Senior Scientist, Biologics Drug Substance Commercialization Process Analytics
Core
Lead process analytics for biologics drug substance commercialization, ensuring scientific rigor and operational readiness during R&D to commercial transition.
Role type
Senior Scientist, Process Analytics (Biologics)
Builds
Robust analytical methods and data analysis for diverse biologics pipelines
Domain
Biopharmaceuticals / Biologics Process Development
Required skills
Analytical Chemistry, Chromatographic Techniques (HPLC/UPLC/IEX/SEC/HIC), Method Development, Troubleshooting, Process Development, cGMP, Data Analysis, Project Management, Technical Leadership
Preferred skills
Critical Quality Attributes (CQA) testing, Capillary Electrophoresis, icIEF, ELISA, PCR, ICH Guidelines, Process Validation, Tech Transfer, Electronic Laboratory Notebooks, Empower
Technologies
HPLC, UPLC, IEX, SEC, HIC, capillary electrophoresis, icIEF, ELISA, PCR, SoloVPE, CAD, fluorescence, Empower, TECAN
Responsibilities
Provide technical leadership and guidance to the Process Analytics team; Support routine testing, troubleshooting, and robust data analysis; Collaborate with drug substance/product teams for lifecycle support; Establish new methods and oversee handoff from R&D to commercial analytics; Author technical protocols and regulatory documents for process comparability.
Seniority
Senior, hands-on IC with leadership responsibilities
