Senior Research Associate, Assay Development

Cell therapy is emerging as a paradigm-shifting strategy in healthcare. To harness this potential, stringent process controls must be put into place that monitor and measure critical parameters of the cell product at every step, from patient sample acquisition to drug product release. While traditional flow cytometers are the gold standard for cell analysis, they are not well suited for the manufacturing environment.

Accellix has developed a rapid, fully automated, sample to analysis, cell phenotyping platform, bringing a simple, standardized quality control solution to the cell therapy market. Currently serving global pharma and biotech companies, Accellix is well on the way to setting the standard for quality control in cell and gene therapy. See more information about the company on our website at https://www.accellix.com

The Accellix Assay Development team is looking to recruit a Senior Research Associate to help develop custom flow cytometry assays in partnership with many leading pharmaceutical companies, as well as to expand our catalog of off-the-shelf assay kits. The candidate should bring to the table relevant experience, enthusiasm for having a tangible impact on cell therapy, and a collaborative and down-to-earth attitude.

Responsibilities

  • Work with scientists to develop and qualify flow cytometry assay panels on the Accellix platform, including optimization of formulations and protocols
  • Collaborate with cross-functional teams while following design and development plans, executing assay verification and validation, and ensuring all assay requirements are satisfied
  • Follow good manufacturing practices (GMP) in lab, clearly document experimental procedures and results, and assist team in maintaining inventory of lab supplies and reagents
  • Participate in drafting and editing protocols for assay kit manufacturing and QC, and in tech transfer of new assays to the manufacturing team
  • Present updates on projects and initiate brainstorming/troubleshooting discussions within the team and to external customer audiences
  • Promote a strong working relationship with others in the lab, facilitate open communication, proactively identify and address issues, and support other team members to meet deadlines and manage shifting priorities

Required Qualifications

  • B.S with 4+ years or M.S. with 2+ years of assay development experience in diagnostic, therapeutic, or other biotech industry settings
  • Experience with experiment design and execution of flow cytometry assays, including antibody titrations, and optimizing and troubleshooting multicolor assays
  • Experience with flow cytometry data analysis using FlowJo or similar analysis software
  • Demonstrated ability to manage multiple projects, meet goals in a timely fashion, communicate delays and escalate challenges immediately
  • Ability to design, execute, and analyze experiments with minimal oversight

Desired Qualifications

  • Experience with generating and optimizing compensation matrices to address fluorescence spectral overlap in multiparametric flow data
  • Familiarity with common biomarkers found on leukocytes, and/or familiarity with cell-based therapies and cellular engineering
  • Experience with product development and/or instrument automation in an industry setting
  • Experience with assay transfer to internal or external collaborators
  • Experience with good documentation practices (GDP) and with drafting and reviewing documents such as SOPs and development reports