Responsibilities
- Deliver technical expertise and hands-on support for pathogen safety initiatives, focusing on mitigation strategies for unintended contaminants like viruses and prions
- Work across departments with teams such as Technical Operations, Regulatory Affairs, Pharmacovigilance, Manufacturing, and Quality to provide scientific analysis and guidance
- Design and carry out scientific risk assessments related to pathogen safety for process changes, deviations, and investigations, including evaluation of contamination controls, material safety, testing methods, and new pathogen threats
- Develop and review technical documentation such as reports and audit materials, ensuring scientific data is presented clearly, compliantly, and in alignment with regulatory standards
- Support research and development and product lifecycle activities by contributing to virus validation study planning, improving virus clearance methods, and integrating Quality by Design principles, including preparing regulatory submission content
- Perform scientific literature reviews and summarize findings on emerging pathogen-related research and regulatory updates to inform risk assessments and decisions
- Author and implement standard operating procedures, work instructions, and training content related to pathogen safety practices
- Carry out responsibilities in a global setting across multiple time zones, following established project governance and organizational priorities
Work Arrangement
On-site
