Mr. Lebherz spent more than 40 years as a contractor to US Government Agencies. He began as a laboratory scientist (microbiology) in 1972, supporting the National Cancer Institute-Frederick Cancer Research Facility (NCI-FCRF) at Ft. Detrick MD, and rose to the position of manager of the NCI-FCRF Fermentation Production Facility in 1984, serving in that capacity until transferring to SAIC Corporate’s Life Sciences Operation (SAIC LSO) in 1996. The principal focus of the Fermentation Production Facility was the production of experimental drugs for pre-clinical studies on cancer and AIDS. As such, Mr. Lebherz became trained and developed substantial expertise in FDA’s Good Manufacturing Practices and Good Laboratory Practices (GMP and GLP). Such training included executing audits of facilities and processes and procedures for compliance with GMPs/GLPs.
In 1994, Mr. Lebherz was granted permission by NCI-FCRF to serve as a Large-scale Industrial Biotechnology Expert to the United Nations Special Commission (UNSCOM) on Iraq, serving on a Biological Weapons (BW) inspection mission to Iraq (1994) and provided technical assessments to UNSCOM during temporary assignments at UN headquarters in New York (1995).
After transferring to SAIC’s Life Sciences Operation in 1996, Mr. Lebherz was assigned by SAIC to serve as a Research/Program Analyst to the United States Army Medical Biological and Medical Chemical Defense Research Program (MBCDRP), a position he held until retiring from SAIC in November 2010. During his tenure with the MCBDRP, Mr. Lebherz providing the following support relevant to auditing systems, policies, and procedures:
· Was a member of an UNSCOM team sent to Iraq in 1997 to verify Iraq’s Full, Final and Complete Disclosures (FFCD) for the manufacturing of Biological Weapons. This involved auditing various iterations of the FFCD and interviewing individuals that were assigned to manage and operate Iraq’s biological production facilities.
· Provided regulatory affairs consultation to the Department of Defense (DoD) and commercial customers in compliance with FDA regulations for manufacturers of licensed biological products.
· Audited the DoD’s sole provider of anthrax vaccine for compliance with and adherence to its Strategic Plan for Compliance to FDA requirements.
· Prepared an establishment license application submittal for BioPure (commercial customer), which required auditing BioPure’s production facilities, processes, and procedures.
· Assisted a commercial customer (Centeon) in preparing an amendment to its establishment license for changes to its blood product manufacturing operations in Marburg, Germany.
· As a member of the Visiting Team and performed a mock trial visit exercise at the Armed Forces Institute of Pathology as part of DoD’s analysis and assessment of a draft inspection protocol under the Biological Weapons Convention.
Since retiring from SAIC in November 2010, Mr. Lebherz has been focusing on music, gardening, and travelling. He began supporting Green Advantage, Inc. as an external auditor of some of its Board and Operational Systems in December 2016.