PRIMARY RESPONSIBILITIES
Independently develop expression and potency assays from the ground up, from assay concept and biological rationale through feasibility, optimization, and qualification.
Serve as the subject matter expert for assigned methods and define assay strategy, format, biological readout, controls, and system-suitability criteria.
Develop and optimize fit-for-purpose methods for transgene expression and product characterization, including flow cytometry, ELISA, real-time PCR, and cellular assays.
Evaluate assay performance, including precision, specificity, sensitivity, relative accuracy, range, robustness, and repeatability, as appropriate to the method and stage of development.
Independently troubleshoot assay failures, conduct root-cause investigations, interpret complex data, and recommend scientifically justified paths forward.
Culture, isolate, expand, characterize, and maintain mammalian primary cells and cell lines while controlling sources of biological variability.
Manage critical reagent and reference-material lifecycles, including cell banks, standards, antibodies, controls, inventory, and lot-bridging studies.
Partner with QC and cross-functional stakeholders on method transfer, assay alignment, and transfer-related troubleshooting.
Author and review development and qualification documents, maintain accurate laboratory records, communicate results and risks, and provide technical guidance to junior team members.
BASIC QUALIFICATIONS
B.S. or B.A. in cell biology, immunology, biomedical engineering, or a related scientific discipline with 6-8 years of relevant industry experience, or an M.S. with 4-6 years of relevant industry experience.
Demonstrated experience independently developing analytical methods from initial concept and feasibility through optimization, qualification, and implementation.
Hands-on experience developing, optimizing, and troubleshooting assays that measure biological activity or potency.
Expertise in mammalian cell culture and assay development using flow cytometry and ELISA, including control strategy and troubleshooting.
Experience designing controlled experiments, interpreting multivariable data, evaluating assay performance, and establishing fit-for-purpose controls and acceptance criteria.
Ability to independently manage laboratory work across concurrent projects, document and communicate scientific results clearly, and collaborate effectively across functions.
PREFERRED QUALIFICATIONS
Direct experience developing cell-based potency assays, particularly with engineered primary cells, endothelial cells, immune-mediated mechanisms, or complex functional readouts.
Experience with analytical method qualification and transfer to a QC or regulated testing environment.
Experience establishing and monitoring critical reagent or cell-bank controls, including lot qualification and bridging studies.
Experience providing technical mentorship or guidance to research associates or junior scientists.
