Scientist Analytical Development

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.  The role will focus on both on-site support of GMP continuous manufacturing and PAT model development. Specific responsibilities include compliance to cGMPs, 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).  Leading and executing GMP activities in continuous manufacturing is critical to the role.
 
Key Responsibilities:

• 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
• 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
• 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.

Minimum Qualifications :

• Ph.D. degree in the physical sciences, mathematics or engineering or equivalent experience
• Minimum Experience: 0 - 5 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

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. 

Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. 

Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards. For additional information and the latest updates from the Company, please visit www.vrtx.com. 

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.