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Job Description

General Summary:

Vertex is seeking a talented individual to join our Analytical Development – Process Analytics and Control 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. 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. Specifically, the role will focus on development and maintenance of process analytical technology, the implementation of the automated control strategy, and the validation of Process Analytical Techniques (PAT) methods, automation, and data reporting.

Key Duties and Responsibilities:

• Supporting GMP continuous manufacture, including leading PAC activities in support of clinical and commercial manufacturing
• Managing and coordinating activities related to qualification and maintenance of PAT equipment
• Leading the development and validation of automation control software related to continuous manufacturing.
• Developing a control strategy and implementing PAT methods (NIR, Raman, particle size) and data models to support manufacturing unit operations.
• Presenting to and aligning with cross functional teams on critical issues and solutions
• Authoring and reviewing documents required for a cGMP environment.
• Authoring, reviewing, and assessing quality events including change controls, deviations, and CAPAs
• Supporting inspections by regulatory agencies

Knowledge and Skills:

• Experience managing a team, coordinating resources and delivering results is essential
• The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects
• The ability to work successfully in both a team/matrix environment as well as independently i
• Excellent written and verbal communication skills as demonstrated by symposia presentations and research publications in peer reviewed journals
• Hands-on experience developing, integrating, and maintaining analytical or process instrumentation

Education and Experience:

• PhD (physical sciences, mathematics or engineering) and 2+ years, or Master's and 5+ years, or Bachelor's and 8+ years or equivalent experience.

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