Summary
Oversees processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.
About the Role
Key Responsibilities:
- Act as the SPOC for the interface with global MS&T network and with technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment.
- Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
- Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements.
- Collaborate with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge.
- Assure that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.
- Be a recognized scientific expert internally and externally by reporting and presenting scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.
- Maintain their work in inspection readiness level.
- Support Product Stewards in creation of Quality Risk Assessments.
- Support creation of SOPs for Process Unit.
- Provide technical expertise to Engineering for design activities in Capex projects around technologies within area of responsibility.
- Provide technical expertise for equipment qualification around technologies within area of responsibility.
- Approve validation reports under their area of responsibility (as needed) e.g. packaging validation.
- Provide technical expertise for validation activities around technologies within area of responsibility.
- SME for specific Technology Platform or pharmaceutical processes following process product/process transfer or handover from launch to commercial production.
Essential Requirement:
- Minimum 8-year experience in GMP manufacturing relevant to the specialist area of expertise.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
Desirable Requirement:
- BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
- Desirable MSc. or equivalent experience.
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
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