Process Dev Engineering Principal Scientific Associate

Process Dev Engineering Principal Scientific Associate

Location:

50 Northern Avenue, Boston, Massachusetts 02210

• 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 (Ambr
  15/Ambr
  250).
• 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.

• 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 Graph Pad 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.