Senior Associate - Biomanufacturing, Compliance - Manufacturing Technical Support
Core
Lead rapid response as incident commander for biomanufacturing operations, ensuring compliant GMP execution and delivering high-quality biologics.
Role type
Senior Associate, Biomanufacturing Compliance & Technical Support
Builds
Clinical and commercial production of biologics (mammalian cell lines, mRNA, molecular therapeutics) in a cGMP environment
Domain
Biopharmaceutical manufacturing / Biomanufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, batch documentation authoring, statistical data analysis, manufacturing equipment troubleshooting, tech transfer support, upstream/downstream bioprocess knowledge, root cause analysis, process optimization
Preferred skills
late-phase/PPQ/commercial program experience, facility fit expertise, process scale-up knowledge
Technologies
single-use systems, computer monitor screens
Responsibilities
Lead rapid response as incident commander for manufacturing operations; Author and oversee batch documentation; Analyze and present process data and trends; Support deviations, change controls, and CAPAs; Drive process and equipment improvements; Partner with cross-functional teams on tech transfer and project delivery; Coach and develop team members
Seniority
Senior, hands-on IC