AS&T Principal Scientist - CGT & Biologics

Job Description

General Summary:

The Principal Scientist will be part of Analytical Sciences and Technology (AS&T) team within Commercial Manufacturing & Technical Operations (CMTO) 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 Biologics and Cell and Gene therapy (CGT) programs.

Key Duties and 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:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid
 

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]