Coldstream Laboratories, Inc.
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Coldstream Laboratories, Inc. Employees
Coldstream Laboratories, Inc. January 2015 - Present
Piramal Enterprises Limited July 2013 - January 2015
KPMG India October 2011 - July 2013
KPMG India November 2009 - September 2011
Articleship Experience June 2006 - July 2009
Skills
Strategic Financial..., Management Accounting, Business Planning, Variance Analysis, Working Capital..., Forecasting, IFRS, Contractual Agreements, Auditing, Internal Audit, Accounting, Financial Accounting, External Audit, Financial Reporting, Financial Analysis, Income Tax, Consolidation, Management, MIS, Consolidated Financial..., Management reporting, Statutory Accounting, Internal Controls, Statutory Audit, Finance, GAAP, Assurance, FPA, Budgets, Cash Flow, Analysis, Managerial Finance, Contract Negotiation, Financial Modeling, Due Diligence, Financial Statements, Corporate Finance, Team Management, Financial Planning, Budgeting, Strategy, Business Strategy, Business Analysis, Leadership, Hyperion
Education
The Chartered Institute of Management Accountants 2011 — 2013
Chartered Global Management Accountant, Management Accounting
The Institute of Chartered Accountants of India 2006 — 2009
Chartered Accountant, Management Accounting, Costing, Finance, Accounts, Taxation and Law
ACCA 2010 — 2010
Diploma in International Financial Reporting, ACCA UK, IFRS, First Class
Institute of Company Secretaries of India 2006 — 2009
Company Secretary, Corporate, Finance, and Securities Law
University of Mumbai 2003 — 2006
Bachelor of Commerce (B.Com.), Costing, Management and Financial Accounting, First Class
SES
Catalent Pharma Solutions August 2012 - Present
Novel Laboratories, Inc. December 2010 - September 2011
Coldstream Laboratories, Inc. March 2010 - July 2010
City of Troy Waste water treatment plant January 2009 - May 2009
Elysium Pharmaceutical Ltd January 2005 - December 2006
Choksi Laboratories Inc January 2004 - January 2005
Skills
Dissolution, Wet Chemistry, GLP, HPLC, UV/Vis, GMP, Validation, V&V, Sop, Chromatography, CAPA, Technology Transfer, Pharmaceutical Industry, Chemistry, USP, Cleaning Validation, UV, R&D, 21 CFR Part 11, Analytical Chemistry, Viscosity, TLC, Titration, Method Transfer, ANDA, Stability Studies, Method Development, IR, Karl Fisher, Raw Materials, Change Control, Analytical Method..., FDA, Empower, pH meter, Column Chromatography, TOC, IR spectroscopy, FTIR, Viscometry, Particle Size Analysis, Spectrophotometry, Ion Chromatography, Sample Preparation, Atomic Absorption, Gas Chromatography, ICH guidelines, Quality Control, ICH Guidelines, SOP
Education
Troy University 2007 — 2009
MS, Environmental and Biological Science
M.S.University of Baroda 2001 — 2003
MS, Inorganic and Analytical Chemistry
M.S.University of Baroda 1998 — 2001
BS, Chemistry
Coldstream Laboratories, Inc. April 2015 - Present
Johnson & Johnson November 2013 - March 2015
Amgen February 2013 - October 2013
Abbott Vascular October 2011 - October 2012
Alacer August 2009 - July 2011
Skills
Biacore, Membrane Proteins, Analytical..., Isothermal Titration..., Protein Crystallization, Glycobiology, Protein Chromatography, Hydrophobic Interaction..., Protein Structure, Analytical Biochemistry, Protein Kinases, Directed Evolution, Process Validation, IQ/OQ/PQ, Annual Drug Product..., SOP Authoring, Training, Forklift Operation, Document Review, FDA GMP, ICP-AES, Validation, GMP, Quality Assurance, Laboratory, Documentation, Deviations, CAPA, Lead Qualification, Regulatory Compliance, Engineering Change..., Change Control Board, Impact Assessment, Process Design, Trend Analysis, Metric Development, Process Improvement, FDA
Education
University of California, Riverside 2004 — 2008
Bachelor's Degree, Biochemistry, 3.7
LGC (Previously HFL Sport Science) August 2014 - Present
Fouser Environmental Services June 2012 - August 2014
Coldstream Laboratories, Inc. February 2011 - May 2012
Murty Pharmaceuticals, Inc. May 2009 - February 2011
Skills
GMP, GLP, Analytical Chemistry, Sop, LIMS, FDA, Microbiology, SOP development, Pharmaceutical..., Validation, SOP authoring, Biotechnology, CAPA, Wet Chemistry, HPLC, Laboratory, Pharmaceutical Industry, Quality Control, Chemistry, Chromatography, Quality System, UV/Vis, SOP
Education
Kentucky State University 2014 — 2016
Master of Science (M.S.), Environmental Studies
University of Kentucky 2003 — 2008
Bachelor of Science (BS), Plant Sciences
Baxter International Inc. June 2015 - Present
Cambridge Major Laboratories, Inc. October 2014 - June 2015
Coldstream Laboratories, Inc. April 2012 - February 2014
Coldstream Laboratories, Inc. October 2011 - April 2012
Schwarz Pharma Mfg, Inc May 2010 - August 2010
Skills
GMP, FDA, Aseptic Processing, CAPA, Process Simulation, HPLC, Manufacturing, Quality Control, Validation, Technology Transfer, Process Engineering, SOP, Pharmaceutical Industry, Change Control, Biotechnology, R&D, 21 CFR Part 11, Quality System, V&V, Formulation, GLP
Education
University of Louisville 2006 — 2011
BS, Chemical Engineering
SynergyBridge, LLC May 2010 - Present
MedTouch January 2014 - Present
Scoppechio (Formerly Creative Alliance) October 2011 - October 2014
Coldstream Laboratories, Inc. April 2011 - October 2011
Symbiotix, Inc November 2004 - April 2010
National Healing Corporation 2010 - 2010
Kentucky STRIDE January 2003 - November 2004
Skills
Marketing Communications, Digital Marketing, Pharmaceutical Industry, Project Management, Marketing Strategy, Microsoft Office, Social Media Marketing, Digital Strategy, Marketing, Event Planning, Graphic Design, Integrated Marketing, Strategy, Email Marketing, Advertising, Copywriting, Brand Development, Direct Marketing, Interactive Marketing, SEO, Social Media, Online Marketing, Strategic Planning, Account Management, Mobile Marketing, SEM, Brand Management, Corporate Communications, Marketing Management, Web Analytics, Blogging, New Business Development, Content Strategy, Editing, E-commerce, Lead Generation, Online Advertising, Media Planning, Digital Media, Event Management
Education
Eastern Kentucky University
BS
Coldstream Laboratories, Inc. February 2014 - Present
Catalent Pharma Solutions May 2013 - February 2014
Beam September 2012 - May 2013
MediVet America, LLC 2010 - September 2012
Woodford Equine Hospital December 2009 - August 2010
Hagyard Equine Medical Institute January 2006 - December 2009
Advanced Spectroscopy Research Group (Now Spherix, Inc) October 2002 - December 2005
Skills
Microbiology, ELISA, DNA extraction, Cell Culture, Biochemistry, Chromatography, Purification, Western Blotting, Validation, HPLC, Aseptic Technique, Assay Development, Flow Cytometry, Gas Chromatography, GMP, UV/Vis
Education
University of Kentucky
Bachelor's degree, Biotechnology
Regeneron Pharmaceuticals, Inc. March 2015 - Present
Coldstream Laboratories, Inc. December 2014 - Present
Lonza: A Global Leader In Life Sciences May 2014 - November 2014
Shire Pharmaceuticals July 2013 - December 2013
Teva December 2012 - January 2013
Pfizer June 2011 - October 2012
Prosoco April 2008 - June 2009
Diggs Electric June 2006 - January 2008
