Researcher - Cell- Bioassay Scientist

Cognizance Technologies, LLC | Full time

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.

• 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).

• 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.

• 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.

• 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 Graph Pad Prism or Excel, and with Microsoft Office.
• Excellent written and oral communication skills.
• PPO/HMO Health Plan (includes medical, dental, and vision)