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.
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.
The annual salary range for this position is $98,000.00-$163,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.
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
