Vertex
pharmaceutical
AnalyticalScienceandTechnologySeniorScientist
Neural analysis suggests this role is
optimal for Senior candidates.
“Analytical Science and Technology Senior Scientist at Vertex. Skills: Analytical Science, Method Development, Validation. Accountable for commercial analytical activities. Prioritize commercial analytical activities”
What You'll Achieve.
Meet program commitments
Industry & Context.
Analytical event investigations
What They're Looking For.
Must Have
Bachelor’s degree or above in Science, 8 years of experience in pharmaceutical industry, GMP background
Nice to Have
small molecule related preferred, Experience managing contract analytical testing, technical support of commercial small molecule products, dissolution test
What You'll Do.
Accountable for commercial analytical activities
Prioritize commercial analytical activities
Execute commercial analytical activities
Ensure robustness of analytical methods
Manage analytical event investigations
Author technical documents
Review technical documents
Partner with internal functions
Partner with external functions
Manage analytical technology transfer
Perform analytical method validations
Perform continuous improvement
Manage lifecycle management
Collaborate with cross-functions
Provide oversight for analytical testing
Provide oversight for method performance
How You'll Work.
Team & Collaboration
Vertex cross-functions; Analytical Development; Process Development; Commercial Manufacturing; Supply Chain; Quality teams; Vertex Partners; Contract Test labs; CDMOs; Contract testing labs
Communication Scope
Technical writing; Communication skills
Full Job Description
**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 on analytical requirements to ensure launch readiness and lifecycle management for the commercial small molecule 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, commercial testing requirements, and managing analytical event investigations * Author and/or review technical documents, including methods, study protocols and technical reports * 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 * Knowledgeable in ICH/FDA/EMA guidelines with a strong GMP background, small molecule related preferred * Experience managing contract (CMO/CDMO) analytical testing, highly desirable * Experience with technical support of commercial small molecule 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 experienc
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