CMSC Analytical Science and Technology Manager

This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted.

Job Summary:

The Manager will be part of the Analytical Science and Technology (ASAT) function within the Commercial Manufacturing & Supply Chain (CMSC) team. This role supports the execution of analytical strategies by contributing to team objectives, managing critical data, and generating high-quality technical documentation for late-stage and commercial programs, particularly within Cell and Gene Therapy (CGT).

Key Responsibilities:

• Contribute to the preparation of regulatory submission content for analytical CMC, including control strategies, justification of specifications, and comparability assessments.
• Draft and/or review technical reports such as method bridging, stability studies, and specification justifications.
• Support Quality Management System (QMS) processes including change control, impact assessments, and implementation tracking.
• Conduct data verification, trend analysis, and statistical evaluations to support regulatory and product development strategies.
• Collaborate across internal teams and with external partners to ensure analytical readiness for commercial launch and continued lifecycle activities.

Qualifications and Skills:

• Exceptional technical writing skills; experience with regulatory submissions (e.g., eCTD Module 3, response to health authorities) is a strong advantage.
• Demonstrated experience in analytical CMC for biologics or cell and gene therapies, especially during late-stage development and commercialization.
• Experience working with contract testing laboratories or external manufacturing partners is preferred.
• Strong knowledge of GMP, ICH, and USP standards related to analytical methods and commercial-stage CMC.
• Solid understanding of analytical requirements for commercial biologic products and cGMP manufacturing processes.
• Ability to handle multiple priorities, meet deadlines, and work effectively in a fast-paced environment.
• Strong communication, collaboration, and organizational skills.
• Familiarity with regulatory expectations for commercial products and QMS systems is desirable.
• Proficiency with statistical analysis tools (e.g., JMP, GraphPad Prism) is required.

Education and Experience:

• Master’s degree in biochemistry, chemical engineering, or a related scientific field with 6 years of relevant industry experience, or
• Bachelor’s degree in biochemistry, chemical engineering, or a related scientific field with 9 years of relevant industry experience.

Please submit your resume and send to recruiters@vsearchgroup.com if you are interested. Thank you!