Analytical Development Principal Scientist

Job Description General

Summary:

Vertex is seeking an experienced scientist eager to help develop cutting-edge small molecules and the science underpinning the analytical control of their syntheses. As a member of the Drug Substance Control Strategy team in Analytical Development, this role will support synthetic drug development programs at Vertex with a focus on small molecule drug substance process and control strategy development across clinical and commercial-enabling phases.

Specifically, the individual will oversee and execute experiments to develop the overall control strategy for novel drug substances, collaborate closely with associated CMC functions, and act as a subject matter expert liaison with our global network of external drug substance manufacturing and development vendors. The ability to develop novel and creative solutions to overcome project obstacles and make significant conceptual contributions to project teams are criteria for success.

Key

Duties and Responsibilities:

Collaboratively design and oversee drug substance process development analytical activities across all phases of development, including late phase development following Quality by Design (QbD) principles

Serves as subject matter expert for setting and justifying drug substance, intermediates, and starting materials specifications with the understanding of clinical study design, supporting toxicology studies, and CMC processes and applicable regulatory guidelines

Identify critical in-process-control issues and develop appropriate IPC methods

Serve as the subject matter expert for drug substance analytical development with contract manufacturing and testing labs Develop analytical methods, suitable for progressive stages of pharmaceutical development

Justify and set retest period, storage, and shipping conditions for starting materials and intermediates

Understand chemical development and solid-state development to identify and document critical factors that impact quality, method performance, or associated analytical development activities

Develop and review source documents for regulatory submissions

Present to cross functional teams and effectively communicate critical analytical issues and solutions

Knowledge and

Skills:

Excellent verbal and written communication skills are essential

Experience and/or working knowledge of control strategy development, spike / purge studies, drug substance QbD process development

Good understanding of cGMP, ICH, FDA, and USP guidelines, including ICH guidelines on the control of impurities (organic, residual solvents, and elemental, DNA reactive (including ICH M7 option 4 / in silico control), and nitrosamines)
Skilled in modern analyses for small molecule pharmaceuticals, particularly chromatography.

The ability to work successfully in both a team/matrix environment as well as independently

The ability to work in a fast-paced environment, manage priorities, communicate outcomes and maintain timelines for multiple projects

Education and Experience:

Ph.D. with 4+ years of relevant analytical development experience, particularly focused on development of novel small molecule drug substances . Exceptional candidates with MS degree and 7+ years or BS degree and 10+ years of high-level experience will also be considered

Background in, or good understanding of modern synthetic organic chemistry, as well as of the drug substance development process, process chemistry, and pharmaceutical manufacturing, and their interrelationship with analytical development

Pay Range:$140,800 - $211,200

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,…