Product Steward

About the role

Novartis is seeking a Product Steward to own process knowledge of drug substance manufacturing throughout its commercial lifecycle, ensuring continuous improvement and seamless knowledge flow across functions and sites.

Key responsibilities

• Maintain end‑to‑end oversight of the drug substance manufacturing process from technology transfer through commercialization as the single point of contact.
• Support development, maintenance, and improvement of the process control strategy based on CQAs, CPPs, and CMAs.
• Monitor critical process variables through statistical analysis, OPV, and APQR, and communicate insights at site level.
• Provide technical data for product transfer activities and support troubleshooting, root‑cause investigations, and CAPA implementation.
• Assist validation leads with planning and assessing process validation and re‑validation requirements.
• Contribute to product registration strategies, regulatory submissions, lifecycle management, and site inspections.

Required profile

• Master’s degree in Biotechnology, Chemistry, Pharmacy, Chemical Engineering or related field.
• Minimum 5 years of experience in GMP manufacturing, late‑stage development or QA/QC.
• Strong understanding of upstream and downstream bioprocessing technologies, including cell culture, chromatography and filtration.
• Fluent in English and German with strong written and verbal communication skills.

Required skills

• Proficiency with SAP, MS Office, Minitab and JMP for data analysis.
• Experience in statistical analysis and product‑specific trending activities.
• Knowledge of GMP, ICH and other regulatory quality standards.

What we offer

• Temporary 2‑year contract with a market‑competitive base salary (€66,918 – €112,600 per year).
• Attractive incentive program, modern pension scheme, childcare facilities and learning & development opportunities.
• Potential performance‑based bonus and worldwide career possibilities within the Novartis group.