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Scientist Process Analytical Technology
at Vertex
Boston, MA

Scientist Process Analytical Technology
at Vertex
Boston, MA

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Description

Job Description:

Vertex is seeking a talented individual to join our Analytical Development - Process Analytical Technology group in Boston, MA. As a member of the Process Analytics and Control team, this individual will also be a member of the industry leading continuous drug product manufacturing team supporting drug development programs at Vertex. Specifically, the role will focus on the development and validation of Process Analytical Techniques (PAT) methods and data models, statistical data analysis including the justification for sampling plans, Monte Carlo simulations, etc., and the evaluation of new technology to support Formulation Development, Continuous GMP Manufacturing and Real Time Release Testing (RTRT).

Key Responsibilities:
  • Developing PAT methods (NIR, Raman, particle size) and data models to support unit manufacturing operations.
  • Implementation of PAT methods/models for real time in-process controls and real time release testing
  • Supporting the development and validation of automation control software related to continuous manufacturing.
  • Supporting GMP continuous manufacture.
  • Presenting to cross functional teams and effectively communicate critical issues and solutions
  • Interfacing with key CMOs to generate PAT data during early development for key unit operations (blending, drying, etc).
  • Transfer and validation of methods/models for unit operations to allow for application to continuous manufacturing.
  • Authoring and reviewing documents required for a cGMP environment.

Qualification:

  • Ph.D. degree in the physical sciences, mathematics or engineering or equivalent experience
  • Minimum Experience: 0 - 3 years (PhD). Pharmaceutical Industry experience is an asset, but is not required.
  • Experience with statistics, chemometrics, programming and data modeling packages such as Matlab, Unscrambler, Eigenvector PLS Toolbox, etc.
  • Experience with programming (SQL, .Net, XML, C#, etc.), automation, databases, configuring SQL reports is a plus but not a requirement
  • 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

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