SENIOR CONTRACT MANUFACTURING MANAGER
The Sr. Manager, Contract Manufacturing is responsible for bulk manufacturing, commercial/clinical drug product fill activities, commercial/clinic drug product finish activities and occasionally other operations (such as creating Cell Banks, coordinating manufacturing schedules with corporate partners) outside the manufacturing facility.
- While functioning as the person in the plant at contract manufacturing activities, this person will ensure that the work has been completed as per company instructions and is, therefore, within the scope of the contract.
- As part of negotiating contracts for manufacturing this individual will evaluate the need for capital investments (in the form of dedicated equipment at contract manufacturing sites) and will have input into program budgets.
- He/she will coordinate all clinical and commercial material needs between the various manufacturing groups and the project teams to ensure that all clinical and commercial product needs are defined and met.
- He/she will lead the coordination for all clinical and commercial material needs between the various manufacturing groups and the project teams to ensure that all clinical and commercial product needs are defined and met.
- Monitor clinical/commercial production efforts at contract manufacturers.
- Coordinate production logistics, control documentation and metrics.
- With the Process Development, Regulatory Affairs and Quality departments, lead technology transfer and the final stages of process development.
- Optimize the inclusion and contributions from the Contract Manufacturing Staff, Process Development, Quality and Contractor staffs.
- Troubleshoot equipment and process failures. Follow-up on variance reports generated during production efforts.
- Communicate with members of the manufacturing group, and with other departments, as needed to optimize the production schedule.
- Write and review regulatory documentation as assigned.
- Contribute to the development of formal systems and procedures for the selection of CMOs.
- Contribute to the selection contract manufacturers for audit; initiate and implement necessary control systems within budget and to reduce cost of goods.
- With the Corporate Compliance and Quality departments, ensure that the physical contract facility is compliant with cGMPs.
- Manage contract and confidentiality agreements with the contract manufacturers, ensuring consistency between sites.
- Customarily and regularly exercises discretion and independent judgment in the performance of the duties described above.
- Some travel is required.
- Bachelors degree in science with 8 years of directly related experience GMP manufacturing experience, including at least 3 years of management/ supervisory experience. Ideally coming from the BioPharma industry.
- Masters degree in science with 4 years of directly related GMP manufacturing experience, including at least 3 years of management/ supervisory experience.
- Experience of working in a highly regulated facility governed by FDA and IMB.
- Working knowledge of manufacturing processes
- Highly developed organizational and leadership skills.
- Process development or technology transfer experience preferred.
- Excellent written and verbal communication skills.
- Strong Project Management experience coupled with strong negotiation experience.
- Ability to read/speak German an advantage.
If this position is of interest, please forward your CV Fastnet Recruitment to or phone Catriona for a confidential discussion at 021 4509200. [email protected]
Fastnet Recruitment has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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