Product Steward, Oligonucleotides (80-100%*)
- Basel, Switzerland
7! The current processing stages to deliver a complex innovative medicine in high quality to up to 4 million patients.
You play an important role in building up and supporting the start-up of a new production plant dedicated to oligonucleotides production. Only 4 companies worldwide manufacture with this technology today. Novartis planned a significant investment in this very complex process technology and we are very much excited to start the new oligonucleotides production with YOU.
The position is within Chemical Operations Switzerland. We play an essential role in the late phase delivery, launch and lifecycle management of small molecule drug substances.
Specifically for this position you support the activities related to the transfer in of the new oligonucleotides production, from the design and specifications of the plant to the start-up and the validation activities.
After the launch you will continue supporting production as product steward with the following
• Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC
• Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending
• Lead / support root cause investigation of process failures, initiate and lead product
• Design and manage optimization projects
• Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed
• Responsible for ensuring the continued state of validation (process, cleaning, ongoing verification etc.)
What you will bring to the team:
• MSc. in Pharmacy, Pharmaceutical Technology, Chemistry, Chemical Engineering or equivalent scientific degree. PhD desirable
• Expert knowledge in the field of oligonucleotide production processes
• Fluent in English and German
• Quick-wittedness and flexibility coupled with strong project management skills, dedicated and thoughtful to a diverse global team, motivated to perform in a highly dynamic environment and strong communication and problem solving skills
• 8+ years experience in process support, e.g. Process Manager role on the shopfloor of pharmaceutical manufacturing and/or QA/QC
• Proven IQP Background, IQP Silver certified and process understanding (Pharma, GMP, Regulatory aspects) and sound experience of data handling and applied statistics
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.
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