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Manufacturing science & technology lead

Ferentino
Pubblicato il 11 settembre
Descrizione

1. Ensure departments complete and uphold the VMP activities in their scope, including annual revalidation and cleaning procedures
2. Coordinate robust product stewardship and provide technical oversight of manufacturing processes
3. Act as a single point of contact for process technical issues within and across sites
4. Maintain and develop scientific information of product processes
5. Ensure all site products remain validated throughout their lifecycle
6. Monitor CPP and CQA through continuous process verification and review of APRs/PQRs
7. Collaborate with technical R&D to ensure robust commercial scale-up of new products
8. Lead technical transfer activities into the site
9. Resolve issues and ensure process capability in collaboration with a distributed team in MSAT
10. Lead technical change control management and regulatory engagements
11. Support excellence in manufacturing through standard setting and capability development

Qualifications and Requirements

12. MSc. in Science, Pharmacy, Chemical Engineering, Pharmaceutical Technology or equivalent experience; desirable
13. Fluent in English and proficient in site local language
14. Minimum of 10 years’ experience in manufacturing; additional specialist experience preferred
15. Proven quality and compliance experience
16. Strong knowledge of applied statistics, quality systems, and regulatory requirements
17. Fundamental understanding of pharmaceutical analytical testing
18. Willingness to travel up to 15%

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