Senior Consultant - Biologics Consulting Group, Inc., Germantown, MD.

• Review client internal policies and SOPs to assess suitability of their technical and quality practices for product development activities; prepare gap analysis reports for existing deficiencies relative to current FDA/ICH expectations.
  
• Provide technical and quality assistance in identity, purity, potency, and stability test method development, validation, troubleshooting and OOS investigations for biopharmaceuticals.
  
• Evaluate client CMC regulatory strategies for product development from pre-Phase I to BLA, with emphasis on drug substance and drug product characterization, comparability assessment, release and stability testing.
  
• Prepare and review client IND and BLA submissions for suitability relative to current FDA expectations for CMC data from biotechnological/biological products.
  
• Develop and deliver training sessions on technical, regulatory and quality elements of biological product development.

Consultant (Affiliate) - Biologics Consulting Group, L.L.C., Germantown, MD.

Contractor, American Red Cross Plasma Derivatives, Rockville, MD.

• Served as principle CMC RA/QA associate for Plasma Derivative product development projects.
  
• Established and implement R&D quality practice policies ("Good Development Practices" or "GDP") to support the development of plasma-derived products for FDA and international submissions.
  
• Established and implement $250K NuGenesis SDMS electronic documentation system for six product discovery and development laboratories.
  
• Prepared internal guidance documents and conduct training sessions on technical, regulatory and quality elements of biological product development.
  
• Prepared and review FDA IND and BLA submissions for nationally and internationally manufactured plasma products.
  
• Participated in international project teams to plan and execute regulatory and quality strategies for product development from Phase I to BLA.

Biotechnology Product Consultant, NMR Biotech, Germantown, MD.

• Provided expertise on biotechnology product development, laboratory quality practices, test method validation, product stability programs, and management of outsourced biopharmaceutical testing and manufacturing.
  
• Prepared and review CMC sections for IND and BLA submissions for a wide variety of biological and biotechnological products, participate in IND/BLA meetings with regulators, and respond to regulatory reviewer questions.
  
• Conducted quality audits of US and international facilities for cGMP and GLP compliance assessment. Design and review quality system documentation required for laboratory facilities for R&D, GLP and cGMP.
  
• Designed and review protocols for product characterization, process and test method validation and product stability programs.
  
• Presented seminars and training classes on the technical, regulatory and quality elements required in biotechnology product development and commercialization. Serve as subject matter expert in preparation and review of journal articles and book chapters.
  
• Facilitated professional meetings on biopharmaceutical industry issues, including interactions among industry and regulatory bodies.

Director of Technical and Regulatory Affairs, BioReliance Corporation, Analytical Services Division, Rockville, MD.

• Served as the principal point of scientific and regulatory CMC interaction with over 150 worldwide pharmaceutical clients for their national and international product submissions for biotechnology products.
  
• Provided expertise on product development requirements for recombinant proteins, monoclonal antibodies, plasma products, transgenic proteins, viral vectors, vaccines, and synthetic biomolecules (e.g. peptides and oligonucleotides).
  
• Supported Analytical Division project managers and study directors to ensure successful design and execution of complex or custom projects.
  
• Served as consultant to clients for technical and regulatory issues related to the CMC sections of INDs, BLAs, NDAs, annual reviews and supplements.
  
• Consulted internally and externally on quality practices and compliance issues.
  
• Developed and updated corporate Analytical marketing and training materials.
  
• Supported the sales force and other members of the Sales and Marketing team as Analytical expert for client inquiries.
  
• Delivered client presentations, professional seminars and training classes on biomolecular methods, regulatory product development guidelines, laboratory management, and quality/compliance practices.
  
• Interacted with regulatory bodies as industry expert and served as client advocate to regulatory reviewers for product submissions.
  

Director of Analytical Services Operations, BioReliance Corporation, Analytical Services.

• Managed a $4 million department of 20-24 project managers, technical writers, study directors and analytical scientists to provide contract biomolecular analysis for the characterization, stability and release testing of over 200 bulk and formulated biotechnology products.
  
• Designed and managed CMC analytical studies from pre-Phase I through Phase III and commercialization.
  
• Supervised divisional quality system programs to ensure top-down GLP and cGMP compliance.
  
• Served as the responsible divisional authority for quality audits conducted by project sponsors, national and international regulatory officials.
  
• Implemented management systems to increase efficiency in resource scheduling and facilities utilization.
  
