Povzetek
Responsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or other process adaptations.
Leads technical transfer project team at site and liaises efficiently with involved functions. (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites)
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
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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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.
