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Analytical Development Senior Scientist - Early Phase Project Lead

Hampton Research

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Boston, MA
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Job Description

As posted by the hiring company

Job Overview:

Job Description

General Summary:

Vertex is seeking a talented individual to join our small molecule Analytical Development group in Boston, MA. This role will involve strategic planning, coordination, and experimental execution within established timelines of analytical activities supporting the advancement of early phase clinical programs (Preclinical through Phase 2). Responsibilities include oversight and accountability for all assigned analytical deliverables for a program, which may include but not be limited to analytical method development and validation, purity and stability characterization, setting specifications, CMO oversight, and overall strategic alignment, for both small molecule drug substance and drug product development. 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:

  • Leads analytical aspects of drug substance and drug product development for projects assigned, including designing, planning, and executing on IND and/or IMPD enabling analytical activities.
  • Designs and performs elaborate and technically challenging analytical experiments in compliance with applicable regulations and SOPs.
  • Performs and oversees advanced, complex experimental troubleshooting and method development.
  • Performs technical data review, with overall accountability for all data generated in support of assigned deliverables.
  • Mentors laboratory staff and is responsible for the quality and accuracy of the work done by others.
  • Authors, reviews, and approves analytical methods, protocols, and reports, including source documents for regulatory submissions.
  • Establishes specifications and retest/expiry to support clinical development.
  • Authors CMC sections of regulatory submissions and responds to information requests (IND, IMPD).
  • Presents to cross functional teams and effectively communicates critical issues and solutions within the organization.

Qualifications:

  • Ph.D. degree in Chemistry, Chemical Engineering, Pharmaceutical Chemistry or other natural science with a minimum of 2 years or MS with 5+ years or BS with 8+ years of experience.
  • Strong skills in analytical chemistry are required.
  • An in-depth knowledge of common techniques used in the pharmaceutical industry, such as HPLC, GC, KF, dissolution, ICP and spectroscopy, including both theory and practice, and troubleshooting.
  • Expertise in other analytical techniques used in small molecule pharmaceutical development is a plus.
  • Demonstrated analytical leadership including the ability to work successfully in both a team/matrix environment as well as independently
  • The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects
  • Excellent written and verbal communication skills as demonstrated by symposia presentations and research publications in peer reviewed journals.
  • Knowledge of cGMPs and applicable regulatory guidelines.

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.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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.