Analytical Science and Technology Senior Scientist

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 experience with methods related to small molecule products, prefer dissolution test

Education and Experience:

• Bachelor’s degree or above in Science or related discipline
• 8 years of experience in the pharmaceutical/biopharmaceutical industry with increasing project the equivalent combination of education and experience

Pay Range:

Disclosure Statement:

Flex Designation:

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
 

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]