Process Manager (m/f/d) MSAT Upstream - 2 year contract
Core
Oversee upstream processes for customers' APIs throughout the complete product life cycle, including design, scale-up, transfer, and validation.
Role type
Process Manager (Upstream)
Builds
Upstream processes for biopharmaceuticals
Domain
Biopharmaceutical manufacturing / CDMO
Required skills
Upstream processing, Process scale-up and transfer, Process qualification and validation, Control strategy definition, Continued process verification (CPV), CMC dossier review, Regulatory compliance, Risk assessment, Statistical concepts and tools
Preferred skills
Downstream processing knowledge
Technologies
Scalable technologies for biopharmaceutical manufacturing
Responsibilities
Design robust, scalable, and economic upstream processes; Support process qualification and validation at manufacturing scale; Definition of control strategies for commercial manufacturing; Setup and performance of continued process verification; Direct communication and representation towards customers; Troubleshooting and process optimization at manufacturing scale; Review of relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA); Participation in customer audits and authority inspections
Seniority
Mid-level, hands-on IC
