Senior Scientist - Method Transfer CMO
Core
Transferring analytical methods for small molecule drug substances to Contract Manufacturing Organizations (CMOs) and validating methods for late-phase and commercial pharmaceutical projects.
Role type
Senior Scientist, Method Transfer & Validation
Builds
GMP-compliant drug substances, intermediates, and starting materials for commercial products
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
small-molecule drug substance IPC and stability methods, chromatography (HPLC, GC, MS), compendial methods (KF, elemental impurities, spectroscopy), cGMP and ICH guidelines, root cause analysis for quality events, commercial data trending
Preferred skills
analytical development, technical operations, commercial change control procedures
Technologies
HPLC, GC, MS, spectroscopy
Responsibilities
Execute method transfers for small molecule drug substances to CMOs, perform method validation for commercial projects, author and review GMP documentation (SOPs, transfer protocols), manage CMOs for manufacturing of starting materials, review CMO analytical data (release and stability), generate commercial data reports for continuous process verification
Seniority
Senior, hands-on IC