The External Manufacturing Manager has responsibility for the operation of clinical and commercial parenteral drug product manufacturing in the External Manufacturing Network.
They coordinate all aspects of manufacturing operations including overseeing day-to-day operations, technology transfer, new technology introduction, issue resolution, relationship management, and supply fulfilment at drug product manufacturing sites.
- Oversee production on site, co-ordinate the activities at Drug Product manufacturing sites to meet the company Supply requirements.
- Coordinated all DP Manufacturing operations at contract and/or business partner manufacturing sites, including but not limited to: scheduling of all batches, supply of materials, direct shipment of bulk and finished product at manufacturing site, track and monitor cycle times, technology transfer execution and providing any required associated reports and technical expertise.
- Ensure the timely routing and review of all master manufacturing records (MRs), standard operations procedures (SOPs), tech transfer reports, validation master plans, and other documentation related to clinical and commercial drug product manufacturing at drug product manufacturing sites and/or business partners.
- Provide regulatory filing supports (IND, BLA, MAA, etc.).
- Maintain required training status on specific work instructions and SOP’s.
- Lead sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
- Support all investigations which concern DP Manufacturing or associated shipping operations, when required.
- Ensure product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
- Travel to contract manufacturers or business partners, as required. Ability to travel up to 50%.
- BS/BA in Life Sciences or a related field and 7 years of industry relevant work experience. Relevant experience may be substituted in lieu of educational requirement.
- Aseptic Parenteral Filling operations or development experience.
- Previous experience providing technical support and interacting with Contract Manufacturing organisations.
- Good interpersonal, cross-cultural, communication, negotiation and problem-solving skills
- Good knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, IMB, etc.)
- Project management (PMP or equivalent) qualification preferable.
For a confidential discussion on the above role please contact Michael O’Leary on 061-512270