Washington Community Trade and Economic Development May 2005 - September 2005
TVW and Washington State House January 2005 - May 2005
Skills
Technical Writing, Visio, SharePoint, SnagIt, Adobe Acrobat, Access, Technical Documentation, Troubleshooting, Project Management, Technical Communication, Manuals, Windows, Software Documentation, OS X, Adobe CS6, MS Office, Quality Assurance, Root Cause Analysis, Serif PagePlus, AutoDesk, Document Management, Microsoft Office
Education
Southern New Hampshire University
Master's Degree, Operations Management, In Process
Southern New Hampshire University
MBA, Finance
Eastern Oregon University
Bachelor of Science, Philosophy and Economics
Coldstream Laboratories, Inc. January 2012 - Present
Reliv International June 2008 - October 2011
KV Pharmaceutical September 2006 - June 2008
Mallinckrodt Pharmaceuticals April 2005 - September 2006
AFB International November 1999 - October 2004
Meridian Medical Technologies January 1993 - November 1999
Skills
QAQC, Quality Assurance, Quality System, Quality Control, Quality Auditing, Quality Management, Process Improvement, Process Simulation, Process Control, Internal Audit, External Audit, Aseptic Processing, Aseptic Technique, Employee Training, Technical Training, Laboratory Skills, Laboratory Safety, Laboratory Equipment, Document Management, Technical Documentation, Document Review, Internal Investigations, Failure Analysis, Pharmaceutical Packaging, Cleaning Validation, Instrument Validation, Staff Development, Pharmaceutical Industry, Pharmaceutics, FDA, FDA GMP, GMP, Biotechnology, Biopharmaceuticals, Technology Transfer, Contamination Control, Sterilization, Sterility Assurance
Education
Southern Illinois University, Edwardsville
B.S, Biology/ Chemistry
Appriss April 2015 - Present
Coldstream Laboratories, Inc. October 2006 - April 2015
Hilliard Lyons 1999 - 2000
Skills
Pharmaceutical Industry, Business Development, Product Development, Cross-functional Team..., Medical Devices, GMP, FDA, Biotechnology, Commercialization, Leadership
Education
Patterson School of Diplomacy and International Commerce--University of Kentucky 2003 — 2005
Master of Arts, International Commerce
University of Kentucky 2000 — 2003
Bachelor of Arts, International Economics, Spanish, Latin American Studies
Coldstream Laboratories, Inc. 2015 - Present
Mallinckrodt/Covidien November 2012 - Present
Alkermes, Inc. November 2011 - November 2012
APTALIS PHARMA (Formerly Eurand) November 2009 - November 2011
Xanodyne Pharmaceuticals July 2006 - November 2009
IPC, Cardinal Health April 1996 - July 2006
(CPST) Center for Pharmaceutical Science and Technology 1993 - 1996
ZeaGen (Coors BioTech) October 1988 - November 1993
Skills
GMP, CAPA, FDA, Validation, Pharmaceutical Industry, Sop, Regulatory Affairs, Change Control, Technology Transfer, Quality System, V&V, Aseptic Processing, Trackwise, 21 CFR Part 11, GxP, Quality Assurance, Clinical Trials, Drug Development, Quality Control, LIMS, Biopharmaceuticals, Cleaning Validation, GLP, Computer System..., Pharmaceutics, Quality Auditing, Biotechnology, cGMP practices, Regulatory Requirements, Medical Devices, Quality Management
Education
Eastern Kentucky University 1983 — 1987
Bachelors, Chemistry
Bluegrass Advanced Materials, LLC 2014 - 2014
Coldstream Laboratories, Inc. June 2011 - July 2011
Skills
Human Resources, Manufacturing, Microsoft Office, Microsoft Excel, Research, PowerPoint, Public Speaking
Education
Eastern Kentucky University 2013 — 2015
B.S. Geology
Marietta College 2010 — 2013
Petroleum Engineering, Oil and Gas, Junior
ITW Powertrain Fastening January 2013 - Present
Hitachi Automotive Systems Americas, Inc. February 2012 - January 2013
LeTourneau University August 2006 - December 2011
Coldstream Laboratories, Inc. June 2009 - May 2010
White Oak Radiator Service Inc. May 2007 - August 2008
Skills
Portuguese, English, Solidworks, AutoCAD, Matlab, Machining, Lathe, Millwork, Welding, Soldering, Six Sigma, Microsoft Office 2007, Excel, Word, PowerPoint, MS Project, C++, Java, Power Tools, Instrumentation, Instructional Technology, Teamwork, TS16949, PFMEA, Process Improvement, Project Engineering, Engineering, Finite Element Analysis, SolidWorks
Education
LeTourneau University 2006 — 2011
Bachelor of Science, Engineering, mechanical concentration
LeTourneau University 2006 — 2011
B.S, Engineering (Mechanical)
Proove Biosciences, Inc. July 2014 - Present
Coldstream Laboratories, Inc. 2012 - 2013
Toyota Motor Manufacturing of Kentucky October 2011 - September 2012
Skills
cGMP practices, cGMP manufacturing, GMP Documentation, Pharmaceutical..., Automotive Manufacturing, Quality Assurance, Inspection, Aseptic Technique, Incubators, Biotechnology Industry, Kaizen, Autoclave, Lyophilization
Education
Medtech College-Lexington Campus 2010 — 2011
Associate of Science (A.S.), Biotechnology
Coldstream Laboratories, Inc. February 2015 - Present
Coldstream Laboratories, Inc. February 2014 - February 2015
Coldstream Laboratories, Inc. August 2013 - February 2014
Coldstream Laboratories, Inc. January 2012 - August 2013
Hobby Lobby June 2009 - December 2011
JCPenney May 2007 - December 2011
Hobby Lobby May 2008 - September 2008
Skills
Microsoft Office, PowerPoint, HTML, Java, Microsoft Excel, Data Entry, Customer Service, Retail, Microsoft Word, Access, Windows 8, Windows 7, Ubuntu, Microsoft Server 2008 R2, Apache 2, Android, Spiceworks, IIS, SQL, POS, Active Directory, Visual Basic, BASIC, Database Design, Fedora, Macromedia Fireworks MX, GIMP, PLC Ladder Logic, RSLogix 500, Outlook, Microsoft Exchange, LabTech, ShoreTel ShoreWare..., Meraki, Windows, Data Analysis, Programming, Technical Writing, MySQL, Quality Assurance, Servers, Technical Support, Pharmaceutical Industry, Hardware, Information Technology, Help Desk Support, Network Administration, GMP, Troubleshooting
Education
Eastern Kentucky University 2008 — 2013
Bachelor of Science (B.S.), Computer Science
Coldstream Laboratories, Inc. January 2014 - Present
Nestlé S.A. January 2005 - January 2014
Nestlé USA April 2001 - January 2014
Nestlé S.A. January 2001 - January 2005
ACS January 2000 - January 2001
ACS January 2000 - January 2001
Dairy Queen January 1992 - January 1995
Dairy Queen January 1992 - January 1995
Skills
HACCP, Food Safety, Food Microbiology, Environmental..., Analytical Techniques, Laboratory Analysis, Laboratory Techniques, Leadership Development, Laboratory, Quality Assurance, Microbiology, Food Manufacturing, Food, GLP, GMP, Quality System, Sop, Food Science, SOP, Food Processing
Education
Eastern Kentucky University 1996 — 2000
Bachelor of Science (B.S.), Forensic Science
Eastern Kentucky University
B.S, Forensic Science; Biology
University of Kentucky August 2014 - Present
Coldstream Laboratories, Inc. May 2014 - July 2014
University of Kentucky June 2013 - March 2014
Skills
Lyophilization, Solid State..., solid-state NMR, DSC, FDM, UV/Vis, HPLC, GMP, Pharmaceutics, Chemical Engineering, Leadership, TLC, Column Chromatography, Matlab, Microsoft Excel, Aspen Plus, R&D
Education
University of Kentucky 2014 — 2018
Graduate Student, Pharmaceutical Sciences
University of Kentucky 2010 — 2014
Bachelor of Science (BS), Chemical Engineering
