Analytical Development Senior Research Associate (contract)

Vertex PharmaceuticalsBoston, MA
2d$44 - $46Onsite

About The Position

Vertex pharmaceuticals is seeking a principal research associate to join the analytical development, cell and gene therapy team. This position is expected to serve as a key contributor in expanding our protein characterization and separation capabilities for supporting biologics program development. Extensive hands-on experience in liquid chromatography, mass spectrometry, or other separation methods is required. The individual in this role will collaborate closely with process development, manufacturing, regulatory, and quality to develop and innovate Vertex next generation biologics products. This is a 12 month contract to start. On site in Boston.

Requirements

  • Strong hands-on experience on biologics and antibody separation method development is required.
  • Strong understanding of analytical method development, qualification & validation, and critical quality attribute assessment is required.
  • Demonstrated capabilities to independently digest and formulate experimental conclusions by referencing orthogonal analytical results.
  • Ability to use information gained from experiments to inform method and program decisions.
  • Skilled in efficient study design and demonstrated expertise in writing SOPs, analytical protocols, and reports.
  • Ability to multi-task as necessary, managing competing priorities, and advancing multiple projects within required timelines.
  • Demonstrated ability to work cross-functionally to drive communication, strong track record in cross-team collaboration.
  • Strong oral and written communication skills.
  • Typically requires the following, or the equivalent combination of education and experience: Master's (3+ years) or Bachelor's (5+ years) relevant experience in biopharmaceutical industry.

Nice To Haves

  • Hands-on experience with mass spectrometry based analytical methods such as intact mass, peptide mapping, sub-unit analysis, N-glycan analysis, O-glycan analysis, and sequence variant analysis is strongly preferred.
  • Hands-on experiences on preparative-scale separation method development for fraction collection and fraction enrichment is strongly preferred.
  • Understanding protein glycosylation and hands-on experience on glycan and glycopeptide analysis is strongly preferred.

Responsibilities

  • Provide hands-on support for separation method development and testing support. Key assays include but not limit to SEC, CE-SDS, icIEF, HILIC, HIC, AEX, CEX, RPLC, etc.
  • Perform biotherapeutic characterization using state-of-art LC-MS platforms (Orbitrap, Q-ToF, QQQ, etc.) coupled with different front-end chromatographic separation techniques (reverse phase, HILIC, ion exchange, size exclusion, etc.) to advance Vertex’s pipeline.
  • Perform N-glycan and O-glycan analysis for therapeutical proteins, including site occupancy analysis, released N-glycan analysis, glycopeptide analysis, and sialic acid quantification.
  • Participate in critical quality attribute assessment, design and execute experiments, summarize data, and author reports.
  • Perform data analysis using relevant software, including Waters Empower, Protein Metrics, Biopharma Finder, Compass, etc.
  • Provide expertise in experimental design, data analysis, assay trouble shooting, technical report writing, and presentations.
  • Interface with external vendors and partners, manage external sample testing, review and analyze data as needed.
  • Author analytical method, qualification, and validation reports; author data summary reports.
  • Maintain proper documentation of experimental results and data interpretations.
  • Ensure data quality and maintain data integrity of analytical results to support decision making.
  • Collaborate with research and process development teams to develop fit-for-purpose analytical characterization methods for product characterization.
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