Bioassay Scientist: Drug Potency & Transcytosis

Cognizance Technologies, LLC; Silver Spring (MD); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Plan

Job summary

Cognizance Technologies, LLC in Silver Spring, MD, is seeking a Researcher II to provide laboratory support for drug potency bioassays within OPQR/CDER. This role focuses on developing and validating cell-based assays for biological therapeutics under FDA laboratory standards.

You will work with interdisciplinary teams, culture mammalian cells, and contribute to regulatory science projects, delivering reproducible data and technical reports.

Qualifications

• Hands-on laboratory experience with mammalian cell culture and immortalized cell lines.
• Experience developing and validating in vitro bioassays.
• Proficiency in qRT-PCR, ELISA, western blotting, and immunohistochemistry.
• Ability to design, optimize, and validate assays to performance criteria (reproducibility, sensitivity, specificity).
• Strong documentation practices compliant with FDA/GLP-aligned standards.
• Excellent written and oral communication; ability to present complex findings clearly.
• Ability to work independently and collaborate in interdisciplinary teams.

Responsibilities

• Provide lab support to advance bioassay development under TPOC guidance.
• Culture and characterize cell lines for transcytosis bioassays.
• Contribute to collaborative research with internal/external partners.
• Document methods, results, and analyses per FDA standards; prepare scientific summaries.

Skills

Cell culture

qRT-PCR

ELISA

Western blot

Immunohistochemistry

Documentation

Communication

Independent work

Job description

Cognizance Technologies, LLC in Silver Spring, MD, is seeking a Researcher II to provide laboratory support for drug potency bioassays within OPQR/CDER. This role focuses on developing and validating cell-based assays for biological therapeutics under FDA laboratory standards.

You will work with interdisciplinary teams, culture mammalian cells, and contribute to regulatory science projects, delivering reproducible data and technical reports.