Company

Analytical Associate/Scientist – Mass Spec

Burlington, MA, USA | (Hybrid/Remote)

ProtaGene is a world-leading analytic CRO partner for the biopharmaceutical and cell and gene therapy industries. From research through product commercialization, we provide the most advanced, integrated, and quality system driven analytic capabilities and packages for biologic therapeutics as well as cell and gene therapy platforms. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services in Europe and BioAnalytix in the US. In 2021 GeneWerk’s unique capabilities in vector safety, integration site analysis, and bioinformatics were integrated into our platforms and service offerings, establishing ProtaGene. The organization operates over four sites in Europe and North America, and works with leading large pharma, biopharmaceutical, and gene therapy companies worldwide.

Key Responsibilities

  • Successfully execute advanced analytical studies on complex biologics using high performance LC-MS based platforms and related sample preparation approaches
  • Collaborate with internal & external scientific teams in study execution and delivery
  • Generate project data and results to enable successful delivery of project plans, milestones and timelines
  • Participate in the development of analytic data and methods for regulatory packages in biologic drug development
  • Prepare, review and present project progress, results and analysis both internally and externally
  • Document experiments, results and findings in laboratory notebook and LIMS system
  • Must be able to lead MS execution of experiments independently

Qualifications

  • Master or PhD degree in analytical chemistry with 1-3 years of biopharmaceutical or related CRO industry experience; Title will be commensurate with experience level
  • The ideal candidate should have direct experience in analytical development in the field of biologics, gene therapies and/or vaccines
  • Hands-on experience and in-depth understanding of protein characterization using LC-MS (e.g., Thermo QE series, etc.) and associated bioinformatics (e.g., BioPharma Finder, etc.) is required.
  • Familiarity with LC-MS analysis of nucleic acid is a plus
  • Familiarity with additional chromatographic (e.g., SEC, IEX) and/or electrophoretic (e.g., CE-SDS) approaches is a plus
  • A strong background in bioanalytical chemistry, assay development, in-depth protein and/or glycan characterization, including product and process related impurities identification and quantitation
  • Experience with analytical method qualification, transfer, validation and general understanding of regulatory requirement (cGMP) for biotherapeutics development is a plus
  • Enthusiasm for scientific excellence with motivation for making contributions in a team environment

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