Analytical Science and Technology Senior Scientist

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Vertex Pharmaceuticals LLC is seeking a Senior Scientist in Analytical Sciences & Technology (AS&T) to support launch readiness and lifecycle management for the commercial CGT portfolio. You will lead analytical method development, validation, and technology transfer, collaborating across Analytical Development, Process Development, Commercial Manufacturing, and Quality teams.

With a strong GMP background and experience in biologics, you will ensure testing readiness for CDMOs and external labs,

Qualifications

• Demonstrated expertise in analytical method development, characterization, and qualification/validation for biologics.
• Knowledgeable in ICH/USP/EMA guidelines with a strong GMP background.
• Experience managing contract (CTO/CDMO) analytical testing, highly desirable.
• Experience with technical support of commercial biological products and cGMP manufacturing.

Responsibilities

• Accountable for the success of commercial analytical activities, prioritization, and execution to meet program commitments.
• Subject Matter Expert for ensuring the robustness of analytical methods and commercial testing requirements.
• Author and/or review technical documents, including method SOP, study protocol and technical report.
• Partners effectively with internal and external functions for commercial analytical technology transfer.
• Oversight for analytical testing and method performance executed at CDMOs and contract testing labs.

Skills

Analytical method development

Biologics knowledge

GMP background

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree or higher in Science or related discipline

Job description

## Analytical Science and Technology Senior ScientistApply: Boston, MA: Full time: Posted Today: REQ-30151**Job Description****General Summary:**The Senior Scientist, Analytical Sciences & Technology (AS&T), plays a critical role in the Commercial Manufacturing & Supply Chain team. You will be responsible for providing strong expertise with biological assays and analytical requirements to ensure launch readiness and lifecycle management for the commercial Cell and Gene therapy (CGT) portfolio.**Key Duties and Responsibilities:**- Accountable for the success of commercial analytical activities, prioritization, and execution to meet program commitments- Subject Matter Expertise (SME) for ensuring the robustness of analytical methods and commercial testing requirements- Author and/or review technical documents, including method SOP, study protocol and technical report- Partners effectively with internal and external functions for commercial analytical technology transfer- Primary responsibilities extend to analytical method validations, continuous improvement, and lifecycle management- Collaborate with Vertex cross-functions, including Analytical Development, Process Development, Commercial Manufacturing, Supply Chain, Quality teams, Vertex Partners, and Contract Test labs.- Provides oversight for analytical testing and method performance executed at CDMOs and contract testing labs**Knowledge and Skills:**- Demonstrated expertise in analytical method development, characterization, and qualification/validation for biologics- Knowledgeable in ICH/USP/EMA guidelines with a strong GMP background, CGT related preferred- Experience managing contract (CTO/CDMO) analytical testing, highly desirable- Experience with technical support of commercial biological products and cGMP manufacturing- Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency- Excellent technical writing skills, and communication skills with the proven ability to build open and collaborative- Hands-on experience with methods related to CGT products, prefer in-vitro cell-based functional, potency and/or microbiology assays**Education and Experience:**- Bachelor’s degree or above in Science or related discipline- 6 years of experience in the pharmaceutical/biopharmaceutical industry with increasing project the equivalent combination of education and experience At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.**Pay Range:**$120,000 - $180,000**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**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