Analytical Project Leader

Vor 6 Tagen

Basel BS, Schweiz Coopers Group AG Vollzeit

Analytical Project Leader m/f/d, Basel-Stadt We are hiring for Analytical Project Leader for our client in Basel. In this role, you will join a highly motivated and experienced team of analytical scientists and take a leading role in the analytical development of synthetic molecule projects with a focus on peptides , from early development through commercialization. This is an exciting opportunity to apply your expertise in a dynamic, fast-paced environment and make a meaningful contribution to the development of life-changing medicines. 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) Sounds like a great job? Then we look forward to receiving your complete application documents through our online application form. When applying by email, the sender agrees that his or her data will be used in accordance with our data privacy policy. Find more vacancies at: coopers.ch

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