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CSL

Senior Principal Scientist, Pathogen Safety

Posted Yesterday
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Remote or Hybrid
Hiring Remotely in Japan
Senior level
Remote or Hybrid
Hiring Remotely in Japan
Senior level
Serves as the senior pathogen safety scientific expert for a biopharmaceutical manufacturing site. Leads complex assessments involving deviations, changes, emerging pathogens, product complaints, pharmacovigilance investigations, contamination control, audits, inspections, and regulatory requests. Partners with Operations, Quality, Regulatory, MS&T, and Global Pathogen Safety to resolve issues, influence cross-functional decisions, maintain compliance, improve processes, and provide scientific coaching and training.
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Location: Holly Springs, NC or Melbourne, AustraliaWork Arrangement: Hybrid – three days per week on siteReports To: Pathogen Safety Support Lead
About CSL

CSL is a global biopharmaceutical leader committed to developing and delivering innovative medicines and therapies that make a meaningful difference for patients around the world.


We are seeking a Senior Principal Scientist, Pathogen Safety to serve as the senior scientific interface for pathogen safety at our Holly Springs, NC or Melbourne, Australia site and across broader Operations.


This is a highly visible scientific leadership role for an experienced pathogen safety professional who can work independently, solve complex problems, and influence decisions across a cross-functional organization.


The Opportunity

You will serve as the senior pathogen safety scientific representative for the assigned site, partnering with Operations, Quality, Regulatory, MS&T, and Global Pathogen Safety to assess and resolve complex scientific and operational matters.


The work is varied and may include evaluating deviations and changes, assessing emerging pathogen risks and potential product impact, supporting contamination control strategies, responding to regulatory requests, and providing scientific guidance on complex manufacturing and product-related issues.


You will operate with a high degree of independence while remaining connected to the broader Global Pathogen Safety organization and contributing to global scientific standards and best practices.


Key Responsibilities
  • Serve as the senior pathogen safety scientific expert and primary interface for the assigned site.
  • Independently assess and resolve complex pathogen safety matters throughout the product lifecycle.
  • Provide expertise for risk assessments, deviations, changes, product complaints, pharmacovigilance investigations, contamination control strategies, audits, inspections, and regulatory requests.
  • Partner with Operations, Quality, Regulatory, MS&T, and other functions to provide scientific recommendations and drive resolution.
  • Evaluate emerging pathogens and assess potential impact to products and operations.
  • Influence decisions and drive alignment across functions and sites without direct authority.
  • Contribute to global Pathogen Safety initiatives, standards, best practices, and knowledge sharing.
  • Provide scientific coaching, technical guidance, and pathogen safety training.
  • Support continuous improvement of pathogen safety processes, risk assessments, and tools.
  • Ensure activities meet applicable regulatory requirements and internal quality standards

What We're Looking For
  • Postgraduate degree, preferably PhD, in Virology, Biology, Microbiology, Immunology, or a related life sciences discipline.
  • 5+ years of relevant biopharmaceutical industry experience, with significant experience in pathogen safety, viral safety, biologics manufacturing support, or a related discipline.
  • Strong expertise in pathogen safety, including virus and prion safety.
  • Demonstrated ability to independently lead complex scientific assessments and solve problems.
  • Experience working cross-functionally in a matrix organization and influencing without direct authority.
  • Strong stakeholder management and communication skills.
  • Ability to communicate complex scientific concepts and recommendations to both technical and senior business audiences.
  • Experience working across functions, cultures, and/or international locations is preferred.

What Success Looks Like

Success in this role means becoming a trusted scientific authority for pathogen safety at the site. You will bring independent scientific judgment to complex situations, provide practical recommendations, influence cross-functional decisions, and serve as a strong connection between the local manufacturing site and the global Pathogen Safety organization.


Why Join CSL?

This role offers the opportunity to take on a highly visible senior scientific position while remaining on a scientific career path. You will have significant autonomy, broad exposure across Operations, Quality, Regulatory and MS&T, and the opportunity to work on a wide variety of scientific and manufacturing challenges. You will also be part of a global Pathogen Safety network, giving you the opportunity to exchange expertise across international sites, contribute to global practices, and represent the organization at relevant scientific and industry forums.


Working Conditions

Hybrid schedule with three days per week on site.

Ability to manage multiple priorities in a fast-paced, matrixed environment.

May occasionally require meetings outside standard business hours due to global collaboration.

Some travel to manufacturing/development sites, partners, meetings, or conferences may be required.


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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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