MSAT – Process Expert Mammalian Cell Culture DSP, Ibex
Core
Process Expert responsible for technology transfers, scale-up, and optimization of mammalian cell culture processes for large-scale manufacturing (up to 20,000L) in the Drug Substance area.
Role type
Senior IC Process Expert (Mammalian Cell Culture)
Builds
Manufacturing units and biologic drug substances
Domain
Biopharma / Life Sciences / Mammalian Cell Culture
Required skills
Mammalian bioprocess technology, GMP compliance, Technology transfer management, Process scale-up, Project lifecycle management, Risk analysis, CMC documentation, Change control, Troubleshooting, Mentoring
Preferred skills
PhD in Biotechnology or Chemical Engineering, Experience in Capital investment projects, Standard procedure development, Innovation in process performance
Technologies
MSAT (Manufacturing Scale-Up and Transfer) framework, GMP systems
Responsibilities
Lead cross-functional teams for technology transfers and process implementation; Act as interface between process development and operations; Manage technology transfer risks and change controls; Deliver inputs for capital investment projects (block-flow diagrams, media lists); Compile CMC sections and validation reports; Supervise production staff and resolve process issues; Mentor scientific and production staff.
Seniority
Senior, hands-on IC with mentorship responsibilities
