Main Mission
Support technology transfer, process validation, and Continued Process Verification (CPV) activities for mammalian cell-based biotechnological manufacturing processes, across internal sites and Contract Manufacturing Organizations (CMOs).
Key Responsibilities
Technology Transfer:
- Support transfers from development to internal manufacturing and CMOs.
- Contribute to drafting key documents (risk assessments, protocols, reports).
- Collaborate with MSAT bio-process leads.
Validation & CPV:
- Contribute to validation strategy (risk assessments, documentation).
- Implement and coordinate CPV activities for both internal sites and CMOs.
Operational Support:
- Provide support for manufacturing campaigns (process performance monitoring, equipment/material qualification, troubleshooting).
- Participate in regulatory inspections and submission activities (e.g., PAS).
Process Improvement / COGS Reduction:
- Monitor commercial manufacturing and implement process improvements within approved parameters.
- Conduct and coordinate small-scale studies and change controls.
- Act as a subject matter expert (SME) during deviations, audits, and cross-functional projects.
Quality:
- Comply with cGMP requirements and complete all required training.
- Ensure validation/CPV documentation is current and inspection-ready.
- Present documentation during inspections and audits.
Health, Safety & Environment (HSE):