USA-Scientist I (Scientific)

USA-Scientist I (Scientific)#26-13194 Waltham, MA Onsite Job Description

Description:

Client is seeking a highly motivated Scientist to join the BioAnalytics 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. Key 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