Overview
In this role you will provide technical leadership and support for the global external manufacturing of commercial sterile drug products. You will partner with contract manufacturers and internal Technical Operations to ensure state-of-the-art processes, drive transfers, and manage investigations and CAPAs. The position offers exposure to senior management and opportunities to lead cross-functional teams on strategic external manufacturing initiatives. You will apply your expertise to maintain compliant, robust manufacturing operations and enable successful regulatory inspections.
Retribuzione / Benefits
- annual premio
- long-term incentives
- hybrid work arrangements
- benefits (unspecified)
- competitive compensation
- occupational healthcare
Responsabilità
- Lead technical issues for global external manufacturing of commercial Drug Product
- Provide technical leadership for sterile drug product management within Technical Operations
- Support technical transfers of new sterile drug products to contract manufacturing sites
- Drive internal and external changes to implement advanced technologies and processes
- Lead day-to-day technical activities including troubleshooting, process changes, and new technology implementation
- Serve as primary interface on technical matters between Technical Operations and third-party drug product manufacturers
- Provide leadership on Change Controls, investigations, CAPAs, and support for Health Authority Inspections
- Lead critical technical projects related to manufacturing of commercial sterile drug product
- Organize cross-functional teams to manage investigations and CAPA/change control implementations
- Coordinate risk assessments and develop innovative solutions for complex issues
Requisiti fondamentali
- Bachelor's degree in engineering, biological/chemistry sciences or related discipline
- 7+ years in manufacturing (process startup, routine manufacturing, and/or technical transfer)
- 3+ years in sterile/aseptic
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