Bioassay Researcher
Guidehouse•Silver Spring, MD
•$85,000 - $141,000•Onsite
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- 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
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.)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
