Department: Global Pathogen Safety North America (GPS-US)

Reporting Relationship:

This position directly reports to the Associate Director, Global Pathogen Safety Support (GPSS), or equivalent

Position Purpose:

As a Pathogen Safety Scientist with over 3 years of industry experience, you will play a crucial role within the Global Pathogen Safety North America (GPS-US) team. Reporting directly to the Associate Director, you will contribute to the provision of pathogen safety support for North American Cell and Gene Therapy programs while also offering global support across the entire CSL organization when required. Your responsibilities will include assisting in change control and manufacturing incident assessments, conducting product risk assessments, raw materials risk assessments, adventitious agent testing strategies, and segregation risk assessments.

Main Responsibilities and Accountabilities:

Contribute to the development of risk assessments through a thorough review and comprehension of operating procedures, regulatory guidance, in-house data, and scientific literature under general direction.

Assist in the execution of globally distributed projects as needed.

Develop solutions for problems and challenges within projects under supervision.

Contribute to the authorship and review of scientific reports and risk assessments.

Qualifications/Education:

• Master's degree or equivalent in a Science-related field. An advanced degree (PhD) in Science or equivalent is preferred.
• Experience in virology, cell and gene therapy, bio-analytics, cell biology, biotechnology, or a similar field is highly preferred.

Experience:

• 3+ years of experience in the biotechnology or pharmaceutical industry.

Capabilities:

• Thinks beyond and maintains an external and strategic focus.
• Builds bridges and helps teams develop collaboration.
• Unleashes outcomes and creates an accountable work environment.

Note: Due to the global nature of the position, candidates may be required to participate in global telecon meetings outside of local business hours.