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