Senior CMC Project Manager / Associate Director CMC

Über den Job

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.