Knowledge and Skills: Demonstrated expertise in analytical method development, characterization, and qualification/validation for biologicsKnowledgeable in ICH/USP/EMA guidelines with a strong GMP background, CGT related preferredExperience managing contract (CTO/CDMO) analytical testing, highly desirableExperience with technical support of commercial biological products and cGMP manufacturingAbility to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiencyExcellent technical writing skills, and communication skills with the proven ability to build open and collaborativeHands-on experience with methods related to CGT products, prefer in-vitro cell-based functional, potency and/or microbiology assays. Key Duties and Responsibilities: Accountable for the success of commercial analytical activities, prioritization, and execution to meet program commitmentsSubject Matter Expertise (SME) for ensuring the robustness of analytical methods and commercial testing requirementsAuthor and/or review technical documents, including method SOP, study protocol and technical reportPartners effectively with internal and external functions for commercial analytical technology transferPrimary responsibilities extend to analytical method validations, continuous improvement, and lifecycle managementCollaborate with Vertex cross-functions, including Analytical Development, Process Development, Commercial Manufacturing, Supply Chain, Quality teams, Vertex Partners, and Contract Test labs.