Analytical Development Principal Scientist

About the role

Vertex is seeking an experienced scientist 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 substance process and control strategy development across clinical and commercial-enabling phases. 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 external drug substance manufacturing and development vendors.

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
• Serve as subject matter expert for setting and justifying drug substance, intermediates, and starting materials specifications with 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

Requirements

• Excellent verbal and written communication skills
• 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, elemental, DNA reactive, nitrosamines)
• Skilled in modern analyses for small molecule pharmaceuticals, particularly chromatography
• Ability to work successfully in both a team/matrix environment as well as independently
• Ability to work in a fast-paced environment, manage priorities, communicate outcomes, and maintain timelines for multiple projects

Qualifications

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

Pay range: $140,800 - $211,200. 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.

Benefits

• Medical, dental, and vision benefits
• Generous paid time off, including a week-long company shutdown in the Summer and Winter
• Educational assistance programs including student loan repayment
• Generous commuting subsidy
• Matching charitable donations
• 401(k) retirement plan

Schedule

This is an on-site role requiring five days per week on-site with ad hoc flexibility.