Regulatory Biostability Modeling Researcher

Job Family:

Travel Required:

Clearance Required:

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:

• Bachelors 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:

• Masters 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.

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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