Senior Scientist, Process Development (T-Cell)

Senior Scientist, Process Development (T-cell)

  HireMinds is conducting a search for a talented Senior Scientist to contribute hands-on with process development and characterization of cell therapy programs. In this role you will design experiments to characterize downstream T-cell and cell therapy products in a variety of projects. You will need to have expertise with cellular processes and immunology techniques for testing including: phenotyping, cytokine analysis, cytotoxicity, and proliferation assay. Your contributions will be vital to drug product success in this exciting role. Contact Victoria O’Connor on the HireMinds team to learn more today!

In This Role You Will: 

•    Lead hands-on design and execution of complex small-scale and commercial-scale experiments following a Quality by Design (QbD) 
•    Support process control strategy including classification of critical process parameters that impact CQAs as well as the strategies for appropriate control of CQAs
•    Generate Process Justification and Control Strategy documents
•    Draft and implement process validation documents and technical reports as well as related CMC regulatory submissions 
•    You will manage one report initially in lab work focused in characterization assays and technologies for genetically modified and non-genetically modified T-cell therapies
•    Lab experience with T-cell culture and techniques to characterize cells with: phenotyping, cytokine analysis, cytotoxicity, and proliferation assays is required

You Are Required To Have: 

•    Ph.D. 3+ industry experience or MS degree 7+ years industry in Cellular Biology or Immunology 
•    Experience with Process Validation guidelines (ICH, PDA) and quality risk assessment tools
•    Possess advanced skills in experimental design (e.g. DOE), data analysis and presentation to key stakeholders within the organization
•    Exposure to Quality by Design (QbD) for process characterization activities 
•    Contributions to written sections of CMC regulatory submissions
•    Experience with immune and cell processing technologies, cell characterization methods, manufacturing under cGMP is highly desired
•    Effective communication and collaborative work style to adapt with a novel and diverse portfolio of cell therapy and immunotherapy products and programs
•    Biotech work ethic with ability to problem solve and troubleshoot on the fly while working within proper quality and regulated standards