Researcher II - Drug Potency Bioassay

About the Program The FDA's Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to the public, regulating over-the-counter and prescription drugs, biological therapeutics, and generic drugs. Within CDER, the Office of Pharmaceutical Quality (OPQ) integrates assessment, inspection, surveillance, policy, and research to strengthen pharmaceutical quality globally.

The Office of Pharmaceutical Quality Research (OPQR), a sub-office of OPQ, improves the FDA's capacity to evaluate and monitor drug quality, safety, and efficacy; helps modernize regulatory pathways; addresses mission-critical regulatory science issues; and maintains research readiness to respond rapidly to emergent public health needs.

Background OPQR operates 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 assessing the potency, functionality, and critical quality attributes of therapeutics, and are increasingly important in the regulatory evaluation of complex biological drug products.

OPQR has identified a need for the establishment and characterization of cell-based and biochemical assays to support the evaluation of biological therapeutics — work requiring specialized expertise in cell culture, in vitro model system development, and functional assay design and validation. This requirement is for a contractor to provide laboratory-based experimental and scientific support to complete ongoing OPQR-approved bioassay projects.

Objective To obtain expert laboratory research support services to establish and characterize bioassays supporting OPQR's regulatory science mission. Success will be defined by delivery of validated, reproducible research data evaluating the functional performance of bioassays, forming the foundation for laboratory tools supporting ongoing and future OPQR research.

Duties and Responsibilities

Cell Line Characterization and Bioassay Development Support

• Provide scientific laboratory support, under TPOC guidance, to advance completion of a transcytosis assay for biological therapeutics using identified candidate cell lines to establish a transcytosis and permeation bioassay evaluating deposition and 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 (m. Abs) and other biological therapeutics across polarized epithelial cell layers.
• Validate established bioassays against relevant performance criteria, including reproducibility, sensitivity, and specificity.
• Document all experimental methods, results, and analyses in accordance with FDA laboratory standards 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 scientific expertise and laboratory skills to collaborative research efforts between OPQR and internal or external research partners, including joint experimental activities, protocol sharing, and collaborative data collection/analysis.
• Perform systematic collection, processing, and analysis of laboratory data in support of approved projects, documenting results accurately and completely per FDA laboratory standards.
• Contribute to preparation of scientific summaries, technical reports, presentations, and other written materials related to office-approved projects and collaborations, as directed by the TPOC. Task 3: Collaboration and Knowledge Transfer
• Contribute to interdisciplinary teams across OPQR and CDER on collaborative regulatory science projects.
• Participate in scientific discussions and presentations of research findings.
• Communicate complex scientific concepts to internal and external audiences.
• Participate in weekly and ad hoc research meetings as scheduled by the TPOC.

Requirements

Required Knowledge, Skills, and Abilities

• Hands-on laboratory experience with mammalian cell culture, including maintenance of immortalized cell lines and polarized epithelial cell layer/air-liquid interface culture systems.
• Experience with in vitro model system development and functional cell-based or biochemical assay design and validation.
• Proficiency in quantitative real-time PCR (qRT-PCR), ELISA, western blotting, and immunohistochemistry.
• Ability to design, optimize, and validate assays against performance criteria such as reproducibility, sensitivity, and specificity.
• Strong laboratory documentation practices; ability to record and report experimental methods, results, and analyses in accordance with FDA/GLP-aligned laboratory standards.
• Excellent written and oral communication skills, including the ability to prepare scientific summaries, technical reports, and presentations, and to communicate complex scientific concepts to varied audiences.
• Ability to work independently in a laboratory setting while collaborating effectively within interdisciplinary and cross-institutional research teams. Preferred Expertise
• Experience with transcytosis, permeation, or transport bioassays for monoclonal antibodies or other biological therapeutics.
• Familiarity with inhaled or intranasal biologic drug delivery systems.
• Experience supporting regulatory science, GLP, or quality-assessment laboratory environments.
• Prior collaborative research experience spanning multiple institutions or research groups.

Benefits

PPO/HMO Health Plan (includes medical, dental, and vision) 401K Retirement Plan Paid Time Off (PTO)