AS&T Principal Scientist - CGT & Biologics
Vertex Pharmaceuticals
4 days ago
Remote friendly (Boston, MA)
United States
Operations
General Summary:
The Principal Scientist will support 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; regulatory writing experience (e.g., eCTD Module 3 sections and/or responding to health authority responses) highly desirable.
- Experience in analytical CMC development for cell and gene therapy or biologics, particularly from late-stage development through commercialization.
- Familiarity with GMPs, USP/ICH, and regulatory guidance for analytical methods and commercial-stage CMC; strong understanding of analytical support for commercial biological products and cGMP manufacturing.
- Proficiency in statistical analysis tools (e.g., JMP, GraphPad Prism) required.
Education And Experience:
- M.S. (or equivalent) in biochemistry, chemical engineering, or relevant discipline with 6+ years biopharmaceutical industry experience; or B.S. with 9+ years.
Pay Range:
$138,400 - $207,600
Application Instructions:
Make accommodation requests to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
The Principal Scientist will support 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; regulatory writing experience (e.g., eCTD Module 3 sections and/or responding to health authority responses) highly desirable.
- Experience in analytical CMC development for cell and gene therapy or biologics, particularly from late-stage development through commercialization.
- Familiarity with GMPs, USP/ICH, and regulatory guidance for analytical methods and commercial-stage CMC; strong understanding of analytical support for commercial biological products and cGMP manufacturing.
- Proficiency in statistical analysis tools (e.g., JMP, GraphPad Prism) required.
Education And Experience:
- M.S. (or equivalent) in biochemistry, chemical engineering, or relevant discipline with 6+ years biopharmaceutical industry experience; or B.S. with 9+ years.
Pay Range:
$138,400 - $207,600
Application Instructions:
Make accommodation requests to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.