Regulatory Biostability Modeling Researcher

Job Family:

Scientific Research & Analysis

Travel Required:

Up to 10%

Clearance Required:

Ability to Obtain Public Trust

Our federal client within the Office of Pharmaceutical Quality Research (OPQR) conducts scientific analyses to support regulatory decision-making for biotechnology products and biosimilars. The team supports efforts to modernize analytical approaches and improve the efficiency of stability assessment for protein drug products.

This role supports research focused on evaluating protein drug stability and developing predictive methodologies to inform regulatory science and decision-making.
 

What You Will Do:

• Provide scientific research and analytical support to evaluate protein drug stability and inform regulatory science efforts

• Conduct laboratory-based studies to investigate the stability of protein drug products using analytical techniques, including chromatographic methods, mass spectrometry, and capillary electrophoresis

• Analyze stability-indicating attributes of protein drug products under accelerated, stress, and real-time conditions

• Develop and optimize analytical methods and experimental approaches for biopharmaceutical stability studies

• Collaborate with subject matter experts to translate analytical stability data into predictive statistical models and support kinetic modeling applications

• Apply statistical and analytical techniques to evaluate stability characteristics and assess their impact on predictive modeling

• Prepare technical reports, manuscripts, and presentations summarizing research findings and supporting regulatory science initiatives

• Support development of regulatory guidance concepts, training materials, and best practices related to stability modeling applications

• Collaborate with interdisciplinary teams across the agency to support scientific research projects

• Present findings in internal meetings and scientific forums and communicate results to technical and non-technical stakeholders

What You Will Need:

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.

• Minimum of one to 3 years of experience conducting laboratory research or analytical studies.

• Experience with data collection, analysis, and preparation of scientific manuscripts and technical reports.

• Familiarity with analytical instrumentation and laboratory techniques.

• Understanding of experimental design and scientific data analysis

• Foundational knowledge of statistical analysis methods.

• Strong written and verbal communication skills.

• Ability to work effectively in a collaborative, cross-functional team environment.

• Hybrid role requiring the ability to work onsite at the client location in Silver Spring, MD.

What Would Be Nice To Have:

• Master’s degree in a relevant scientific discipline.

• Experience working with protein therapeutics, biologics, or biosimilar products.

• Experience applying statistical or modeling techniques to scientific data.

• Familiarity with statistical programming tools (e.g., R, Python, JMP)

• Experience supporting FDA or other regulatory science research programs.

• Knowledge of Good Laboratory Practices (GLP) or related regulatory standards.

• Experience contributing to peer-reviewed publications.

 

The annual salary range for this position is $85,000.00-$141,000.00. 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.

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 Develop