Sr. Scientist, Process Analytics & Control
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.
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.