Catalent Pharma Solutions May 2013 - Present
Coldstream Laboratories, Inc. July 2011 - May 2013
AMRI February 2008 - July 2011
AMRI August 2001 - February 2008
Bristol-Myers Squibb June 1992 - October 1992
Skills
GMP, Technology Transfer, Chemical Processing, Analytical Skills, Validation, Design of Experiments, Procurement, Quality Assurance, Sterile Injectables, API manufacturing, Project Management, FDA, Change Control, Drug Discovery, Chemistry, HPLC, Laboratory, Regulatory Submissions, R&D, Pharmaceutics, Pharmaceutical Industry
Education
University of Illinois at Urbana-Champaign 1998 — 2001
Post Doctoral Research, Organic Chemistry
Trinity College, Dublin 1993 — 1998
PhD, Organic Chemistry
University College Dublin 1989 — 1993
BSc, Chemistry and Math
Numerous LEAN, cGMP, and Continuous Improvement training sessions
“CAP: Change Acceleration Process”
“Chemical Development and Scale-up in the Fine Chemical Industry, Principles and Practices”
“Cornell Project Management Program”
“Leadership Skills Training”
“Practical Process Research and Scale-up”
“Short course on Heterocyclic Chemistry”
Nektar Therapeutics January 2012 - Present
Aptalis Pharma (formerly Eurand) December 2008 - February 2012
Coldstream Laboratories, Inc. 2008 - 2008
Camargo Pharmaceutical Services 2004 - 2007
Boehringer Ingelheim Roxane Laboratories September 1999 - April 2004
Southwestern Company April 1994 - September 1995
Skills
CMC, Pharmaceutical..., NDA, Regulatory Documentation, Regulatory Affairs, eCTD, IND, ANDA, SPL, GMP, FDA, DMF, MAA, CTA, GCP, Clinical Trials, EMA, OTC, Auditing, CMO, CRO, Product Development, Biotechnology, Regulatory Submissions, Drug Development, Pharmaceutical Industry, Sop, GxP, Change Control, GLP, 21 CFR Part 11, SOP
Education
The Ohio State University 1994 — 1998
B.S., Biology
Purdue University 1992 — 1994
Coldstream Laboratories, Inc. April 2015 - Present
CTI Foods December 2014 - April 2015
Avantor Performance Materials, Inc. August 2008 - November 2014
Summit Biosciences Inc. May 2008 - January 2013
Intranasal Therapeutics Inc April 2006 - May 2008
Kentucky Department for Public Health June 1998 - March 2006
Skills
Analytical Chemistry, FDA, GMP, Sop, Validation, GLP, Geology, Microbiology, Quality Control, LIMS, Technology Transfer, SOP
Education
Morehead State University 1993 — 1997
BS, Biology
Coldstream Laboratories, Inc. December 2014 - Present
University of Kentucky September 2012 - December 2014
Lowe's Companies, Inc. March 2013 - October 2013
The Ohio State University September 2011 - June 2012
The Ohio State University 2011 - 2012
Northern Westchester Hospital 2008 - 2011
Skills
Eagle Scout, Polymers, Drug Delivery, Research, Biotechnology, Lifesciences, C++, Matlab, Microsoft Office, Engineering, Testing, Medical Devices, Biomedical Engineering
Education
University of Kentucky 2012 — 2014
Master of Science (M.S.), Biomedical/Medical Engineering
The Ohio State University 2009 — 2012
Bachelor of Science (BS), Biomedical/Medical Engineering
The Ohio State University 2009 — 2012
Minor, Business Administration and Management, General
Whitaker Bank July 2014 - Present
Transylvania University August 2013 - May 2014
Coldstream Laboratories, Inc. June 2013 - August 2013
Idle Hour Country Club April 2011 - October 2012
Skills
Biology, Molecular Biology, Research, PCR
Education
Transylvania University 2010 — 2014
Bachelor of Arts (B.A.), Biology, General
BPPR July 2015 - Present
Banco Popular de Puerto Rico August 2014 - Present
Eli Lilly and Company June 2013 - August 2014
Banco Popular de Puerto Rico August 2012 - June 2013
Coldstream Laboratories, Inc. January 2012 - June 2012
Skills
DMAIC, Microsoft Office, Root Cause Analysis, Six Sigma, FMEA, Continuous Improvement, Process Improvement, Facilities Engineering, Statistical Data..., Minitab, Quality Control, Time Study, Iso 9000, Engineering, Training
Education
Universidad Politécnica de Puerto Rico 2009 — 2013
Bachelor of Science (BS), Industrial Engineering
UPR Mayaguez 2005 — 2009
World Help November 2013 - Present
Bethesda Homes August 2013 - Present
Freelance / Graphic Design Services 2010 - Present
Deer Park Alliance Church 2012 - Present
Coldstream Laboratories, Inc. 2013 - May 2013
Triple D Bending 2012 - 2013
Bridgewater Bank September 2012 - December 2012
Robert Half International 2008 - 2012
International Development Bank 2011 - 2011
SMART Technologies 2011 - 2011
Skills
Graphics Layout, Digital Illustration, Graphic Design, Visual Communication, Adobe Creative Suite, InDesign, Illustrator, Photoshop, Muse, Dreamweaver, Fontographer, Cinema 4D, Graphic Arts, Layout, Magazine Layout Design, Illustration, Vector Illustration, Digital Photography, Photography, Visual Arts, Adobe Design Programs, Art Direction, Microsoft Office, PowerPoint, Microsoft Publisher, Microsoft Word, Microsoft Excel, Access, Adobe Bridge, Logo Design, Corporate Identity, Typography, Art, Advertising, Mac, Editing
Education
Liberty University 2009 — 2013
Bachelor of Science (B.S.), in Visual Communication Arts with a specialization in Graphic Design
Liberty University 2009 — 2013
Minor in Studio Art, Visual Communication Arts: Graphic Design
Avid Bioservices, Inc. January 2012 - Present
Spectrum Pharmaceuticals, Inc. Irvine, CA November 2009 - May 2010
Coldstream Laboratories, Inc. May 2006 - November 2009
University of Iowa 2001 - 2006
Education
University of Iowa 2001 — 2006
PhD, Chemistry
Tianjin Polytechnic University
Metrics, Inc. January 2013 - Present
Catalent Pharma Solutions August 2011 - January 2013
Summit Biosciences Inc. May 2010 - August 2011
Coldstream Laboratories, Inc. January 2008 - December 2009
Skills
HPLC, Analytical Chemistry, Formulation, UV/Vis, GMP, Chromatography, Pharmaceutical Industry, Pharmaceutical Research, Lyophilization, Peptide Synthesis, Controlled Release, Analytical R&D, R&D, Technology Transfer, Nasal Formulation, Liquids, Sarcasm
Education
University of Kentucky 2001 — 2011
Ph.D., Pharmaceutical Sciences
Asbury College 1994 — 1999
B.A, Biology and Chemistry
Coldstream Laboratories, Inc. November 2013 - Present
Mineral Labs, Inc. September 2012 - October 2013
Skills
Cell Culture, Molecular Biology, PCR, Aseptic Technique, Microscopy, ELISA, Western Blotting, ICP, Water Quality, Conductivity, Tissue Culture, GMP, Sop, GLP, Gas Chromatography, LIMS, SOP, Aseptic Processing, Quality Assurance, Laboratory, FDA, Pharmaceutical Industry, Biotechnology
Education
Morehead State University 2008 — 2012
Bachelor of Science (B.S.), Biology
Magoffin County High School 2004 — 2008
Commonwealth Diploma
Maratono November 2006 - Present
Coldstream Laboratories, Inc. August 2010 - September 2012
San Carlos Properties May 2003 - July 2007
Strategic Business Insights June 2004 - November 2006
dLoo February 2000 - February 2002
ZAP Electric Vehicles July 1995 - August 1999
AS Graphics & Publications July 1997 - June 1998
ASUCD July 1996 - June 1997
Education
INSEAD 2008 — 2008
MBA
University of California, Los Angeles 2012 — 2014
Certificate with Distinction
The Chinese University of Hong Kong 2013 — 2013
Certificate with Merit
University of California, Davis 1994 — 1999
B.S. & B.A.
