Analytical Project Leader (m/f/d) (80-100%)
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Analytical Project Leader (m/f/d) (80-100%) Switzerland
About the roleLocation: Basel, Switzerland Role Purpose: We are looking for an Analytical Project Leader to support Analytical Research & Development which sits within the Global Technical R&D department of Global Drug Development and plays a crucial role in the characterization and analysis of Small Molecule Drug Substances and Drug Products from the time they leave the discovery laboratory until they are transferred to Commercial Production. We need an experienced APL with a strong background and hands on experience in parenteral development to join our team. Expertise in RLT or peptide analytics is an asset. Your main responsibilities:
- Be a member of a global CMC subteam, responsible for leading the technical development of Drug Substance and Drug Products from early to late phase clinical development.
- Lead analytical activities within a Technical CMC project team, e. g. defining control and specification setting strategies for Drug substances and Drug products of small molecule new modalities (e.g., Radioligand Therapies, xRNAs,)
- Lead a global analytical subteam and prepare analytical project plans and be accountable to meet quality, timelines and budget for assigned projects.
- Responsible to provide valuable input to the analytical CMC documents and support regulatory submissions.
- Write or contribute to analytical source documents (e.g., Analytical methods, Specifications, Validation reports, Stability reports)
- Collaborate with internal and external stakeholders of drug development and mentor analytical experts.
- Lead outsourced analytical activities at CROs / CDMOs and contribute to manage the external partnership.
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.
Role RequirementsEssential Requirements:
- Desirable: PhD in analytical chemistry or equivalent and a minimum 5 years experience in the pharmaceutical industry in analytical development, preferable in development of sterile parenteral products. Experience in Peptide or RLT analytic is a plus.
- Proven knowledge in Early or late phase parenteral development and filings
- Proven leadership experience in managing development projects, ideally in a global matrix environment.
- Excellent understanding and awareness of regulatory guidelines for analytical development.
- Collaborative spirit, self-driven attitude, high level of learning agility are key attitudes
- Strong quality focus and experience in a cGMP environment.
- Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences, ability to perform in a highly dynamic environment.
- Fluent in English (oral and writing), German/ French a plus
Business UnitTECHNICAL R & D GDD
Company/Legal EntityNovartis Pharma AG
Functional AreaResearch & Development
Job TypeFull Time
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Post Date : 01-02-2024
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