Analytical Science and Technology Senior Scientist

About the role

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.

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

Qualifications

• 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

Pay

$120,000 - $180,000

Benefits

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.

Schedule

In this Hybrid-Eligible role, you can choose to be designated as: Hybrid: work remotely up to two days per week; or select 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.