: Analytical Program Lead (APL) overseeing analytical activities for biologics or vaccines supporting regulatory filings (IND, BLA/MAA) and post-approval lifecycle.
Responsibilities: define and execute analytical strategies including specifications, control and comparability strategies, method validation, process transfer, and lifecycle management; author and review regulatory submissions and respond to health authority queries; ensure analytical readiness for clinical and commercial manufacturing; collaborate cross-functionally with QC, Regulatory CMC, MS&T, and Manufacturing; identify and mitigate analytical risks; mentor team members.
Qualifications: Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related with 5+ years of industry experience, or M.S./B.S. with 8+ years in biologics or vaccine analytical development or quality control.
Preferred skills include expertise in biologics or nucleic acid therapeutics, regulatory justification, ICH and GMP knowledge, experience with BLAs/MAAs, and support for technology transfer and validation.
HighValue: biologics/vaccines, late-stage development, IND/BLA/MAA support, analytical control strategies, regulatory authoring, cross-functional collaboration.
WorkSetup: 100% onsite; no travel specified.
#J-18808-LjbffrSr. Scientist, Analytical Development in norwood at Unknown Company
This position is listed as full time and onsite.