Researcher II - Drug Potency Bioassay

Cognizance Technologies, LLC | Full time Researcher II - Drug Potency Bioassay Silver Spring, United States | Posted on 09/10/2026 TheFDA's Center for Drug Evaluation and Research (CDER) ensures that safe andeffective drugs are available to the public, regulating over-the-counter andprescription drugs, biological therapeutics, and generic drugs. Within CDER,the Office of Pharmaceutical Quality (OPQ) integrates assessment, inspection,surveillance, policy, and research to strengthen pharmaceutical qualityglobally. The Office of Pharmaceutical Quality Research (OPQR), a sub-office ofOPQ, improves the FDA's capacity to evaluate and monitor drug quality, safety,and efficacy; helps modernize regulatory pathways; addresses mission-criticalregulatory science issues; and maintains research readiness to respond rapidlyto emergent public health needs. Background OPQRoperates as an integrated testing and research laboratory supporting science-and risk-based quality assessment of regulatory submissions, standards,guidance, and policy development. Bioassays are critical tools for assessingthe potency, functionality, and critical quality attributes of therapeutics,and are increasingly important in the regulatory evaluation of complexbiological drug products. OPQR has identified a need for the establishment andcharacterization of cell-based and biochemical assays to support the evaluationof biological therapeutics — work requiring specialized expertise in cellculture, in vitro model system development, and functional assay design andvalidation. Thisrequirement is for a contractor to provide laboratory-based experimental andscientific support to complete ongoing OPQR-approved bioassay projects. Objective Toobtain expert laboratory research support services to establish andcharacterize bioassays supporting OPQR's regulatory science mission. Successwill be defined by delivery of validated, reproducible research data evaluatingthe functional performance of bioassays, forming the foundation for laboratorytools supporting ongoing and future OPQR research. Dutiesand Responsibilities Task 1:Cell Line Characterization and Bioassay Development Support Provide scientificlaboratory support, under TPOC guidance, to advance completion of atranscytosis assay for biological therapeutics using identified candidate celllines to establish a transcytosis and permeation bioassay evaluating depositionand transport of inhaled or intranasally delivered biological therapeutics. Culture and maintain identified immortalized cell lines under air-liquid interface conditions to support bioassay development. Optimize a transcytosis bioassay to evaluate apical-to-basal and basal-to-apical transport of monoclonal antibodies (mAbs) and other biological therapeutics across polarizedepithelial cell layers. Validate established bioassays against relevant performance criteria, including reproducibility, sensitivity, and specificity. Document allexperimental methods, results, and analyses in accordance with FDA laboratorystandards and as directed by the TPOC. Task 2:Scientific Research Support for Office-Approved Projects Provide hands-on laboratory assistance for office-approved research projects, applying cell-based, biochemical, or other relevant laboratory techniques as needed to support project objectives. Contribute scientificexpertise and laboratory skills to collaborative research efforts between OPQR and internal or external research partners, including joint experimentalactivities, protocol sharing, and collaborative data collection/analysis. Perform systematiccollection, processing, and analysis of laboratory data in support of approvedprojects, documenting results accurately and completely per FDA laboratorystandards. Contribute topreparation of scientific summaries, technical reports, presentations, andother written materials related to office-approved projects and collaborations,as directed by the TPOC. Task 3:Collaboration and Knowledge Transfer Contribute tointerdisciplinary teams across OPQR and CDER on collaborative regulatoryscience projects. Participate inscientific discussions and presentations of research findings. Communicate complexscientific concepts to internal and external audiences. Participate in weeklyand ad hoc research meetings as scheduled by the TPOC. Requirements RequiredKnowledge, Skills, and Abilities Hands-on laboratoryexperience with mammalian cell culture, including maintenance of immortalizedcell lines and polarized epithelial cell layer/air-liquid interface culturesystems. Experience with in vitromodel system development and functional cell-based or biochemical assay designand validation. Proficiency inquantitative real-time PCR (qRT-PCR), ELISA, western blotting, andimmunohistochemistry. Ability to design,optimize, and validate assays against performance criteria such asreproducibility, sensitivity, and specificity. Strong laboratorydocumentation practices; ability to record and report experimental methods,results, and analyses in accordance with FDA/GLP-aligned laboratory standards. Excellent written andoral communication skills, including the ability to prepare scientificsummaries, technical reports, and presentations, and to communicate complexscientific concepts to varied audiences. Ability to workindependently in a laboratory setting while collaborating effectively withininterdisciplinary and cross-institutional research teams. PreferredExpertise Experience withtranscytosis, permeation, or transport bioassays for monoclonal antibodies orother biological therapeutics. Familiarity with inhaledor intranasal biologic drug delivery systems. Experience supportingregulatory science, GLP, or quality-assessment laboratory environments. Prior collaborativeresearch experience spanning multiple institutions or research groups. PPO/HMO Health Plan (includes medical, dental, and vision) #J-18808-Ljbffr Cognizance Technologies LLC