Leidos is seeking a Viral Diagnostics and Assay Development Manager who will direct testing and develop assays for viral products manufactured at a manufacturing facility in Silver Spring, MD. S/he will manage, oversee, and perform assays for the detection of viruses in various matrices, such as culture media, animal and human plasma/blood/serum, and other tissues.
This position is contingent upon contract award.
- Oversee a group of qualified technicians that are responsible for all aspects of testing for quality and safety of viral products that are required in the development process.
- Maintain a validated and calibrated laboratory that will generate data used for Investigational New Drug submissions to the FDA.
- Development of new assays including potency and safety assays for products intended for human use.
- Write and review standard operating procedures.
- Conduct testing, which may include assay of infectivity, protein and antigen content, potency, purity and other characterization assays required for complete analysis of final products or intermediates.
- Qualification or validation of assays dependent upon the level of regulatory scrutiny
- Participate in the generation of product testing summary reports and Certificates of Analyses.
- MS degree in biochemistry or related science and at least six years of experience in viral testing desired
- At least six years of experience in viral assay development and testing of viral products
- GLP and GMP experience.
- Must possess skills using various types of analytical and laboratory equipment, as well as proficiency with IBM compatible software including spreadsheet programs and word processing programs.
- Must also have four years of managerial/supervisory experience.
- All proposed personnel to perform services contractor must verify employment eligibility (E-Verify) and obtain a favorable National Agency Check (NACI).