Technical Leader Sterile Products & Large Molecules (Process Validation & Life Cycle Management)

TL;DR

Technical Leader Sterile Products & Large Molecules (Process Validation & Life Cycle Management) (Biotech): Acting as global technical reference for sterile biotech products throughout the product lifecycle with an accent on industrialization strategy, process validation, and lifecycle management. Focus on leading technology transfers, coordinating cross-functional teams, and implementing modifications to critical components like APIs and devices.

Location: Primary work in Parma, Italy, combining on-site presence with remote work; may allow working from other strategic European locations. Willingness to travel up to 30% required.

Company

International research-focused biopharmaceutical group headquartered in Parma, Italy, with 8,000+ employees across 30+ countries, producing innovative drugs including sterile biotech products.

What you will do

• Lead technology transfer activities from R&D or partners to manufacturing sites, focusing on process validation.
• Coordinate product technical teams and cross-functional workstreams for project milestones.
• Provide technical leadership for lifecycle management projects, including site transfers and component changes.
• Review and approve technical protocols, reports, bills of materials, and master data.
• Support preparation of deliverables for governance bodies and collaborate on commercial agreements.
• Contribute to global harmonization of biotech sterile processes and perform sustainability assessments.

Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
• 10+ years in pharmaceutical/biotech drug product manufacturing with aseptic processing experience.
• Fluency in written and verbal English.
• Willingness to travel up to 30%.
• Strong knowledge of regulations, GMP manufacturing, and sterile processes.

Nice to have

• Experience in multicultural/multinational or CRO/CMO environments.

Culture & Benefits

• Comprehensive healthcare, work-life balance initiatives, and flexible working arrangements including remote options.
• Competitive salary with performance bonuses, benchmarked to market.
• Robust relocation support and tax assistance for foreign colleagues.
• Development resources, training, and focus on sustainability as a B Corp.
• Diversity, inclusion, and equal opportunity employer.