Job Family:

Travel Required:

Clearance Required:

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. 

What You Will Do:

• 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. 

What You Will Need:

• 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. 

What Would Be Nice To Have:

• 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. 

What We Offer:

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:

• Medical, Rx, Dental & Vision Insurance

• Personal and Family Sick Time & Company Paid Holidays

• Parental Leave

• 401(k) Retirement Plan

• Group Term Life and Travel Assistance

• Voluntary Life and AD&D Insurance

• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts

• Transit and Parking Commuter Benefits

• Short-Term & Long-Term Disability

• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities

• Employee Referral Program

• Corporate Sponsored Events & Community Outreach

• Care.com annual membership

• Employee Assistance Program

• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)

• Position may be eligible for a discretionary variable incentive bonus

About Guidehouse

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.

If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at [email protected]. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or [email protected].  Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse.  Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse’s Ethics Hotline. If you want to check the validity of correspondence you have received, please contact [email protected]. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.