Bio Bioassay Researcher Candidate Comparison Matrix

Guidehouse; Silver Spring, Northern (MD, KY); Hybrid; USD 98.000 - 163.000; Vollzeit

Zusammenfassung

Guidehouse, located in Silver Spring, MD, seeks a Bio Bioassay Researcher to perform laboratory experiments and develop cell-based and biochemical assays for evaluating biological therapeutics, generating validated data in accordance with FDA SOPs.

The role requires hands-on work with cell culture, qRT-PCR, ELISA, Western blotting, and immunohistochemistry, plus thorough data documentation and strong scientific writing.

Qualifikationen

• Bachelor's degree required; four years lab experience in cell-based assays.
• Experience with mammalian cell culture and in vitro models.
• Experience with qRT-PCR, ELISA, Western blotting, IHC.
• Ability to document data thoroughly following FDA standards.
• Strong scientific writing and communication skills.

Aufgaben

• Culture and maintain immortalized cell lines under air-liquid interface.
• Optimize bioassays for transcytosis and permeation across epithelial layers.
• Validate bioassays for reproducibility, sensitivity, and specificity.
• Conduct hands-on lab work: cell culture, qRT-PCR, ELISA, Western blot, IHC.
• Document data and maintain electronic notebooks with no gaps.
• Contribute to reports, presentations, and knowledge-transfer activities.
• Report safety incidents via FDA channels.
• Protect government data from unauthorized release.

Kenntnisse

Cell culture

Bioassay development

Data analysis

Scientific writing

Documentation

Presentation

Ausbildung

Bachelor's degree

Tools

qRT-PCR

ELISA

Western blotting

Immunohistochemistry

Jobbeschreibung

## Bio Bioassay Researcher Candidate Comparison MatrixApply: US - MD, Silver Spring: Full time: Posted Today: 44962**Job Family:**Scientific Research & Analysis**Travel Required:**None**Clearance Required:**NoneThis 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