Senior Expert Technical Transfers

About the role

The Senior Expert Technical Transfers oversees clinical manufacturing site activities for drug substance and product process transfers, acting as the main contact throughout all transfer phases. The role is onsite in Menges, Slovenia and covers scale-ups and adaptations, leading the technical transfer team and coordinating with Technical Development, Supply Chain and Quality Control.

Key responsibilities

• Initiate technology transfer activities after the documented supply point decision and run them through a change control procedure
• Provide leadership and oversight of change control during the transfer
• Communicate the project strategy, key issues and critical topics to management and project teams
• Nominate the process transfer team at the receiving site, set priorities and give performance feedback
• Develop a scientifically sound transfer strategy aligned with the CMC team strategy and coordinate between transferring and receiving sites
• Ensure knowledge transfer, adherence to best practices, regulatory guidelines and quality standards, and monitor project progress
• Collaborate with the sub-team on risks and mitigation plans, and outline internal resources and external costs
• Draft key transfer documents and source and registration materials, and contribute expert answers to health authority questions

Required profile

• Minimum: bachelor's degree or equivalent; desirable: advanced degree (master's or Ph.D.)
• Proven 3 years of directly related experience as an expert or equivalent
• Recognized expertise in a specific area and thorough understanding of business processes
• Ability to work in and/or lead interdisciplinary and cross-cultural teams
• Technical knowledge of English

Required skills

• Good knowledge of software and computer tools
• Strong knowledge of SOP, GLP, GMP and Novartis regulations and policies
• Leadership, project management, communication, presentation and scientific/technical writing skills
• Advanced coaching skills

What we offer

• Base salary range of EUR 46,550 to 86,450, with a possible performance-based bonus
• Insurance plans, retirement plans, wellbeing resources and global recognition programs
• Flexible and hybrid working options where possible, and at least 14 weeks of paid parental leave