Research Scientist, Analytical Development

Job Description

General Summary:

Vertex is seeking a talented scientist to join our Analytical Development group in Boston, MA.  As a member of an industry leading CMC team, this individual will play a central role in advancing transformative medicines treating the underlying cause of serious diseases by leading analytical activities for small molecule development programs from preclinical through to late stage development.  Responsibilities include analytical method development and validation, purity and stability characterization of drug substance and drug product, as well as contributing scientifically in the resolution of broader drug development challenges in collaboration with other CMC functions.  Experience in laboratory techniques commonly used in the analysis of pharmaceutical products, especially HPLC. As a member of a dynamic and diverse CMC team focused on science and innovation, this position will provide the opportunity to learn new technologies, collaborate across CMC functions, and grow broadly beyond one’s own discipline and as a scientific leader. Hands-on experimental work is expected, as is the ability to work both independently and in a matrix team environment. 

This is an onsite position at our Boston, MA location.

Key Duties and Responsibilities:

• Defines, develops, and conducts experiments that follow applicable regulations and SOPs with a high degree of reliability, independence, and attention to detail.
• Maintains accurate records of experiments and results in a laboratory notebook and authors reports as assigned.
• Performs advanced, complex experimental troubleshooting for a broad array of control methods suitable to determine potency, purity, and stability for drug substances and/or drug products. Collaborates and align with Analytical Development subject matter expert (SME) teams to develop analytical methods, suitable for progressive stages of pharmaceutical development
• Designs stability studies for drug substances and drug products to help assess stability liabilities and to support retest/expiry periods.
• Designs validation protocols that comply with ICH and FDA guidelines and identifies critical factors that may not be mandated by the guidelines but are essential for validating methods for their intended use.
• Develops, reviews, and approves source documents for regulatory submissions.
• Performs analytical testing and data review, as well as systematic collation and interpretation of complex datasets to guide project decisions and new research activities.
• Independently prepares presentations and presents to cross functional teams and effectively communicates critical issues and solutions to colleagues at all levels within the organization.
• Serves as the direct contact with contract manufacturing and testing laboratories. Aids in investigations related to validation, release testing, and stability.
• Troubleshoots and maintains general lab equipment, including HPLCs.

Knowledge and Skills:

• Designs and executes complex, challenging experiments
• Technical expertise in analytical techniques that include LC/LCMS, GC/GCMS, KF, XRF and others
• Demonstrated written and verbal communication skills especially in peer-directed presentations and report writing
• Advanced troubleshooting skills and problem-solving capabilities
• Strong analytical data assessment, review and interpretation skills
• Ability to work in a fast-paced matrix environment, managing priorities and maintaining timelines
• Familiarity of cGMPs and Regulatory guidelines pertaining to compliance, documentation, and method validation.

Education and Experience:

• Ph.D. (or equivalent degree) and 0-3 years of relevant post-doctoral employment experience in the life or physical sciences with a preference for a concentration in analytical chemistry
• Masters Degree (or equivalent degree) and 3+ years of relevant employment experience , or
• Bachelors Degree (or equivalent degree) and 6+ years of relevant employment experience

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

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 [email protected]