Biotechnology Consultant

Biotechnology Consultant (1045)

1999 - Present Independent Consultant

Vaccine company - Wrote and investigated GMP manufacturing deviations and corrective actions, performed manufacturing process analyses and recommended process modifications and improvements
Biological reagents company - Improved several recombinant fermentation process yields by greater than ten-fold.
Biopesticide company - Improved fermentation process yields of a bacillus by greater than ten-fold and scaled the process to 100,000 liter scale.
Gene therapy company - Audited several domestic and European GMP contract manufacturers for client. Improved recombinant fermentation process DNA yields by up to twenty-fold. Recommendations significantly improved clinical production capacity of cell culture operation.
Agricultural product company - Solved major process problem and arranged contract supply of recombinant protein at large scale.
Engineering design company - Led technical design for state-of-the-art $30MM cell culture process development facility for major west coast biotechnology company; led technical design for GMP clinical manufacturing facility for major west coast hospital.
Evaluated biological warfare production capability of terrorists for the U.S. DOD.

1998 Vice President of Operations, PHARMANEX, INC, Simi Valley, CA

Developed manufacturing specifications and arranged for the contract manufacture of a broad spectrum of nutritional supplement products
Coordinated the launch of a new line of 32 different nutritional supplement products

1995 – 1997 Director of Clinical Manufacturing, AMGEN, INC. Thousand Oaks, CA

Directed the activities of all departments involved in the manufacture of Amgen's clinical products. These departments included bulk manufacture (microbial fermentation, cell culture, recovery and purification), filling and finishing, packaging and labeling, and contract manufacturing (150 staff with annual budget of $25 MM).
Developed and implemented a coordinated forecasting and scheduling process for the production of all clinical products.
Negotiated contracts and supply agreements with outside vendors

1983 – 1995 Director of Process Development, AMGEN, INC Thousand Oaks, CA

Starting at the scientist level in 1983, held positions of increasing responsibility in technical development and manufacturing support.
Developed Amgen's microbial fermentation, cell culture and recovery process technologies.
Transferred manufacturing processes into clinical and commercial manufacturing facilities and assisted with plant/process start-up.
Established and led commercial manufacturing support efforts that increased

Neupogen process yield by 50% and Epogen process yield by 300%.

Led client design of state-of-the art $20 MM process development facility.
Held matrix management position of Hepatitis B vaccine project team leader and similar position of stem cell factor process team. Responsible for all technical and manufacturing activities associated with stem cell factor.

1981 – 1983 Research Engineer, CELANESE RESEARCH CENTER, Summit, New Jersey

Developed fermentation and recovery procedures for the production of specialty chemicals.
Performed cost estimate analysis on novel production technologies.

1978 – 1979 Associate Engineer, HOFFMANN LA ROCHE, Nutley, New Jersey

Other Professional Activities

Guest lecturer at UCLA, Tufts University and California State Channel Islands
Reviewer of grant proposals for NSF and draft manuscripts for Biotechnology and Bioengineering

Ph.D. in Biochemical Engineering (1983), University of Pennsylvania, Philadelphia, PA
M.S. in Chemical Engineering (1978), University of Pennsylvania, Philadelphia, PA
B.S. in Chemical Engineering (1976), Cornell University, Ithaca, NY