Operator Lead, Production
Core
Senior operator leading aseptic manufacturing processes, equipment operation, and team mentorship in a biopharmaceutical setting.
Role type
Senior IC aseptic production operator lead
Builds
Sterile pharmaceutical products (therapies for family building and disease treatment)
Domain
Biopharmaceutical manufacturing / Aseptic processing
Required skills
aseptic techniques, cleanroom protocols, cGMP compliance, advanced aseptic equipment operation, troubleshooting, process optimization, batch record review, deviation analysis, continuous improvement, shift flexibility
Preferred skills
technical or vocational education, mentorship experience
Technologies
isolators, filling machines, lyophilizers, autoclaves
Responsibilities
Lead and execute complex aseptic processing tasks including setup, sterilization, formulation, filling, and lyophilization. Take charge of advanced equipment operation, troubleshooting, and maintenance. Provide mentorship and training to junior and intermediate operators. Collaborate with cross-functional teams to address deviations and drive process improvements. Lead aseptic process simulations, media fills, and equipment qualifications. Perform in-process inspections and quality checks. Analyze and approve batch records and process data for compliance. Drive continuous improvement initiatives to optimize processes and reduce waste.
Seniority
Senior, hands-on IC with leadership responsibilities