Bioassay Research Scientist II

Job Family:

Travel Required:

Clearance Required:

Our federal client conducts regulatory science research to support the evaluation and monitoring of drug quality safety efficacy and pharmaceutical quality standards.

The researcher will support laboratory-based experiments focused on NF-κB activity and signal detection strategies. This work supports regulatory science objectives related to potency assay development for biological products whose mechanisms of action depend on modulation of specific subunits.

What You Will Do:

• Perform mammalian cell culture cell line engineering support and maintenance of relevant human cell lines used as bioassay substrates.

• Develop optimize and support qualification of cell-based bioassays capable of detecting total NF-κB activity and subunit-specific NF-κB activity with emphasis on c-Rel-specific bioassays for comparative analysis studies.

• Process analyze interpret and document experimental data in accordance with project plans laboratory standards and applicable quality expectations.

• Prepare technical reports scientific summaries presentations and final project documentation describing experimental procedures data analysis findings and conclusions.

• Support manuscript preparation and dissemination of scientific findings through internal and external scientific presentations or conferences.

• Maintain complete and accurate laboratory notebooks experimental records methods data files and supporting documentation.

• Participate in interdisciplinary scientific collaborations with regulatory staff and other project stakeholders to advance public health objectives.

• Provide project updates progress summaries issue identification and recommendations to support effective project execution.

• Complete required corporate and client training and maintain required credentials and system access.

What You Will Need:

• Ph.D. degree in molecular biology cell biology or a closely related scientific field.

• Minimum two (2) years of relevant research experience in general molecular biology cell-based assay development bioassay characterization and experimental design and mammalian cell culture techniques.

• Experience designing and executing scientific studies independently with high-level guidance from project leaders.

• Experience conducting data collection analysis and preparation of scientific manuscripts technical reports or research summaries.

• Ability to process interpret and clearly communicate complex scientific data to technical and non-technical stakeholders.

• Excellent written and oral communication skills including experience preparing technical reports and scientific presentations.

• Ability to work effectively in a collaborative laboratory research environment and support regulatory science objectives.

What Would Be Nice To Have:

• Experience developing optimizing qualifying or validating bioassay methods for biological products biotechnology products biosimilars or complex therapeutics.

• Experience developing potency functional mechanism-of-action or subunit-specific bioassays (i.e. NF-κB c-Rel RelA RelB p50 p52) and analyzing inflammatory and oncology-related signaling pathways.

• Familiarity with ICH USP FDA GLP ISO or equivalent laboratory quality standards.

• Experience preparing manuscripts scientific posters regulatory science reports white papers or conference presentations.

• Prior experience supporting FDA HHS NIH or other public health or regulatory science research programs.

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.

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