Analytical Development Principal Scientist

Vertex Inc.•Boston, MA

3d•$140,800 - $211,200•Onsite

About The Position

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.

Requirements

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
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

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