FDA Fellowship - Analysis of Codon Optimized FIX and FVIII Delivered Adeno Associate Virus

Organization

U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), White Oak, Maryland

FDA-CBER-

August 1, 2026 (flexible)

Initially one year, may be renewed subject to funding.

Full time

Monthly stipend commensurate with educational level and experience.

U.S. citizens or Legal Permanent Residents.

Supports investigations into the functional and structural consequences of synonymous codon substitutions and codon optimization in therapeutic biologics. Projects include examining how codon optimization and naturally occurring synonymous variants modulate gene expression, translational kinetics, RNA secondary structure, protein folding, post-translational modifications, and immunogenicity. Model systems include recombinant coagulation factors (Factor VIII, Factor IX, ADAMTS
13/MDTCS) expressed across multiple platforms, including transient transfection, lentiviral delivery, AAV‑mediated gene delivery, and targeted genomic integration.

• Develop proficiency in molecular biology techniques relevant to recombinant protein expression, including cell culture, transient transfection, lentiviral and AAV‑mediated gene delivery, and stable genomic integration systems.
• Apply proteomics and glycoproteomics workflows, including mass spectrometry‑based post‑translational modification analysis, to evaluate protein quality attributes of therapeutic biologics.
• Develop skills in structural characterization of recombinant proteins using conformation‑sensitive antibody panels, circular dichroism, and/or Ankyron‑based assays.
• Gain experience in computational analysis of codon usage metrics (e.g., CAI, codon‑pair optimization, RNA secondary structure modeling) and their integration with experimental data.

Chava Kimchi‑Sarfaty (chava.kimchi-sarfaty.gov)

The qualified candidate must have received or be currently pursuing a master’s or doctoral degree in life/health/medical sciences, biochemistry, chemistry, genetics, or related fields. The degree must be received within the past five years or currently being pursued.

• Basic knowledge of biology or biochemistry.
• Familiarity with codon optimization using in vitro methods.
• Experience with cell culture, protein purification, Western blotting.
• Willowish to research with antibodies, recombinant proteins and gene therapy.

• Citizenship: U.S. citizen or LPR.
• Degree:
  Master’s or Doctoral degree received within last 60 months or currently pursuing.
• Discipline:
  Chemistry, Biophysical Chemistry, Life Health and Medical Sciences.

Ashley