Lead Tech, Operations
Core
Lead end-to-end production operations and unit operations for biologics drug substance manufacturing, ensuring GMP compliance and troubleshooting process issues.
Role type
Senior IC biomanufacturing operations lead
Builds
Clinical supply, registration, and commercial launch biologics drug substances
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
Biotechnology manufacturing, Good Manufacturing Practices (GMP), troubleshooting, process equipment operation, contamination control, batch release, automation, single-use technologies, SOP authoring, data analytics
Preferred skills
None stated
Technologies
Delta V, Pas X, SAP Comet, elogs, Liquid Chromatography (LC), Autoclaving, Cell Culture Process Development
Responsibilities
Execute manufacturing processes per SOPs, act as unit operation lead and shift delegate, lead troubleshooting and continuous improvement projects, coach teams on documentation and safety, participate in audits and incident investigations, author and review technical documents
Seniority
Senior, hands-on IC