Principal Scientist - Tech Transfer and Outsourcing

6d6 days ago

CSL

Bern, CH · Full-time · CHF 130,000 – CHF 160,000

About this role

This role leads technology transfer activities for processes and QC analytical methods, coordinating between development, manufacturing, and external partner laboratories. The Principal Scientist defines and executes transfer strategies, protocols, and readiness assessments to ensure successful implementation at receiving sites.

Day-to-day responsibilities include serving as the primary technical point of contact for CDMOs and contract laboratories, ensuring alignment on technical expectations, timelines, and quality standards. The position provides scientific oversight of outsourced activities, including issue resolution, deviation investigations, and performance monitoring.

The role collaborates with cross-functional stakeholders such as Development, Manufacturing, Quality, and Regulatory Affairs to support CMC regulatory documentation and health authority interactions. It also supports post-approval lifecycle activities, including site additions, method updates, and continuous improvement initiatives.

This position offers the opportunity to provide high-level scientific expertise and guidance in specialist technical areas, contributing to the planning, evaluation, and reporting of experiments at the highest levels of scientific integrity. The Principal Scientist also contributes to training staff in relevant research and development technology platforms.

Requirements

Recognized subject matter expert in job area typically obtained through advanced education and work experience.
Ability to manage large projects or processes with limited oversight from manager.
Experience coaching, training, reviewing, and delegating work to lower-level professionals.
Capable of solving difficult and often complex problems requiring analysis of issues and consideration of other job areas.
Postgraduate degree (preferably MSc or PhD) in a relevant scientific discipline.
Strong understanding of technology transfer, outsourcing, and CMC regulatory requirements.
Experience serving as primary technical contact for CDMOs or contract laboratories.

Responsibilities

Lead and oversee technology transfer activities for processes and QC analytical methods between development, manufacturing, and external partner laboratories.
Define and execute transfer strategies, protocols, acceptance criteria, and readiness assessments for successful implementation at receiving sites.
Serve as the primary technical point of contact for external partners including CDMOs and contract laboratories, ensuring alignment on technical expectations, timelines, and quality standards.
Provide scientific oversight of outsourced activities including issue resolution, deviation investigations, and performance monitoring.
Support preparation, review, and defense of CMC-related regulatory documentation associated with tech transfer, outsourcing, and lifecycle changes.
Support post-approval lifecycle activities including site additions, method updates, and continuous improvement initiatives.
Provide high-level scientific expertise and guidance in specialist technical areas of research and product development.
Contribute to training of staff in relevant research and development technology platforms.