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:
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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No C2C or Third-Party Vendors
