Bioanalytical Project Manager, Biomarker and Flow Cytometry

LabConnect   •  

San Diego, CA

5 - 7 years

Posted 235 days ago

This job is no longer available.

Bioanalytical Project Manager, Biomarker and Flow Cytometry

Summary:

LabConnect has an immediate opening for a Project Manager that will be responsible for providing oversight and management of assay development, validation, study monitoring and troubleshooting of outsourced flow cytometric and biomarker methods.  He/she will provide project management and technical support to teams conducting training, data review and data representation.  The Project Manager must have the ability to effectively monitor the performance of CROs and service providers. The incumbent will also be responsible for operational documentation including SOPs, validation protocols and reports, transfer protocols and reports, and management reports.

Responsibilities

  • Industry expertise in development and qualification of flow cytometric methods including immunophenotyping and receptor occupancy assays
  • Experience with flow cytometry analysis platforms and template development
  • Strong understanding of clinical biomarker assay development, troubleshooting, and data review
  • Demonstrated project and timeline management skills
  • Good planning and organizational skills with attention to detail
  • Effective oral and written communication skills with experience in technical writing
  • Understanding of clinical trial processes
  • Working knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or Clinical Laboratory Improvement Amendments (CLIA)
  • Strong computer literacy, including word processing, SharePoint, presentation and spreadsheet applications
  • Ability to work effectively in a cross-functional team matrix environment
  • Provide project management oversight and subject matter expertise in flow cytometry and biomarker assays, method development, validation and technical transfer to ensure scientific integrity and adherence to the protocol/plan/contracts and applicable regulations
  • Interact with CROs and effectively communicate updates, reports, and recommendations to management teams
  • Provide analytical project oversight by performing data review and collation, evaluate assay quality, monitor performance and manage timelines
  • Provide technical support to troubleshoot specific issues that impact the project
  • Manage Supplier performance and relationships with attention toward opportunities to cut costs, alleviate risks and drive continuous improvement
  • Recommend and implement new processes and procedures to standardize, simplify and enhance quality and compliance of the department’s operations
  • Expected to participate in the management and control of GCP/GLP documentation and records, contribute to and (co) author scientific and/or operational documents such as SOPs, validation protocols and reports, transfer protocols and reports, posters journal publications and other technical reports

Qualifications

  • M.S., Life Sciences or related field with a minimum of 2 years of industry-relevant project, laboratory, and management experience OR
  • B.S., Life Sciences or related field with a minimum of 5 years of industry-relevant project, laboratory, and management experience
  • Microsoft Office applications: Word, Excel, and PowerPoint.

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