Piramal Enterprises Limited / CLI May 2015 - Present
Coldstream Laboratories, Inc. January 2013 - May 2015
CSL Behring October 2009 - January 2013
Starbucks Coffee Company October 1999 - April 2012
Empire Today October 2006 - February 2009
Abraxis BioScience January 2005 - October 2006
Abraxis Oncology July 2003 - January 2005
Skills
GMP, Management, Quality Assurance, Training, Project Management, Team Leadership, Team Building, Budgets, Access, Cross-functional Team..., Microsoft Excel, Vendor Management, CAPA, Inventory Management, Leadership, Manufacturing, Process Improvement, Root Cause Analysis, Software Documentation, Troubleshooting, V&V, FDA, Aseptic Processing, Technology Transfer, Validation, Continuous Improvement, Operations Management, Quality Control, Technical Writing, Aseptic Technique, Pharmaceutical Industry, Quality Auditing, LIMS, Customer Service, Biotechnology, SOP development, Interviews, Regulatory Affairs, Coaching, Retail, 21 CFR Part 11, Sales, Forecasting, Laboratory, Six Sigma, Change Control, GLP, Quality System, SOP, Microsoft Office
Education
Northern Illinois University 1994 — 1999
BS & BA, Biological Sciences & Spanish Language & Lit
ASQ
Certified Quality Auditor
Therapeutic Proteins International, LLC September 2014 - Present
Pharmaceuticals in Chicago September 2012 - July 2014
Coldstream Laboratories, Inc. June 2011 - September 2012
Pfizer June 2010 - June 2011
Baxter Healthcare September 2009 - April 2010
Eli Lilly July 2004 - June 2009
Eli Lilly July 1994 - June 2009
Fujisawa August 1993 - April 1994
Skills
Methods Development, HPLC, Method Validation, LC-MS, Gas Chromatography, IR, Analytical Skills, Analytical Chemistry, UV, Wet Chemistry, Method Development, Chemistry, Laboratory, Chemstation, Chromatography, Dissolution, GLP, Empower, EZ Chrom, particulate matter, Project Management, Project Coordination, V&V, Validation, Analytical Techniques, Pharmaceutical Industry, Technology Transfer, Biotechnology, FDA, USP, R&D, Quality Control, Quality System, Pharmaceutics, GMP, SOP, Quality Assurance, Drug Development, CAPA, UV/Vis, Life Sciences, Change Control, 21 CFR Part 11, Biopharmaceuticals
Education
Northeastern Illinois University 1992 — 1994
MS, Analytical Chemistry
Aligarh Muslim University 1984 — 1986
M.Sc, Chemistry
Osmania University 1981 — 1984
B.Sc, Chemistry, Physics, Biology
Highlands Diversified Services March 2015 - Present
Jones Plastic and Engineering October 2014 - March 2015
Highlands Diversified Services April 2013 - October 2014
Covidien October 2012 - April 2013
Coldstream Laboratories, Inc. July 2010 - September 2012
Coldstream Laboratories, Inc September 2008 - July 2010
JaVi Publishing June 2005 - September 2008
Skills
Medical Writing, Technical Writing, Finished Product Labels, Document Control, GMP, Document Management, Finished Goods, Sop, Microsoft Office, Adobe Acrobat, CAPA, FDA, Validation, Manufacturing, HPLC, Biotechnology, Technology Transfer, Pharmaceutical Industry, Change Control, Quality Control, Software Documentation, 21 CFR Part 11, SOP, Quality Assurance, Quality System, Continuous Improvement, Quality Auditing, SOP Development, Regulatory Affairs, Process Simulation
Education
Eastern Kentucky University
B.A. in English, Technical Writing
CreoSalus January 2012 - Present
Summit Biosciences Inc. 2010 - August 2011
Coldstream Laboratories, Inc. December 2008 - July 2009
Coldstream Laboratories, Inc May 2007 - November 2008
University of Kentucky, College of Pharmacy December 2004 - June 2005
Patheon Pharmaceuticals Inc, Cincinnati, OH 01/03-06/04 June 1996 - June 2004
Patheon 2003 - 2004
Aventis 2000 - 2003
Hoechst Marion Roussel Inc June 1988 - June 1996
Marion Merrell Dow 1992 - 1995
Skills
GMP, Chromatography, Quality Assurance, Materials Management, Mass Spectrometry, Specifications, Research, Validation, Quality Control, Protocol, Analytical Chemistry, Project Management
Education
Northern Kentucky University 1984 — 1988
B.S., Chemistry
ABC Laboratories June 2013 - Present
Coldstream Laboratories, Inc. September 2011 - June 2013
Aptuit January 2001 - June 2011
Quintiles 2001 - 2005
Quintiles 2001 - 2005
Quintiles 2001 - 2005
Quintiles 2001 - 2005
Quintiles August 1992 - January 2001
Midwest Research Institute June 1992 - July 1992
Skills
GMP, Validation, Pharmaceutical Industry, Change Control, FDA, Sop, GLP, Clinical Development, CRO, Technology Transfer, Clinical Research, Biopharmaceuticals, R&D, Drug Development, Biotechnology, 21 CFR Part 11, Formulation, Lifesciences, Quality Control, Aseptic Processing, LIMS, CAPA, Cross-functional Team..., Regulatory Affairs, GxP, Clinical Trials, GCP, Analytical Chemistry, V&V, Cell Culture, IND, Regulatory Submissions, Life Sciences
Education
Maple Woods Community College
AS, Animal Science, Veterinary Technology
MidAmerica Nazarene University
Mgmt./Human Relations, Management and Human Relations
Washington High School, KCK
Aerpio Therapeutics September 2014 - Present
Oxygen Biotherapeutics July 2011 - September 2014
Oxygen Biotherapeutics January 2011 - June 2011
Sandoz January 2010 - November 2010
Sandoz November 2007 - December 2009
Trimeris September 2004 - November 2007
Wyeth Consumer Healthcare August 2002 - September 2004
Coldstream Laboratories, Inc. August 1998 - August 2002
Fresenius Kabi May 1999 - August 1999
Skills
Formulation, Biotechnology, Drug Delivery, R&D, Pharmaceutics, Product Development, Technology Transfer, Clinical Development, Innovation Management, GMP, ANDA, IND, IMPD, Process Optimization, Clinical Trial Material, Project Management, Scale-up, Due Diligence, Vendor Management, Biopharmaceuticals, Validation
Education
North Carolina State University - College of Management 2008 — 2010
MBA, BioSciences Management and Financial Management
University of Kentucky College of Pharmacy 1999 — 2002
PhD, Pharmaceutical Sciences
University of Kentucky College of Pharmacy 1998 — 1999
MS, Pharmaceutical Sciences
University of Kentucky College of Engineering 1993 — 1998
BS, Chemical Engineering
The nearest golf course! Program Manager
Webasto Roof Systems October 2010 - March 2012
Coldstream Laboratories, Inc. April 2009 - October 2010
International Profit Associates March 2008 - April 2009
Highlands Diversified Services March 2006 - February 2008
Ford Motor Company January 2000 - January 2006
Highlands Diversified Services March 1997 - October 1999
Bailey Corporation March 1995 - October 1996
TI Automotive August 1985 - March 1995
Education
Northern Michigan University 1969 — 1973
BS, Physical Education
Northern Michigan University 1969 — 1973
Midland High School 1967 — 1969
Westfield High School 1966 — 1967
Coldstream Laboratories, Inc. August 2011 - Present
Stericycle October 2010 - August 2011
Oso BioPharmaceuticals Manufacturing, LLC March 2008 - August 2009
Oso BioPharmaceuticals Manufacturing, LLC January 2007 - August 2009
Catalent Pharma Solutions July 2005 - January 2007
Cardinal Health , Specialty Pharmaceutical Distribution July 2004 - July 2005
Wyeth Pharmaceuticals September 2003 - July 2005
Caguas Mechanical Contractor, Inc. January 2001 - January 2002
Intel January 1995 - January 2001
Skills
Lean Si, Lean Manufacturing, Six Sigma, FMEA, Validation, Troubleshooting, FDA, GMP, Aseptic Processing, 21 CFR Part 11, CAPA, Calibration, Engineering, Manufacturing, Pharmaceutical Industry, Process Improvement, Quality System, Sterilization, Software Documentation
Education
Universidad Politécnica de Puerto Rico 1995 — 2003
BSME, Mechanical Engineering
Polytechnic University of Puerto Rico
Bachelor of Science, Mechanical Engineering
Catalent Pharma Solutions July 2015 - Present
Coldstream Laboratories, Inc. September 2014 - May 2015
University of Kentucky August 2014 - December 2014
Coldstream Laboratories, Inc. May 2014 - August 2014
Josie's August 2013 - May 2014
Texas State University May 2013 - August 2013
Catalent Pharma Solutions December 2012 - May 2013
Toyota May 2012 - August 2012
O'Charley's September 2011 - May 2012
Skills
Chemical Engineering, Process Simulation, Chemistry, Laboratory, Engineering, Pharmaceutical Industry, Microbiology, Research, Biopharmaceuticals, Characterization, Design of Experiments, Materials Science, UV/Vis, Data Analysis
Education
University of Kentucky 2010 — 2015
Bachelor of Science (BS), Chemical Engineering, 3.8 GPA
Patheon May 2015 - Present
Coldstream Laboratories, Inc. August 2013 - May 2015
WILD Flavors, Inc. September 2007 - August 2013
Skills
Ingredients, Food Science, Food Industry, Flavors, Food Processing, Food Technology, GMP, HACCP, Cross-functional Team...
