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