Regulatory Bioassay Research Scientist

Scientist

We are currently searching for research personnel/scientist to support our federal client in bioassay development, validation and implementation for biotechnology products (biosimilars) and complex generics. The researcher will independently lead and conduct research projects that will generate valuable scientific findings to support data-driven regulatory decisions and policies.

• Perform cell-based assays for therapeutic proteins or peptides and compile sample information into multiple databases/data management systems;
• Operate and maintain laboratory instrumentation such as plate reader or bioanalytical analyzer for the analysis of the effect of therapeutic protein and peptides on cellular metabolism;
• Culture mammalian cells using aseptic techniques for BSL 2 cell lines cell lines;
• Perform characterization analyses such as RNA extraction for RNAseq analyses, protein preparation for western-blot analyses, or cytokine/hormone measurement in supernatant or serum;
• Perform surveillance testing and investigate the mechanism of action of therapeutic protein and peptides to identify relevant assay readouts that could be monitored using a cell-based assay;
• Establish new analytical methods to evaluate the biological activity of biotechnology products and/or complex generics;
• Collect sample information and laboratory testing results from multiple data sources/databases and perform data processing and analysis of acquired according to project plan.
• Assist with the upkeep of inventory of lab supplies, lab purchases, and laboratory equipment and instrumentation maintenance and repair;
• Prepare analysis reports, status reports and presentations to support regulatory operation decisions and improvements; write manuscripts and/or technique reports for publications or white papers.
• Conduct weekly meetings with program lead on programs status, action items and/or issues;
• Provide monthly status reports to program leadership and project stakeholders including research findings, project schedule and milestone updates;
• Complete all corporate and client mandatory training and maintain required credentials.

• Master's degree in Chemistry, Biotechnology, Biology, Biochemistry, Cell Biology, Bioengineering, or related field(s) of study.
• 3-6 years of experience in developing bioassays for biotechnology products and peptides for the comprehensive characterization of the biological activity of these therapeutic proteins and peptides.
• Experienced in data collection, analysis, and writing scientific writing and technical reports.
• Knowledge of Good Laboratory Practices (GLP) or International Organization for Standardization (ISO) practices.
• Strong oral and written communication skills to engage with stakeholders
• Understanding of regulatory interpretations (e.g. CMC), targets (e.g. product efficacy/safety thresholds), project plans and timelines.
• Hybrid role requiring the ability to work onsite at the client location in Silver Spring, MD.

• PhD degree in Chemistry, Biotechnology, Biology, Biochemistry, Cell Biology, Bioengineering, or related field(s) of study.
• A working knowledge of biopharmaceutical manufacturing, process development, and biotechnology research, as well as understanding of insulin and GLP1-R signaling pathways are also preferred; or experience in developing potency bioassays in a relevant field.

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

• 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  protection, etc.)
• Position may be eligible for a discretionary variable incentive bonus

About Guidehouse

Guidehouse is an Equal Opportunity Employer–Protected 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…