Bio Bioassay Researcher Candidate Comparison Matrix

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:

• Bachelors 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

• 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 EmployerProtected 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- or via email at . 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 @ or . 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.

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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.