Director, Therapeutics, Biologics Consulting Group iNC..

• Responsible for the scientific and regulatory review and analysis of a wide range of therapeutic products at all stages of product development, from pre-IND development through post-marketing.
• Provide regulatory, scientific and manufacturing analysis and support, develop product-and facility-related regulatory documents for submission, review SOPs and validation packages, and perform facilities audits.

Chief, Hybridoma and Hematologic Products Branch, Division of Application Review and Policy, Office of Therapeutics Research and Review, CBER.

• Products under the purview of my branch included:
  
  • monoclonal antibodies for therapeutic or in vivo diagnostic usethrombolyticshematologic growth factors
  • devices used with or for therapeutic purposes, assigned to CBER by intercenter agreement.
  Reviewed scientific and regulatory analyses prepared by my staff, as well as agency correspondence, related to both market and investigational submissions, for scientific and regulatory accuracy. Responsible for the quality assurance review of the scientific and regulatory bases for approval of biologic and medical device submissions, including review of applicable labeling. Responsible for assuring adherence to review deadlines for market applications, by providing guidance on the managed review process to both branch members and other Center personnel. This often involved building consensus among individuals with highly diverse personal and professional styles. Acted as a liaison between the biotech industry and the agency, routinely providing consultative services to a broad cross-section of the biotech industry at all stages of product development, from pre-clinical submission through post-marketing. Responsible for assuring equity of the workload among my staff, assigning projects based on scientific and regulatory expertiseMaintained an open-door policy and held frequent discussions with branch members and others to keep current with, and provide guidance on, all aspects of the projects ongoing within the branch Encouraged staff to pursue training programs and professional development to both broaden and deepen their scientific and regulatory strengths, and to participate in intra- and inter-center activities in their areas of expertise. Through this mechanism, branch members developed versatility and independence, coupled with a strong sense of "team", in a collegial and highly productive atmosphere. The resulting work products were of high quality, complete and submitted in a timely fashionResponsible for hiring actions and staff evaluations and was the direct supervisor of five doctoral level scientific/regulatory reviewers and one secretarial support staff individual. Served as member of the ICH Expert Working Group on Quality of Biotechnology Products, serving as the FDA lead on the viral safety and cell substrates documents, and represented the Center in the discussions on the quality portion of the Common Technical DocumentOrganized the 1995 CBER workshop on viral safety and cell substrate issues, in collaboration with industry and international regulatory agenciesConsidered a resource on cell substrate issues, providing information both within and outside my immediate officeParticipated in Center managed review and strategic planning committees, Gave scientific and policy presentations internally, before agency committees and before regulated industry
• Led and performed facility inspections, while continuing to have primary responsibility, as described in the following position description, for a limited number of regulatory submissions

Microbiologist, Hybridoma and Hematologic Products Branch, Division of Application Review and Policy, Office of Therapeutics Research and Review, CBER.

• Had regulatory responsibility for a wide variety of monoclonal antibodies, hematologic growth factors, cytokines and devices both within the investigational phase as well as post-licensure. Performed reviews as well as coordinated review teams, formulating and drafting review letters and working with the team to adhere to review time lines. Depending on the product, the regulatory mechanism under which it is reviewed, and the stage of development, submissions have been in the form of INDs, Master Files, Product, Biologic and Establishment License Applications and PMAs. Interfaced with a broad cross-section of the biotech industry, at all stages of product development from pre-clinical submission through post-marketing.Member of the ICH Expert Working Group on Quality of Biotechnology Products as the FDA lead on the viral safety and cell substrates documents and chaired the CBER/CDER group working on the ICH virus and cell substrate documents. Member of internal committees to draft the Cell Substrates and Monoclonal Antibodies PTCs Served as a resource on cell substrate issues, providing information both within and outside my immediate office.Responsible for assuring adherence to review deadlines for market applications by providing guidance on the managed review process; this often involved building a consensus among individuals with highly diverse work styles.
• Led and participated in facilities inspections.

Study Director, Microbiological Associates, Rockville, MD.

• Areas directed: biochemical retrovirology, electron microscopy and mycoplasma and sterility testing
• Responsible for managing multiple simultaneous GLP-compliant studies as varied as reverse transcriptase assays, co-cultivation and induction protocols with multiple endpoints (including infectivity assays)
• Responsible for scanning and transmission electron microscopic analyses (on both cells and cell culture fluids)
• Responsible for assays for mycoplasma contamination in cell cultures and culture fluids as well as in raw materials, and assays to assure the sterility of both production substrates and final product formulations.
• Served as study director for a number of studies designed to evaluate viral clearance utilizing at least six different viruses to challenge a diverse collection of columns and buffer systems, as well as studies designed to evaluate mycoplasma clearance.
• Have considerable experience working with members of the industry and academia to design and implement testing protocols for a wide variety of products.
• Worked closely with firms to design studies to address specific concerns expressed by regulatory agencies, and have prepared documents for submission to these agencies. At the time I left, I was working with the director of the QA unit to bring the laboratory into compliance with applicable cGMP requirements.
• Served as direct supervisor of one supervisory, three mid-level and one entry-level technical personnel
• Responsible for hiring actions and staff evaluations.
• Responsible for multipartite studies performed by any additional personnel required to complete the study.

Senior Scientist, IGEN Incorporated, Rockville, MD.

• Molecular biology department project involved the design and synthesis of expression vectors for a series of proprietary antibody constructs.
• Responsible for providing oligonucleotides to be used in conjunction with a proprietary detection technology for nucleic acid analyses, using an Applied Biosystems Model 380B DNA synthesizer .
• Member of a team tasked with the identification and preliminary evaluation of potential targets for catalytic antibody development.
• Involved in the final review process for the applications literature accompanying release of the initial system utilizing IGEN’s proprietary detection technology.

Research Chemist, Walter Reed Army Institute of Research (WRAIR), Washington, DC.

• Within the Division of Communicable Diseases and Immunology, my work involved the study of the kinetics of induction of mRNA synthesis in response to treatment with several cytokines.
• Within the Division of Biochemistry, my work involved regulation of cell surface membrane components of parasitic protozoa for immunoprophylactic or chemotherapeutic studies.
• Supervised the operation of an Applied Biosystems Model 380B DNA synthesizer, utilizing synthesized oligonucleotides in collaborative projects with the malaria vaccine and bacterial toxin programs.
• Non-research duties included
  • Served as a liaison for several contracts
  • Participated in contract review boards.
  • Supervised two technicians and four summer personnel.