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Job Description
General Summary:
The successful candidate will have a strong interest in laboratory work and will be key to driving the development of safe and scalable chemistry with an emphasis on mutagenic impurity formation and control.
This role 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.
In addition, you will be responsible for mentoring internal process chemistry scientists and to promote the department through publications in peer reviewed journals and participation in external conferences.
Key Duties and Responsibilities:
- 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
- Direct contribution to technology transfer to internal sites or external vendors
- Identify and oversee vendors to gain access to technologies as needed to deliver pipeline
- Lead project teams and provide fundamental understanding of mutagenic impurity formation and control
- Leverage cross-functional knowledge to guide teams on potential impact of decisions
- Establish and deliver on agreed timelines while integrating activities across various departments
- Assess data integrity to provide expert interpretation and recommendations to project teams and leadership
- Present synthetic and experimental plans clearly and persuasively to all parts of the organization.
- May draft process descriptions for the CMC section of regulatory documents for early development projects and contribute to internal and external documents on mutagenic control
- Maintain standards for all laboratory records, internal reports, patents and external communications
- Author publications, patents, and regulatory submissions
- Work with Pharmaceutical Sciences team to develop project strategy, timelines, and leverages technical skills as a Process Chemistry expert within Vertex.
Knowledge and Skills:
- 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.
- Proven track record of successfully achieving goals and solving problems in the pharmaceutical environment
- Ability to communicate difficult concepts, ideas, and solutions to project teams and leadership
- Demonstrated technical leadership
- Familiar with early and late phase pharmaceutical development and regulatory expectations
- Demonstrated experience in managing CRO/CMO resources effectively
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
- Experience in mutagenic impurity risk assessment, establishing control strategies for small and large molecule therapeutics, and successful implementation and control of nitrosamines a must.
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
#LI - Onsite
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.
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 Human Resources at ApplicationAssistance@vrtx.com.