FDA Focus Towards Efficient Factor VIII Drug Products to Treatment of Hemophilia

Position Overview

We are offering a research opportunity with the Office of Therapeutics Proteins (OTP) at the Center for Biologics Evaluation and Research (CBER) in Silver Spring, Maryland.

The project focuses on investigating the biochemical mechanisms of blood coagulation to enhance the safety and efficacy of drug products that treat coagulation disorders. The selected participant will study mechanisms of plasma clearance of blood coagulation factor VIII (FVIII), particularly the molecular interactions, and will learn methodologies to model and test these interactions in vitro.

• The mechanisms of blood coagulation and in‑vitro assays modeling this process.
• The mechanisms of FVIII plasma clearance and protein interaction assays modeling relevant processes in vitro.
• Gene/construct design, recombinant protein expression, purification, and testing.
• Various structural and functional assays modeling the biomolecule interactions in vitro.

• Start date:
  
  2026 (flexible).
• Length:
  One year, renewable upon recommendation and available funds.
• Participation level:
  Full‑time.
• Stipend:
  Monthly stipend commensurate with educational level and experience.
• Citizenship: U.S. citizen or lawful permanent resident required.
• Health insurance:
  Proof of coverage required.
• Background investigation:
  Completion of a background investigation by the Office of Personnel Management required.

• Currently pursuing or have received a master’s or doctoral degree in a relevant field.
• Eligible disciplines include Chemistry and Materials Sciences, Life Health and Medical Sciences, and related sub‑fields such as Analytical Chemistry, Bio‑organic Chemistry, Biophysical Chemistry, Environmental Chemistry, Inorganic Chemistry, Organic Chemistry, Physical Chemistry, Polymer Chemistry, Theoretical Chemistry.

• Experience in biochemistry and molecular biology, including plasmid design, cloning, cell culture techniques, recombinant protein expression and purification, PAGE/Western blot analysis, and functional/binding assays.
• Knowledge of chemical kinetics and surface plasmon resonance techniques.