Principal Scientist, Bioanalysis, Immunogenicity & Biomarkers

Posted 3 Days Ago
Be an Early Applicant
3 Locations
Remote
Senior level
Biotech
The Role
Lead development, validation, implementation and transfer of PK, ADA, biomarker, and flow cytometry assays. Provide scientific leadership, ensure regulatory compliance and data quality, collaborate with cross-functional teams and external labs, troubleshoot datasets, and drive innovation via advanced platforms, automation, and AI-enabled solutions to support non-clinical and clinical programs.
Summary Generated by Built In

We are seeking an experienced and highly motivated Principal Scientist to join our Bioanalysis, Immunogenicity & Biomarkers team. This is an exciting opportunity for a scientifically driven leader to play a critical role in advancing innovative therapies from non-clinical development through clinical trials.

In this position, you will lead the development, validation, execution, and technical transfer of highly specialised PK, ADA, biomarker, and flow cytometry assays, delivering high-quality data that supports critical drug development decisions. Reporting to the Associate Director, Bioanalysis, Immunogenicity & Biomarkers, you will provide scientific leadership, collaborate across global cross-functional teams, and help drive innovation in bioanalytical sciences.

About the Role

You will be responsible for ensuring bioanalytical and biomarker assays are scientifically robust, regulatory compliant, and aligned with project requirements across the development lifecycle. You will work closely with internal stakeholders and external partners to successfully implement and transfer assays that support non-clinical and clinical studies.

Key Responsibilities

  • Lead the development, validation, implementation, and technical transfer of PK, ADA, biomarker, and flow cytometry assays to support non-clinical and clinical programs.
  • Provide scientific leadership and subject matter expertise to ensure assay robustness, regulatory compliance, data quality, and successful project delivery.
  • Collaborate with cross-functional teams to define assay strategies, align priorities, manage timelines, and support progression of programs through all stages of development.
  • Interpret complex datasets, troubleshoot technical challenges, and communicate scientific findings and recommendations to diverse stakeholders.
  • Partner with external laboratories and vendors to support assay outsourcing, transfer, oversight, and delivery of high-quality results.
  • Contribute to due diligence activities and provide expert guidance on bioanalytical strategy, regulatory expectations, clinical readiness, and associated risks.
  • Drive innovation through the adoption of emerging technologies, advanced assay platforms, automation, and AI-enabled solutions

About You

You are a collaborative scientist with deep technical expertise, strong communication skills, and a passion for translating scientific innovation into meaningful clinical impact.

Essential Requirements

  • Postgraduate qualification (MSc, PhD preferred) in Immunology, Bioanalytical Sciences, Life Sciences, or a related discipline.
  • Minimum 5 years' relevant industry or equivalent research experience.
  • Demonstrated expertise in PK, ADA, biomarker and/or flow cytometry assay development, validation, and implementation.
  • Strong understanding of regulatory expectations for bioanalytical and biomarker assays supporting clinical studies.
  • Proven ability to interpret complex scientific data and solve challenging technical problems.
  • Experience working effectively in multidisciplinary, international environments.
  • Experience collaborating with and managing external laboratories or vendors.

Why Join Us?

  • Contribute to the development of innovative therapies that improve patient outcomes globally.
  • Work alongside highly regarded scientific experts in a collaborative environment.
  • Influence strategic scientific decisions across a diverse development pipeline.

Apply now and help advance the next generation of life-changing therapies. Applications Close on 14 July 2026

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.

Skills Required

  • Postgraduate qualification in Immunology, Bioanalytical Sciences, Life Sciences, or related discipline (MSc required, PhD preferred)
  • Minimum 5 years relevant industry or equivalent research experience
  • Demonstrated expertise in PK, ADA, biomarker and/or flow cytometry assay development, validation, and implementation
  • Strong understanding of regulatory expectations for bioanalytical and biomarker assays supporting clinical studies
  • Proven ability to interpret complex scientific data and solve technical problems
  • Experience working in multidisciplinary, international environments
  • Experience collaborating with and managing external laboratories or vendors
  • Experience with automation and AI-enabled assay platforms (desirable)
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The Company
HQ: Melbourne, Victoria
20,401 Employees

What We Do

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra

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