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Manufacturing and Technical Expert
1 week ago
Key Responsibilities:
- Lead the MFG 7 Batch-Fed Single Use facility, ensuring production timelines are met
- Provide technical oversight to teams, coaching associate staff, and serving as MFG 7 drug substance process subject matter expert
- Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections
- Oversight of design, construction, and qualification of the MFG 7 facility in Dundalk
- Technical Point of Contact for customers in relation to MFG 7
- Providing technical and commercial leadership of: day-to-day Upstream and Downstream manufacturing activities, equipment, facility, and documentation changes within the facility
Requirements:
The ideal candidate will have more than 15 years' experience in a cGMP biological manufacturing environment, with previous experience managing and/or leading functional and project teams. Experience across both Upstream and Downstream manufacturing activities is essential. Greenfield or large site expansion experience is beneficial, as is experience working with lean principals and implementing CI processes within a complex manufacturing operation.
The successful candidate will also possess significant expertise in manufacturing processes and systems, a proven track record in delivering large-scale manufacturing projects, and demonstrated success in scientific and technical proficiency, bioprocess implementation, cGMP operation, and teamwork.