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