Education
Spring Hill College 2003 — 2007
Bachelor of Science, Biology
Piramal Enterprises Limited January 2015 - Present
Coldstream Laboratories, Inc. August 2010 - January 2015
Johnson Matthey Pharma Services February 2009 - August 2010
AMRI October 2007 - January 2009
Albany Molecular Research, Inc. and Organichem August 2004 - September 2007
Albany Molecular Research, Inc. June 2000 - October 2004
Skills
Pharmaceutical..., New Business Development, Business Management, Business Planning, Organic Synthesis, Process Development, Manufacturing, Technical Leadership, Process Simulation, Project Management, Scale Up, Generic Drugs, Contract Negotiation, Contract Management, CRO, Business Strategy, Strategic Planning, Product Development, Business Development, Management, Technology Transfer, Cross-functional Team..., Drug Development, R&D, Lifesciences, FDA, Leadership, Drug Discovery, Pharmaceutical Industry, Regulatory Affairs, Validation, GMP, Organic Chemistry, Biopharmaceuticals, Contract Manufacturing, CRM, Biotechnology, Pharmaceutics, Sop, Clinical Development, Oncology, Formulation, Life Sciences, Medical Devices, HPLC, Chemistry, Analytical Chemistry, Chromatography, Commercialization
Education
University at Albany 2005 — 2011
MBA, Marketing
University of New Hampshire 1995 — 1999
Ph.D., Synthetic Organic Chemistry
Genentech October 2014 - Present
Genentech October 2012 - October 2014
Genentech September 2011 - October 2012
Coldstream Laboratories, Inc. April 2011 - August 2011
PharmaForce Inc. May 2007 - April 2011
Georgia-Pacific LLC August 2000 - May 2007
Marathon Petroleum Corporation August 1999 - August 2000
Skills
Technology Transfer, Team Building, GMP, FDA, CAPA, Sop, Pharmaceutical Industry, Aseptic Processing, Biotechnology, Change Control, Validation, 21 CFR Part 11, Aseptic Technique, LIMS, Lean Manufacturing, Root Cause Analysis, Process Improvement, Continuous Improvement, Six Sigma, Process Simulation, SAP, Regulatory Affairs, Operational Excellence, Contract Manufacturing, Chromatography, Biopharmaceuticals, Cleaning Validation, Manufacturing, Quality System, Trackwise, Quality Assurance, Formulation, Lyophilization, cGMP manufacturing, Regulatory Submissions, Regulatory Requirements, Commercialization, Design of Experiments, Microbiology, Sterilization, Protein Purification, Filtration, FDA GMP, cGMP practices, Quality Auditing, GLP, GxP, Operations Management, Work Ethic, SOP
Education
George Fox University 2011 — 2014
Bachelor of Science (BS), Project Management, GPA - 4.0
Marylhurst University 2014 — 2016
Master of Business Administration (M.B.A.), MBA, GPA - 3.9
Kroger January 2015 - Present
Jeyes North America, LLC July 2012 - July 2015
Kroger December 2006 - July 2012
Coldstream Laboratories, Inc. October 2006 - August 2008
Lexington Medical June 1998 - September 2006
NAMSA June 1992 - June 1998
Skills
Pharmacy, Prescription, Medicare Part D, Data Entry, Pharmacueticals, Analytical Chemistry, Quality Assurance, Quality Control, Technical Writing, Medical Devices, Cpr Certified, Computer Hardware, Solid computer skills, Method Development, Technical Documentation, Pharmaceutical Research, Medical Terminology, Wet Chemistry
Education
Spencerian College 2009 — 2009
Certificate, Phlebotomy Technician/Phlebotomist
Cumberland College 1987 — 1992
Bachelor of Science (B.S.), Chemistry
Oleon January 2015 - Present
Actiprime Inc/Actitech LP/Actifirm June 2012 - January 2015
BeautiControl June 2010 - April 2012
Vi-Jon February 2008 - June 2010
Coldstream Laboratories, Inc. November 2006 - February 2008
University of Kentucky August 2005 - July 2006
Centocor Biologics Inc February 2005 - August 2005
Arizona State University August 2003 - May 2004
Saint Louis University June 2001 - May 2003
University of Missouri October 2000 - May 2003
Skills
Cell Culture, Western Blotting, Northern Blotting, Chemistry, R&D, Quality Assurance, Quality Control, sourcing, Project Management, Stability, Validation, Process Improvement, Process Engineering, Formulation, Color Correction, OTC, Food & Beverage, Skin Care, Pharmaceutical Industry, Cross-functional Team..., Regulatory Affairs, Cosmetics, Sourcing, Manufacturing, Personal Care, Emulsions, HPLC, Management, Product Development, Gas Chromatography, Sop, Ingredients, Technology Transfer, Laboratory, Organic Chemistry, Raw Materials, Analytical Chemistry, UV/Vis, Polymers, GMP, GLP, FDA, Continuous Improvement, Biochemistry
Education
University of Kentucky College of Medicine 2005 — 2007
MS, Biomedical
University of Missouri-Saint Louis 2000 — 2003
BS, Chemistry
Saint Louis University 1999 — 2000
Bachelor's degree, Chemistry
Coldstream Laboratories, Inc. August 2013 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, QuickBooks, Outlook, Validation, New Product Validation, Test Equipment, PowerPoint, Hotmail, Physical Inventory, Inventory Control, SOP, Pharmaceutical Industry, GMP, Quality Control, Quality System, Biotechnology, FDA, CAPA, Aseptic Processing, Quality Assurance, 21 CFR Part 11
Education
University of Kentucky 2005 — 2006
English as Second Language
Universidad Rafael Belloso Chacin 1992 — 1996
Bachelor Degree in Bussines, Finances
Coldstream Laboratories, Inc. May 2015 - Present
Galls June 2014 - Present
Coldstream Laboratories, Inc. February 2011 - May 2014
Skills
Accounts Payable, Accounts Receivable, Customer Service, QuickBooks, Invoicing, Payroll, Financial Reporting, PowerPoint, Process Improvement, Microsoft Office, Data Analysis, Project Management, Microsoft Excel, Pharmaceutical Industry, Account Reconciliation, Cost Accounting, Job Costing, Fixed Assets, Accounting, Financial Accounting, Depreciation, Accruals, Contract Manufacturing, cGMP manufacturing, cGMP practices, GMP
Education
University of Kentucky 2005 — 2009
Bachelor of Science (B.S.), Accounting
University of Kentucky 2005 — 2009
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General
Coldstream Laboratories, Inc. August 2013 - Present
Staples April 2013 - August 2013
Transylvania University September 2009 - May 2013
Staples May 2011 - April 2013
Skills
Inventory Management, Customer Service, Instrumentation, NMR, FTIR, GC-MS, UV-Vis-NIR, Gaussian 03, Organic Synthesis, Inorganic Synthesis, Titration, Soil Sampling, Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Time Management, Gas Chromatography
Education
Transylvania University 2009 — 2013
Bachelor of Arts (B.A.), Chemistry
Coldstream Laboratories, Inc. June 2015 - Present
Baxter BioPharmaceutical Solutions LLC May 2009 - June 2015
AstraZeneca LP January 2003 - January 2009
Professional Detailing Inc October 2000 - January 2003
University Directories 2000 - 2000
Skills
Gastroenterology, Cardiology, Pulmonology, Asthma, Allergy, Internal Medicine, Product Launch, Immunology, Pediatrics, Respiration, Cardiovascular Disease, Cold Calling, Medical Devices, Sales, COPD, Pharmaceutical Industry, Sales Operations, Building Relationships, Account Management, Cross-functional Team..., Selling, Leadership, FDA, GMP, Pharmaceutics, Pharmaceutical Sales
Education
University of Evansville 1996 — 2000
B.S., Biology, emphasis in Microbiology
Coldstream Laboratories, Inc. January 2013 - Present
University of Kentucky September 2007 - May 2013
Coldstream Laboratories, Inc. October 2012 - December 2012
Shanghai Institute of Pharmaceutical Industry September 2004 - June 2007
Skills
HPLC, Protein Purification, Protein Chemistry, NMR, Organic Synthesis, UV/Vis, Fluorescence..., Biochemistry, Peptides, IR, Chromatography, Mass Spectrometry, LC-MS, GC-MS, TEM
Education
University of Kentucky 2007 — 2012
PhD candidate, Nanotechnology, Biotechnology, Analytical Chemistry
Shanghai Institute of Pharmaceutical Industry 2004 — 2007
MS, Medicinal Chemistry
East China University of Science and Technology 2000 — 2004
Bachelor, Pharmaceutical Engineering
Piramal Sterile Products January 2015 - Present
Coldstream Laboratories, Inc. 2012 - January 2015
Coldstream Laboratories, Inc. January 2012 - October 2012
Albany Molecular Research, Inc. and Organichem 2000 - 2008
AlliedSignal June 1996 - January 2000
Albemarle June 1993 - June 1996
US Navy 1985 - 1993
Skills
Contract Negotiation, Project Management, Territory Management, Pharmaceutical Industry, Technology Transfer, Biotechnology, CRO, GMP, Contract Manufacturing, Lifesciences, Chemistry, Commercialization, R&D, Drug Discovery, Validation
Education
University of Maryland College Park 1989 — 1991
Master of Business Administration (M.B.A.)
