Process Development Engineering Scientist
PharmaBiotechRegulatory AffairsQuality Assurancegmpcroinform
Job description
Job Description General Summary: Vertex is seeking a talented individual to join our CGT Process Development team as a Scientist. The primary focus of this role is to lead the design and execution of process development studies for a cell-based drug candidate designed to treat diabetes. The Scientist will provide scientific and technical rigor in study design, execution, and data analysis and leveraging innovative technologies to deliver robust cell banking and hESC expansion processes. The ideal candidate has experience and understanding of embryonic stem cell biology and cell culture platforms. This is a full-time position based in our Boston, MA facilities. Key Duties and Responsibilities: Design, execute, analyze, and interpret studies supporting process development, optimization, robustness, and characterization activities with a focus on cell banking and hESC expansion. Apply scientific, engineering, and Quality by Design (QbD) principles to build process understanding, establish process parameters. Evaluate and implement novel technologies that advance process and project strategy. Troubleshoot process challenges and contribute to manufacturing investigations using sound technical judgment and experimental data. Clearly communicate experimental results, technical conclusions, and recommendations to project teams and stakeholders. Ensure data integrity through timely completion of phase-appropriate documentation, including electronic lab notebooks, as well as authoring development protocols and technical reports to support technology transfers and regulatory filings. Drive cross-functional alignment, including material planning, scheduling, sampling strategies, resource allocation, and execution planning, to ensure study readiness and timely delivery. Lead team projects and provide mentorship, training and technical support to colleagues. Knowledge and Skills: Demonstrated experience in process development, process engineering, or a related biopharmaceutical development environment with a working knowledge of GMP requirements. Strong scientific foundation in study design, experimental execution, and data analysis, including experience with statistical principles and design of experiments (DOE). Experience supporting cell culture process development, cell banking, and/or embryonic stem cell expansion desired. Experience working with cell processing equipment such as stirred tank bioreactors, media exchange and harvesting technology [e.g., centrifuge, ATF] as well as automation [e.g., Ambr] is strongly preferred. Proven ability to collaborate across technical and operational functions, coordinating study activities, materials, sampling strategies, and execution plans. Strong written and verbal communication skills, including technical documentation, presentation of results, and clear explanation of complex scientific concepts. Highly organized, accountable, and effective in a fast-paced, team-oriented environment. Participate in weekend work rotation with the broader team. Authorized to legally work in the US. Education and Experience: Bachelor's degree in a relevant field is required Bachelor's degree and 6+ years of experience or a Master's degree and 4+ years of experience or a PhD and 0-3 years of experience, or the equivalent combination of education and experience 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: $104,000 - $156,000 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: 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
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