Research Scientist - Product development
Core
Provide scientific and technical leadership for analytical activities, specifically overseeing analytical method transfer, qualification, validation, and lifecycle management for biopharmaceutical therapeutics.
Role type
Senior IC analytical development scientist (biologics)
Builds
Analytical methods and transfer strategies for biotechnology therapeutics
Domain
Biopharma / Animal Health
Required skills
Analytical method lifecycle management, method transfer execution, vendor/CDMO management, technical writing, risk assessment, problem-solving, GMP/GRP compliance
Preferred skills
Experimental design (DoE), statistical data analysis, root cause investigation, early-to-late phase development experience
Technologies
HPLC, CE, ELISA
Responsibilities
Oversee analytical method transfer to internal and external labs/CROs/CDMOs; Partner with AD/PD SMEs to develop transfer strategies; Manage technical relationships and deliverables with external vendors; Evaluate analytical data and method performance trends; Author and review regulatory and quality documentation; Support analytical readiness for clinical and commercial supply.
Seniority
Senior, hands-on IC
