Biologics Pharmaceutical Development and Manufacturing Consultant

Technical Consultant #1948


Expertise

  • Biologics pharmaceutical development and manufacturing, working in process development, purification, formulation, lyophilization, analytical development and stability for both clinical and commercial products.
  • Formulation development work and stability testing, from early stage through commercial, for proteins, monoclonal antibodies, vaccines and small molecules.
  • Sterile fill support for manufacturing operations.
  • Scale up and troubleshooting of formulation processes and transfer to manufacturing.
  • Selection and qualification of container and closure systems.
  • Comprehensive pharmaceutical manufacturing for FDA inspections, IND and marketing applications for the U.S. and Europe.
  • Manage clinical product stability programs.

Experience

Independent Pharmaceutical Consultant, 2004 - 2010

  • Providing various comprehensive pharmaceutical manufacturing support to clients.

Chiron Corporation, Emeryville, CA, 1996 - 2004

Director of Formulation and Drug Delivery and Associate Director, Formulation Development

Responsibilities

  • Manage a staff of 30 developing formulations for protein therapeutics, vaccines and small molecules for clinical and commercial applications.
  • Developed project budgets and staffing plans.
  • Provided development support for sterile fill manufacturing operations.
  • Scale up and troubleshooting of formulation processes and transfer to manufacturing.
  • Selection and qualification of container/closure systems.
  • Manage clinical product stability program.
  • Technical team leader for the post-marketing approval of a second generation syringe delivery device for Betaseron┬«, approved.
  • Coordinated activities with European partners.
  • Selected device components and contract manufacturing sites.
  • Developed physical and functional product test methods and specifications.
  • Technical team leader for Menjugate conjugate vaccine registration in the U.K.
  • Developed international supply chain for intermediates; validated aseptic transport of adjuvant.
  • Designed stability program for intermediates, adjuvant and final product.
  • Developed an informal clinical stability program into a GLP compliant operation.

NABI, Rockville, MD, 1991 - 1996

Director of Analytical and Formulation Development

  • Manage staff of 6, including 2 Ph.D. scientists.
  • Responsible for analytical method development and validation for polysaccharide and polysaccharide-protein conjugate vaccines.
  • Developed methods for quantitation, O-acetylation, and polysaccharide/protein content in vaccines.
  • Responsible for development of formulations for vaccines and intravenous gamma globulins.
  • Implemented improved in-process analytical methods for protein and polysaccharide content to improve control of final product.
  • Developed and validated an analytical method for polysaccharide content of conjugate vaccines using refractive index detection and SEC-HPLC.

Director and Associate Director - Formulation and Pharmaceutics

  • Managed a group of 28 people, including 4 Ph.D. scientists.
  • Formulation development, dosage form development, protein stabilization technologies, advanced delivery system development and stability studies.
  • Managed 10 person bioassay testing laboratory which performed bioassays for product release and stability testing.
  • Managed project team to improve precision of major product bioassay to meet MCA requirements for registration.
  • Developed a stable liquid formulation with 2 year stability of major product and back up lyophilized formulation.
  • Implemented lyophilization technology in the company.

Cetus Corporation, Emeryville, CA, 1982 - 1991

Director - Formulation and Pharmaceutical Development and Associate Director of Formulation

  • Managed a group of 3 scientists and 6 laboratory assistants.
  • Responsible for developing stable formulations of therapeutic protein products, developing controlled delivery systems, and assisting in manufacturing scale-up and trouble-shooting in the areas of filling, filtration, lyophilization and container-closure selection.

Scientist-Process and Product Development Department

  • Development group leader of a program to produce human IgM monoclonal antibodies to gram-negative endotoxin for the treatment of septic shock.
  • Brought two antibodies into clinical trials.
  • Managed a team of 12 which developed and ran a process for making clinical material. Developed analytical methods.
  • Developed retroviral inactivation procedures for production process.
  • Group leader of a team of eight which developed a process for making clinical grade tumor necrosis factor.
  • Scale up process to support clinical trials.

Associate Scientist--Process and Product Development Department

  • Development of preparative scale reverse phase chromatography for production of interferon and interleukin-2. Member of project team which developed a manufacturing process for clinical grade interleukin-2.
  • Purification and characterization of fungal glucoamylases for industrial production of sugar and ethanol.

University of Wisconsin, Madison, WI, Department of Biochemistry, 1979 - 1982

Postdoctoral Fellow

  • Studies of sensory transduction in paramecium tetraurelia. Protein methylation reactions and their regulation of behavioral responses.

Graduate Student

  • Ph.D. Thesis: Purification and properties of the respiratory chain NADH: Quinone oxidoreductase of E. coli.

Honors & Publications

Publications and Patents

  • Author-Co-Author of numerous publications in peer reviewed journals and presentations.
  • 8 U.S. patents

Education

Ph.D. Biochemistry, University of Washington, Seattle, WA

  • B.A. Biochemistry, Rice University, Houston, TX
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