Drug Product Project Leader (Biologics) | Chemiker/in
Novartis Pharmaceutical Manufacturing GmbH
Job Summary
This role seeks an experienced, resilient leader to act as the strategic lead for late-stage drug product development of Biologics within a global team at Novartis. The Drug Product Project Leader will represent Drug Product Development in the global Chemistry Manufacturing Controls (CMC) team, ensuring the timely delivery of agreed milestones and championing scientific excellence in formulation and process development, technical transfers, process validation, and registration. Key responsibilities include leading and coordinating the global drug product sub-team, setting priorities, managing project budgets, and proactively communicating strategy to stakeholders. The ideal candidate holds a Ph.D. in a relevant scientific field and possesses a minimum of eight years of industry experience focused on drug product development, regulatory submissions (IND/BLA), and proficiency in Quality by Design (QbD) and Good Manufacturing Practice (GMP). This impactful role is crucial for bringing innovative biological products to market.
Required Skills
Education
Ph.D. in Pharmaceutical Technology, Biotechnology, Chemical Engineering, or equivalent
Experience
- Minimum of 8 years of relevant industry experience with a focus on drug product formulation and process development, technology transfers and regulatory submissions
- Track record of leading cross-functional global teams and projects
- Professional experience with Investigational New Drug (IND) / Biologics License Application (BLA) submissions
Languages
Additional
- Hybrid working model; Position located in Schaftenau, Austria; Openness to digital transformation and adopting new digital tools and AI-driven solutions.