We are currently looking for a Principal Scientist Tech Ops (Tech Transfer and Outsourcing) to join our global team in Bern. In this position you will be leading and overseeing technology transfer activities for processes and/or QC analytical methods, including transfer between development, manufacturing, and external partner laboratories.
Define and execute transfer strategies, protocols, acceptance criteria, and readiness assessments to ensure 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.
Provide scientific input to regulatory interactions, including responses to health authority questions related to transferred technologies.
Support post‑approval lifecycle activities, including site additions, method updates, and continuous improvement initiatives.
Collaborate effectively with cross‑functional stakeholders (e.g., Development, Manufacturing, Quality, Regulatory Affairs, etc).
Researches and develops new medicines for unmet medical needs through innovative medical science from inception, through clinical trials to commercialization.
Assesses, monitors and ensures products meet clinical safety standards.
Conducts sophisticated analysis, manages research information systems and technical documentation.
May be involved in providing para-professional laboratory support for product testing after collection.
Provide high level scientific expertise and guidance in specialist technical areas of research and product development related activities.
Implements technical capabilities with and provides relevant technical guidance to other team members in order to achieve specified research project objectives within defined time parameters.
Contributes to the planning, performance, evaluation and reporting of scientific experiments at the highest levels of scientific integrity
Contributes to training of staff in relevant research and development technology platform
Providing leadership for projects and workstreams in a matrix organization
Provide high level scientific expertise and guidance in specialist technical areas of research and product development related activities.
Implements technical capabilities with and provides relevant technical guidance to other team members in order to achieve specified research project objectives within defined time parameters.
Contributes to the planning, performance, evaluation and reporting of scientific experiments at the highest levels of scientific integrity
Contributes to training of staff in relevant research and development technology platform
Recognized subject matter expert in job area typically obtained through advanced education and work experience
Manages large projects or processes with limited oversight from manager
Coaches, trains, reviews, and delegates work to lower level professionals
Problems faced are difficult and often complex, requiring analysis of issues and consideration of other job areas
