About the Role
- Technical transfer milestones achieved in time and in full. Including schedule for registration and launches.
- Robust manufacturing process, delivering critical quality attributes.
- Analytical methods in place, meeting cGMP standards.
- No critical observations during internal and external GMP inspections and Pre-Approval Inspections (PAI).
- Adheres to project / Capital Approval Request CAR costs
Stewardship – Manage change control for process transfers and process adaptations and modifications
Validation – Ensure that all relevant technical information and documentation for validation is available.
Launch & Transfer - Act as SPOC on site for technical transfer
Manufacturing Excellence – Contribute to process improvement and optimization for product transfers.
Training - Own the Training Curriculum for own Job Profile and direct reports.
Novartis Manufacturing Manual - Support implementation of Novartis Manufacturing Manual principle 3.
Essential Requirements:
- 8 years of relevant experience in pharmaceutical manufacturing; comprehensive know how in pharmaceutical technology, project management experience.
- BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree. Desirable MSc. or equivalent experience.
- Fluent in English and proficient in site local language
Role Requirements
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
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
