Job Description
General Summary:
Vertex is seeking an experienced scientist eager to help develop both cutting-edge small molecule pharmaceuticals and the science underpinning the analytical control of their syntheses. As a member of the Analytical Development team, this role will support drug development programs at Vertex with a focus on Drug Substance process and control strategy development. Specifically, the individual will help design the tests and testing strategy for novel drug substances, collaborate closely with associated CM&C functions, and act as a subject matter expert liaison with our global network of external drug substance manufacturing and development vendors. The role may include management of a small group, in addition to providing independent contributions as dictated by project needs. The ability to develop novel and creative solutions to overcome project obstacles and make significant conceptual contributions to project teams are criteria for success.
Key Duties and Responsibilities:
- Collaboratively design and oversee drug substance process development 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 the understanding of clinical study design, supporting toxicology studies, and CMC processes.
- 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 and/or supervise activities.
- 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 method performance and/or analytical development activities.
- Develop and review source documents for regulatory submissions.
- Present to cross-functional teams and effectively communicate critical analytical issues and solutions.
Knowledge and Skills:
- 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 is essential, 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), and the ability to apply the guidelines in the context of the stage of pharmaceutical development.
- 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.
Education and Experience:
- Ph.D. with 4-6 years of relevant analytical development experience, particularly focused on the development of novel drug substances. Exceptional candidates with MS or BS degrees and extensive high-level experience will also be considered.
- Background in, or deep 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 is essential.
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 ...@vrtx.com.
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