Manufacturing Tech Lead
Core
Leads and performs complex manufacturing operations for biopharma and medical device products, including aseptic compounding, filling, packaging, and equipment operation in cleanroom environments.
Role type
Senior Manufacturing Technician / Tech Lead
Builds
Biopharma and medical device products (finished doses)
Domain
Biopharmaceuticals / Medical Devices
Required skills
aseptic techniques, fill finish operations, GMP/ISO compliance, equipment operation (lyophilizers, autoclaves, vial washers), sterile environment gowning, SOP/MBR review, team leadership, troubleshooting, documentation management
Preferred skills
pharmaceutical or medical device industry experience (2-4 years), finished dose form experience, mechanical aptitude, risk analysis
Technologies
lyophilizers, autoclaves, vial washers, depyrogenation equipment, centrifuges, mills, benchtop instruments
Responsibilities
Lead team to accomplish daily manufacturing tasks; operate and maintain aseptic filling and lyophilization equipment; prepare solutions and perform sterile/non-sterile filling and labeling; troubleshoot equipment and process issues; train less experienced staff on aseptic techniques; maintain production documentation and batch records; ensure compliance with safety and GMP/ISO standards.
Seniority
Mid-Senior, hands-on IC with team lead responsibilities