Geforderte Skills
- HPLC
- UHPLC
- Analytical Chemistry
- Analytical Method Development
- Mass Spectrometry
- Gas Chromatography
- Titration
- Project Management
- Regulatory Dossier Authoring
Sprachen: English
Jobbeschreibung
Project overview
Do you have a strong experience in the analytical development of synthetic drug substances with a specialization for peptides? Then you might be the team member who we are looking for!
Responsibilities
Your background:
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Job profile (68XLU0)
Life Sciences - R&D Laboratory
Basel-Stadt
Contracting
Full Time
Analytical methods
- You 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.
- You actively contribute to portfolio delivery by ensuring efficient and effective process development analytics, including the adoption of modern techniques like modeling and simulation.
- You coach technicians and junior scientists on project work and serving as a central point of contact for project-related information
- You supervise internal laboratory activities and / or testing activities at CLOs/CDMOs
- You collaborate cross-functionally with key partners in research and early development, Regulatory, and Quality to ensure seamless project execution and alignment.
- You author, review, and approve critical documents and regulatory dossiers (e.g., QIMPD, NDA) while ensuring compliance with quality standards and data integrity.
- You act as a Chemistry Project Lead (CPL), leading external testing activities at CDMOs or CLOs.
- 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 peptides.
- You have 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.
- You possess a solid understanding of analytical chemistry, particularly chromatographic techniques (HPLC, GC), titrations, and various physicochemical methods.
- You demonstrate excellent collaboration, technical supervision, and project management skills, with a structured and rigorous approach
- Digital acumen to support digital transformation initiatives; familiarity with statistical analysis of analytical data is also advantageous
Project details
- Start: flexible
- Location: Basel-Stadt, CH
- Languages: English
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