Bioassay Research Scientist II

Guidehouse Inc.; Silver Spring (MD); On-site; USD 65,000 - 108,000; Full time

Benefits offered by this job

Medical, Rx, Dental & Vision Insurance

401(k) Retirement Plan

Paid Holidays

Tuition Reimbursement

Life Insurance

Transit and Parking

Professional Development

Employee Assistance Program

Discretionary bonus

Job summary

Guidehouse is seeking a Scientist to support regulatory science research focused on NF-κB activity and bioassay development for biological products. The role involves mammalian cell culture, cell line engineering, data analysis, and scientific reporting to support potency assay development and regulatory objectives.

You will work in a collaborative laboratory setting with regulatory staff and project stakeholders, preparing manuscripts and attending conferences to disseminate findings. A Ph.D.

Qualifications

• 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 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 communicate complex scientific data to technical and non-technical stakeholders.
• Excellent written and oral communication skills, including preparing technical reports and scientific presentations.
• Ability to work in a collaborative laboratory research environment to support regulatory science objectives.

Responsibilities

• 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 detecting NF‑κB activity and subunit-specific activity.
• Process, analyze, interpret, and document experimental data per project plans and quality expectations.
• Prepare technical reports, scientific summaries, and final project documentation describing procedures, data analysis, findings, and conclusions.
• Support manuscript preparation and dissemination of scientific findings through presentations or conferences.
• Maintain complete laboratory notebooks and data files with supporting documentation.
• Participate in interdisciplinary collaborations with regulatory staff and project stakeholders to advance public health objectives.
• Provide project updates, issue identification, and recommendations for effective project execution.
• Complete required corporate and client training and maintain credentials and system access.

Skills

Molecular biology

Cell-based assay development

Data analysis

Scientific writing

Communication

Education

Ph.D. in molecular biology / cell biology

Tools

Cell culture techniques

Job description

Job Family : Scientist

Travel Required : Up to 10%

Clearance Required : Ability to Obtain Public Trust

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.

The annual salary range for this position is $65,000.00-$108,000.00. 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:

• 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 Veteran