Process Chemistry Senior Principal Scientist

General Summary:

The successful candidate will possess a deep knowledge of process chemistry skills for the development of synthetic routes, with knowledge and experience in early and mid to late-phase development and delivering drug substance under tight timelines. They will have a strong interest in laboratory work and will be key to driving the development of safe and scalable chemistry. They will spearhead the advancement of Vertex's early phase portfolio through personal laboratory effort as well as overseeing internal and external resources. They will leverage additional Vertex resources (high-throughput experimentation, engineering and material sciences, process safety, analytical, etc.) to assist in identifying and improving reaction conditions for key transformations. The successful candidate will participate in cross-functional teams requiring good communication skills. The successful candidate will have accountability for creating and developing a synthetic route to deliver active pharmaceutical ingredients (APIs) within a specification range fit for the phase of development and delivering the technology and materials to enable candidate progression through development. The Sr. Principal Scientist Process Chemistry will lead/participate in cross-functional technical teams within their field of expertise. They will also be responsible for mentoring internal process chemistry scientists and promote the department through publications in peer reviewed journals and participation in external conferences.

Key Responsibilities Include:

• Demonstrates advanced intellectual and technical leadership

• Developing syntheses meet regulatory expectations in early to mid phase development

• Interface with Medicinal Chemistry and local Medicinal Chemistry Scale-up Group to rapidly scale chemistry to support identification of Vertex's next-generation medicines

• Work with Pharm Sci team to develop project strategy, timelines, and leverage technical expertise and planning ability.

• Seek to employ state-of-the art technologies in their lab work and maintain lab safety in their work

• Will contribute directly to technology transfer to internal sites or external vendors

• Proactively identifies and oversees vendors

• Assesses data integrity to provide expert interpretation and recommendations to project teams and leadership

• Presents synthetic and experimental plans clearly and persuasively

• Authors publication, patent, and regulatory submissions

Knowledge and Skills:

• Effectively managing CRO/CMO resources

• Maintain standards for all laboratory records, internal reports, patents and external communications

• Establishing and delivering on agreed timelines while integrating activities across various departments

• May draft process descriptions for the CMC section of regulatory documents for early development projects

• A track record of successfully achieving goals and solving problems in the pharma environment

• Ability to communicate difficult concepts, ideas, and solutions

• Knowledge and understanding regulatory factors and maintaining expert knowledge in chemistry

• Other duties as defined

Education and Experience:

• Bachelor's degree and 11+ years of experience or a Master's degree and 9+ years of experience or a PhD and 6-8+ years of experience in the pharmaceutical industry

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