Process Expert MSAT Downstream- Mammalian Large Scale (m/f/d)
Core
Lead cross-functional teams to execute technology transfers, process design, up-scaling, and implementation of mammalian large-scale bioprocesses at manufacturing scale.
Role type
Senior Process Expert (Mammalian Large Scale Downstream)
Builds
Manufacturing units and scaled biopharmaceutical processes
Domain
Biopharma manufacturing / Mammalian cell culture
Required skills
Bioprocess technology, GMP compliance, Technology transfer, Process up-scaling, Project management, Risk analysis, Batch execution, CMC documentation, Change control, Continuous improvement, Mentoring, Training
Preferred skills
PhD, Biotechnology or chemical engineering background, Mammalian manufacturing experience, Leadership, Innovation
Technologies
MSAT, GMP, Block-flow diagrams, Validation reports
Responsibilities
Lead technology transfers and process up-scaling; Act as interface between process development and operations; Manage process risks and change control; Execute GMP risk analyses; Deliver inputs for capital investment projects; Implement manufacturing processes in plant; Interact with customers during campaigns; Compile deviations and validation reports; Mentor and train production staff.
Seniority
Senior, hands-on IC with leadership responsibilities
