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 Pharmaceutical Chemistry and 0-3 years’ experience or a Masters and 2-5 years experience or Bachelor's degree and 6+ years of experience of relevant analytical experience Pay Range: $99,400 - $149,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information 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 View email address on click.appcast.io Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.