Project Manager Quality Control
Resume:
Robert A. Ivey, III, PhD
Home Address Contact Information
*** **** **** **** ***** Cell: 941-***-****
Tarpon Springs, FL 34688 Email: ********@*****.***
Summary
Goals oriented Project Manager. Experiences include managing fermentation production operations, pharmaceutical 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
Staff Scientist (2013-Present) James A. Haley VA Medical Center, Tampa, FL (government research facility)
Duties
--Continuation of diabetes research from Scientist II position (see below)
Accomplishments
--Elucidated molecular mechanisms for autoinhibition and activation of the central biomarker for metabolic syndrome and type 2 diabetes mellitus
--Generated viral and bacterial expression systems for multiple proteins involved in the laboratory’s research
--Updated and optimized the majority of the laboratory’s common techniques and protocols to increase efficiency and productivity
Director of Fermentation (2010-2013) Osprey Biotechnics, Sarasota, FL (small corporation, privately traded)
Duties
--Managed multiple fermentation and culture processing teams
--Upgraded equipment and modernized processes
--Established performance benchmarks for new products and contract manufacturing
--Directed laboratory and pilot-scale fermentation trials
--Served on company's Executive Committee
Accomplishments
--Developed investigational procedures that identified and isolated multiple instances of microbial and viral contamination in production scale fermentations
--Successfully responded to contamination threats to revive production of failing target strains
--Optimized growth and stabilization procedures of company's legacy strains to produce many record yields
--Characterized and scaled up several novel microbial culture products
--Elevated quality and increased productivity of manufacturing personnel and equipment
--Overhauled Standard Operating Procedures and Manufacturing Procedures
--Improved growth and recovery yields of customers' proprietary products
Head, Structural Biology and Drug Formulation (2008-2009) Archer Pharmaceuticals, Sarasota, FL (private start-up corporation)
Duties
--Managed junior R&D and drug manufacturing staff
--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, organized and maintained 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 (non-profit research foundation)
Duties
--Designed and executed multiple lines of experimentation exploring 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 multiple therapeutic compounds that were soon patented
Academic 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
--Optimized and maintained multi-stage, continuous flow, multi-grain yeast fermentation systems
--Developed multi-variant approach to statistics-based fermentation optimization for ethanol production
Education
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.
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
Sajan, Mini P., Hansen, Barbara C., Ivey, Robert A., Sajan, Joshua P., Ari, C., Braun, Ursula, Song, Shijie, Leitges, Michael, Farese-Higgs, M.G. and Robert V. Farese. “Brain Insulin Signaling is Increased in Insulin-Resistant States and Decreases in FoxOs and PGC-1α and Increases in Aβ1-40.42 and Phospho-Tau May Abet Alzheimer Development” (2016). Diabetes [Epub ahead of print].
Sajan, Mini P., Ivey, Robert A., and Robert V. Farese. “BMI-related progression of atypical PKC-dependent abberrations in insulin signaling through IRS-1, Akt, FoXO1 and PGC-1a in livers of obese and type 2 diabetic humans” (2015). Metabolism 64:1454-65.
Sajan, Mini P., Ivey, Robert A., Lee, McKenzie, and Robert V. Farese. “Hepatic insulin resistance in ob/ob mice involves increases in ceramide, aPKC activity, and selective impairment of Akt-dependent FoXO1 Phosphorylation” (2015). J Lipid Res 56:70-80.
Ivey, Robert A., Sajan, Mini P., and Robert V. Farese. “Requirements for pseudosubsrate arginine residues during autoinhibition and phosphatidylinositol 3,4,5-(PO4)3-dependent activation of atypical PKC” (2014). J Biol Chem 289: 25021-30.
Sajan, Mini P., Ivey, Robert A., Lee, McKenzie, Mastorides, Steven, Jurczak, Michael, Samuel, Varman T., Shulman, Gerald I., Braun, Ursula, Leitges, Michael, and Robert V. Farese. “PCK haploinsuffiency prevents diabetes by a mechanism involving alterations in hepatic enzymes” (2014). Mol Endocrinol, 28:1097-107.
Sajan, Mini P., Acevedo-Duncan, Mildred E., Standaert, Mary L., Ivey, Robert A., Lee, McKenzie, and Robert V. Farese. “Akt-dependent phosphorylation of hepatic FoXO1 is compartmentalized on a WD40/ProF scaffold and is selectively inhibited by aPKC in early phases of diet-induced obesity” (2014). Diabetes, 63:2690-701.
Sajan, Mini P., Ivey, Robert A., and Robert V. Farese. “Metformin action in human hepatocytes: coactivation of atypical protein kinase C alters 5’-AMP-activated protein kinase effects of lipogenic and gluconeogenic enzyme expression” (2013). Diabetologia, 56:2507-16.
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, 3884-92. **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, 35622-9.
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, 134-43.
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, 1289-310.
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. Christopher Reuter, Vice President of Science
Osprey Biotechnics
1833-A 57th St.
Sarasota, FL 34243
*******@*****************.***
Dr. Michael Mullan, Chairman of the Board and CEO
Rockcreek Pharmaceuticals, Inc.
2040 Whitfield Ave.
Suite 300
Sarasota, FL 34243
*******@************************.***
Dr. Fiona Crawford, President and CEO
Roskamp Institute
2040 Whitfield Ave.
Sarasota, FL 34243
*********@****.***
Dr. Hee-Won Park, Associate Professor
Structural Genomics Consortium
University of Toronto
MARS South Tower, 7th Floor, Rm 737
101 College St.
Toronto, ON M5G 1L5
******.****@********.**
Contact this candidate