Scientist II, Analytical Development, Flow, Function and Bioanalytical Assays
$110,706–$145,303 year
On-site · Somerset, New Jersey, United States
Job Summary
Scientist II in Analytical Development focusing on establishing, developing, and qualifying flow cytometry-based methods, cell-based potency assays, and other bioanalytical strategies to support release, characterization, and stability testing of cell therapy products. Responsibilities include assay development and optimization (potency, flow cytometry, ELISA), qualification of analytical methods (LVV characterization, infectious titers, vector potency), tech transfer to QC and execution in QC, SOP generation, cross-functional collaboration with PD/QC/Manufacturing, data presentation at forums, and meticulous documentation (ELN, test method development plans, reports). The role requires independent judgment in planning and execution of assays, with higher-level approvals for significant methodology changes or cross-functional collaborations. Proficiency in analytical method development, regulatory expectations (ICH), and a range of analytical tools (GraphPad Prism, FlowJo, CytExpert, ELN systems) is expected, along with excellent scientific communication skills.
Required Qualifications
- For Scientist II, PhD or Master in scientific discipline or equivalent in engineering, and a minimum of 2-5 years related experience; may include post-doctoral experience.
- Expert knowledge of analytical method development and qualification/validation is required.
- Experience in developing multicolor flow cytometry methods, cell culture including reporter gene cell line development, potency assays, cytotoxicity assays and cytokine release assays, immunoassays, infectious titer assays.
- Experience in developing LVV residual impurities assays.
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