Product Support Scientist

Job Description

Job Summary:

• This is a contract position in the Operations Product Support team , located in Rochester, NY.
• This role supports validation activities for new products within a medical device manufacturing facility and requires the ability to work both independently and as part of a cross-functional team.

Duties and Responsibilities:

• Support validation work for new products, including laboratory testing utilizing VITROS analyzers.
• Prepare and handle clinical test specimens according to approved procedures, best practices, and safety requirements, including appropriate PPE.
• Perform pilot-scale formulations with biological materials, as needed.
• Operate and maintain laboratory equipment; complete all required documentation in real time (QC records, instrument logs, test records).
• Independently execute laboratory experiments and assist with troubleshooting instrument and test failures, as needed.
• Review and analyze data; document conclusions and test summaries in appropriate quality records within client’s quality system.
• Ensure organization, documentation, and tracking of long-term studies with multiple factors, products, and conditions.
• Maintain a working knowledge of cGMP requirements and adhere to all quality, regulatory, and safety guidelines.
• This role involves both laboratory and computer-based work.

Education and Experience:

• Bachelor’s degree in a scientific field (e.g., Chemistry, Biology, or equivalent) required.
• Experience in an FDA-regulated industry and in validation for medical devices preferred.

Knowledge, Skills and Abilities:

• Familiarity with VITROS products and VITROS analyzers highly desired.
• Familiarity with biological formulations and processing techniques highly desired.
• Strong written and verbal communication skills with excellent attention to detail required.
• Strong organizational skills and ability to manage complex, long-term studies required.
• Proficiency in Excel required, with additional statistical analysis skills preferred.