Vanderbilt University 1981 — 1985
BS, Chemistry
Plattsburgh High School 1978 — 1981
High School
Boehringer Ingelheim Roxane Laboratories March 2011 - Present
Coldstream Laboratories, Inc. November 2009 - February 2011
Pfizer Inc. August 2007 - November 2009
Pfizer Inc. April 2002 - August 2007
City University of New York - Hunter College January 1998 - December 2001
Skills
HPLC, GMP, Pharmaceutical Industry, Sop, LIMS, Validation, Analytical Chemistry, GLP, Dissolution, UV/Vis, FDA, Cleaning Validation, LC-MS, Chromatography, UV
Education
City University of New York Graduate Center 1998 — 2002
M. Phil Chemistry, Chemistry
Universitatea „Babeș-Bolyai” din Cluj-Napoca 1990 — 1995
BS Chemistry, Chemistry
Thomas A. Walker, PhD and Associates, Inc. August 2001 - Present
ce2l November 2012 - Present
Metropolitan State College of Denver December 2011 - Present
Agilent Technologies 2009 - 2011
Coldstream Laboratories, Inc. 2010 - 2010
Atrix Laboratories June 2000 - June 2001
Geneva Pharmaceuticals February 1997 - 2000
The Univserity of Missouri Kansas City 1991 - 2000
Marion Laboratories/Marion Merrell Dow/Hoechst Marion Roussel 1988 - 1997
The NutraSweet Company January 1987 - January 1989
Skills
Technical Writing, Chromatography, Analytical Chemistry, Training & Development, Regulatory Filings, Ion Chromatography, Chiral Chromatography, Method Validation, Methods Development, Instrument Qualification, Equipment Qualification, Report Writing, GMP, GLP, Laboratory Experience, Drug Development, Pharmaceutical..., Product Specification, Technical Transfer, Quality Control, Preformulation, HPLC, Bioanalytical Chemistry, Expert Witness, cGMP, Pharmaceuticals, SOP, Regulatory Affairs, R&D, Pharmaceutical Industry, Sop, Product Development, Formulation, Technology Transfer, V&V, Employee Training, Chemistry, Validation, FDA, Laboratory, Drug Delivery, Mass Spectrometry, LIMS, Drug Discovery, Assay Development, Medicinal Chemistry, Quality System, Biochemistry, Quality Assurance, Clinical Development
Education
University of Iowa 1981 — 1985
PhD
Oral Roberts University 1977 — 1981
BS
Spectrum Pharmaceuticals 2014 - Present
Coldstream Laboratories, Inc. 2010 - 2013
Ception Therapeutics 2009 - 2010
Gemin X 2006 - 2009
Pfizer 2001 - 2006
Eisai 1998 - 2001
AAIPharma Services Corp. 1997 - 1998
Novartis 1992 - 1997
Skills
Formulation Development, Pharmaceutical..., Technology Transfer, Pharmaceuticals, Analytical Chemistry, Validation, Lyophilization, Drug Delivery, Process Validation, Aseptic Processing, Generics, Biopharmaceuticals, Clinical Development, Regulatory Submissions, Biotechnology, Pharmaceutical Research, Contract Manufacturing, Technical Leadership, Strategic Leadership, Cross-functional Team..., Staff Mentoring, CRO, CMO, GMP, R&D, Oncology, Strategic Planning, Change Management, CMC, Project Management, Parenteral, Pharmaceutical Industry, V&V, Formulation, Product Development, Drug Development, FDA, Pharmaceutics, Chemistry, GLP, Clinical Trials, Protein Chemistry, ANDA, IND, Laboratory, HPLC, Pharmacology, CAPA
Education
Indiana Wesleyan University
MSM
Colorado State University
Coldstream Laboratories, Inc. May 2015 - Present
Coldstream Laboratories, Inc. November 2013 - Present
Summit Biosciences Inc. December 2012 - November 2013
SiO2 Medical Products February 2012 - December 2012
SurModics Pharmaceuticals October 2010 - February 2012
SurModics Pharmaceuticals October 2009 - October 2010
Brookwood Pharmaceuticals (Acquired by Surmodics 08/2007) August 2006 - October 2009
Bausch and Lomb November 2002 - August 2006
Skills
FDA, Manufacturing
Education
University of Kentucky 1999 — 2002
Ph.D., Biomedical Engineering
University of Kentucky 1997 — 1999
MS, Biomedical Engineering
University of Kentucky 1993 — 1997
BS, Chemical Engineering
Russell High School 1989 — 1993
Coldstream Laboratories, Inc. July 2009 - Present
Education
Indiana University-Purdue University at Indianapolis 2000 — 2002
M.S., Organic Chemistry
Bellarmine University 1996 — 2000
B.A., Chemistry
Akorn, Inc July 2013 - Present
Akorn, Inc July 2011 - July 2013
Coldstream Laboratories, Inc. February 2010 - April 2011
Particle Sciences Inc July 2009 - February 2010
Bilcare GCS Inc. April 2008 - July 2009
Allan Pharmaceutical (Currently Versa Pharm-Akorn Company) December 2004 - April 2008
Able Laboratories November 2003 - December 2004
Wockhardt Research Centre August 1999 - August 2003
Jain Foods & Chemicals Ltd October 1997 - July 1999
Lupin Laboratories Ltd. October 1994 - August 1997
Skills
Cleaning Validation, HPLC, Validation, cGMP, SOP, Reverse Engineering, deformulation of..., Sop, GMP, Polymers, Dissolution, R&D, Technology Transfer, V&V, GLP, Analytical Chemistry, FDA, Chemistry, Pharmaceutical Industry, Formulation, Biotechnology, Gas Chromatography, UV, UV/Vis, Stability Studies, Characterization, USP, Wet Chemistry, Quality Control, Differential Scanning..., Method Development, FTIR, Pharmaceutics, ANDA, Chromatography
Education
Indian Institute of Technology, Roorkee 1993 — 1994
M.Phil
K.T.H.M. College, Nasik 1990 — 1992
M. Sc.
Avid Radiopharmaceuticals September 2012 - Present
Self Employed January 2012 - Present
AMRI - Burlington September 2010 - January 2012
Coldstream Laboratories, Inc. March 2010 - August 2010
MBK Consulting July 2009 - April 2010
UCB, Inc. June 2003 - July 2009
Bristol-Myers Squibb October 1988 - June 2003
Skills
HPLC, cGMP, Validation, Analytical Chemistry, Pharmaceutical..., GLP, Pharmaceuticals, R&D, GMP, Chromatography, Technology Transfer, UV-Vis, Cross-functional Team..., Biotechnology, Product Development, Pharmaceutical Industry, Drug Development, FDA, Formulation, Quality Control, Pharmaceutics, UV/Vis
Education
Binghamton University 1981 — 1986
Ph.D., Analytical Chemistry
State University of New York College at Buffalo 1977 — 1981
BA, Chemistry
Coldstream Laboratories, Inc. April 2013 - January 2015
PharmaGap September 2011 - October 2012
Variation Biotechnologies Inc August 2010 - August 2011
Variation Biotechnologies Inc January 2009 - August 2010
Variation Biotechnologies Inc April 2008 - January 2009
Laval University January 2005 - December 2007
PPD International March 2005 - November 2005
Skills
Vaccines, Protein Purification, Cell Culture, Biotechnology, FDA, Chromatography, Formulation, Proteomics, Biochemistry, Technology Transfer, Process Simulation, Life Sciences, Laboratory
Education
Université Laval 2005 — 2007
MSc, Chemical Engineer, Biotechnology
Universidad Iberoamericana, Ciudad de México 2000 — 2005
Chemical Engineering
Patheon November 2013 - Present
Catalent Pharma Solutions October 2011 - February 2013
Coldstream Laboratories, Inc. August 2010 - October 2011
PharmaForm September 2008 - June 2010
PharmaForm March 2007 - September 2008
PharmaForm February 2006 - March 2007
PharmaForm October 2004 - February 2006
Education
The University of Texas at Austin 2001 — 2004
Bachelor of Science (B.S.), Cell/Cellular and Molecular Biology
Coldstream Laboratories, Inc. 2005 - Present
Skills
FDA, Pharmaceutical Industry, GMP, Aseptic Processing, Biotechnology, SOP, Technology Transfer, Validation, Quality Control, CAPA, 21 CFR Part 11, Change Control, Microbiology, GLP, Bacterial Endotoxin
Education
University of Kentucky
Coldstream Laboratories, Inc. February 2013 - Present
Catalent Pharma Solutions January 2008 - Present
Coldstream Laboratories, Inc. 2013 - 2014
Coldstream Laboratories, Inc. 2013 - 2014
Coldstream Laboratories, Inc. 2013 - 2014
American Woodmark, Inc September 2005 - January 2007
Faulkners's Garage April 2005 - September 2005
MedVenture Technology March 2004 - September 2005
Skills
FDA, Quality Assurance, Sop, GMP, Manufacturing, Trackwise, Quality Management, CAPA, GLP, Validation, 21 CFR Part 11, Software Documentation, Medical Devices, LIMS, Testing, Change Control, Aseptic Processing, V&V
Education
Eastern Kentucky University 1998 — 2002
Bachelors of Science, Industrial Technology/ Quality Assurance
Eastern Kentucky University 1998 — 2002
