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Title: Fill & Finish Lead
Location: Schaffhausen, Switzerland
Rate: Open
Openings: 1 Lead
Contract/Perm: Contract (18-Months)
Join the team and be part of an innovative company that values inclusion, growth, and impact. Our dynamic work environment offers brilliant opportunities for advancement. We're seeking talented and driven individuals who share our passion for making a difference within the Life Science industry.
Proclinical is seeking a Fill & Finish Lead to join our client's team in Schaffhausen, Switzerland. This role focuses on leading fill and finish projects within the pharmaceutical industry, particularly in analgesics and anaesthetics.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Key responsibilities
1. Lead Fill Finish (and Device Assembly) projects (Focus on fill & finish)
2. Representation of Fill Finish Pilot Plant interfacing with the Drug Product Development group, the Drug
3. Delivery Systems group, the supply management team ensuring timely clinical supplies.
4. Ensure that manufacturing relevant information and technical capabilities are in place for the operations team to flawlessly produce the DP/DA according to GxP, EHS and business requirements
5. Ensure timely plant readiness and support the operations team in the execution of the experimental/clinical activities
6. Ensure timely delivery of clinical material from to Pack&Label sites (internal and/or external)
7. Manage the overall relationship with internal/external stakeholders and act as the single point of contact between the organization and pilot plant facility
8. Provide pilot plant input & requirements as required
9. Source raw materials and components when required
10. Ensure that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations
11. Ensure and/or support planning, execution and documentation (protocols, reports, memo)
12. Support investigations, CAPAs, change controls according to assigned responsibilities, and performs critical raw data review for key documents
13. Forecasts and monitor actual spending vs budget
14. Maintain compliance with all company policies and procedures
Requirements
15. A degree in Pharmaceutical/Biochemical/Chemical or relevant Sciences or comparable experience in pharmaceuticals or in a related field with demonstrated ability (3+ years) OR a PhD with proven experience (1+ years)
16. Demonstrated proficiency and experience in biologics drug product development and/or device assembly within the biopharmaceutical industry is helpful
17. Demonstrated proficiency and experience of biopharmaceutical process design is helpful
18. Solid understanding and experience of technology transfer operations is preferred
19. Solid understanding and experience in fill/finish operations and/or device assembly is preferred
20. Proven track record of creativity and problem solving
21. Ability to collaborate with cross-functional teams is a must
22. Excellent oral and written language skills in English (German is a plus)