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CSL

Principal Scientist, Tech Ops (Tech Transfer and Outsourcing)

Posted 6 Days Ago
Be an Early Applicant
Remote
Hiring Remotely in Ireland, IRL
Senior level
Remote
Hiring Remotely in Ireland, IRL
Senior level
Lead and oversee technology transfer and outsourcing for processes and QC analytical methods between development, manufacturing, and external partners. Define transfer strategies, protocols, acceptance criteria, and readiness assessments; serve as technical lead with CDMOs and contract labs; provide scientific oversight, resolve deviations, support CMC regulatory documentation and health‑authority interactions, and drive post‑approval lifecycle changes. Manage large projects, mentor staff, and collaborate cross‑functionally to ensure product quality and continuous improvement.
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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 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​

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 leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

 

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.


You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

 

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

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