Deadline for applications: 28th of July, 2025.

Major accountabilities:

• Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
• Technical Transfer Lead, review first APQR after transfer to ensure adequate product performance, ensure all relevant technical information and documentation for validation is available. Review APQR and decide on state of control.
• Define pre-validation / validation strategy including process, cleaning, packaging and supportive studies (e.g., hold times). Act as Validation Lead / Validation Expert in creation of validation protocol and report, maintaining the process control strategy.
• Coordinate technical, regulatory and validation batches at site.
• Product Steward, maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC.
• Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
• Technical Steward - Acting as 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. Harmonize and optimize technical processes across the site.
• Provide technical expertise for validation activities around technologies within area of responsibility.
• Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV), ongoing cleaning verification.
• Senior Scientist MS&T, managing complex projects with deep understanding of development process requirements, participating in root cause investigations.
• New by-product investigation, complex deviations. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Contributing to improvement of following KPIs: Product Unit Cost, achievement of project plans & milestones, ensuring completeness of Validation Master Plan (VMP), Manufacturing Robustness Review (MRR).

Minimum Requirements:

• Education: Scientific Degree in Pharmaceutical studies or equivalent/similar such as, Chemistry, Chemical Engineering.
• 5-10 years of experience in similar role within Pharmaceutical industry, special focus on tech transfer, API changes, demonstrated expertise in manufacturing processes for oral solids technologies.
• Team player with strong problem solving skills, collaborative approach and proactive self-starter approach, able to coordinate technical investigations.
• Experience working and navigating in a crossfuctional matrix organization and able to work autonomously.
• Fluent English, written and spoken.

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? http://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: http://www.novartis.com/careers/benefits-rewards

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.