Manager, Clinical Trial Flow Cytometry - CAR-T

1 in 5 men and 1 in 6 women worldwide develop cancer during their lifetime, and far too many will lose their battle every year. At Navigate we envision a disease free world – our talented and passionate team is at the forefront of enabling drug development by using transformative science to deliver high quality, world class clinical biomarker solutions so we can one day realize that vision. Join us on our journey to turning innovative treatment ideas into reality to improve and extend patient lives across the globe. Navigate Biopharma, a fully owned subsidiary of Novartis, provides assay development, clinical trial testing, and companion diagnostics services to companies in the precision medicine field. At present, Navigate supports 100+ clinical trials from 30+ pharma, biotech, and diagnostic companies, including 8 of the top 15 oncology companies globally.<br><br>The Manager, Clinical Trial Flow Cytometry will manage technical and laboratory aspects of multi-parameter flow cytometry based PK/PD biomarker clinical trial testing projects. Will manage performance and mentoring of other associates. Serve as the key point of contact for other functional teams, departments, and external partners. Works closely with directors and leadership team. Will participate on cross-functional teams and projects. Executes and troubleshoot new procedures and assays with high level of independence while working on multiple projects. Serve as technical lead for execution of clinical sample testing from concept to completion. Evaluates test data, reviews associated documentation, writes bioanalytical reports and supports the team with adherence to appropriate quality regulations. Provides key scientific knowledge to drive success of strategic activities. Ability to forge relationships with scientists at all levels and provide guidance. Develop timelines and work flows to ensure successful execution of assigned projects and processes. Strategizes to identify and mitigate risks. Makes recommendations for scientific processes and drives projects to completion. <br><br>Key responsibilities:<br>• Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations<br>• Provides guidance, instruction, direction and leadership to a group of scientists in their assigned functional/technical area<br>• Ensure all team members are aligned of team goals and work together to achieve the collective goals of the team.<br>• Manage team resources and communicate any issues and team concerns effectively to management<br>• Manage multiple projects simultaneously and under tight timelines<br>• Act as a Subject matter expert related to operational processes in the functional area<br>• Responsible for writing and reviewing technical documents <br><br>Other Responsiblities:<br>• Ensuring that Quality Events such as incidents and deviations are proper documented, and for supporting/owning the immediate remediation and preventative actions<br>• Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed<br>• Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions<br>• Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed<br><br><br>[#video#https://www.youtube.com/watch?v=ggbnzRY9z8w&t=3s{#400,300#}#/video#]