Principal Scientist, Pathogen Safety

Principal Scientist, Pathogen Safety Support Overview

The Principal Scientist, Pathogen Safety Support provides scientific and operational expertise to support pathogen safety activities across manufacturing, technical operations, and product lifecycle management. This role partners closely with cross‑functional stakeholders to assess pathogen safety risks, support regulatory and compliance obligations, and contribute to projects that ensure the continued safety, quality, and supply of CSL products.

• Plan and execute scientific work packages supporting pathogen safety activities across the product lifecycle.
• Conduct scientific risk assessments related to manufacturing changes, deviations, product complaints, pharmacovigilance investigations, and other operational matters.
• Author and review technical documents, annual reports, regulatory submissions, and responses to health authority requests.
• Support internal and external inspections, audits, and regulatory commitments.
• Provide scientific and technical support to pathogen safety projects and cross‑functional initiatives.
• Resolve technical and operational issues impacting pathogen safety deliverables and project timelines.

• Collaborate with Manufacturing Sciences & Technology, Technical Operations, Quality, Regulatory Affairs, and other stakeholders to assess and prioritize pathogen safety requests.
• Participate in cross‑functional planning and resource discussions within the Pathogen Safety organization.
• Support projects governed through Technical Operations and other business functions.
• Build effective partnerships across global, multicultural, and matrixed teams.

• Identify and implement opportunities to improve workflows, processes, and knowledge‑sharing practices.
• Champion best practices, operational excellence initiatives, and digital solutions that enhance efficiency and scientific effectiveness.

• Deliver training and scientific guidance to Operations and Technical staff on pathogen safety topics.
• Support the development and maintenance of pathogen safety knowledge within the organization.

• Ensure all scientific activities are performed in accordance with applicable regulations, quality standards, and internal procedures.
• Promote a strong culture of quality, compliance, and scientific rigor.

The role operates within a dynamic matrixed organization requiring flexibility, prioritization, and effective collaboration across multiple functions. The individual must navigate ambiguity and competing priorities while maintaining high‑quality scientific output.

Occasional domestic and international travel may be required to manufacturing and development sites.

• Education:
  
  Bachelor’s degree in Virology, Microbiology, Biotechnology, Biology, Chemistry, or a related scientific discipline.
• Advanced degree (MSc or PhD) in a relevant field strongly preferred.
• Minimum 5 years of experience within the biopharmaceutical, biotechnology, or life sciences industry.
• Demonstrated experience supporting drug development, commercial manufacturing, or technical operations environments.
• Proven ability to contribute technical expertise within cross‑functional pharmaceutical projects.
• Experience working in global, multicultural, and matrixed organizations.
• Strong scientific expertise in pathogen safety and related disciplines.
• Excellent analytical, problem‑solving, and risk assessment capabilities.
• Strong stakeholder management and collaboration skills with the ability to influence without direct authority.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities and deliver results in a fast‑paced environment.

CSL is an Equal Opportunity Employer. Individuals with a disability who require reasonable accommodation for any part of the application process may request assistance.