Senior CMC Project Manager Associate Director CMC
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Job Location:
Basel - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
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
- 815 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.
Key Skills
- Project / Program Management
- Public Health
- Virology
- Vendor Management
- FileMaker
- Education Administration
- Construction Management
- Restoration
- Project Management
- Project Management Software
- Budgeting
- Auto Restoration
