Viral Diagnostics and Assay Development, Head
Job Locations US-MD-Silver Spring
# of Openings : 1
Type : Regular Full-Time
CAMRIS International is an medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.
CAMRIS is seeking a Viral Diagnostics and Assay Development Manager who will direct testing and develop assays for viral products manufactured at a Bioproduction Facility in Silver Spring, MD.
*This is a forecasted position and it is contingent upon contract award.
Oversee a group of qualified technicians that is responsible for all aspects of testing for quality and safety of viral products that are required in the development process.
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.
Pay special attention to some assays which may require custom development for new products and writing of standard operating procedures. Assays may also need qualification or validation depending on the level of regulatory scrutiny that is anticipated. Assay results will be used for regulatory support of potency and safety of products intended for human use.
Maintain a validated and calibrated laboratory that will generate data used for Investigational New Drug submissions to the FDA.
Participate in the generation of product testing summary reports and Certificates of Analyses.
A MS degree in biology or related science and at least six years of experience in viral testing.
At least six years of experience in viral assay development and testing of viral products documented 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).