Cell-Based Bioassay Scientist I - Regulatory Science

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 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.