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Senior Scientist/Principal Scientist, Clinical Biomarker & Bioanalysis (Cambridge, MA)

Snap Staffing - Cambridge, MA

Scientist/Principal Scientist, Clinical Biomarker & Bioanalysis (Cambridge, MA)

SNAPSHOT!

Looking for a chance to join a team that is pathing the way for cancer immunotherapies as a Scientist/Principal Scientist, Clinical Biomarker & Bioanalysis?? READ ON!!

Our client harnesses the immune system to reveal the optimal targets for each patient to develop cancer immunotherapies that will be better, more accessible and more affordable. Their proprietary technology is a clinically validated platform that selects therapeutically relevant antigens that drive powerful anti-tumor immune responses. This technology is the only platform able to identify personal neoantigens that drive suppressive T cell responses, abrogate protection of therapeutic anti-tumor vaccines that can reverse or dampen the immune responses.

Immediate opening for a Senior Scientist/Principal Scientist, Clinical Biomarker & Bioanalysis, Cambridge, MA, who possesses:

  • Proficient in multi-color flow cytometry and ligand binding assay design and execution
  • Experienced in fit-for-purpose clinical biomarker assay validation or bioanalytical assay validation
  • Skilled in clinical study sample analysis in a regulated setting compliant with GxP guidelines
  • Experienced in SOP development/update, study report generation, and critical review of raw data and study results
  • Experienced in managing direct reports
  • Experienced in delivering clinical biomarker and bioanalytical data in the regulated setting
  • Subject matter expert in the development and validation of clinical-grade assays (flow cytometry and/or ligand binding assays)
  • Strong knowledge in GLP/GDP and regulatory guidelines for assay validation and clinical study sample analysis
  • Experience in immuno-oncology and cell therapy product development
  • Excellent ability to perform hands on experiments, research, design, and organize projects and maintain detailed documentation

Duties and Responsibilities:

  • Support clinical biomarker strategies for cancer cell therapy
  • Lead by model, responsible for leading flow cytometry and/or ligand binding assay validation and clinical study sample analysis
  • Responsible for maintaining regulatory compliance appropriate for clinical study data generation and documentation. Subject matter expertise in GLP/GDP guidelines
  • Responsible for SOP development/update, report generation, QC and review of raw data and results
  • Leverage external contract research organizations and vendors along with appropriate internal laboratories to execute biomarker analysis
  • Mentor junior scientists in clinical-grade assay development, validation, data generation and analysis
  • Participate in continuous improvement of scientific and regulatory processes to enhance functional capabilities and productivity
  • Effective communications and collaborations across functional lines

If you’d like to explore, send your resume to admin@snapstaffing.com and we’ll follow up with you ASAP!



Posted On: Tuesday, July 20, 2021



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