• Developed budgets, monitored profits and costs, and operated laboratories and support functions at the highest levels of responsiveness to meet timelines and deliverables to clients.
  
• Successfully recruited and retained highly skilled scientific staff in a competitive technical location.
  
• Improved and expanded testing services and optimized laboratory growth to support new client projects.

Senior Scientist, Bulk Biomolecular Products, Abbott Diagnostics Division, Analytical Development and Validation, Infectious Diseases Sector R&D, Chicago, IL.

• Served as a senior technical supervisor of $2.2 million analytical R&D laboratory with 12 analysts developing and validating analytical methods for well-characterized biologicals used in CBER-regulated immunodiagnostic products.
  
• Prepared molecular biology, manufacturing, purification, analytical characterization and lot release and stability sections for 12 IND, 6 PLA/BLA submissions, 25 PMA submissions, and 10 IPMF submissions to international regulatory agencies.
  
• Acted as divisional R&D representative in major technology transfer projects of antibody and viral bulk products from contract manufacturing operations.
  
• Directed outsourced analytical studies though contract testing organizations.
  
• Provided expertise on Abbott test method and process validation strategies at the division and corporate levels.
  
• Established the Abbott "Quality Technical Reviewer" model for approval of divisional analytical method validations and method SOPS to provide greater technical and quality expertise and increase efficiency.
  
• Served as scientific specialist for two 40-member cGMP QC operations teams that manufactured and tested over 100 biotechnology bulk products from US and international plants.

Senior Research Biochemist, Biomolecular Products, Abbott Diagnostics Division, Infectious Diseases Sector R&D, Chicago, IL.

• Performed analytical biochemistry of over 75 natural and rDNA proteins, monoclonal and polyclonal antibodies, and synthetic peptides using characterization techniques such as HPLC, amino acid analysis, protein sequencing, peptide mapping, SDS-PAGE, scanning densitometry, IEF, immunoblots and assays, capillary electrophoresis, light scattering, surface plasmon resonance and protein identification via proteomic databases.
  
• Prepared method SOPS, with transfer, training and troubleshooting of methods to a 30-member QA laboratory.
  
• Established ISO-9000 compliance activities in the department, and served on corporate ISO certification task force.
  
• Certified in the use of biohazardous and potentially biohazardous viral materials, including BL3 biohazard suite access.
  
• Contributions to over 125 analytical test method characterizations and validations.
  
• Performed direct supervision and review of 5 R&D laboratory scientists.

Postdoctoral Research Fellow, University of Texas Dental Branch, Department of Biological Chemistry, Houston, TX.

• Performed biochemical characterization of the protein-protein interactions between the bone protein osteopontin and other bone extracellular matrix proteins.
  
• Techniques included tissue culture, protein purification and characterization, various ligand binding assays, in vitro and in vivo radiolabelling of proteins, SDS-PAGE, immunoblots, and glycoprotein analysis.
  

Graduate Fellow, Rice University, Department of Biochemistry and Cell Biology.

• Conducted molecular and cell biology studies of the subcellular translocation of glutamine synthetase and other urea cycle enzymes in shark and stingray tissues.
  
• Techniques included DNA and RNA isolation, RIPA, nucleic acid blots, subcellular fraction purification, kinetic enzyme assays, immunohistochemistry, radiolabelled pulse/chase assays, IEF and SDS-PAGE.
  
• Certified in the use of beta and gamma radiation emitters.
  

Senior Research Assistant, University of Texas, Dental Science Institute, Houston, TX.

• Purification and comparative biochemical analysis of proteins from microbial and animal models of biomineralization. Techniques included microbial culture, lipoprotein purification and characterization, in vitro mineralization assays, and Xray diffractometry.
  
• Contributed to cartilage extracellular matrix studies aboard Space Shuttle missions for NASA.
  

Research Assistant, University of Texas, Dental Science Institute, Houston, TX.

• Analytical biochemistry of calcified cells and tissues for the functional characterization of mineralizing proteolipids.
  
• Techniques included microbial and tissue culture, protein concentration and enzyme assays, and electron microscopy.
  

CONTINUING EDUCATION

Spirakes, T., Steffens, M., Schmidt, D., Lang, E., Singh, K., Nguyen, C., Ritter, N., and Watanabe, S. Monoclonal Antibody Characterization. ADD Technology Exchange (1998).