Scientific Director - Histopathology Operations

Company: CellCarta
Location: Lake Forest
Posted on: March 13, 2023

Job Description:

About CellCartaCellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The company operates globally with over 800 employees in its nine facilities located in Canada, the USA, Belgium, Australia, and China.At CellCarta, Organizational Development is about ensuring we elevate our people to their highest potential, cultivate an engaging and productive environment, build passionate high-performing teams, and drive strategic solutions to maximize our business performance and support our growth.
A scientific team that upholds the highest quality standards.SummaryThe Scientific Director, Histopathology Operations, is responsible for the oversight and technical conduct of assay development, and preclinical, and clinical trial studies, in accordance with standard operating procedures. -ResponsibilitiesDemonstrate an in-depth knowledge and expert understanding of the underlying technology. Scientific Directors will be assigned to studies based on their experience and competence with the proposed study design.The Scientific Director shall exercise overall responsibility for the technical conduct of the study; including interpretation, analysis, documentation, and reporting of results, and represents the single point of study control. - The Study Director's responsibility includes, but is not limited to the following:Sign protocol to initiate the start of the study. - - - - Ensure that the procedures specified in the protocol and SOPs are followed, and that authorization for any modification is obtained and documented together with the reasons for them, if necessary.Ensure that corrective action is taken and documented as it occurs if necessary to ensure the quality and integrity of the study. Work with the pathology and licensed staff to ensure that slides are reviewed in a timely manner.Ensure that all data generated is fully documented and recorded. Ensure that controls are run and passed for each reported analysis.Work with IT and project managers to ensure that results are reported properly and in a timely manner.Sign and date the final report to indicate acceptance of responsibility for the validity of the data. Ensure that after the termination of the study, the study plan, the final report, raw data, and supporting material are transferred to the archives.Ensure that QA audits are responded to promptly.Select duties may be delegated to project managers and principal scientists.Provide mentorship to project managers, principal scientists, and assay development managers.Provide oversight of IHC/ISH/IF/FISH assay development, including assay design, execution, analysis, and deployment as assigned.Maintain a work culture that is focused on customer service, the highest quality results, and meeting deadlines.Actively participate in various management activities and initiatives, taking an active role in advancing Mosaic's overall goals, objectives, and growth.Perform other duties as assigned by supervisor. -Education

Keywords: CellCarta, Lake Forest , Scientific Director - Histopathology Operations, Executive , Lake Forest, California