Senior Cmc Project Manager / Associate Director Cmcgloor & lang ag • Basel, Basel-Stadt, Switzerland

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Senior Cmc Project Manager / Associate Director Cmc

gloor & lang ag

Basel, Basel-Stadt, Switzerland

Basel, Basel-Stadt, Switzerland

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À propos

Small Molecules | Basel, Switzerland About BioVersys BioVersys is a Swiss clinical-stage biotech company dedicated to the development of innovative antibacterial therapies addressing the global crisis of antimicrobial resistance. With two small molecule assets in clinical development and a strong scientific foundation, BioVersys offers a unique opportunity to contribute to life-saving innovation in infectious diseases within a focused and agile environment. The Role To strengthen our Chemistry, Manufacturing and Controls (CMC) organization, we are seeking a Senior CMC Project Manager / Associate Director CMC. Reporting directly to the Head of CMC, you will play a key role in driving and coordinating CMC development activities across BioVersys’ small molecule pipeline, supporting the transition from Phase 2 into Phase 3 and towards commercialization. This is a hands-on role with broad responsibility and significant impact in a growing biotech setting. Key Responsibilities Lead and coordinate CMC development activities for innovative small molecule anti-infective drug candidates Drive late-stage CMC readiness for key clinical and regulatory milestones, including Phase 3 preparation Manage and oversee external partners such as CDMOs, CMOs, analytical laboratories and consultants Coordinate formulation development, process development, manufacturing, and scale-up activities Ensure timely, high-quality CMC documentation for regulatory submissions (e.g. IMPD, IND, CTD modules) Collaborate closely with Regulatory Affairs, Quality, Clinical Operations and external stakeholders Support interactions with Health Authorities as required Contribute to overall CMC strategy and planning in a fast-moving biotech environment focused on anti-infectives Your Profile Advanced degree (PhD or MSc) in Chemistry, Pharmacy, Biotechnology or a related discipline 8–15 years of experience in CMC development of small molecule drug products in biotech or pharmaceutical environments Strong experience managing external manufacturing networks and CDMO relationships Experience supporting regulatory submissions (IMPD, IND, NDA, MAA) is highly desirable Structured, proactive and comfortable driving complex projects with multiple external interfaces Strong communication skills and ability to work effectively in cross-functional, international teams Fluent in English (German is an advantage, but not required) Why Join BioVersys? At BioVersys, you will join a science-driven organization addressing one of the most urgent challenges in global healthcare: antimicrobial resistance. The company offers broad ownership, close interaction with senior leadership, and the opportunity to shape late-stage CMC development within a focused and highly motivated team. jid1ef34fca jit0206a jiy26a

Basel, Basel-Stadt, Switzerland

Compétences linguistiques

English

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