Recombinant DNA E. Coli Fermentation Development Expert (Scale-Up, Fermentation and Validation)
Technical Consultant #2023
Expertise
- Development of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.
- Scale up of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.
- Technical transfer of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.
- Validation of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.
Experience
Independent Consultant, Present
- Providing technical expertise for development, scale up, and validation of rDNA E.coli, yeast, and actenomycete fermentations.
- Fermentation development expert providing technical transfer and scale-up.
- Develop fermentation processes for E. coli fermentations producing insulin, an insulin analog, human growth hormone, and glucagon at pilot scale using efficient experimental designs based on statistics to identify and optimize key parameters.
- Significantly improve yields, reduce variability with less experiments in less time.
- Successful scientist in transferring process improvements to production.
Eli Lilly & Co, Indianapolis, IN, Assistant Senior Microbiologist, 1973 - 2008
- Supervised high throughput automated screen which produced a number of improved yield antibiotic producing strains and managed 8 technicians.
Assistant Senior Microbiologist, 1987 - 2000
- Responsible for fermentation of field trial quantities of Spinosad for DowElanco.
- Relocated to Harbor Beach, MI, to construct and run fermentation pilot plant to support production plant.
- Returned to Indianapolis to do pilot scale strain evaluation, managing several technicians.
- Developed insulin analog fermentation process using a novel control strategy which improved yields, reduced variability, and resulted in an easier scale-up to production.
Microbiologist, 1981 - 1987
- Worked on several recombinant E. coli fermentations including Bovine Somatotropin, insulin, and human growth hormone.
- Developed the production human growth hormone fermentation process and was the technical service representative for production campaigns.
Education
- B.S. Zoology, Butler University, Indianapolis, IN