Scientist to Principal Scientist – Analytical (Flow Cytometry)
Location: Cambridge, MA
HireMinds is Exclusively partnered with a growing Boston Biotech which is developing novel immune-oncology cell therapies. By engineering specific immune cells this team is able to tune adaptive and innate immune system response to attack cancers. In this role you will be relied upon to develop analytical tools and process in support of Phase I clinical trials for cell process development and manufacturing. You will join a team that has amazing founding scientists, recent $50M dollar financing investment, and multiple clinical stage assets. You will need to have expertise with hands-on flow cytometry in Quality Control methods in this position. If this sounds like an exciting next step for your career reach out the HireMinds Biotech and Lifesciences team to learn more.
In This Role You Will:
• Lead a biotech team in hands-on fashion in the design and execution of analytical assays and development studies that support the development of a cell therapy products
• Design, develop, qualify and transfer novel flow cytometry methods to QC and troubleshoot a variety of assays
• Develop, qualify and troubleshoot functional activity assays, perform experiments for phenotype characterization
• Establish specificity, sensitivity, linearity, precision, accuracy and range of complex cell-based test methods.
• Develop new test methods for the characterization of purity and potency of cell-based intermediates and drug product.
• Execute test methods in support of Process Development activities including: flow cytometry, FACS, cell-based potency, and functional assays
• Understand GxP regulations in the transfer of complex cell-based assays to QC and author, review, and transfer of methods to CRO partners
• Use statistical analysis tools and DoE to establish relevant systems and method criteria
• Establish reference standard materials as required to support assay validation protocols and documentation
In This Role You Are Required To Have:
• Ph.D. in Immunology, Biochemistry, Cellular or Molecular Biology with 4+ years of experience in analytical assay development setting
• Hands-on technical expertise in design and execution of assays including Flow cytometry, ELISA, and cell-based functional assays
• Proven track record developing assays for the assessment of cell-based products including potency testing employing multiple analytical methods
• Experience with mammalian culture methods and scale-ups
• Track record of successful collaboration with contract research (CRO) or contract manufacturing organizations (CMO)
• A Proven track record of scientific accomplishments demonstrated by publications or patents in the fields or cell or gene therapy
• Collaborative team-first and leadership from the bench mentality in building a team and capabilities to develop analytical technical abilities and lab operations
• Ability to work in a fast-paced biotech environment and adapt to changing demands