Bioanalytical Project Manager, Biomarker and Flow Cytometry

Job 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.

Required Knowledge and Skills

• Industry expertise with 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

Essential Duties and Responsibilities

• 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.

Education/Experience

• 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