Senior Scientist, Global Pathogen Safety Support Senior Scientist, Global Pathogen Safety Suppo[...]

Seeds Renewables; Holly Springs (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

A global life sciences company is seeking a pathogen safety expert to join their Global Pathogen Safety Support Team. This role involves collaborating with various functions to ensure product safety and compliance with regulatory guidelines. Key responsibilities include analyzing epidemiological data, providing guidance on pathogen reduction for new and existing products, and creating standard operating procedures. The ideal candidate will drive efficiency and innovation in pathogen safety solutions. This position is based in Holly Springs, North Carolina.

Qualifications

• Expertise in pathogen safety for biological products.
• Ability to analyze epidemiological data and emerging pathogens.

Responsibilities

• Serve as the subject matter expert on pathogen safety.
• Collaborate with global and local teams for regulatory submissions.
• Monitor and assess emerging pathogens and regulatory guidelines.
• Contribute to Global Pathogen Safety Team with innovative solutions.
• Participate in cross-functional project teams for guidance and development.

Job description

Job Description

Eurofins PSS is looking for a candidate to join the mission of the Global Pathogen Safety (GPS) Support Team is the development and evaluation of reduction strategies for viruses and other pathogens/adventitious agents to provide products that patients can trust and know to be safe.

Main Responsibilities and Accountabilities:

• Be the subject matter expert for all pathogen safety aspects of the biological products in scope. This includes providing expertise and documentation with regards to drug product development, manufacturing procedures (pathogen reduction steps, cleaning etc.), starting material selection, and testing.
• Collaborate with various functions across the global company organization, including Global Regulatory Affairs and Pharmacovigilance as well as the local Manufacturing/Operations units on Pathogen Safety relevant matters. Provide global and local deviation and change risk assessments, regulatory submission documents, position papers, presentations, training materials and data analyses in support of the business needs.
• Ensure global alignment both with regulatory guidelines/expectations and within GPS. Organize and assemble data and supporting documentation, and conduct scientific literature searches. Analyze epidemiological data and monitor and assess emerging pathogens.
• Effective contributor to the Global Pathogen Safety Support Team. Actively participate in meetings and seek innovative solutions to provide excellent support across the company. Create efficiencies across the global Pathogen Safety organization, i.e. setting up standard procedures (SOPs), white papers etc.
• Actively participate on cross‑functional project teams and global project teams. E.g. provide Guidance on and co‑development of pathogen reduction steps for new products in development and for Life Cycle of existing commercial products. You collaborate with the GPS Virological Development Laboratories to evaluate experimental results and contribute to establishment of Quality by Design, e.g. definition of targets, robustness ranges and critical parameters.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eurofins works with the biggest companies in ...