Manager Quality Control (Analytical Testing)
Core
Oversee day-to-day analytical testing activities (raw materials, utilities, in-process, release, stability) for biologics and small molecule manufacturing, ensuring compliance with cGMP and data integrity.
Role type
Manager, Quality Control (Analytical Testing)
Builds
Qualified analytical testing results supporting product release and manufacturing operations
Domain
Pharmaceutical/Biotechnology Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP laboratory operations, analytical chemistry, bioassay, immunoassay, HPLC/UPLC, GC/HS-GC, FTIR, UV-Vis Spectroscopy, Karl Fischer Titration, TOC/Conductivity/pH testing, Capillary Electrophoresis, Compendial testing, LIMS/CDS/ELN, biologics testing (ELISA, cell-based bioassays, HCP, potency), method validation/transfer, team leadership, operational excellence/Lean
Preferred skills
Cross-functional collaboration, troubleshooting analytical methods, regulatory inspection readiness, continuous improvement initiatives
Technologies
HPLC, UPLC, GC, HS-GC, FTIR, UV-Vis, Karl Fischer, TOC, Conductivity, pH, Capillary Electrophoresis, LIMS, CDS, ELN
Responsibilities
Lead day-to-day analytical testing activities; Manage laboratory resources, staffing, and capacity planning; Ensure compliance with cGMP and data integrity; Review and approve analytical records and quality documentation; Lead operational excellence and Lean initiatives; Coach and develop a team of analysts and senior analysts
Seniority
Manager, hands-on leadership