Associate of Science, Quality
Actavis April 2011 - Present
University of maryland at Baltimore, Pharmaceutical Sciences December 2009 - April 2011
Coldstream labs June 2009 - December 2009
Coldstream Laboratories, Inc. June 2007 - July 2009
Skills
HPLC, Gas Chromatography, Protein Chemistry, Mass Spectrometry, LC-MS, Assay Development, Validation, GMP, Drug Development, Laboratory, Formulation, Method Development, Wet Chemistry, NMR, Pharmaceutical Industry, GC-MS, Project Management
Education
University of Kentucky 2002 — 2007
PhD, Chemistry
Institute of Chemistry, Chinese Academy of Sciences 1999 — 2002
Master of Science (MS), Organic Chemistry
Pearl Interactive Network June 2013 - Present
Coldstream Laboratories, Inc. March 2010 - October 2012
SVAC dba American Specialty Cars (ASC) August 2007 - March 2010
Global Automotive Systems, LLC September 2004 - August 2007
Rand McNally November 1994 - August 2004
Humana Hospital - Lexington November 1989 - November 1994
Skills
Performance Management, Deferred Compensation, Human Resources, Employee Relations, HRIS, Employee Benefits, Temporary Placement, Onboarding, New Hire Orientations, Interviews, Policy, Recruiting, FMLA, Job Descriptions, Talent Acquisition, Labor Relations, Benefits Administration, Payroll, Personnel Management, Management, Training, Workforce Planning, Applicant Tracking..., Succession Planning, Leadership, College Recruiting, Talent Management, Employee Engagement, Technical Recruiting, HR Policies, Internet Recruiting, Resume Writing, Staffing Services, Temporary Staffing, Employee Handbooks, Employment Law, Hiring
Education
University of Kentucky 1988 — 1990
Accounting
Virgie High School
Cempra Pharmaceuticals August 2015 - Present
Eisai September 2012 - August 2015
Coldstream Laboratories, Inc. May 2011 - August 2011
Eisai, Inc August 2007 - April 2011
Hospira May 2005 - August 2007
American Pharmaceutical partners 2001 - 2005
Morton Grove Pharmaceuticals 1999 - 2001
Skills
GMP, Validation, Formulation Development, Pharmaceuticals, Drug Delivery, HPLC, cGMP, Technology Transfer, FDA, SOP, GLP, Process Validation, Process Development, Manufacturing, R&D, Quality Assurance, Oncology, Research, UV-Vis, Documentation, ANDA, Auditing, Troubleshooting, Drug Development, Formulation, Pharmaceutical Industry, Pharmaceutics, Regulatory Affairs, Software Documentation, Sop, UV/Vis
Education
University of Missouri-Kansas City 1996 — 1999
pharmacy
College of pharmaceutical sciences, manipal 1994 — 1996
pharmacy, pharmacy
Coldstream Laboratories, Inc. 2010 - 2011
Avrio Biopharmaceuticals 2010 - 2010
Galaxe Pharma Sciences 2008 - 2009
Hollister-Stier Laboratories 2005 - 2007
AAI Development Services 2003 - 2005
B. Braun Medical 1997 - 2003
Steris Pharmaceuticals 1994 - 1997
Abbott Laboratories 1985 - 1994
Skills
cGMP, Manufacturing, Scheduling, Operations Management, Aseptic Processing, Aseptic Technique, Budgets, Business Development, CAPA, Change Control, Continuous Improvement, Contract Manufacturing, Cross-functional Team..., Engineering, FDA, GMP, Leadership, Lean Manufacturing, Management, Operational Excellence, Pharmaceutical Industry, Process Improvement, Process Scheduler, Process Simulation, Project Management, Project Planning, Purchasing, Quality Assurance, Regulatory Requirements, Sop, Start-ups, Sterilization, Technology Transfer, Training, V&V, Validation
Education
Mars Hill College
B.S., Biology
Coldstream Laboratories, Inc. October 2011 - September 2013
Pfizer October 2001 - February 2002
GlaxoSmithKline 2001 - 2001
GlaxoWellcome 2000 - 2001
GlaxoWellcome 1999 - 1999
Novalon Pharmaceuticals 1998 - 1999
AAIPharma 1997 - 1998
Geneva Pharmaceuticals January 1993 - May 1997
Novartis 1993 - 1997
Skills
cGMP, HPLC, Safety, cGMP practices, Data Analysis, LC-MS, Dissolution, FTIR, SOP's, MSDS, Karl Fisher, Wet Chemistry, Method Development, LIMS, Validation, Drug Discovery, USP, GMP
Education
Colorado State University
BS, Microbiology
NY- Broome Community College
Associate of Arts and Sciences (AAS), Chemical Engineering
Coldstream Laboratories, Inc. 2011 - 2011
Bosch Rexroth Group September 2007 - October 2010
Education
Piedmont College 1996 — 1998
BA, Sociology/Psychology
Rodem Process Equipment August 2012 - Present
Alltech Inc. March 2010 - August 2012
Martek Biosciences July 2009 - March 2010
Rodem Inc. June 2008 - June 2009
Intranasal Therapeutics Inc September 2007 - March 2008
Coldstream Laboratories, Inc. January 2007 - September 2007
Martek Biosciences 2000 - 2006
Education
University of Kentucky 1997 — 2000
BS Engineering, Biosystems and Agricultural Engineering
Coldstream Laboratories, Inc. May 2015 - Present
Coldstream Laboratories, Inc. September 2010 - May 2015
Alkermes October 2006 - September 2010
Forest Pharmaceuticals June 2003 - September 2006
Dean Foods April 2001 - March 2003
Skills
Quality Assurance, GMP, CAPA, Quality Auditing, Biochemistry, Microbiology, Quality Systems, Life Sciences, Compliance, Regulatory Inspections, Supplier Quality...
Education
LSU Shreveport 1999 — 1999
Microbiology & Immunology
Bellarmine University 1994 — 1998
BA, Biology
Seneca High School 1990 — 1994
Coldstream Laboratories, Inc. March 2011 - Present
Ebewe Pharma January 2008 - April 2009
MicroConstants, Inc. July 2007 - January 2008
Morton Grove Pharmaceuticals July 2004 - September 2005
SkyePharma February 1996 - January 2004
Allergan April 1995 - February 1996
Granutec Inc August 1991 - April 1994
Chelsea Laboratories Inc February 1989 - August 1991
The NutraSweet Company May 1988 - February 1989
Technology Applications Inc August 1986 - May 1988
Skills
GMP, Pharmaceutical Industry, Biotechnology, HPLC, Technology Transfer, Formulation, V&V
Education
California State University San Marcos 2010 — 2010
Certificate, Biotechnology
University of North Carolina at Charlotte
BS, Chemistry
Coldstream Laboratories, Inc. 2014 - Present
Coldstream Laboratories, Inc. July 2007 - March 2014
Avantor Performance Materials, Inc. February 2007 - June 2007
Martek Biosciences 2005 - 2006
Skills
Aseptic Processing, HPLC, Manufacturing, Consulting, FDA, 21 CFR Part 11, Cleaning Validation, Change Control, Microsoft Office, LIMS, CRO, GC-FID, ICH guidelines, Stability Studies, Contract Manufacturing, USP, Laboratory
Education
Mount Mercy College 1996 — 1999
Bachelor's degree, Human Biology/Chemistry
ROC Consulting August 2011 - Present
Coldstream Laboratories, Inc. August 2008 - February 2011
University of Kentucky August 2004 - August 2008
Skills
Validation, Analytical Chemistry, Technology Transfer
Education
National University of Ireland, Galway 2004 — 2007
M.Sc., Biochemistry
Coldstream Laboratories, Inc. Research AssociateMimetic Solutions, LLC2007 - 2007
Skills
Lyophilization, Formulation, Aseptic Processing, Technology Transfer, GMP, Pharmaceutical Industry, HPLC, R&D, Chromatography, UV/Vis, GLP
Education
University of Kentucky 1995 — 2000
BS, Biology
Coldstream Laboratories, Inc. December 2010 - Present
Coldstream Laboratories, Inc. January 2005 - December 2010
Catalent Pharma Solutions September 2008 - March 2009
Nestle USA April 1998 - October 2005
Education
Eastern Kentucky University 1993 — 1997
BS Biology
Coldstream Laboratories, Inc. December 2013 - Present
University of Louisville August 2010 - December 2013
University of Louisville August 2009 - July 2010
Skills
Mass Spectrometry, Chromatography, GC-MS, LCMS, Metabolomics, Biomarker Discovery, GCXGC-TOFMS, Gas Chromatography, Bioinformatics, Biomarkers, High Throughput..., Chemistry, HPLC, Analytical Chemistry, UV/Vis
Education
University of Louisville 2009 — 2013
Doctor of Philosophy (PhD), Analytical Chemistry
East China Normal University 2006 — 2009
Master's degree, Analytical Chemistry
Cook Pharmica May 2015 - Present
Cook Pharmica May 2013 - Present
Cook Pharmica April 2012 - May 2013
Cook Pharmica June 2010 - April 2012
Coldstream Laboratories, Inc. March 2008 - May 2010
Skills
