Process Dev Engineering Principal Scientific Associate

JOB TITLE: Process Dev Engineering Principal Scientific Associate  

LOCATION: 50 Northern Avenue, Boston, Massachusetts 02210 

OPENINGS: 1 

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:   Employer will accept a Master’s degree in Biotechnology, Science, Engineering or a related field and 3 years of experience in the job offered or in Process Dev Engineering Principal Scientific Associate-related occupation.  

Alternatively, employer will accept a Bachelor’s degree in Biotechnology, Science, Engineering or a related field and 5 years of experience in the job offered or in a Process Dev Engineering Principal Scientific Associate-related occupation. 

Position requires demonstrable experience in the following: 

• Experience in process development, optimization and characterization using DoE/QbD approaches for cell therapy products in ongoing and future projects.  
• 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 with 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.