14 set
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EUSA Pharma
|
Monza
OverviewIn 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.
ResponsabilitàLead 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 fondamentaliMin.
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