Contract Manufacturing - Product Stewardship

Salary Range: €81,600.00 - €151,500.00 Job Description Summary Accountable technical/scientific steward for assigned Drug Substance products, ensuring robust processes, lifecycle knowledge, continued validation, technical problem solving and an effective scientific interface between manufacturing and CMO customers. Job Description Major accountabilities: • Maintain end-to-end scientific and technical ownership of assigned external-customer drug substance processes manufactured within the Novartis Contract Manufacturing network; act as the Novartis technical SPOC for the customer. • Monitor process and product performance using statistical analysis, ongoing process verification (OPV), and agreed technical and quality indicators; translate trends into clear customer updates and actions. • Evaluate customer- or Novartis-initiated process and technical changes, including feasibility, regulatory impact, technical batch requirements, risks, timelines, cost implications, and business benefit. • Track customer product commitments and manufacturing performance; identify issues early and ensure timely implementation of corrective and preventive actions in alignment with Quality Agreements and contractual responsibilities • Lead or support joint root cause investigations and cross-functional product improvement initiatives. • Design and manage customer-funded or jointly agreed optimization projects, controlling scope, deliverables, timelines, technical risks, and implementation readiness • Lead and support technology transfers of biological drug substances into Novartis manufacturing sites. • Ensure efficient knowledge and information flow between the customer, Novartis project governance, and site functions. • Represent MS&T/Product Stewardship in internal and joint customer governance meetings. Minimum Requirements • Academic degree (MSc, PhD) in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Technology or equivalent. • Total 9+ years of exp and several years of experience in biopharmaceutical drug substance manufacturing, process development, MS&T, or technical product stewardship, preferably in a contract manufacturing environment or in a customer-facing technical role. • Proven understanding of biotechnology processes (Microbial and/or mammalian fermentation, downstream processing, GMP, regulatory aspects). • Thorough experience in computerized systems, sound experience of data handling and fundamental understanding of applied statistics (i.e. MS-office, SAP, Minitab). • Strong commercial awareness, including the ability to connect technical execution with contract scope, customer commitments, capacity, cost, and supply performance. • Demonstrated ability to resolve complex technical and operational issues, drive timely decisions, manage risk, and maintain a strong customer- and delivery-focused mindset. Rewards At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave. Expected Annual Base Salary Range for role: • 81,600 151,500 EUR …