Act as the global technical reference for sterile biotech products
Ensure technical robustness throughout the product lifecycle
Deliver innovative, compliant solutions supporting the business and Quality organization
Contribute to the definition and execution of the industrialization strategy for new products
Structure, plan, and coordinate industrial process validation activities
Provide technical leadership for lifecycle management projects concerning established products
Lead and oversee Technology Transfer activities
Coordinate Product Technical Teams and contribute to development meetings
Review and approve technical protocols and reports
Support Program Managers and product teams in the preparation of key deliverables and updates
Collaborate with Virtual Plant Managers and Procurement
Participate in due diligence activities for multidisciplinary projects
Contribute to the global harmonization of processes in collaboration with relevant stakeholders
Perform product Sustainability Assessments and define improvement plans

Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field
10+ pharmaceutical/biotech industry years in drug product manufacturing, with experience in aseptic processing
Fluency in written and verbal communication in English
Willingness to travel up to 30%
Experience working in multicultural and multinational environments
Experience working within a CRO or CMO environment
Demonstrated strength in project management, problem-solving, and interpersonal communication
Solid understanding of the pharmaceutical industry and end-to-end Biotech sterile products manufacturing
Experience in pharmaceutical or biotech MSAT process development and/or GMP manufacturing
Strong working knowledge of current regulations, quality expectations, and industry trends related to sterile manufacturing and testing
Ability to lead cross-functional project teams in an international environment
Strong interpersonal skills and ability to interact with different stakeholders

Technical Leader – Sterile Products, Large Molecules

Key skills