Researcher I - Cell-Based Bioassay Scientist

Cognizance Technologies LLC; Silver Spring (MD); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

PPO/HMO Health Plan (includes medical,

Job summary

Cognizance Technologies, LLC in Silver Spring, MD, is seeking a Researcher I - Cell-Based Bioassay Scientist to support FDA OPQR. You will establish and characterize cell-based and biochemical assays to evaluate biologics, focusing on transcytosis and permeation bioassays across epithelial layers.

Responsibilities include cell line culture, assay optimization and validation, data analysis, and preparation of scientific reports.

Qualifications

• Ph.D. or Master’s with 3+ years lab experience as described.
• Hands-on mammalian cell culture experience, including immortalized cell lines.

Responsibilities

• Establish and characterize cell-based and biochemical assays.
• Optimize transcytosis bioassay for antibody transport across epithelial layers.
• Validate assays for reproducibility, sensitivity, and specificity.
• Document methods, results, and analyses per FDA SOPs.
• Support collaborative projects and data sharing with OPQR/CDER.

Skills

Cell culture

Bioassay development

qRT-PCR

ELISA

Western blotting

Immunohistochemistry

Data analysis

Documentation

Education

Ph.D. in cell biology/molecular biology/pharmacology/immunology/biochemistry or related life science

Master's degree + 3+ years lab experience

Tools

GraphPad Prism

Job description

Cognizance Technologies, LLC | Full time

Researcher I - Cell-Based Bioassay Scientist

Silver Spring, United States | Posted on 09/22/2026

Vets Synergetic Group is seeking a Cell-Based Bioassay Scientist to provide laboratory research support to the FDA's Office of Pharmaceutical Quality Research (OPQR). OPQR runs an integrated testing and research laboratory that supports science- and risk-based quality assessment of regulatory submissions, guidance and policy development, and rapid response to public health issues.

In this role, you will establish and characterize cell-based and biochemical assays used to evaluate biological therapeutics. Your main focus will be completing a transcytosis and permeation bioassay that measures how inhaled or intranasally delivered biologics, including monoclonal antibodies, are deposited on and transported across epithelial cell layers. Your data will help build laboratory tools that support FDA's regulatory science mission.

Key Responsibilities

Cell Line Characterization and Bioassay Development

• Culture and maintain immortalized epithelial cell lines under air-liquid interface (ALI) conditions.
• Optimize a transcytosis bioassay that measures apical-to-basal and basal-to-apical transport of monoclonal antibodies and other biological therapeutics across polarized epithelial layers.
• Validate assays against performance criteria including reproducibility, sensitivity, and specificity.
• Document all methods, results, and analyses according to FDA laboratory standards and as directed by the Technical Point of Contact (TPOC).

Scientific Research Support

• Provide hands-on laboratory work for other office-approved OPQR projects, using cell-based, biochemical, and other relevant techniques.
• Support collaborative research between OPQR and internal or external partners. This includes joint experiments, sharing protocols, and collaborative data collection and analysis.
• Collect, process, and analyze laboratory data systematically, with complete and accurate documentation.
• Contribute to scientific summaries, technical reports, and presentations.

Collaboration and Knowledge Transfer

• Work on interdisciplinary regulatory science teams across OPQR and CDER.
• Present research findings and take part in scientific discussions.
• Communicate complex scientific concepts clearly to internal and external audiences.
• Attend weekly and ad hoc research meetings scheduled by the TPOC.

Documentation and Reporting

• Keep electronic laboratory notebooks and experimental records current throughout the period of performance, with no gaps and full compliance with FDA/OPQR SOPs.
• Document results in enough detail for independent reproduction, and promptly flag any anomalous results to the TPOC.
• Deliver weekly research updates, as discussions or PowerPoint presentations.
• Prepare a final research summary in Word or PowerPoint, due 15 business days before the end of the period of performance.

Education and experience

• Ph.D. in cell biology, molecular biology, pharmacology, immunology, biochemistry, or a related life science field, or a Master's degree with 3+ years of relevant laboratory experience.
• Demonstrated hands-on experience in mammalian cell culture, including maintaining immortalized cell lines.

Laboratory techniques

• Proficiency in:
  • quantitative real-time PCR (qRT-PCR)
  • ELISA
  • western blotting
  • immunohistochemistry

Documentation, analysis, and communication

• Strong record-keeping practices and familiarity with laboratory SOPs.
• Proficiency with data analysis tools such as GraphPad Prism or Excel, and with Microsoft Office.
• Excellent written and oral communication skills.
• PPO/HMO Health Plan (includes medical, dental, and vision)