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Product Steward

**382111BR** **Job ID:** 382111BR **About the role:** About the role: The Product Steward is responsible for participation as part of a team for the technical leadership of an assigned product. The product may be manufactured by Novartis Technical Operations or by a 3rd party CMO. • The product steward is responsible for the technical life-cycle management and participation in regulatory filing review or assisting the Sr. Product Steward with these functions depending on the size and scope of the product. • Technical stewardship and lifecycle management includes drug substance and drug product manufacturing, as well as labeling/packaging, and supply chain distribution, from initial license approval until retirement of the product. • Technical review/approval of regulatory documents (e.g. Market expansion and variations). Resolution of information requests and market specific commitments. • Deviation investigation and change management. • Product Quality Impact Assessments for ex-US supply owned by Novartis. • Works with 3rd party counterpart for establishing cross-company meeting agenda topics, collaboration benchmarks, market submission timelines, etc. • Continuous monitoring of CPV program and collaboration with CMOs for potential improvements. • Participates in supply and quality risk management activities with cross-functional teams. • Participates in audits of 3rd party manufacturers as well as their audits to support regulatory audits. • Works with packaging validation team to ensure that unique market requirements for label/pack is implemented. \n\n\n\n **Position Title:** Product Steward **Role Requirements:** • Bachelor of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 6 years of experience in support of biopharmaceutical manufacturing; OR • Master of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and 4 years of experience in support of biopharmaceutical manufacturing; OR • PhD in biochemistry, chemical engineering, bioengineering, or related technical field with 2 years of experience in support of biopharmaceutical manufacturing. • Technical understanding of biotechnological/gene therapy systems such as cell-culture, transfection, and/or purification. • Previous experience with viral vector production is preferred. • Strong technical writing ability. • Experience in working with 3rd party manufacturing operations strongly preferred. 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. The pay range for this position at commencement of employment is expected to be between $124,000 and $186,000 annual; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 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 Accessibility and Reasonable Accommodations: The Novartis Group of Companies are 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 application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. 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: Novartis Talent Pool. **Job Type:** Full Time **Country:** USA **Work Location:** Durham, NC **Functional Area:** Technical Operations **Division:** Operations **Business Unit:** NOVARTIS GENE THERAPIES **Employment Type:** Regular **Company/Legal Entity:** Novartis Gene Therapies **Commitment to Diversity & Inclusion::** _The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential._ **Shift Work:** No **Early Talent:** No


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