We are currently looking for a Principal Scientist Tech Ops (CMC Science) to join our global team in Bern. In this position you will be responsible for supporting and executing Chemistry, Manufacturing, and Controls (CMC) strategies for pharmaceutical and/or biologic products across clinical development and early commercialization. This role ensures that drug substance and drug product development activities meet regulatory, quality, and business objectives.
This role works cross-functionally to drive CMC deliverables, manage external partners, and support global regulatory submissions.
Key Responsibilities
CMC Strategy & Execution
- Contribute to the development and implementation of phase-appropriate CMC strategies
- Support CMC activities for assigned programs from early development through late-stage clinical development
- Identify risks and develop mitigation strategies to ensure timelines and quality standards are met
Process & Analytical Development
- Support drug substance and drug product development activities
- Support analytical method development, validation, and specification setting
- Support process characterization, validation, and lifecycle management
Manufacturing & Tech Transfer
- Manage relationships with CDMOs and manufacturing partners
- Support technology transfer and scale-up activities
- Ensure compliance with GMP requirements
Regulatory Support
- Author, review, and contribute to CMC sections of regulatory submissions (IND, CTA, NDA, BLA)
- Support interactions with global regulatory authorities, including the U.S. Food and Drug Administration and the European Medicines Agency
- Address regulatory questions and inspection readiness activities
Cross-Functional Collaboration
- Partner with Regulatory Affairs, Quality, Supply Chain, and Technical Operations teams
- Provide technical expertise to management team
- Support budget planning and timeline management for CMC activities
Your Profile
- PhD, MSc, or equivalent degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or related scientific discipline
- Typically 8-10 years of experience in pharmaceutical or biotechnology development
- Demonstrated experience in CMC development and regulatory submissions
- Experience managing external manufacturing partners preferred
- Strong scientific and technical expertise in CMC disciplines
- Knowledge of global regulatory guidelines (ICH, GMP)
- Project leadership and stakeholder management
- Risk assessment and problem-solving skills
- Excellent communication and organizational skills
Are you interested? We are looking forward to receiving your online application
