Regulatory Bioassay Research Scientist

Guidehouse is hiring a full-time Regulatory Bioassay Research Scientist in Silver Spring, Montgomery County, to drive bioassay innovation in support of a key federal client. If you thrive on independent, high-impact laboratory science within a regulatory framework, this role offers the chance to shape how biotechnology products reach patients.

About the Role

As a Regulatory Bioassay Research Scientist at Guidehouse, you will independently lead and execute research initiatives focused on the development, validation, and implementation of bioassays for biosimilars and complex generic products. Working on-site in Silver Spring, Montgomery County, you will generate the scientific data that informs regulatory decision-making and advances the federal mission. This position requires the ability to obtain Public Trust clearance and may involve travel up to 10 percent.

Key Responsibilities

• Plan, direct, and carry out research projects centered on bioassay development for biotechnology products and complex generics.
• Design, optimize, and validate analytical bioassays to support biosimilar evaluation.
• Implement validated methods and translate experimental findings into actionable, defensible scientific conclusions.
• Operate with a high degree of independence while collaborating with federal stakeholders and project teams.
• Document results thoroughly to meet regulatory and scientific standards.

Qualifications

• Demonstrated expertise in bioassay development, validation, and implementation, ideally for biosimilars or complex generic products.
• Proven ability to lead research projects autonomously from concept through completion.
• Strong scientific background in biotechnology, analytical methods, or a closely related discipline.
• Eligibility to obtain a Public Trust clearance.
• Willingness to travel up to 10 percent as project needs require.

About Guidehouse

Guidehouse partners with government and commercial clients to solve complex challenges through advisory, technology, and managed services. In this Silver Spring, Montgomery County role, you will contribute directly to a federal client's scientific objectives as part of Guidehouse's Scientist job family.

How to Apply

Ready to advance your career as a Regulatory Bioassay Research Scientist with Guidehouse? View the full listing and submit your application via Adzuna to be considered for this full-time, on-site opportunity.