Analytical Science and Technology Senior Scientist

Vertex Pharmaceuticals•Boston, MA

19h•Hybrid

About The Position

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.

Requirements

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
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

Nice To Haves

CGT related preferred
Experience managing contract (CTO/CDMO) analytical testing, highly desirable
prefer in-vitro cell-based functional, potency and/or microbiology assays

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