Job Description

About the Program

The Office of Pharmaceutical Quality Research (OPQR), within the Office of Pharmaceutical Quality (OPQ) at FDA's Center for Drug Evaluation and Research (CDER), provides chemistry, manufacturing, and controls (CMC) expertise for biotechnology products and performs mission-relevant regulatory research using advanced instrumentation and laboratory experimentation. OPQR research generates scientific findings that directly support regulatory actions and policy decisions enabling domestic manufacturers to develop high-quality generic and biosimilar products in the United States.

Purpose of the Project
This project seeks a scientific contract professional to support the development, validation, and implementation of bioassays for biosimilars and complex generics as part of OPQR's bioassay research program. The work supports two mission-critical projects related to bioassay development and validation for biotechnology products, with a focus on insulin analogs and GLP1-R agonists.

Position Summary
OPQR requires a scientist/researcher with expertise in bioassay development, validation, and implementation for biotechnology products (biosimilars) and complex generics, who has previously demonstrated the ability to independently conduct and lead research projects. The contracted professional will assist OPQ/OPQR scientists with developing, validating, and implementing cell-based potency bioassays for biosimilars and complex generics, participate in research and development activities, collect and analyze data, and complete technical reports and manuscripts detailing procedures, outcomes, and observations.



Requirements
Duties and Responsibilities
Bioassay Development and Execution

• Perform cell-based assays for therapeutic proteins or peptides and compile sample information into multiple databases/data management systems.

• Operate and maintain laboratory instrumentation such as plate readers or bioanalytical analyzers for analyzing the effect of therapeutic proteins and peptides on cellular metabolism.

• Culture mammalian cells using aseptic techniques for BSL-2 cell lines.

• Investigate the mechanism of action of therapeutic proteins and peptides to identify relevant assay readouts that could be monitored using a cell-based assay.

• Establish new analytical methods to evaluate the biological activity of biotechnology products and/or complex generics.

Characterization and Analytical Support

• Perform characterization analyses such as RNA extraction for RNA-seq analyses, protein preparation for western blot analyses, or cytokine/hormone measurement in supernatant or serum.

• Perform surveillance testing as requested.

• Collect sample information and laboratory testing results from multiple sources and databases.

• Perform data processing and analysis of acquired data.

Laboratory Operations

• Assist with the upkeep of inventory of lab supplies, lab purchases, and laboratory equipment and instrumentation maintenance and repair.

• Complete all mandatory FDA training and maintain required credentials.

Reporting and Communication

• Prepare Word summary reports or PowerPoint presentations on work projects and progress when requested by the program lead.

• Attend weekly meetings with the program lead for update briefings or to discuss issues.

• Provide status reports to the program lead according to the schedule provided.

• Write manuscripts and/or technical reports for publications or white papers on the project.

Requirements
Minimum 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.

Preferred Expertise

• Prior experience developing bioassays for biotechnology products and peptides, including comprehensive characterization of the biological activity of therapeutic proteins and peptides.

• Working knowledge of biopharmaceutical manufacturing and process development.

• Understanding of insulin and GLP1-R signaling pathways.

• Experience developing potency bioassays in a relevant field will also be considered in lieu of direct insulin/GLP1-R experience.

Additional Information
• Place of Performance: OPQR laboratories, FDA campus.
• Reporting: Weekly update meetings and periodic status reports to the program lead.
• Security: FDA Security clearance and all required credentials must be processed and in place before work begins.

​



Benefits
PPO/HMO Health Plan (includes medical, dental, and vision)
401K Retirement Plan
Paid Time Off (PTO)