Bioassay Research Scientist II

Guidehouse • Silver Spring, MD

5d • $65,000 - $108,000 • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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 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.

Benefits

• 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.)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree