Process Analytics & Control Research Scientist

Job Description

Position Overview:

Vertex is seeking a talented individual to join our Formulation Development team in Boston, MA. Consistently and passionately challenging the boundaries of their knowledge, our Formulation Development team employs traditional and innovative analytical techniques and Quality-by-Design principles to ensure the safety, efficacy and quality of Vertex pharmaceutical products. This position provides a unique opportunity to contribute to drug product development in a dual role as a member of both the Process Analytics and Control team and the Dissolution team.

The Process Analytics and Control team is responsible for the automated control strategy for drug product continuous manufacturing and the development/validation of PAT methods. Specific responsibilities include compliance to cGMPs, the development and validation of Process Analytical Technology (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 and Continuous GMP Manufacturing.

As a member of the Dissolution team this role will also support the drug development programs at Vertex through analytical method development, validation, and transfer. This person will have the opportunity to develop and execute analytical strategies for phase appropriate dissolution methods and specification justifications.

Applicants are not expected to have expertise in all aspects of both process analytics and dissolution testing but should have a strong background in analytical chemistry, chemical engineering, or pharmaceutical chemistry and the ability to grow and develop within the opportunities presented in this role. Both strong analytical technical capabilities and excellent communication skills are required to be successful in this role.

Key

Duties and Responsibilities:

PAT responsibilities:

* Developing PAT methods (multivariate data analysis and spectroscopic methods) and data models to support unit manufacturing operations.

* Implementation of PAT methods/models for real time in-process controls and real time release testing.

* Implementation of automated control strategies to support continuous GMP manufacturing including configuration, bench testing, integrated script testing, report development, and report validation.

* Supporting GMP continuous manufacture, including leading PAC activities in support of clinical manufacturing.

* Qualification and maintenance of PAT equipment.

Dissolution responsibilities:

* Supporting analytical method development, validation, and transfer.

* Develops, troubleshoots, and conducts analytical experiments in support of drug substance/product process development within SOPs and regulations.

* Collates and interprets complex analytical data systematically, and compiles results into a cohesive body of conclusions or recommendations to guide Project decisions and new analytical activities.

* Authors methods, protocols and reports as assigned

* Maintains accurate records of experiments and results in an electronic laboratory notebook.

* Demonstrates knowledge of scientific principles and basic understanding of applicable drug development regulations

Knowledge and

Skills:

* Knowledge and experience in one or more analytical techniques (e.g. Spectroscopic techniques, particle size measurement, HPLC/UPLC, Dissolution testing, KF, etc.)

* Excellent experimental documentation, and ability to exercise sound scientific and technical judgment

* Excellent attention to detail and strong communication skills.

* The ability to work successfully in both a team/matrix environment as well as independently.

* The ability to work in a fast-paced environment, manage priorities, and maintain timelines for multiple projects.

* Demonstrated skills with a scripting language and/or multivariate analysis software (e.g. Matlab, VBA, Python, Aspen Unscrambler)

* Excellent ability to analyze, visualize, and interpret data

* Experience with regulatory requirements and industry standards, including cGMP

Education and Experience:

* A Ph.D. degree in Chemistry, Chemical Engineering or…