Process Dev Engineering Principal Scientific Associate

Process Dev Engineering Principal Scientific Associate 50 Northern Avenue, Boston, Massachusetts 02210

DUTIES

Support the development of robust, scaled upstream or downstream production processes and methods for cell and gene therapy projects. Perform stem cell expansion and differentiation in bench-scale bioreactors to support media development and optimization using high-throughput bench scale systems (Ambr15/Ambr250). Development and documentation of protocols and technologies in support of upstream and downstream cell product development from clinical to commercial scale. Apply DoE/QbD principles in process development and characterization, establishing process parameters, and contributing to CMC sections of regulatory filings. Transfer processes to internal manufacturing and CDMOs, providing documentation, training, and technical support to ensure successful scale-up and implementation in cGMP environments. Plan, execute, and document experiments and data analyses in support of process improvement. Draft study protocols and reports while ensuring data integrity. Contribute to technical reports, regulatory filings, source documents, patents, and external publications. Prepare data analysis and deliver technical presentations to both the internal and external stakeholders in the process development department. Utilize industry standard quality management tools (RCA, FMEA) to troubleshoot and continuously improve process issues. Collaborate with cross-functional teams to meet project deliverables by providing technical expertise from lab experiment results to enable data-driven decisions for key stakeholders.

REQUIREMENTS

Master's degree in Biotechnology, Science, Engineering or a related field and 3 years of experience in Process Dev Engineering or related occupation; alternatively Bachelor's degree with 5 years of experience. Experience in process development, optimization and characterization using DoE/QbD approaches for cell therapy products. Exceptional aseptic techniques and hands‑on cell culture laboratory experience with stem cells and mammalian cells in bench or bioreactor systems. Experience with small‑scale bioreactors and scale‑up parameters and strategies. Hands‑on experience with routine and product‑specific cell culture assays, including cell counting, metabolite analysis, flow cytometry, morphology, ddPCR, nucleic acid and protein assays, stem cell isolations, electroporation and cell harvest methods. Experience in potency and efficacy assay development to evaluate the product quality profile of cell therapy products. Experience with data analysis and statistical software including GraphPad Prism, JMP and Excel. Documentation and technical report writing to support research deliverables, regulatory filings and commercial milestones. Knowledge of cell therapy product profiles, including iPSC‑derived cell therapy products, hematopoietic stem cells and other mammalian cells. Deep understanding of 2D/3D stem cell culture expansion and differentiation in high‑throughput cell culture systems. Experience transferring processes to internal manufacturing or CDMOs, including preparation of technical documentation, training and technical support for cGMP implementation. Utilization of industry‑standard quality management tools (RCA‑FMEA) to troubleshoot process deviations and continuously improve the process. Strong molecular biology expertise with CRISPR/Cas9 genome editing technologies, including assay development to evaluate editing efficiency and therapeutic performance. Rate of Pay $106,870.00 - $110,900.00 Pay Range $86,800 - $130,200

CONTACT

Send Resume to View email address on click.appcast.io. Reference 12140.653. 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 and may be changed at any time. Equal Employment Opportunity Vertex is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants. EOE. #J-18808-Ljbffr Vertex Pharmaceuticals Incorporated