Bioassay Researcher

US132 Guidehouse Digital, LLC; Silver Spring (MD); On-site; USD 85,000 - 141,000; Full time

Benefits offered by this job

Medical insurance

Parental Leave

401(k) retirement plan

Tuition reimbursement

Employee assistance program

Job summary

Guidehouse is seeking a scientific professional to support bioassay development for therapeutic biologics and complex generics.

The role involves establishing, optimizing, and validating cell-based and biochemical assays, with hands-on work in qRT-PCR, ELISA, western blot, and immunohistochemistry. You will document results and contribute to regulatory-ready reports and manuscripts.

Qualifications

• Master’s degree required with 3–6 years bioassay experience.
• Experience with qRT-PCR, ELISA, western blot, immunohistochemistry.
• Experience collecting and documenting lab data per project plans.

Responsibilities

• Provide scientific and lab support to establish, optimize, and validate bioassays.
• Culture and maintain mammalian cell lines using aseptic techniques.
• Develop transcytosis and permeation bioassays for biologics transport.
• Validate bioassays for reproducibility, sensitivity, and specificity.
• Perform assays and analytics such as qRT-PCR, ELISA, western blotting, IHC.
• Document data and maintain notebooks per FDA standards.
• Prepare technical reports and presentations for regulatory decisions.
• Collaborate across interdisciplinary teams and present findings.

Skills

Bioassay development

Cell culture

qRT-PCR

ELISA

Western blot

Immunohistochemistry

Data analysis

GLP awareness

Regulatory understanding

Scientific writing

Education

Master’s degree in Chemistry, Biology, Biochemistry, Cell Biology, Bioengineering, Pharmaceutical Sciences, or related

Tools

Laboratory techniques

Job description

Job Family: Scientific Research & Analysis Travel Required: Up to 10% Clearance Required: Ability to Obtain Public Trust Our federal client conducts mission-relevant laboratory research to support science- and risk-based quality assessments of regulatory submissions, standards development, guidance creation, policy development, and pharmaceutical quality surveillance.

This position will provide scientific and laboratory research support for approved bioassay projects focused on establishing, characterizing, optimizing, and validating cell-based and biochemical assays for biological therapeutics. The researcher will support laboratory-based experiments to advance bioassay development and characterization, including transcytosis and permeation assays for evaluating the deposition and transport of biological therapeutics.

What You Will Do:

• Provide scientific and laboratory research support to establish, characterize, optimize, and validate bioassays for biological therapeutics.


• Culture and maintain mammalian and immortalized cell lines using aseptic laboratory techniques.


• Develop and optimize cell-based transcytosis and permeation bioassays to evaluate transport of biological therapeutics across epithelial cell layers.


• Validate established bioassays against defined performance criteria, including reproducibility, sensitivity, and specificity.


• Perform laboratory techniques including cell culture, qRT-PCR, ELISA, western blotting, immunohistochemistry, and other biochemical or molecular assays.


• Conduct surveillance testing and investigate mechanisms of action of therapeutic proteins and peptides to identify relevant assay readouts.


• Establish new analytical methods to evaluate the biological activity of biotechnology products, biosimilars, and complex generics.


• Collect, process, analyze, and document laboratory data from multiple sources and databases in accordance with project plans.


• Maintain complete and accurate laboratory notebooks, experimental records, methods, and analyses in accordance with FDA laboratory standards.


• Assist with laboratory inventory management, procurement, equipment maintenance, and instrument upkeep.


• Prepare technical reports, scientific manuscripts, status reports, presentations, and final project summaries supporting regulatory decision-making.


• Participate in interdisciplinary scientific collaborations and support OPQR-approved research projects.


• Provide weekly program updates and monthly project status reports detailing research findings, milestone progress, risks, and issues.


• Attend relevant scientific, laboratory, programmatic, and organizational meetings in support of project execution.


• Communicate complex scientific findings and project updates to both technical and non-technical stakeholders.


• Complete all required corporate and client training and maintain necessary credentials.

What You Will Need:

• Master’s degree in Chemistry, Biology, Biochemistry, Cell Biology, Bioengineering, Pharmaceutical Sciences, or a related scientific discipline.


• Three to six (3–6) years of experience developing, optimizing, validating, or implementing bioassays for therapeutic proteins, peptides, biotechnology products, biosimilars, or complex generics.


• Experience with laboratory techniques such as qRT-PCR, ELISA, western blotting, immunohistochemistry, or related analytical methods.


• Experience collecting, processing, analyzing, and documenting laboratory data in accordance with project plans and quality standards.


• Experience preparing scientific manuscripts, technical reports, presentations, and research summaries.


• Knowledge of Good Laboratory Practices (GLP), ISO laboratory standards, or equivalent laboratory quality systems.


• Strong oral and written communication skills with the ability to engage scientific, programmatic, and regulatory stakeholders.


• Understanding of regulatory interpretations, product efficacy and safety considerations, project plans, and timelines.


• Ability to work effectively within interdisciplinary scientific teams in a laboratory research environment.

What Would Be Nice To Have:

• Ph.D. in Chemistry, Biotechnology, Biology, Biochemistry, Cell Biology, Bioengineering, Pharmaceutical Sciences, or a related scientific discipline.


• Experience developing potency, functional, or mechanism-of-action bioassays for biologics, biosimilars, biotechnology products, or complex generics.


• Experience with air-liquid interface cultures, epithelial cell models, transcytosis assays, permeability assays, or related in vitro transport models.


• Understanding of biopharmaceutical manufacturing, process development, biotechnology research and regulatory operations.


• Knowledge of insulin and GLP-1 receptor signaling pathways or related biological systems.


• Experience preparing peer-reviewed publications, scientific posters, regulatory science reports, or white papers.

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 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.) 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 Ordinance of Los Angeles and San Francisco. If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at [e-mail]. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation. All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or [e-mail]. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse.

Guidehouse is a global AI‑led professional services firm delivering advisory, technology, and managed services to the commercial and government sectors. With an integrated business technology approach, Guidehouse drives efficiency and resilience in the healthcare, financial services, energy, infrastructure, and national security markets. Built to help clients across industries outwit complexity, the firm brings together approximately 18,000 professionals to achieve lasting impact and shape a meaningful future. guidehouse.com