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Technical Transfer Production Team Lead required for expanding biotech manufacturing facility in Sligo town. The successful candidate will have NPI and production support experience in the biotechnology and/or pharmaceutical sector. The successful candidate will lead, coach and mentor existing team. Will report into the Technical Transfer Manager.
Get in touch with me for further information : Deirdre Murphy on 01 / or
Please note - applicants need to have a Stamp 4 or to have unrestricted full working rights for Ireland
Role
1. Lead, motivate and develop the team and provide technical expertise and technical leadership for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review, and approval of change controls.
2. Provide team leadership - setting work goals, controlling and meeting goals, professional and personal development of team members.
3. High level of on the floor activity day to day to support production issues.
4. Lead product related problem-solving initiatives – be inquisitive.
5. Understand science of process incl process flows, CPP's, historical failures.
6. Conduct process monitoring/trending.
7. Support QA with generation and closure of annual product reviews.
8. Use Continuous improvement tools for incremental change.
9. Implementation of new production methods, Technology transfer: Examination of production methods prior to their transfer to production, including validation (when needed).
10. Follow-up and training of production teams.
Requirements
11. Min 5 years experience in the biotechnology and/or pharmaceutical industry, with experience of new product introductions and product support.
12. Knowledge of the processes and equipment necessary for the manufacture of pharmaceuticals (oral solid dose), parenterals and/or biologicals
13. Experience in authoring, review and execution of validation studies and reports is a must.
14. Experience with vaccines would be preferable particularly in the area of product development and stewardship.
15. Ability to prioritize workload for self and reports, experience coaching and mentoring a team.
16. Demonstrated ability in leading root cause analysis and effective investigation practices.
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