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About the Role
Senior Technical Steward Medical Devices
Location – Hyderabad #LI Hybrid
About the Role:
Site MSAndT Head-Medium/Small SiteLeads the Site’s MSAndT organization, which is responsible to maintain and improve the scientific oversight of the manufacturing processes and technical changes, the relevant technical knowledge and capabilities at the Site and to ensure the product and technical stewardship, across process units and functions at Site.Senior Technical Transfer LeadResponsible 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.).Senior Product StewardOwns 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). Provides second line technical/scientific process support.Senior Technical Steward / Senior Technical Manager MSAndTProvides to the Site the specialist knowledge and expertise, as Subject Matter Expert (SME), of specific pharmaceutical processes or process technologies (e.g. Technical Steward for galenics, for film coating, biologics – upstream or downstream, etc.).Oversees processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.Senior Validation LeadResponsible 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 compliant with Regulatory Authorities’ expectations and related SOPs.
Key Responsibilities:
- Own and maintain deep knowledge of specific medical device manufacturing process technologies, including pilot scale operations, scale-up/down activities, and Design of Experiments (DoE).
- Act as an expert in molding of device constituent parts; oversee injection molding tool design, qualification, life-cycle management, and performance monitoring at external manufacturing sites.
- Provide expertise in autoinjector device and sub-assembly manufacturing processes to ensure robust and compliant operations.
- Support Technical Steward in device development projects by assessing scalability of new devices transitioning from development to commercial manufacturing phases.
- Advise Technical Stewards on initial qualification and life-cycle maintenance of injection molding machine toolsets and related activities to advance Novartis’ Device Strategy. Ensure accurate and thorough review of technical documentation packages during development handover by applying your technical expertise.
- Ensure adherence to current industry practices, regulatory and quality guidelines, and standards for injection molding and component assembly; apply this knowledge in line qualification and product validation activities.
- Leverage understanding of the molding and assembly supplier landscape to maintain and transform it into a future-ready, robust supplier network.
- Deliver fundamental technical knowledge through regular training and education programs for Process Experts and Operators. Spearhead process and operational excellence initiatives to enhance combination product quality, reliability, and reduce risks and costs.
- Collaborate with technical development teams, other sites, and the global MS&T network to enable effective transfer of technical knowledge. Conduct technical feasibility trials to support process improvements and implementation of new manufacturing technologies.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Essential Requirements
- Exposure to ISO 13485, 21 CFR Part 4 and FDA validation guidelines.
- Bachelor’s or Master’s degree in Mechanical Engineering, Chemical Engineering, or a related discipline.
- Approximately 10 years of experience in combination products development or operations.
- Previous experience in pharmaceutical, biotechnology or engineering environments.
Strong working knowledge of GMP manufacturing principles.
Desirable Requirements
- Proven experience in outsourcing and managing strategic device partners.
- Demonstrated project management experience in combination products.
- Fluency in English (written and spoken) is essential.
- Advanced understanding of mechanical design principles, assembly process expertise and design standards, including proficiency in CAD software (e.g., SolidWorks) for e.g. injection device development and manufacturing).
- Strong interpersonal and negotiation skills, with a proven ability to build effective relationships and influence outcomes.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
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: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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.
