Contract duration: 12 months (possible extension)
Location: Basel
The perfect candidate holds an advanced degree in chemistry or pharmacy and brings a minimum of five years of professional experience in the analytical development of synthetic drug substances. They are a technical expert in liquid chromatography (including HPLC, UHPLC, and advanced detection methods like MS) who can independently drive the development of analytical control packages for intermediates and APIs. As a natural leader and communicator with an excellent command of English, they excel at coaching junior staff, managing external CDMO/CLO activities, and collaborating cross-functionally to deliver seamless project execution. Finally, they possess strong digital acumen, a rigorous approach to statistical data, and proven experience authoring critical regulatory dossiers (such as NDAs) to ensure total data integrity.
Responsibilities
Serve as the Analytical SME/analytical project lead (APL), driving 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 adoption of modern techniques like modeling and simulation.
Coaching technicians and junior scientists on project work and serving as a central point of contact for project-related information.
Supervise internal laboratory activities and / or testing activities at CLOs/CDMOs
Collaborate cross-functionally with key partners in research and early development, Regulatory, and Quality to ensure seamless project execution and alignment.
Author, review, and approve critical documents and regulatory dossiers (e.g., QIMPD, NDA) while ensuring compliance with quality standards and data integrity.
Act as a Chemistry Project Lead (CPL), leading external testing activities at CDMOs or CLOs, and contributing to the hiring and coaching of new colleagues.
Requirements
A Master's or Ph.D. in chemistry, pharmacy, or a related field.
Min. 5 years of professional experience within the analytical development of synthetic molecules drug substances.
A robust foundation in liquid chromatography (HPLC and UHPLC) with proficiency in various detection methods, including UV, Mass Spectrometry (MS), fluorescence, and charged aerosol detection.
Solid understanding of analytical chemistry, particularly chromatographic techniques (HPLC, GC), titrations, and various physicochemical methods.
Digital acumen to support digital transformation initiatives; familiarity with statistical analysis of analytical data is also advantageous.
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