Researcher II - Glycotechnology Research Scientist

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. OPQR requires 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 a component 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 a scientist/researcher with expertise in glyco-technology to analytically characterize therapeutic proteins and glycochemistry to synthesize relevant glycan standards for glycan structure analysis. OPQR requires a candidate who has previously demonstrated the ability to independently conduct and lead research projects.

Requirements

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 assess and 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 toquantify glycoforms of human IgG1 mAb drugs in unprocessed media and formulation;
  
• Optimize and validate the BLI method in application to biomanufacturing and advancedbiomanufacturing 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 HEK293, 293F cells and/or bacterial cells using aseptic techniques for suspension cell culture and analysis with shake flasks, spin flasks, and other cell culture techniques;
  
•  Purify and characterize the recombinant proteins including therapeutic proteins produced by engineered CHO cell lines and other mammalian cells as well as bacterial cells;
  
• Analyze glycoproteins, including glycoprotein drugs such as monoclonal antibodies, fusion proteins, enzyme-replacement therapies, endogenous glycoproteins and other glycoconjugates with mass spectrometry (MS), such as MALDI-TOF, LC-MS, and Ion-mobility spectrometry–MS (IMS-MS or IMS), (U)HPLC and other state-of-the-art technologies;
  
• Establish new analytical methods to release and analyze O-glycans from glycoproteins;
  
•  Establish new analytical methods to identify the O-glycosylation sites of glycoproteins including protein drugs;
  
• Collect sample information and laboratory testing results from multiple sources and databases;
  
• Perform data processing and analysis of acquired data;
  
• Assist with laboratory equipment maintenance and repair;
  
• Assist with the upkeep of inventory of lab supplies and laboratory equipment and instrumentation;
  
• Prepare Word summary report or Power Point presentation on work projects and progress when requested by program lead;
  
•  Have weekly meetings with program lead for update briefing or issues;
  
• Provide status reports to the program lead according to the schedule provided above;
  
• Write manuscripts and/or technique reports for publications or white papers on the project;
  
• Complete all mandatory FDA training and maintain required credentials
  

Benefits

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