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Scientist I, Analytical Development

Company: Vertex Pharmaceuticals Inc (US)
Location: Boston
Posted on: September 17, 2020

Job Description:

Vertex is seeking a talented individual to join our Analytical Development group in Boston, MA. As a member of the Analytical Development team, this role will support the drug development programs at Vertex through analytical method development, validation and transfer efforts, with special emphasis on drug substance support, drug product support or both. Expertise in laboratory techniques commonly used in the analysis of pharmaceutical products, especially HPLC, is required.

Key Responsibilities include but are not limited to:

* Develop methods to determine potency, purity, and stability for drug substances and/or drug products * Set drug substance and drug product specifications with the understanding of clinical study design and CMC processes * Justify and set retest period, storage, and shipping conditions * Understand drug substance and drug product development to independently provide requisite analytical support * Identify critical in-process-control issues and develop appropriate IPC methods * Design stability studies for drug substance and drug product * Design validation protocols that are appropriate for validating methods for their intended use. * Present to cross functional teams and effectively communicate critical analytical issues and solutions * Develop and review source documents for regulatory submissions

Basic Qualifications

* A Ph.D. degree in the life or physical sciences with a preference for a concentration in Chemistry, Analytical Chemistry or Pharmaceutical Chemistry * Minimum Experience: 0 - 3 years current and relevant industry experience working in drug substance and drug product support * Understanding of the drug development process, including chemical development and formulation development, is essential * Good understanding of ICH and FDA method validation guidelines are essential. The ability of to understand the guidelines in context of development phase is preferred. * Good understanding of GMP and hands-on GMP experience as well as how to develop GMP friendly methods is preferred. * Skilled in HPLC, GC, FT-IR, UV-VIS, KF, dissolution and other instruments is essential. Strong expertise in HPLC is preferred. * The ability to work successfully in both a team/matrix environment as well as independently is essential * The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects is essential * Excellent written and verbal communication skills as demonstrated by symposia presentations and research publications in peer reviewed journals are essential

Keywords: Vertex Pharmaceuticals Inc (US), Boston , Scientist I, Analytical Development, Other , Boston, Massachusetts

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