Lead, Manufacturing
Core
Lead daily manufacturing operations, process equipment, and validation protocols in a cGMP biomanufacturing environment.
Role type
Manufacturing Lead (IC)
Builds
Biomanufacturing processes and purified products
Domain
Biotechnology / Biomanufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, process equipment operation, validation protocol execution, batch record management, deviation investigation, corrective and preventative action (CAPA), troubleshooting, shift scheduling, resource allocation, employee training and coaching, technical understanding of unit operations
Preferred skills
Purification leadership experience, Lean/Six Sigma/5S certifications, Trackwise, Delta V, LIMS
Technologies
Trackwise, Delta V, LIMS
Responsibilities
Execute manufacturing processing steps and monitor against batch records; coordinate and lead process steps as a subject matter expert; schedule tasks and plan resource allocation for the shift; document and review cGMP data including deviations; initiate and investigate deviations and implement CAPA; provide training and coaching to associates; serve as SME for audits
Seniority
Mid-level, hands-on IC