Clinical Flow Cytometry QC Analyst

Role Summary

Flow cytometry continues to gain importance with regulators as an essential method in the development of personalized medicine. In this newly created role, the individual would be primarily responsible for supporting analysis and review of clinical flow cytometry data acquired across various clinical studies and therapeutic areas. The role requires a solid, hands-on understanding of flow cytometry and will support data characterization from conventional and spectral cytometry platforms often from large multi-color panels. In this role, the Analyst would develop a pipeline to ensure high data quality, working closely with key internal stakeholders and vendors. This position does not require wet benchwork.

Responsibilities

• Review and analyze raw data (using various gating strategies) to identify irregularities and negative trends
• Provide training data and insights for training supporting AI tools used in flow cytometry data QC
• Contribute independently and in matrix teams to improve data quality from flow cytometry experiments
• Support development of monitoring strategies and KPI implementation with vendors to enhance data quality through best practices and corrections of errors and deficiencies
• Support clinical biomarker strategy leads by ensuring regular raw flow cytometry data uploads and workflow sharing in cloud platforms following vendor transfers
• Support initiatives to reduce instrument and technical variation across assays and vendors
• Support the development of business process documents related to these activities, including acting as the SME for development and review of raw data DTS documents
• Contribute insights and reviews to assay development and validation work performed at clinical vendor labs
• Collaborate with members of the Flow Cytometry Core and research therapeutic areas to optimize data QC
• Lead a weekly flow cytometry review with strategic stakeholders to cross-prioritize efforts and provide updates on flow cytometry data QC progress
• Provide support to monthly and ad-hoc internal flow cytometry meetings through scheduling, maintaining a document repository and sharing meeting agendas and minutes

Qualifications

• B.S./M.S. with at least 10+ years’ experience performing and analyzing flow cytometry assays
• Experience and coursework in Immunology and/or Oncology setting preferred
• Experience independently using at least 1 or more flow cytometry software programs (FlowJo, FCS Express, etc) is required
• Candidate must be detail-oriented, self-starter and possess both strong organizational and communication skills
• Proficiency with Microsoft Word, Excel, Powerpoint