Process Development Engineering Senior Scientific Associate

Job Description General Summary: Vertex is seeking a lab-based Process Development Engineering Senior Scientific Associate to support process development, including raw material evaluation, for the Type 1 Diabetes (T1D) program. This role will work within the process development team to understand material requirements and supply considerations, support translating those needs into scientifically sound study plans, and execute cell-culture and bioreactor differentiation studies that assess material suitability, performance, and process impact. The successful candidate will combine strong hands-on cell-culture and bioreactor skills with careful study execution, rigorous documentation, and an interest in understanding the biological function of raw materials during differentiation. The role will generate data that informs raw-material selection, process optimization, process characterization, and the development of robust, reproducible manufacturing processes. Key Duties and Responsibilities: - Partner with T1D process-development teams and cross-functional stakeholders to understand raw-material needs across programs, stages of development, and differentiation processes. - Translate program and material needs into clear study objectives, experimental plans, acceptance criteria, and executable laboratory workflows. - Plan and execute raw-material evaluation studies, including supplier, grade, lot, concentration, handling, storage, and replacement assessments, as appropriate to the study question. - Perform mammalian and stem cell culture using strong aseptic technique, with particular emphasis on differentiation workflows relevant to T1D cell-therapy processes. - Execute bench-scale and Ambr differentiation studies, including equipment setup, inoculation, media preparation and exchange, feeding or perfusion operations, sampling, harvest, and sample handling. - Assess the impact of raw materials on cell growth, viability, differentiation performance, phenotype, process consistency, and other relevant process or product-quality attributes. - Develop an understanding of the biological function and potential mechanism of action of raw materials used during differentiation, and connect material attributes to observed process outcomes. - Contribute to process optimization and characterization studies by identifying critical sources of variability, evaluating process-material interactions, and supporting definition of appropriate operating ranges and controls. - Coordinate closely with analytical partners to define sample plans, ensure timely sample processing, and integrate analytical results with process observations. - Analyze and summarize study data, identify trends or unexpected outcomes, and communicate conclusions and recommended next steps to multidisciplinary teams. - Maintain accurate, traceable, and contemporaneous study records, material records, data files, and technical documentation in accordance with data-integrity expectations. - Contribute to protocols, study plans, technical reports, presentations, and other documentation supporting development decisions and knowledge transfer. - Operate, maintain, clean, and troubleshoot cell-culture, bioreactor, perfusion, liquid-handling, cell-counting, and associated laboratory equipment. - Establish, follow, and improve standard procedures and study workflows to support safe, consistent, and reproducible execution. - May participate in weekend work rotations, as required to support cell-culture and bioreactor operations. Knowledge and Skills: - Strong hands-on experience with mammalian cell culture; pluripotent stem cell culture and directed differentiation experience are highly desirable. - Working knowledge of bench-scale bioreactor operation and process-development workflows; experience with ambr250, perfusion systems, or comparable platforms is preferred. - Ability to translate a program need or material question into a structured, fit-for-purpose study design and reliable laboratory execution plan. - Interest in learning the biological role of media components, supplements, proteins, small molecules, matrices, enzymes, and other raw materials used during differentiation. - Understanding of raw-material variability and how supplier, grade, lot, composition, storage, preparation, or handling can affect cell-culture and differentiation outcomes. - Fine attention to detail, particularly for material identity, lot traceability, preparation calculations, timing, sampling, and execution of multistep differentiation protocols. - Ability to organize, analyze, and interpret multivariable study data and connect process observations with biological and analytical readouts. - Experience contributing to process optimization, characterization, comparability, or robustness studies is preferred. - Strong technical documentation, data-recording, organizational, and communication skills. - Ability to work collaboratively across process development, engineering, analytical, research, materials, and program teams in a fast-paced laboratory environment. - Ability to prioritize time-sensitive activities while maintaining high standards for safety, quality, scientific rigor, and data integrity. Education and Experience: - Bachelor's degree in Biology, Cell Biology, Chemical Engineering, Biomedical Engineering, Biotechnology, or a related scientific or engineering discipline is required. - Bachelor's degree with 2+ years of relevant experience, or a Master's degree with 0-2 years of relevant experience, or an equivalent combination of education and experience. - Relevant experience should include mammalian cell culture and aseptic laboratory practices. Stem cell differentiation, bioreactor operation, raw-material evaluation, and process-development experience are preferred. At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients. Pay Range: $73,900 - $110,900 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: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will 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-Onsite 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 ApplicationAssistance@vrtx.com