CAPA, Biopharmaceuticals, 21 CFR Part 11, FDA, GMP, Sop, Validation, Biotechnology, Pharmaceutical Industry, Change Control, LIMS, Trackwise, Quality Assurance, Quality System, Regulatory Affairs, Quality Auditing, ISO 13485, Regulatory Submissions, cGMP practices, Document Management, IND, Contract Manufacturing, Technical Writing
Education
Eastern Kentucky University 2000 — 2006
BA, English - Technical Writing
Coldstream Laboratories, Inc. September 2012 - Present
Coldstream Laboratories, Inc. March 2007 - Present
Coldstream Laboratories, Inc October 2010 - September 2012
Skills
Microsoft Office, Data Entry, Microsoft Excel, Microsoft Word, Payroll, PowerPoint, QuickBooks, Employee Benefits, Customer Service, Events, Graphic Design, Invoicing, Internet, JavaScript, Marketing Research, Office Management, Organization, Recruiting, Problem Solving, Visio, Creative Writing, XML, Training, Sop, Accounts Receivable, Purchasing, Access, Software Documentation, Pharmaceutical Industry, SOP
Education
Bluegrass Community and Technical College 2010 — 2013
Accounting and Related Services, 3.5
Coldstream Laboratories, Inc. October 2014 - Present
Ben Venue Laboratories March 2008 - December 2013
Ben Venue Laboratories April 1994 - February 2008
Skills
Sterilization, Lyophilization, Validation, Formulation, Change Control, Quality Assurance, LIMS, FDA GMP, Biotechnology, CAPA, Trackwise, GLP, GMP, Manufacturing, Quality Auditing, 21 CFR Part 11, Computer System..., Regulatory Requirements, Regulatory Affairs, GAMP, Pharmaceutics, Aseptic Processing, cGMP practices, Biopharmaceuticals, Pharmaceutical Industry, FDA, Autoclave, Vaccines, Process Simulation, Cleaning Validation, GxP, cGMP manufacturing, Medical Devices, Sop, Technology Transfer, Equipment Qualification
Education
The University of Akron 1980 — 1985
BSIM, Production Operations and Human Resouces Management
Osram Sylvania April 2013 - Present
Garrett Industries LLC April 2009 - April 2013
Coldstream Laboratories, Inc. 2005 - 2007
GE 1998 - 2001
Education
University of Kentucky 1995 — 1998
Bachelor of Applied Science (BASc), Materials Engineering
University of Kentucky College of Engineering 1995 — 1998
Materials Engineer, Design
Lachman Consultant Services October 2014 - Present
Gilead Sciences May 2012 - October 2014
Coldstream Laboratories, Inc. June 2011 - May 2012
AMRI May 2002 - May 2011
Exchem Organics June 1998 - May 2002
Horseracing Forensic Laboratory June 1996 - June 1998
Skills
Analytical Chemistry, Chromatography, Pharmaceuticals, cGMP, Validation, GLP, Manufacturing, HPLC, Pharmaceutical Industry, GMP
Education
University of Liverpool 1992 — 1996
PhD, Organic Geochemistry
University of Liverpool 1990 — 1996
BSc (Hons)
University of Kentucky March 2013 - Present
Catalent Pharma Solutions December 2010 - March 2013
Coldstream Laboratories, Inc. January 2009 - May 2010
Univ. of KY- Biochemistry 2001 - 2006
Skills
UV/Vis, Analytical Chemistry, GLP, GMP, Protein Chemistry, Gas Chromatography, ELISA, SDS-PAGE, Protein Purification, SOP, HPLC, Method Transfer, FTIR, Karl Fisher, Dissolution, TLC, GC-MS, Density, Cleaning Validation, CAPA, pH, Moisture Analysis, NMR, Biotechnology, Formulation, Sop
Education
Eastern Kentucky University 1999 — 2001
Masters, Chemistry
Alltech April 2012 - Present
ChemSolutions, LLC February 2011 - June 2012
Coldstream Laboratories, Inc. April 2009 - October 2010
Lawrence Pharmaceuticals, LLC February 2007 - April 2009
ChemPharma Intl., LLC December 2002 - February 2007
Education
University of Kentucky
Business Management
Eastern Kentucky University
Chemistry
University of Memphis
MBA Finance
University of Kentucky, College of Pharmacy July 2012 - Present
AllTranz Inc. April 2011 - June 2012
Coldstream Laboratories, Inc. May 2008 - May 2010
Coldstream Laboratories, Inc. May 2005 - May 2008
Skills
Pharmaceutical Industry, Manufacturing, GLP, GMP, Chemistry, Technology Transfer, Formulation, V&V, Validation, Cross-functional Team..., FDA, Sop
Education
University of Kentucky 1996 — 2004
Ph.D., Pharmaceutical Sciences
University of Kentucky June 2010 - Present
University of Kentucky February 2009 - September 2010
Coldstream Laboratories, Inc. May 2007 - April 2008
University of Kentucky January 2007 - April 2007
University of Kentucky May 2005 - December 2006
University of Kentucky September 2002 - April 2005
Commonwealth of Kentucky May 1998 - August 2002
Commonwealth of Kentucky December 1996 - April 1998
Commonwealth of Kentucky April 1996 - December 1996
Bank One June 1991 - March 1996
Skills
Nonprofits, Research, Public Speaking, Budgets, Higher Education, Administration, PowerPoint, Grant Writing, Microsoft Office, Microsoft Word, Microsoft Excel, Outlook, Data Analysis, Database Administration, Data Entry, Accounting, SAP, QuickBooks, Critical Thinking, MAS 200, Mas 90, Time Management, Customer Service, Government, Event Planning, Accounts Payable &..., Retail Banking, Contract Management, Human Resources, Newsletter Production, Policy Analysis, Recruiting, Employee Training, Community Outreach, Management, Policy, Program Development
Education
University of Kentucky 2009 — 2010
BA of Economics, Educational Policy Studies and Evaluation Master's Program
University of Kentucky 1987 — 1992
Bachelor of Arts (BA), Economics
Clariant January 2014 - Present
Coldstream Laboratories, Inc. December 2012 - December 2013
Sovereign Pharmaceuticals November 2010 - December 2012
Sovereign Pharmaceuticals October 2010 - November 2010
Thorn BioScience LLC July 2007 - October 2010
Süd-Chemie Inc September 2006 - July 2007
University of Kentucky College of Pharmacy May 2005 - September 2006
Schwarz Pharma Mfg February 2003 - May 2005
Skills
USP, Dissolution, Wet Chemistry, UV, HPLC, Analytical Chemistry, Chromatography, GMP, Gas Chromatography, FDA, Sop, Instrumentation, CAPA, Change Control, Quality Control, V&V, SOP
Education
Indiana University-Southeast 1995 — 2002
BA, Chemistry
Indiana University-Southeast 1995 — 2002
Bachelor of Arts, Chemistry
Coldstream Laboratories, Inc. August 2014 - Present
Coldstream Laboratories, Inc. February 2014 - July 2014
Coldstream Laboratories, Inc. December 2011 - January 2014
Oakwood Laboratories November 2010 - November 2011
Boehringer Ingelheim - Roxane Laboratories October 2007 - October 2010
AMRI January 1999 - October 2007
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, UV/Vis, Sop, HPLC, Gas Chromatography, Drug Discovery, Analytical Chemistry, Chromatography, LC-MS, GLP, Technology Transfer, Organic Chemistry, Validation, Quality Assurance, Method Development, Dissolution, IR
Education
The University of Akron 1991 — 1999
Doctor of Philosophy (Ph.D.), Organic Chemistry
University of North Carolina at Chapel Hill August 2007 - Present
Coldstream Laboratories, Inc. January 2007 - August 2007
Skills
Cell Culture, HPLC, Western Blotting, Fluorescence Microscopy, ELISA
Education
University of Kentucky 2004 — 2006
Master of Science (MS), Analytical Chemistry
Universiteit Leiden 2002 — 2004
Master's degree, Bio-Pharmaceutical Sciences
Central South University 1998 — 2002
Bachelor of Science (BS), Pharmacy
Sovereign Pharmaceuticals 2008 - Present
Coldstream Laboratories, Inc. 2008 - 2008
Intranasal Therapeutics, Inc. 2005 - 2008
Boehringer Ingelheim 1991 - 2005
Battelle 1987 - 1991
Skills
21 CFR Part 11, Analytical Chemistry, CAPA, Change Control, Chromatography, Cleaning Validation, FDA, GLP, GMP, HPLC, Pharmaceutical Industry, SOP, Sop, Technology Transfer, Validation
Education
The Ohio State University
Bachelor of Science (B.S.), Chemistry
Coldstream Laboratories, Inc. March 2014 - Present
Coldstream Laboratories, Inc. March 2011 - March 2014
Coldstream Laboratories, Inc. March 2010 - March 2011
Skills
HPLC, GC, HPLC-MS, GMP, Validation, Method Development
Education
Oregon State University 2004 — 2009
Ph. D., Analytical Chemistry
Shandong University
BS, Chemistry
Coldstream Laboratories, Inc. June 2014 - August 2014
Empyra.com, Inc. June 2013 - July 2013
Education
University of California, San Diego 2012 — 2014
Bachelor's Degree, Biochemistry and Cell Biology