Job DescriptionGeneral 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:$120,000 - $180,000
Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:Hybrid-Eligible Or On-Site Eligible
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 select2.
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