Analytical Science and Technology Manager for Commercial Manufacturing & Supply Chain (Contract)

Job Description

Job Summary:

The Manager (contractor) will be part of Analytical Science and Technology (ASAT) team within Commercial Manufacturing & Supply Chain (CMSC) department. S/He/They will provide support with development and execution of the analytical CMC strategy by contributing to team goals, maintaining source data, and delivering high-quality technical documentation for late-stage and commercial Cell and Gene therapy (CGT) programs.

Key Responsibilities:

• Support preparation of global regulatory submission sections, for late-stage and commercial programs in analytical CMC areas (e.g., registrational CQAs, control strategy, justification of specifications, and comparability studies).
• Author and/or review technical documents such as justification of specifications, method bridging, comparability and stability reports.
• Assist with QMS activities (Change Control, Impact Assessment, Change Action Owner) related to CMC implementation.
• Perform data verification, trending and statistical analysis to support regulatory strategy and product characterization.
• Collaborate cross-functionally with internal stakeholders and external partners to support analytical readiness for commercialization and ongoing product lifecycle activities.

Knowledge and Skills:

• Strong technical writing skills are essential; regulatory writing experience (e.g., eCTD Module 3 sections and/or responding to health authority responses) is highly desirable. 
• Experience in analytical CMC development for cell and gene therapy or biologics, particularly from late-stage development through commercialization.
• Prior experience working with contract testing organizations (CTOs) or manufacturing sites (CDMOs) is a plus.
• Familiarity with the GMPs, USP/ICH, and regulatory guidance applicable to analytical methods and commercial-stage CMC. 
• Strong understanding of analytical support for commercial biological products and cGMP manufacturing.
• Proven ability to manage multiple priorities, meet timelines, and maintain flexibility in a fast-paced environment.
• Effective collaboration, communication and multitasking skills.
• Familiarity with commercial program lifecycle, QMS systems, and regulatory submission expectations is preferred
• Proficiency in statistical analysis tools (e.g., JMP, GraphPad Prism) is required.

Education and Experience:

M.S. (or equivalent degree) in biochemistry, chemical engineering, or a relevant scientific discipline and 6+ years of experience in the biopharmaceutical industry, or B.S. (or equivalent degree) in biochemistry, chemical engineering, or a relevant scientific discipline and 9+ years of experience in the biopharmaceutical industry 

Pay Range

$65-$75/HR

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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