Process Dev Engineering Principal Scientific Associate

Process Dev Engineering Principal Scientific Associate Location: 50 Northern Avenue, Boston, Massachusetts 02210 Responsibilities 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). Develop and document 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 contribute 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 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. Qualifications Master’s degree in Biotechnology, Science, Engineering, or a related field and 3 years of experience in process development engineering or a related occupation, or Bachelor’s degree and 5 years of experience. Demonstrable 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 working knowledge of 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 and execution to evaluate the product quality profile of cell therapy products. Experience with data analysis and statistical software including GraphPad Prism, JMP, and Excel to support process optimization and cell culture studies. 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. Pay range: $86,800 - $130,200. Eligible for annual bonus and equity awards. EEO. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)