Director of Fermentation

Location:

Sarasota, FL, 34233

Posted:

August 14, 2011

Contact this candidate

Resume:

Robert A. Ivey, III, PhD

Home Address Contact Information

**** **** **** **. ****: 941-***-****

Sarasota, FL 34233 Email: ********@*****.***

Summary

Goals oriented Project Manager seeking challenging role in upper management of Biotech Manufacturing company. Experiences include managing Fermentation Production Operations, Product and Process Development and Systems Management as well as Basic Research in Biochemistry and Biophysics. Designed and operated cGMP compliant facilities while developing cGMP compliant Manufacturing Protocols and Quality Control methods.

Professional Experience

Director of Fermentation (2010-present) Osprey Biotechnics, Sarasota, FL (small corporation, privately traded)

Duties

--Manage multiple fermentation and culture processing teams

--Upgrade equipment, modernize processes

--Establish performance benchmarks for new products, especially for contract manufacturing

--Direct laboratory and pilot-scale fermentation trials

--Serve on company's Executive Committee

Accomplishments

--Characterized and scaled up several novel microbial culture products

--Elevated quality and increased productivity of manufacturing equipment

--Overhauled Standard Operating Procedures and Manufacturing Procedures

--Improved growth and recovery yields of many microbial products

--Implementing a manufacturing information system

Head, Structural Biology and Drug Formulation (2008-2009) Archer Pharmaceuticals, Sarasota, FL (start-up corporation)

Duties

--Initiated drug formulation development, manufacture and analysis of immediate and modified release formulations of novel small molecule therapeutics

--Collaborated with Archer biologists to screen and validate novel drug compounds and targets

--Developed analytical methods for small molecule isolation and characterization for drug discovery

--Developed Quality Control methods required for drug substance and drug product release and stability

--Prepared Chemistry, Manufacturing and Controls sections for regulatory filings

Accomplishments

--Designed, set up and organized facilities for Manufacturing and Quality Control analysis of cGMP- compliant drug substances (Active Pharmaceutical Ingredients) and products

--Directed Formulation Development and Phase I Manufacture of Final Drug Products

--Established cGMP-compliant protocols for Manufacturing and analysis of drug substances and products

Scientist II (2009-2010 and 2005-2008) Roskamp Institute, Sarasota, FL (private research foundation)

Duties

--Designed and excecuted multiple lines of experimentation concerning Diabetes mellitus type 2

--Negotiated third party contracting for Quality Control testing of experimental therapeutic compounds

--Directed preliminary phases of a proteomics pipeline for biomarker identification and drug discovery for Alzheimer’s disease and drug addiction

--Designed pilot targeting studies of proteins for drug development through small molecule and macromolecular isolation and biochemical, bioinformatic, and structural characterization techniques

--Developed and validated novel in vitro assays for biochemical screening of therapeutic compounds

Accomplishments

--Established enrichment protocols for high through-put proteomics analysis

--Contributed to awarded grant and contract applications

--Isolated and chemically characterized several therapeutic compounds that were soon patented

Research Experience

Post-Doctoral Fellow (2000-2005) St. Jude Children’s Research Hospital, Memphis, TN

Duties

--Developed multidisciplinary projects dealing with novel antibiotic design and characterization of rheumatoid arthritis

--Cloned and mutated genes, expressed and purified proteins, crystallized them, and solved their three- dimensional molecular structures in apo form or bound to small molecule or peptide ligands

--Directed junior scientists in multiple research projects

Accomplishments

--Deduced the catalytic mechanism of an enzyme, leading to several improvements in antibiotic design

--Reconciled 10 years' disparate data in primary literature describing a root cause of rheumatoid arthritis

Graduate Teaching Assistant (PhD granted in 2000) University of Tennessee, Knoxville, TN

Duties

--Studied cellular organization, protein trafficking, and molecular chaperone function

--Developed quantitative catalytic, protein folding and binding assays

--Developed protein refolding techniques and chaperone-ligand affinity algorithms

--Taught almost every course the Biochemistry Department offered, both undergraduate and graduate

Accomplishments

--Cloned, expressed and purified many proteins, some of which were sold to commercial vendors

--Discovered commonality of molecular chaperone-binding sites in proteins' cellular targeting sequences

--Quantitatively described chemical affinities of peptides for transportation molecular motor machinery

