About the Role
Major accountabilities:
- 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.).
- Owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in continued state of validation and continuously improving.
- Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s).
- Oversees processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies when applicable.
- Responsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are aligned with Regulatory Authorities’ expectations and related SOPs.
- Design, plan, perform, interpret and report scientific experiments under the lead of the department head to contribute to overall MS&T strategies and objectives.
Education:
- Higher scientific degree in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific field.
Languages:
- Fluency in English languages.
- undefined
Experience:
- Minimum 5 years of experience in pharmaceutical (chemical) manufacturing and in sterile drug product manufacturing , with a comprehensive know-how in pharmaceutical technology
Compentency
- Applied Business Insights
- Operational Excellence
- Project Excellence
- Manufacturing Process/Product Expertise
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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