Process Hygiene Lead, Biologics Manufacturing
Core
Lead and execute Process Hygiene activities across Biologics Manufacturing, covering Central Services, Cell Culture and Purification, serving as the subject matter expert for contamination control and aseptic practices.
Role type
Senior IC Process Hygiene Lead (Biologics Manufacturing)
Builds
Contamination control strategies, aseptic practices, and facility cleaning/disinfection protocols for biologics manufacturing operations.
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Contamination control, Aseptic techniques, FMEA, Root-cause analysis, CAPA, Change control, GMP compliance, Risk assessment, Data trending, Shop-floor observation
Preferred skills
Regulatory inspection support, Statistical data analysis
Technologies
cGMP, FMEA, CAPA, GMP
Responsibilities
Lead contamination and cross-contamination FMEAs and process hygiene assessments; Support root-cause analysis and CAPA for contamination events; Drive continuous improvement and inspection-readiness initiatives; Assess aseptic techniques via Gemba observations and provide coaching; Partner with cross-functional teams to address process hygiene risks.
Seniority
Senior, hands-on IC