Lead Engineer, MSAT - Purification
Core
Lead process support and technical investigations for cell culture and purification stages in biomanufacturing.
Role type
Senior process support engineer (purification)
Builds
Robust manufacturing operations for biologic therapies
Domain
Biotechnology / Biopharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
biotechnology process development, process support, purification domain expertise, GMP compliance, batch record review, technical investigation, data integrity, change request management, regulatory reporting (APR/CPV/BLA)
Preferred skills
none stated
Technologies
none stated
Responsibilities
Lead preparation, execution, monitoring, and post-campaign activities for cell culture or purification stages; monitor processes to identify issues and lead cross-departmental investigations; review batch records and provide technical input to documentation specialists; support GMP and commercial runs, author technical reports, and troubleshoot process excursions; support Annual Product Review (APR) and Continued Process Verification (CPV) reports and customer BLA filings; maintain process databases and monitor batch-to-batch consistency; support inspections, audits, and data integrity improvements.
Seniority
Senior, hands-on IC
