Biotech Specialist Downstream Processing
Core
Process expert for biologics production, ensuring continuity, robustness, and compliance of commercial downstream processing operations from shopfloor troubleshooting to structural improvements.
Role type
Associate Specialist Engineering (Biotech Specialist Downstream Processing)
Builds
Drug substances for commercial biologics production
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Troubleshooting, Deviation management (CAPA, root cause analysis), Process documentation (MBR, PAS-X), Cleaning protocols, Change control, Sampling plans, Batch evaluation, Project team collaboration
Preferred skills
Lean Manufacturing, Continuous Improvement, Root Cause Analysis, Lean Six Sigma (Yellow/Green Belt)
Technologies
PAS-X, GMP-compliant systems
Responsibilities
First-line troubleshooting on the shopfloor, coordinating deviations and root cause analysis, writing and reviewing process and cleaning documentation, managing change control and SOPs, ensuring availability of process assets, evaluating sampling plans and specifications, collecting and verifying process data, participating in process transfer projects
Seniority
Associate, hands-on IC
