Analytical Project Leader
Vor 7 Tagen
Responsibilities: Lead analytical development activities for peptide-based drug substance and drug product projects from early development through commercialization Develop phase-appropriate control strategies for drug substances and drug products Coordinate and oversee analytical activities, including method development, optimization, validation, and generation of physicochemical data Ensure high-quality documentation, timely delivery of results, and adherence to quality and regulatory standards Collaborate closely with cross-functional stakeholders across technical development, quality, manufacturing, and external partners Coach and guide technicians and junior scientists; act as a central analytical point of contact within project teams Ensure all work is performed in compliance with cGMP, safety, and regulatory requirements Supervise internal laboratory work and/or analytical activities at external CROs/CDMOs Independently plan, execute, and document experiments and contribute to regulatory submissions (e.g., IND, NDA) Must haves: Master’s or Ph.D. in Chemistry, Pharmacy, or a related scientific discipline Minimum 3 years of industry experience in analytical development of peptide drug substances and/or drug products Strong expertise in peptide chemistry, including synthesis, purification, and characterization Hands-on experience with key analytical techniques such as HPLC, UPLC, and Mass Spectrometry (MS) for peptide analysis Proven experience with ICH-compliant analytical method development and validation Solid understanding of peptide degradation pathways, impurity profiling, and stability studies Experience defining specifications for peptide drug substances and/or drug products Strong quality mindset with excellent attention to detail Digital affinity to support data-driven and digital transformation initiatives; statistical data analysis skills are an advantage Open-minded, goal-oriented, and comfortable working in a fast-evolving environment Ability to view challenges as opportunities and collaborate respectfully under pressure Excellent command of English (written and spoken)
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Basel, Schweiz Elan Personal AG VollzeitRoche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for aAnalytical Project LeaderBackground:The Analytical Research & Development department, an integral component of Synthetic Molecules Technical...
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Basel, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
