Researcher I (Insulin Bioassay Research)

Cognizance Technologies LLC; Silver Spring, Northern (MD, KY); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

PPO/HMO Health Plan

Job summary

Cognizance Technologies, LLC is seeking a Researcher I (Insulin Bioassay Research) for our Silver Spring, MD site to advance bioassay development for biosimilars and complex generics. This contract-professional role focuses on developing, validating, and implementing cell-based potency bioassays for insulin analogs and GLP1-R related targets.

The candidate will independently conduct projects, collect and analyze data, and prepare technical reports and manuscripts while collaborating with OPQR

Qualifications

• Master's or Ph.D. degree in Chemistry, Biotechnology, Biology, Biochemistry, Cell Biology, Bioengineering, or a related field.
• Demonstrated ability to independently conduct and lead research projects.

Responsibilities

• Develop, validate, and implement cell-based potency bioassays for biosimilars and complex generics.
• Perform cell-based assays and analyze data across multiple databases.
• Prepare technical reports and manuscripts detailing procedures and findings.

Skills

Bioassay development

Data analysis

Cell culture techniques

Education

Master's or Ph.D. in Chemistry/Biotech/Biology

Tools

Plate readers

Bioanalytical analyzers

Job description

Cognizance Technologies, LLC | Full time

Researcher I (Insulin Bioassay Research)

Silver Spring, United States | Posted on 09/23/2026

TheOffice of Pharmaceutical Quality Research (OPQR), within the Office ofPharmaceutical Quality (OPQ) at FDA's Center for Drug Evaluation and Research(CDER), provides chemistry, manufacturing, and controls (CMC) expertise forbiotechnology products and performs mission-relevant regulatory research usingadvanced instrumentation and laboratory experimentation. OPQR researchgenerates scientific findings that directly support regulatory actions andpolicy decisions enabling domestic manufacturers to develop high-qualitygeneric and biosimilar products in the United States.

Purposeof the Project

Thisproject seeks a scientific contract professional to support the development,validation, and implementation of bioassays for biosimilars and complexgenerics as part of OPQR's bioassay research program. The work supports twomission-critical projects related to bioassay development and validation forbiotechnology products, with a focus on insulin analogs and GLP1-R agonists.

PositionSummary

OPQRrequires a scientist/researcher with expertise in bioassay development,validation, and implementation for biotechnology products (biosimilars) andcomplex generics, who has previously demonstrated the ability to independentlyconduct and lead research projects. The contracted professional will assistOPQ/OPQR scientists with developing, validating, and implementing cell-basedpotency bioassays for biosimilars and complex generics, participate in researchand development activities, collect and analyze data, and complete technicalreports and manuscripts detailing procedures, outcomes, and observations.

Dutiesand Responsibilities

BioassayDevelopment and Execution

• Perform cell-basedassays for therapeutic proteins or peptides and compile sample information intomultiple databases/data management systems.
• Operate and maintainlaboratory instrumentation such as plate readers or bioanalytical analyzers foranalyzing the effect of therapeutic proteins and peptides on cellularmetabolism.
• Culture mammalian cellsusing aseptic techniques for BSL-2 cell lines.
• Investigate themechanism of action of therapeutic proteins and peptides to identify relevantassay readouts that could be monitored using a cell-based assay.
• Establish new analyticalmethods to evaluate the biological activity of biotechnology products and/orcomplex generics.

Characterizationand Analytical Support

• Perform characterizationanalyses such as RNA extraction for RNA-seq analyses, protein preparation forwestern blot analyses, or cytokine/hormone measurement in supernatant or serum.
• Perform surveillancetesting as requested.
• Collect sampleinformation and laboratory testing results from multiple sources and databases.
• Perform data processingand analysis of acquired data.

LaboratoryOperations

• Assist with the upkeepof inventory of lab supplies, lab purchases, and laboratory equipment andinstrumentation maintenance and repair.
• Complete all mandatoryFDA training and maintain required credentials.

Reportingand Communication

• Prepare Word summaryreports or PowerPoint presentations on work projects and progress whenrequested by the program lead.
• Attend weekly meetingswith the program lead for update briefings or to discuss issues.
• Provide status reportsto the program lead according to the schedule provided.
• Write manuscripts and/ortechnical reports for publications or white papers on the project.

Requirements

MinimumQualifications

• Master's or Ph.D. degreein Chemistry, Biotechnology, Biology, Biochemistry, Cell Biology,Bioengineering, or a related field.
• Demonstrated ability toindependently conduct and lead research projects.

PreferredExpertise

• Prior experiencedeveloping bioassays for biotechnology products and peptides, includingcomprehensive characterization of the biological activity of therapeuticproteins and peptides.
• Working knowledge ofbiopharmaceutical manufacturing and process development.
• Understanding of insulinand GLP1-R signaling pathways.
• Experience developingpotency bioassays in a relevant field will also be considered in lieu of directinsulin/GLP1-R experience.

AdditionalInformation

• Place of Performance:OPQR laboratories, FDA campus.
• Reporting: Weekly updatemeetings and periodic status reports to the program lead.
• Security: FDA Securityclearance and all required credentials must be processed and in place beforework begins.
• PPO/HMO Health Plan (includes medical, dental, and vision)