Assoc Research Scientist – GxP Operations
Core
Lead deviation and investigation reviews for Drug Product Facilities and Kilo Labs, perform PAT operator tasks during GMP manufacture, and author/approve batch record workflows and SOPs.
Role type
Senior GxP Operations Scientist (GMP Manufacturing)
Builds
GMP-compliant drug manufacturing processes and documentation
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP/GDP compliance knowledge, deviation and investigation management, batch record review, SOP authoring, Process Analytical Technology (PAT) operations
Preferred skills
None stated
Technologies
Microsoft Office Suite
Responsibilities
Lead, write, and review deviations and investigations; Perform PAT Operator tasks during GMP manufacture; Review executed batch records for compliance; Author and approve workflows for batch records, SOPs, and WIs
Seniority
Senior, hands-on IC
