Group Leader - Biologics
Core
Lead a team of analysts and scientists to execute complex biologics testing, manage resources, and ensure compliance with cGMP/GLP guidelines.
Role type
Senior IC Group Leader (Biologics Testing)
Builds
Certificates of Analysis, technical reports, and deviation/CAPA documentation for clients.
Domain
Life Sciences / Biologics / Contract Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Bioseparations experience, cGMP/GLP compliance, team management, project prioritization, data analysis, protocol writing, failure investigation
Preferred skills
HPLC/UPLC/Mass Spec operation, Elisa/qPCR/ddPCR/SPR/BLI expertise, method transfer coordination
Technologies
HPLC, UPLC, Mass Spec, Electrophoresis, Elisa, qPCR, ddPCR, SPR, BLI, Sanger sequencing, ELIS
Responsibilities
Monitor and maintain staff workflow and schedules; manage resource allocation and project prioritization; write and approve protocols, methods, and technical reports; lead investigations for OOS, OOT, and deviations; execute experiments per SOPs and cGMP; coordinate method transfers between clients and SGS; analyze testing data and prepare reports.
Seniority
Senior, hands-on IC with management duties
