Research Scientist, Cell and Gene Therapy Analytical (Contract)

Research Scientist, Cell and Gene Therapy Analytical (Contract)

This Research Scientist position will be part of the Analytical Science and Technology (ASAT) team within the Commercial Manufacturing & Supply Chain (CMSC) department. The role involves providing expertise in microbiology-related analytical support for the manufacturing and product release of the Cell and Gene Therapy (CGT) portfolio.

Key Responsibilities:

• Work independently or collaboratively in analytical lifecycle activities, including method development, validation, and transfer.
• Serve as a Subject Matter Expert (SME) and represent ASAT in troubleshooting and OOS investigations during release and stability testing.
• Assess deviations, CAPA, and change controls as SME.
• Participate in internal and external meetings.
• Author and review technical documents such as SOPs, study protocols, and technical reports.
• Prepare and review regulatory filings and responses.

Knowledge and Skills:

• Hands-on experience and in-depth knowledge of microbiology or potency assays.
• Experience in Gene and Cell Therapy is desirable.
• Knowledge of relevant ICH and regulatory guidelines, with a good understanding of GMP.
• Experience supporting late-stage or commercial biological products and cGMP manufacturing.
• Ability to prioritize multiple projects, adhere to timelines, and maintain flexibility.
• Effective partnership with internal and external teams.
• Experience with JMP or similar statistical tools is a plus.
• Strong technical writing skills.

Requirements:

• B.S. or higher in Biology or related field.
• Minimum of 8 years of experience in the pharmaceutical/biopharmaceutical industry or equivalent education and experience.

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Science
• Industries: IT Services and IT Consulting