Biologics Pharmaceutical Development and Manufacturing Consultant

Technical Consultant #1948

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.

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.

Publications and Patents

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

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