**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office **Position: Manufacturing Science & Technology Lead**:
Location: Ferentino, Province of Frosinone, Italy **Company information**:
Thermo Fisher Scientific Inc. leads in science services, with over $45 billion annual revenue. **Group/division summary**:
DPD, part of Pharma Services Group, serves large & specialty pharma and biotech companies in drug development. **Position summary**:
Leads the Site’s MSAT organization, which is responsible for maintaining and improving scientific oversight of the manufacturing processes and technical changes. This role ensures flawless product stewardship, across process units and functions at the Site. **Key Responsibilities**: - Ensure departments complete and uphold the VMP activities in their scope, including annual revalidation and cleaning procedures
- Coordinate robust product stewardship and provide technical oversight of manufacturing processes
- Act as a single point of contact for process technical issues within and across sites
- Maintain and develop scientific information of product processes
- Ensure all site products remain validated throughout their lifecycle
- Monitor CPP and CQA through continuous process verification and review of APRs/PQRs
- Collaborate with technical R&D; to ensure robust commercial scale-up of new products
- Lead technical transfer activities into the site
- Resolve issues and ensure process capability in collaboration with a distributed team in MSAT
- Lead technical change control management and regulatory engagements
- Support excellence in manufacturing through standard setting and capability development **Qualifications and Requirements**: - MSc. in Science, Pharmacy, Chemical Engineering, Pharmaceutical Technology or equivalent experience; Ph.D. desirable
- Fluent in English and proficient in site local language
- Minimum of 10 years’ experience in manufacturing; additional specialist experience preferred
- Proven quality and compliance experience
- Strong knowledge of applied statistics, quality systems, and regulatory requirements
- Fundamental understanding of pharmaceutical analytical testing
- Willingness to travel up to 15%
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