American Gene Technologies is an early clinical stage company developing genetic therapies for important human diseases. We are expanding a translational core component that will be intermediary between our discovery and late stage preclinical programs. The position of Core Manager will help develop and implement all functions of the core, as well as supervise all operations within the core, develop new technical capacities as needed, create SOPs, oversee the creation of data sets suitable for patent applications, regulatory filings, publications and data archives. The Core Manager establishes work schedules for core functions, provides input to formal development and interfaces with the company’s service providers. The Core Manager works closely with Product Development, Project Management, Document Control and Clinical Affairs teams at AGT. The position reports to the Vice President of Clinical Development.
MS or PhD in a relevant area. PhD with a minimum of 3 years industry experience in a QA/QC setting or core facility or a MS with 6+ years industry experience; knowledge of GLP requirements is a plus. Familiarity with assay validation and previous experience with flow cytometry, viral vectors, immunology and molecular assays also preferred. Experience supervising small teams of staff is mandatory. The successful applicant should also demonstrate knowledge of vendor relations, development of standard operating procedures.