14 set - Monza
EUSA Pharma
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
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