International Foundation Process Analytical Chemistry
: Scientist I Analytical Development, October 2014
: Boston, MA.
Vertex is seeking a talented individual to join our Analytical Development - Process Analytical
Technology group in Boston, MA. As a member of the PAT 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 include but are not limited to:
- Developing PAT methods (NIR, Raman, particle size) and data models to support unit
- 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
- Implementation of PAT methods/models for real time in-process controls and real time release
- Present to cross functional teams and effectively communicate critical issues and solutions
- Authoring and reviewing source documents for regulatory submissions
- A Ph.D. degree in the physical sciences, mathematics or engineering.
- Minimum Experience: 0 - 3 years (PhD). Pharmaceutical Industry experience is an asset, but
is not required.
- Understanding of NIR, Raman, particle size and other measurement techniques that are
suitable for PAT and RTRT.
- Experience with statistics, chemometrics, programming and data modeling packages such as
Matlab, Unscrambler, Eigenvector PLS Toolbox, etc.
- The ability to work successfully in both a team/matrix environment as well as independently is
- 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