Scientist I

Job Description

Job Summary:

• Client is seeking a highly motivated Scientist to join theBioAnalytics Characterization group within the Genomic Medicine Unit BioAnalytics.
• The Genomic Medicine Unit at Client is dedicated to the establishment of best-in-class platforms to support development of life-changing advanced gene therapy products, including recombinant AAV vectors and lipid nanoparticles.
• The BioAnalytics Characterization group uses advanced analytical techniques for in-depth structural and functional characterization of gene therapy products in support of drug development, from pre-candidate selection through commercialization.
• This role is predominantly wet-lab involving sample processing and complex instrumentation operation for LC-MS analysis.
• As Client BioA supports CMC, a successful candidate should have familiarity working within a regulated environment, documenting analyses in ELN and an understanding of drug development life cycle.

Duties and Responsibilities:

• Perform characterization testing of gene therapy samples to determine and quantify host cell proteins using solid-phase enhanced sample preparation and LC-MS analytical techniques commonly used in proteomics (i.e. proteomic profiling using DDA or DIA, targeted quantitation using MRM or PRM).
• Assist in analytical method development and execute method qualification experiments to establish. accuracy, precision, linearity and sensitivity of quantitative method.
• Assist in developing automated liquid handler platforms to increase sample throughput.
• Document all method development and testing activities/results accurately in compliance with internal and regulatory standards.

Basic Qualifications:

• Master’s degree in Analytical Chemistry, Biochemistry, or a related discipline with 2-4 years of relevant biotechnology or pharmaceutical industry experience, preferably performing impurity monitoring using LC-MS or proteome/HCP profiling or Doctorate degree with 1-3 years of relevant experience in proteomics.
• Effective planning, communication and collaboration skills.
• Strong theoretical understanding of macromolecules (e.g., DNA, RNA, proteins) and their chemical properties.

Preferred Qualifications:

• LC-MS systems: ThermoOrbitrap Exploris/Eclipse/Fusion Lumos/Astral; Sciex LCMS Triple Quad 6500.
  Software: Skyline, Proteome Discoverer, Byos, Spectronaut.
• Practical, hands-on troubleshooting and programming experience with automation equipment, such as Agilent Bravo LT, Hamilton, Andrew+ or KingFisher.
• Gene therapy experience with AAV or LNP is preferred.