Technical R&D - Analytical Project Lead

Technical R&D - Analytical Project Lead: HPLC/ UHPLC/ MS/ UV, Mass Spectrometry / Fluorescence/ synthetic molecules drug substances / German/ English Background: Pharma Technical Development (PTD) is a global team of over 2,000 experts focused on developing innovative medicines to address patients' needs. Within PTD, Synthetic Molecules Technical Development (PTDC) specializes in drug substance, drug product, and analytical sciences. PTDC is instrumental in advancing the synthetic molecules pipeline, supporting research, early development, and clinical trials through technical innovation and collaboration. This opportunity lies within analytical development for synthetic molecules, where cutting-edge techniques like high-performance liquid chromatography, gas/ion chromatography, and mass spectrometry are employed to develop efficient and robust analytical methods. The goal is to ensure the release of clinical trial products and their eventual commercial supply through a strong control strategy. Take the lead in pioneering innovative analytical techniques while contributing to the successful delivery of clinical and commercial therapies-apply now and help shape the future of healthcare! The Perfect Candidate: 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. Tasks & Responsibilities:

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Reference Nr.: 924992 Rolle: Technical R&D - Analytical Project Lead Industrie: Pharma Location: Basel

Start: ASAP ( Duration: 12+ months Deadline: If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs[at]itcag[dot]com. Contact us for more information about our company, our positions, or our attractive payroll-o

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• 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 ( , 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.
• A Master's or 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
• 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
• Excellent command of the English language.
• Proficiency in German is considered a plus