Manufacturing Science & Technology Director

Thermo Fisher Scientific; Ferentino; In loco; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

A global leader in scientific services is seeking a Manufacturing Science & Technology Director in Ferentino, Italy. In this role, you will lead the MSAT organization, ensuring oversight of manufacturing processes and compliance. The ideal candidate will have an MSc and at least 10 years of manufacturing experience, along with strong knowledge of regulatory requirements and quality systems.

Competenze

• Minimum of 10 years’ experience in manufacturing.
• Proven quality and compliance experience.
• Fundamental understanding of pharmaceutical analytical testing.

Mansioni

• Lead the Site’s MSAT organization.
• Ensure departments complete VMP activities.
• Coordinate product stewardship and technical oversight.
• Act as point of contact for technical issues.
• Collaborate with R&D for scale-up of new products.

Conoscenze

Fluent in English

Proficient in local language

Applied statistics knowledge

Quality systems knowledge

Regulatory requirements awareness

Manufacturing experience

Formazione

MSc in Science, Pharmacy, Chemical Engineering or equivalent

Ph.D. (desirable)

Descrizione del lavoro

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Position: Manufacturing Science & Technology Director
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%