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 Task 1: 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 (mAbs) 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. 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.

Pay:

$100,000.00 - $115,000.00 per year

Benefits:

Dental insurance Health insurance Vision insurance

Work Location:

In person