Development Scientist II, Analytical Development and Clinical QC (ADQC)
Core
Provide end-to-end scientific and operational oversight of Good Manufacturing Practice analytical activities for external laboratories supporting biologic drug substance and drug product programs.
Role type
Senior IC analytical development scientist (external lab oversight)
Builds
Batch release, stability programs, regulatory submissions, and product lifecycle activities for biologic drugs
Domain
Biopharmaceuticals / Analytical Development / Quality Control
Required skills
GMP analytical testing, laboratory investigations (OOS/OOT), root cause analysis, regulatory compliance (FDA/ICH/USP/EP), cross-functional collaboration, scientific writing, data management
Preferred skills
External contract lab oversight, biologic analytical methods (chromatography, electrophoresis, potency), LIMS experience, regulatory submission documentation, statistical data analysis
Technologies
Veeva Vault Quality, Laboratory Information Management Systems (LIMS), ValGenesis, Kneat, JMP, Tableau
Responsibilities
Provide scientific and operational oversight of external analytical laboratories; Lead laboratory investigations from initiation through closure; Serve as primary technical liaison with contract laboratories; Review analytical data and technical documentation; Coordinate external testing activities across multiple programs; Partner with cross-functional teams; Drive continuous improvement of external laboratory oversight; Support audit, inspection, and regulatory readiness
Seniority
Mid-Senior, hands-on IC