Summary
About the Role
Key Responsibilities:
• Act as SPOC on site for technical transfer.
• Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches for transfer and provide input into overall project strategy and plans including timelines. Initiate local change control in system on site and ensure approval and closure.
• Form and lead site project team, coordinate project team activities.
• Ensure timely availability of technical documentation. Write Manufacturing Process Transfer Documents (protocol, report).
• Review and update Quality Risk Assessment (QRA) prior to transfer and prior to validation, adapt control strategy if needed. Review first APQR after transfer to ensure adequate product performance.
• Contribute to process improvement and optimization for product transfers.
• Ensure that all relevant technical information and documentation for validation is available.
• Coordinate technical, regulatory and validation batches at site in line with defined validation strategy. Support Validation Lead / Validation Expert in creation of validation protocol and report.
Commitment to Diversity & Inclusion: :
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements:
• University degree in pharmacy, pharmaceutical technology, chemistry, engineering sciences, or another relevant scientific field. A Master's or Ph.D. is preferred.
• Experience in managing technological projects in manufacturing, knowledge of GMP production, experience in biopharmaceutical production, or other comparable industries (pharmaceuticals, food industry, chemical industry).
• Project management skills.
• Strong communication abilities.
• Proficient in English language.
We offer permanent employment, with 6 months of probation period.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being, Unlimited learning and development opportunities.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
