Researcher II - Glycotechnology Research Scientist

Cognizance Technologies, LLC | Full time

Silver Spring, United States | Posted on 09/21/2026

The Office of Pharmaceutical Quality Research (OPQR) within the Office of Pharmaceutical Quality (OPQ) provides chemistry, manufacturing and controls (CMC) expertise for biotechnology products and performs mission-relevant regulatory research using advanced instrumentation and laboratory experimentation. OPQRrequires scientific operations support for an active project developing novel and feasible technologies to quantify different glycoforms of human IgG mAb drugs and biosimilars in the production media as acomponent of process analytic technology (PAT) and the identification and characterization of glycans on therapeutic glycoproteins.

OPQR research initiatives such as this generate valuable scientific findings that support regulatory actions and policy.

To further strengthen OPQR’s delivery on its mission and strategic goals, there is a need for ascientist/researcher with expertise in glyco-technology to analytically characterize therapeutic proteins andglycochemistry to synthesize relevant glycan standards for glycan structure analysis. OPQR requires acandidate who has previously demonstrated the ability to independently conduct and lead research projects.

This project will fund a contracted professional with a Master’s or Ph.D. degree in Chemistry,Glycobiology, Glycochemistry, Biochemistry, Cell Biology, Biotechnology, Bioengineering, or related course(s) of study. For candidates with a Master’s, a minimum of 2 years’ experience is needed. Preference will be given to candidates with prior experience in developing advanced analytical techniques for the characterization of glycosylation of glycoproteins, including therapeutic proteins, such as monoclonal antibodies, fusion proteins, and enzyme- replacement therapies (ERTs), and/or in glycochemistry to synthesize relevant glycans as structural standards.

A working knowledge of glyco-biotechnology research is also preferred, although experience in developing quality analytics in a relevant field will be considered.

The candidate will assist OPQ/OPQR scientists with the development and testing of novel and feasible technologies for the identification and characterization of glycans on therapeutic glycoproteins to assessand ensure their quality and safety as the glycosylation is a critical quality attribute. In addition to participating in research and development activities, the candidate will collect and analyze data and be responsible for completing internal technical reports detailing procedures, outcomes, and observations,and drafting manuscripts for publications.

The selected professional must be able to work towards and accomplish the tasks outlined below:

• Generate and comprehensively characterize novel reagents, such as mouse monoclonal antibodies
  specifically recognize different glycoforms of human IgG1 mAb drugs;
• Develop a rapid and high-throughput biotechnology with biolayer interferometry (BLI) platform to quantify glycoforms of human IgG1 mAb drugs in unprocessed media and formulation;
• Optimize and validate the BLI method in application to biomanufacturing and advanced biomanufacturing settings as a component of process analytic technology (PAT) to facilitate the development and manufacturing of human IgG1 mAb drugs and their biosimilars;
• Continue advancing the BLI method for quantification of the glycoforms of human IgG1 glycoforms by generating and characterizing the recombinant mouse monoclonal antibodies that specifically recognize different glycoforms of human IgG1 mAb drugs, including biosimilars;
• Culture mammalian cells such as CHO and HEK
  293, 293F cells and/or bacterial cells using…