Analytical Science and Technology Senior Scientist
The Senior Scientist, Analytical Sciences & Technology (AS&T), plays a critical role in the Commercial Manufacturing & Supply Chain team. You will be reponsible 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.
- 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
Education and Experience
- 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
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
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 ApplicationAssistance@vrtx.com.