Related skills
quality assurance iso gmp process validation capa📋 Description
- Oversee day-to-day operations at contract sites to hit targets and quality.
- Serve as secondary Adverum contact with CMOs to ensure clear comms.
- Monitor CMOs performance; implement improvement plans as needed.
- Coordinate production runs with CMOs to meet schedule and budget.
- Ensure manufacturing processes comply with specs, regs, and standards.
- Review and approve manufacturing docs (MBRs, specs, deviations).
🎯 Requirements
- Bachelor’s degree in scientific or engineering discipline.
- 8+ years in manufacturing management; travel 30%+ to CDMOs.
- Drug Substance Viral Vector/AAV or biologics exp (upstream or downstream).
- Strong knowledge of manufacturing processes, aseptic processing, regulatory compliance.
- Proven track record managing external manufacturing partners; driving ops excellence.
- Excellent leadership, communication, and negotiation; multi-project management.
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