Job Description
General Summary:
The successful candidate will possess a deep knowledge of process chemistry skills for the development of synthetic routes, with early and late-phase development experience 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 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, mutagenic impurity risk assessment, etc.) to assist in identifying and optimizing reaction conditions for key transformations. The successful candidate will represent process chemistry 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
- Familiar with early and late phase pharmaceutical development and regulatory expectations
- Work with Pharm Sci team to develop project strategy, timelines, and leverages technical skills as a Process Chemistry expert within Vertex.
- Individual lab work focused on developing safe, scalable processes
- Seek to employ state-of-the art technologies, including flow chemistry, photochemistry, electrochemistry, computational and predictive tools
- Will contribute directly to technology transfer to internal sites or external vendors
- Proactively identifies and oversees vendors to gain access to technologies as needed to deliver pipeline
- Leverage cross-functional knowledge to guide pharmaceutical sciences teams on potential impact of decisions
- Assesses data integrity to provide expert interpretation and recommendations to project teams and leadership
- Presents synthetic and experimental plans clearly and persuasively to all parts of the organization.
- Recognized as a technical leader by the group and may mentor junior staff
- 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
- Knowledge and experience with fundamental understanding of mutagenic impurity formation and control
- Ability to communicate difficult concepts, ideas, and solutions to project teams and leadership
- 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 8+ years of experience in the pharmaceutical industry
Flex Designation: On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
Company Information:
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
