Regulatory Biostability Modeling Researcher

Guidehouse•Silver Spring, MD

1d•Hybrid

About The Position

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.

Requirements

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.
Ability to work onsite at the client location in Silver Spring, MD.

Nice To Haves

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.

Responsibilities

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

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.)
Discretionary variable incentive bonus