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Guidehouse is seeking a skilled scientist to support FDA bioassay projects at the White Oak Campus. You will culture immortalized cell lines, optimize transcytosis assays, and validate bioassays for accuracy and reproducibility, following FDA SOPs.
You will document data meticulously and contribute to reports and presentations within interdisciplinary teams. The role requires a Bachelor’s degree plus at least four years of hands-on lab experience in cell-based assays, with mammalian culture and
Job Family: Scientific Research & Analysis Travel Required: None Clearance Required: None
This role will support the FDA by performing laboratory-based experiments and providing scientific support for approved bioassay projects. The role will establish and characterize cell-based and biochemical assays used to evaluate biological therapeutics and will generate validated, reproducible research data in accordance with FDA laboratory standards and SOPs.
Culture and maintain identified immortalized cell lines under air-liquid interface conditions. Optimize transcytosis and permeation bioassays to evaluate apical-to-basal and basal-to-apical transport of monoclonal antibodies and other biological therapeutics across polarized epithelial cell layers. Validate bioassays for reproducibility, sensitivity, and specificity. Perform hands‐on laboratory work using cell culture, qRT‐PCR, ELISA, western blotting, immunohistochemistry, and other relevant in‑vitro and analytical techniques. Collect, process, analyze, and document laboratory data accurately and completely in accordance with FDA laboratory standards. Maintain electronic laboratory notebooks and experimental records on a rolling basis with no documentation gaps. Contribute to collaborative research activities, data analysis, scientific summaries, technical reports, presentations, and other written materials. Participate in interdisciplinary teams, scientific discussions, weekly research updates, ad hoc meetings, and knowledge‑transfer activities. Immediately report safety incidents, near‑misses, potential hazards, anomalous results, risks, issues, and concerns through the required FDA channels. Protect all government research information and data from unauthorized release.
Bachelor's Degree Required Minimum of four (4) years of hands‑on laboratory experience in cell‑based assay development and biological therapeutics research. Experience with mammalian cell culture and in‑vitro model systems. Experience with one or more relevant techniques, including qRT‑PCR, ELISA, western blotting, immunohistochemistry, or comparable biochemical assays. Experience designing, optimizing, characterizing, and validating bioassays against defined performance criteria. Ability to produce scientifically sound, reproducible, and thoroughly documented experimental work and data. Strong laboratory documentation, data analysis, scientific writing, presentation, and technical communication skills. Ability to work onsite at the White Oak FDA Campus and comply with FDA facility access, safety, security, badging, and laboratory requirements. Ability to obtain a favorable Tier 1 background determination and PIV card. The solicitation does not specify a minimum degree or minimum years of experience.
Experience developing transcytosis or permeation assays using polarized epithelial cell layers and air‑liquid interface conditions. Experience evaluating monoclonal antibodies, inhaled or intranasally delivered biological therapeutics, or other complex biological products. Familiarity with FDA or OPQR laboratory standards, SOPs, pharmaceutical quality research, or regulatory science. Experience collaborating with internal and external research partners and sharing laboratory methods and protocols. Experience preparing weekly research updates and final research summaries in Microsoft Word or PowerPoint.
Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
Benefits include:
Position may be eligible for a discretionary variable incentive bonus.
Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.
Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.
Guidehouse is a global AI‑led professional services firm delivering advisory, technology, and managed services to the commercial and government sectors. With an integrated business technology approach, Guidehouse drives efficiency and resilience in the healthcare, financial services, energy, infrastructure, and national security markets. Built to help clients across industries outwit complexity, the firm brings together approximately 18,000 professionals to achieve lasting impact and shape a meaningful future.
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