Plans, manages, organizes, directs and ensures quality of all the regulatory review operations, program segment(s), function and activities of the Branch.Provides the day-to-day leadership, supervision, guidance and support, both technical and administrative, to the professional, technical and clerical personnel assigned to the Branch.Develops and implements Branch policies and plans and makes critical decisions and provide expert advice. Receives, reviews and manages investigational New Drug Applications (INDs) and Biological License Applications (BLAs).Recognizes the need to initiate new and amend regulations, policies and procedures and guidelines for such regulated product.Provides regulatory managed review training to new FDA review staff.Develops an affirmative action plan for the Branch including appropriate objectives and goals. Provides written conclusions on review products.Directs the preparation, clearance and finalization of Branch responses to inquiries covering all aspects of the program. Participates in meetings with the Division Director and other Office and Center officials on problems related to products under review.Provides verbal conclusion and consultation to FDA staff, private industry and other sponsors on regulatory managed review of products.Spokesperson and authoritative source of information and advice on issued involving managed review of biological products.

As a Primary Reviewer in Regulatory Review Branch 1 (RRB1), managed 140 Investigational New Drug (IND) applications & Master Files (MF) for new preventive vaccines against bacterial & parasitic diseases. Reviewed 87 original IND /MFs & 2,503 IND/MF amendments . Chaired a new Biologics License Application (BLA) for Timothy grass pollen allergen extract tablets for sublingual use, & a new clinical efficacy supplement to extend the usage of a pneumococcal vaccine to children aged 6 through 17 years. Served as Regulatory Project Manager of a new BLA for a Coccidioides immitis Skin Test Antigen. Served as regulatory project manager or regulatory coordinator on 90 new manufacturing, labeling, annual report, post-marketing commitment and product correspondence supplements to Biologics License Applications (BLAs) for bacterial vaccines (gram negative & gram positive) & related products such as Tuberculosis (TB) skin test antigens. Authored 902 regulatory communications (letters, emails, telecons) & chaired 48 regulatory meetings with sponsors. Served on an Inter-Agency Task Group on Agricultural Biotechnology Risk Analysis Research. Served on the FDA Inter-Center Products Derived from Bioengineered Plants Guidance Committee. Served on six (6) FDA/CBER committees: Global Vaccine Initiative Working Group; FDAAA Tropical Diseases Working Group; CBER Vaccine Potency Working Group; CBER Critical Path Proposal Review Committee; CBER Electronic Viewing System/UAT Working Group; “CBER 101” Planning Committee. Represented FDA at domestic (19) & international (13) meetings (including as a WHO Temporary Advisor/Expert). Served as a member of NIH grant review Special Emphasis Panel on infectious disease research. Served as a Contributing Reviewer for the 27th (2006), 28th (2009) and 29th (2012) editions of the American Academy of Pediatrics Red Book. Served as Acting Team Leader & Acting Branch Chief for CMC1 when Branch Chief was out of the office.

As a Project Officer in the Clinical and Regulatory Affairs Branch (CRAB), Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, managed a $5 million dollar contract for pilot lot production of vaccines and therapeutics under current Good Manufacturing Practices (cGMP). Provided assessments of ongoing studies and capacity under production and clinical studies contracts on a routine basis to Office of the Director, Division of Microbiology and Infectious Diseases (DMID), the Clinical Studies Group, and other DMID committees. Served as lead scientist in the Clinical and Regulatory Affairs Branch for issues of fundamental vaccine design, i.e., adjuvants, expression systems, and vectors. I Represented the NIH on the New Vaccines Technologies Subcommittee of the WHO held in Geneva, Switzerland in September 1999. Involved in the organization of national and international workshops on vaccine-related issues (e.g., the use of cell substrates for vaccine production and the possible relationship between vaccination and IDDM). Oversaw development and provision of reagents essential for preclinical and clinical research.Served as Acting Branch Chief for the CRAB when the Branch Chief was on official travel or leave.

Served as a Research Microbiologist in the Department of Immunology, WRAIR, conducting research towards development of a malaria vaccine. Using molecular techniques, designed, constructed and expressed recombinant fragments of a leading malaria vaccine candidate, EBA-175, as part of a collaborative effort with an industrial partner. This research was funded by a World health Organization grant and a Cooperative Research and Development Agreement (CRADA). Managed a contract under which large-scale production of the recombinant antigens was achieved. The malaria polypeptides were expressed as GST fusion proteins using the baculovirus expression system. In collaboration with colleagues, prepared and published in a peer-reviewed journal scientific data documenting the first reported expression of the EBA-175 protein using a eukaryotic expression system. Proposed and was awarded an internal research grant to fund investigations on the use of the yeast Two-Hybrid System to identify novel malaria antigens and the host receptors with which they interact. Planned and organized a Department Research Seminar Series. Served as Department of Immunology Controlled Substances Officer. Other duties as assigned included service as Administrative Officer of the Day for the Walter Reed Army Medical Center and manager of the WRAIR component of the 1997 Army Emergency Relief Fund Charity campaign.

Served in the U.S. Army's 28th Combat Support Hospital as the Clinical Laboratory Section Supervisor and Squad Leader for 6-9 Medical Laboratory Specialists assigned to the deployable clinical laboratory. Maintained the laboratory, associated equipment and vehicles for possible deployment if the Combat Support Hospital were activated in support of operational missions. Received laboratory operational readiness score of 100% during the 1982 annual Inspector General Inspection of the hospital.Worked additional hours as a Medical Laboratory Specialist in the Department of Pathology at the Womack Army Hospital, Fort Bragg, NC, in order to maintain my diagnostic skills.

Served in the Department of Pathology, U.S. Army 5th General Hospital, Bad Cannstatt MEDDAC, as an assistant to the Chief, Microbiology, and as Microbiology Section Supervisor. Supervised 1-3 Medical laboratory Specialists.Routine responsibilities included performance of diagnostic assays on patient clinical specimens in the areas of clinical chemistry, hematology, immunohematology, bacteriology, parasitology and serology while maintaining rapid turn-around times during both regular duty hours and while working as the sole technician on scheduled nights and weekends. Duties in the Clinical Chemistry Section included running routine and stat tests, including arterial blood gases. Hematology duties included performing Complete Blood Counts including differential, and clotting time determinations. Duties in bacteriology included the culture, identification and sensitivity testing of microorganisms isolated from clinical samples. Duties in the Blood Bank Section included performing phlebotomy procedures on volunteer blood donors and typing and cross-matching units of donor blood to recipients. Conducted tests for ova and parasites and conducted routine urinalysis, urine pregnancy tests and other rapid serology screening tests. Maintained a high level of quality control in all aspects of duties.