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Job Description

General Summary:

Vertex is seeking a talented scientist eager to help develop both cutting-edge small molecule pharmaceuticals and the science underpinning the analytical control of their syntheses.

This scientist will become a subject matter expert (SME) in mutagenic impurity within the Drug Substance Control Strategy team in Analytical Development this role will support small molecule drug development programs at Vertex.

The position will focus on understanding the pathways for mutagenic impurity formation and contributing to the design and execution of studies. The Sr. Scientist will also work on developing test methods for characterizing potential risk factors in collaboration with other members of analytical development, such as the control strategy, trace analysis, and chromatography SME teams. Additionally, the position will involve authoring internal and external publications to support the safe and rapid advancement of new drugs.

Candidates with an understanding of small molecule pharmaceutical process development, and modern analytical techniques will be best equipped to succeed in this role.

Key Duties and Responsibilities:

• Serve as subject matter expert for mutagenic impurity control and advance science-driven understandings of their formation, prevention, and rejection.
• Develop, troubleshoot, and execute a broad range of test methods to characterize mutagenic impurity risk factors in pharmaceutically relevant matrices.
• Collaborate closely with project teams and partner organizations to deliver timely solutions across a portfolio of projects
• Author and present results in both oral and written reports.
• Maintains accurate records of experiments and results in an electronic laboratory notebook.
• Complies with applicable SOPs.
• Performs other duties as assigned.

Knowledge and Skills:

• Understanding of current science on the formation and control of mutagenic impurities, particularly nitrosamines.
• Foundational knowledge of organic chemistry is essential along with an understanding of drug substance and drug product process development.
• Experience developing and running analyses relevant to small molecule characterization (HPLC, GC, IC, KF, etc.).
• The ability to design and conduct experiments independently with minimal supervision is essential.
• The ability to work successfully in both a team/matrix environment as well as independently is essential.
• The ability to work in a fast-paced environment, manage priorities, and maintain timelines for multiple projects is essential.
• Excellent written and verbal communication skills as demonstrated by symposia presentations and research publications in peer reviewed journals are required.

Education and Experience:

• Degree in physical sciences or engineering is required along with relevant work experience in analytical chemistry.
• Ph.D. and 2-5 year of relevant employment experience, or an MSc and 5+ years of relevant employment experience, or a BSc and 8+ years of relevant experience

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

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