Technical R&D - Analytical Project Lead (m/f/d)
Gi Life Sciences Basel
Description du poste
Poste a pourvoir : Technical R&D - Analytical Project Lead (m/f/d)
Basel
Gi Life Sciences Basel.
For a leading pharmaceutical company, we are looking for a qualified
Technical R&D - Analytical Project Lead (m/f/d)
General
Information:
- Location: Basel
- Workload: 100%
- Start: ASAP
- Duration: 12 months (Extension possible)
- Home Office: max. 1 day per week
Your Responsibilities:
- Serve as the Analytical SME / Analytical Project Lead (APL) and drive the development of state-of-the-art analytical control packages for synthetic molecules, including direct materials, IPCs, intermediates, and crude APIs
- Actively contribute to portfolio delivery by ensuring efficient and effective process development analytics, including the use of modern approaches such as modeling and simulation
- Coach technicians and junior scientists on project-related tasks and serve as a central point of contact for analytical topics and project information
- Supervise internal laboratory activities and/or external testing activities at CLOs/CDMOs
- Collaborate cross-functionally with key stakeholders in Research, Early Development, Regulatory, and Quality to ensure smooth project execution and alignment
- Author, review, and approve key technical documents and regulatory dossiers such as QIMPDs and NDAs in compliance with quality standards and data integrity requirements
- Act as Chemistry Project Lead (CPL) for external testing activities at CDMOs/CLOs
- Support team development through coaching and contribution to the hiring of new colleagues
Your Profile:
- Master’s degree or Ph.D. in Chemistry, Pharmacy, or a related field
- Minimum 5 years of professional experience in the analytical development of synthetic molecule drug substances
- Strong expertise in liquid chromatography, especially HPLC and UHPLC, combined with hands-on experience in advanced detection methods such as UV, MS, fluorescence, and charged aerosol detection
- Solid understanding of analytical chemistry, especially chromatographic methods such as HPLC and GC, as well as titration and physicochemical techniques
- Proven ability to independently develop analytical control packages for intermediates and APIs
- Strong collaboration, technical leadership, and project management skills with a structured and rigorous working style
- Experience in supervising laboratory work and managing external partners such as CDMOs and CLOs
- Strong digital acumen and familiarity with the statistical analysis of analytical data
- Experience in authoring and reviewing regulatory documentation, especially dossiers such as NDA and QIMPD
- Excellent command of English, both written and spoken, German skills are an advantage
Interested? Then apply today. We look forward to hearing from you!
Interessé(e) ? Postulez directement sur notre site.
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