Reseach and Development Associate (1989-1992) International Bio-Synthetics, Kingstree, SC (large manufacturer of industrial enzymes)

Duties

--Participated in design, construction, and operation of a pilot-scale, continuous yeast fermentation system

--Drafted full scale bioreactor plans (AutoCAD) and performed proof-of-principle design experiments

--Organized, processed, and analyzed large quantities of yeast fermentation data in longitudinal optimization studies

Accomplishments

--Developed manufacturing protocols which maximized ethanol yield and equipment performance

--Minimized operating costs while maintaining maximum yields in multi-grain fermentations

--Optimized and maintained multi-stage, continuous flow, multi-grain yeast fermentation systems

--Developed multi-variant approach to fermentation optimization for ethanol production

Education and Degrees

PhD Biochemistry (2000), University of Tennessee, Knoxville, “Characterization of Chloroplast Transit Peptides and the Major Stromal Hsp70, CSS1: Implications for an ATP-dependent Chloroplast Protein Import Molecular Motor”, advised by Dr. Barry D. Bruce

BS Biochemistry (1993) Clemson University, “Cosmid Library Screening for Regulatory Genes

Involved in Sulfur Metabolism”, advised by Dr. Jessup M. Shively

Inventor on Active, Company-Owned Patents

Pharmaceutical compositions for Reducing Amyloid Deposition, Amyloid Neurotoxicity, and Microgliosis, US Patent Application Number 201********, published in 2010.

Pharmaceutical compositions for reducing amyloid deposition, amyloid neurotoxicity, and microgliosis, US Patent Application Number 201********, published in 2010.

Method for Reducing Amyloid Deposition, Amyloid Neurotoxicity, and Microgliosis with (-)-Nilvadipine Enantiomer, US Patent Application Number 200********, published in 2009.

Publications

Rosloneic, Edward F.**, Ivey, Robert A.**, Whittington, Karen B., Kang, Andrew H., and Hee-Won Park. “Crystallographic structure of a rheumatoid arthritis MHC susceptibility allele, HLA-DR1 (DRB1*0101), complexed with the immunodominant determinant of human type II collagen” (2006). J Immunol, 177:6, 3884-3892. **First and second authors contributed equally to this work.

Virga, Kristopher G., Zhang, Yong-Mei, Leonardi, Roberta, Ivey, Robert A., Hevener, Kevin, Park, Hee-Won, Jackowski, Suzanne, Rock, Charles O. and Richard E. Lee. "Structure-activity relationships and enzyme inhibition of pantothenamide-type pantothenate kinase inhibitors" (2006). Bioorg Med Chem, 14:4, 1007-20.

Ivey, Robert A. , Zhang, Yong-Mei, Virga, Kristopher G., Hevener, K., Lee, Richard E., Rock, Charles O., Jackowski, S., and Hee-Won Park, “The structure of the pantothenate kinase-ADP-pantothenate ternary complex reveals the relationship between the binding sites for substrate, allosteric regulator, and antimetabolites” (2004). J Biol Chem, 279:34 , 356**-*****.

Kumaraguru, Uday, Gouffon, C.A., Ivey, Robert A., Rouse, Barry T., and Barry D. Bruce,“Antigenic peptides complexed to phylogenetically diverse hsp70s induce differential immune responses” (2003). Cell Stress Chap, 8:2, 134-143.

Subramanian, C., Ivey, Robert A., and Barry D. Bruce “Cytometric analysis of an epitope-tagged transit peptide bound to the chloroplast translocation apparatus.” (2001). Plant J, 25:3, 349-63.

Ivey, Robert A. , Subramanian, Chitra, and Barry D. Bruce “Identification of a Hsp70 interaction domain within the rubisco small subunit transit peptide” (2000). Plant Physiol, 122:4, 1289-1310.

Ivey, Robert A. and Barry D. Bruce “in vivo and in vitro interaction between DnaK and a chloroplast transit peptide”, (2000). Cell Stress Chap, 5:1, 62-71.

References

Dr. Michael Mullan, Chief Executive Officer

Archer Pharmaceuticals

2040 Whitfield Ave.

Sarasota, FL 34243

941-***-****

*******@************.***

Dr. Fiona Crawford, Chief Technical Officer

Archer Pharmaceuticals

2040 Whitfield Ave.

Sarasota, FL 34243

941-***-****