Summary
About the Role
Major accountabilities:
- Formulating, developing and driving an overall science, quality and regulatory driven analytical project strategy including contingency plans and risk evaluations in the course of early and late clinical development responsibility for drug substance.
- Leading and overseeing analytical activities throughout drug development within a global project team such as specification setting, method development and validation, stability and release testing. Activities may cover early/late phase clinical development as well as transfer to commercial production sites and New Drug Application registration.
- Being a core member of the technical development sub-team, representing Analytical Research & Development; co-owning the technical development in partnership with Chemical and Pharmaceutical Development; contributing actively to the elaboration of the overall technical development plan and state of the art control strategy.
- Accountability to meet quality, timelines and budget for assigned projects, defining clear analytical project plans
- Managing interactions with internal and external stakeholders, including potential outsourced activities
- Proactively identifying potential scientific, technological and GMP gaps, proposing creative solutions and ensuring appropriate communication within and across units
- Providing input into CMC documents to support regulatory submissions
- Acting as the analytical project representative in peer reviews as well as internal and external audits
- Supporting the analytical project teams with quality awareness, strategic input, scientific and technical expertise in a phase dependent manner
- Strong contribution to advance science, technology and innovation within Analytical R&D
Minimum Requirements:
- Minimum MS in analytical chemistry with significant experience in pharmaceutical industry, preferably PhD in analytical chemistry or equivalent desirable
- Leadership experience in managing projects ideally in a global matrix environment
- Strong quality focus, experience in a GMP environment
- Understanding of regulatory expectations and profound scientific knowledge in analytical development
- Fluent in English (oral and in writing)
- Ability to perform in a highly dynamic environment
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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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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
