Apply to JobJob ID266095BRPosition TitleDrug Product LeaderJob DescriptionPurpose:
5! The number of projects you will be leading to develop our growing pipeline of Gene Therapy products. We are looking for an experienced professional in the area of drug product development for Gene Therapy-based drug products, with special focus on viral vectors. As a member of Pharmaceutical Development in the Cell and Gene Therapy Development Unit, Technical Development NBEs, you will play a key role in the development of parenteral dosage forms of viral and non-viral vectors, for gene therapy, for preclinical and clinical studies, as well as in the development of market formulations.
Your Responsibilities:
Your responsibilities will include but not be limited to the following:
• We rely on your scientific/technical expertise to develop robust formulations and processes, supporting successful production of preclinical toxicology material and process transfers to GMP manufacturing, as well as to provide the required technical documentation for worldwide CTA registration.
• You adhere to timelines and quality requirements and are responsible for the direct oversight of interfaces.
• You will lead and manage all gene therapy drug product development activities for assigned projects within the Cell and Gene Therapy Development Unit, lead and co-ordinate the drug product team and represent Pharmaceutical Development in the global CMC team.
• You will work in multidisciplinary and international teams, reporting scientific/technical results internally (including patents) and representing Novartis externally at meetings, giving talks, being part of industry consortiums, publishing papers.
• As senior drug product lead, you will also be responsible for key strategic initiatives within the Pharmaceutical development team as well as the development of new technologies and supervision of scientific projects, external collaborations and proactively identify and realize opportunities for Invention Disclosures.
• You will also generate scientific documents to hand over to internal/external partners, and actively support generation of international registration documents.
• You will contribute to overall development strategies and improvement of operational excellence of business processes and budget estimation for projects and initiatives of own responsibilityMinimum requirementsWhat you’ll bring to the role:
• Ph.D. in Science (e.g. Pharmacy, Biochemistry, Chemistry) with focus on pharmaceutical technology, or equivalent education.
• Excellent English required (oral & written). Good skills in site (local) language (oral) is an optional asset. Experience (at least 3-5 years) in the development of gene therapy products (early and late phase) in a Pharmaceutical Company,
• Expert knowledge in developing liquid and lyophilized formulations, process development and tech transfer, as well as preparing documentation for Health Authorities.
• Experience with cell therapy would be an optional asset.
• Experience in analytics and GMP systems.
• Successfully demonstrated track record of creativity and problem solving in projects, interdisciplinary thinking, and proven ability to work in cross-functional, international teams.
• Willingness to work in a complex organization and deal with unknowns.
• Ability to drive projects to success, thinking out of the box, engaging stakeholders and proposing solutions.
• Excellent organizational and planning abilities, as well as communication skills.
Why consider Novartis?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
“Currently we are only accepting applications from internal permanent Novartis associates for this opening. If you are self-employed, an external contractor employed by a temporary staffing company or an external worker employed by a third party service provider, please visit www.novartis.com/careers to learn about job opportunities that are available to you.”DivisionGlobal Drug DevelopmentBusiness UnitTECHNICAL R & D GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular
