Overview

In this role you lead technology transfer and industrialization efforts for small molecule products, ensuring robust technical oversight across internal and external manufacturing sites. You will coordinate cross-functional teams to drive project execution, manage risks, and support supply continuity. You help shape scalable processes and maintain regulatory and GMP alignment in a fast-paced environment. This position offers impact across commercialization, lifecycle management, and continuous improvement within a global pharma setting.

Responsabilità

- Lead technology transfer projects for small molecule drug products across internal and external manufacturing sites
- Coordinate TT master plans, protocols, gap assessments, process descriptions, validation strategies
- Support process scale-up, PPQ, and readiness of manufacturing documentation
- Troubleshoot technical issues, propose solutions, and guide SME/CDMO decision-making
- Ensure alignment with CMC, regulatory commitments, and change control processes
- Provide technical oversight for commercial processes across solid dosage, semisolid, sterile and non-sterile forms
- Review and approve manufacturing documentation (batch records, SOPs, control strategies)
- Analyze manufacturing data, identify optimization opportunities
- Support process validation, OOS/OOT investigations, deviation resolution, and CAPA definition




- Drive cross-functional teams to ensure timely delivery of project milestones
- Coordinate information flow with internal and external stakeholders for transparency
- Manage timelines, budget, risks, mitigation plans, KPIs, and governance reporting
- Foster collaboration across functions and geographies while maintaining GMP/regulatory awareness

Requisiti fondamentali

- Min. 6-7 years’ experience in MSAT, Technical Operations, Technology Transfer in pharma
- Solid understanding of manufacturing processes for solid oral dosage forms, semisolids, and sterile/non-sterile liquids
- Experience managing technology transfer, process validation, and commercial manufacturing support
- Competence in reviewing technical documentation and scientific/quality evaluations
- Strong knowledge of ICH guidelines, GMP, validation principles, and change control
- Ability to work under pressure, manage multiple priorities, and operate in cross-functional settings
- Experience with external manufacturing management (CMOs/CDMOs) is a strong plus
- QC/QA or CMC background considered a significant advantage

- Strong analytical mindset
- Problem-solving and autonomous decision-making
- Ability to work with global teams and adapt to different cultures
- MSAT and technology transfer leadership
- Process validation and PPQ
- GMP compliance and regulatory frameworks

📌 Technology Transfer Project Manager (Monza)
🏢 EUSA Pharma
📍 Monza