Senior Scientist
Core
Senior Scientist and Gas Chromatography (GC) Subject Matter Expert leading technical operations in a GMP-regulated Biopharmaceutical Chemistry laboratory.
Role type
Senior Scientist (Analytical Chemistry / GMP)
Builds
High-quality analytical testing services and validated methods for biopharmaceutical products.
Domain
Biopharmaceuticals / Analytical Chemistry / GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Gas Chromatography expertise, GMP/GLP compliance, method development and validation, pharmacopoeial standards (USP/EP/BP/JP), root cause analysis, CAPA management, technical leadership, regulatory inspection support
Preferred skills
None stated
Technologies
Gas Chromatography instruments, GMP documentation systems
Responsibilities
Lead complex analytical testing and method development/validation; Conduct technical reviews, data audits, and batch audits; Lead root cause investigations and quality risk assessments; Develop and approve analytical procedures and GMP documentation; Provide technical guidance and training to the department; Support regulatory inspections and client audits.
Seniority
Senior, hands-on IC with leadership responsibilities
