Principal Scientist, Tech Ops; Tech Transfer and Outsourcing

Position: Principal Scientist, Tech Ops (Tech Transfer and Outsourcing)
## Principal Scientist, Tech Ops (Tech Transfer and Outsourcing)応募locations:
EMEA, CH, Kanton Bern, Bern, CSL Behring time type:
正社員posted on:
募集開始 - 今日job requisition :
R-282284

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.
** Position Description Summary
*** 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
** Main Responsibilities & Accountabilities
*** Providing leadership for projects and work streams 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
** Your Profile
*** Postgraduate degree (preferably MSc or PhD) and / or extensive experience in relevant discipline.
* Minimum of 5 years' relevant industry experience and / or equivalent experience in a relevant academic environment.
* Track record of scientific achievement in relevant Life Sciences discipline.
* Experience working in cross-functional, multicultural and international teams.
* Excellent communication skills (English language).##
** About CSL Behring
** CSL Behring is a global biotherapeutics…