PharmaDirections Company

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PharmaDirections Employees

Employee
Years
Job
Industry
Michelle Higgin Michelle Higgin Raleigh-Durham, North Carolina Area Details
Michelle Higgin's PharmaDirections Experience March 2013 - Present
Job Principal, Program Management at PharmaDirections
Industry Pharmaceuticals
Experience
PharmaDirections   March 2013 - Present
PharmaDirections   May 2006 - March 2013
PharmaDirections   2006 - 2009
National Institutes of Health  May 2004 - May 2006
Magellan (now Catalent)   1998 - 1998
AAI Pharma  June 1995 - August 1997

Skills
Drug Development, Pharmaceutical Industry, Clinical Development, Technology Transfer, Biotechnology, Lifesciences, FDA, CRO, Validation, GMP, Sop, Clinical Trials

Education
University of Wisconsin-Madison   1998 — 2004
Ph.D., Biochemistry

SUNY Geneseo   1994 — 1998
BS, Biochemistry

Andria Barrett Andria Barrett Raleigh-Durham, North Carolina Area Details
Andria Barrett's PharmaDirections Experience 2005 - Present
Job Owner ezReconcile Inc
Industry Accounting
Experience
ezReconcile   March 2013 - Present
PharmaDirections   2005 - Present
Whitsell Innovations   June 2011 - Present
Insight Accounting   January 1995 - Present

Skills
Accounting, Strategic Planning, Budgets, Quality Auditing, Project Management, Small Business, Business Development, Quality Assurance, Marketing Strategy, Product Development, New Business Development, Manufacturing, Financial Reporting, Auditing, Payroll Taxes, Tax Preparation, Negotiation, Management, Bookkeeping, QuickBooks, General Ledger, Start-ups, Finance, Marketing, Leadership, Account Reconciliation, Customer Service, Program Management

Education
University of North Carolina at Chapel Hill   1993 — 1995
MBA - Kenan-Flagler Business School, Masters of Business Administration

North Carolina State University   1980 — 1984
BS, Computer Science

Rachelle R. Robinson Rachelle R. Robinson Raleigh, North Carolina Details
Rachelle R. Robinson's PharmaDirections Experience 2008 - 2008
Job Accountant at North Carolina State University
Industry Financial Services
Experience
North Carolina State University  October 2012 - Present
SECU  August 2008 - July 2012
Robert Half Management Resources  April 2008 - July 2008
PharmaDirections   2008 - 2008
NCM Capital  May 2006 - June 2007

Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, English, Research, Outlook, Photoshop, Teaching, Budgets, Public Speaking, Financial Analysis, Financial Reporting, Financial Accounting, Account Reconciliation, Trading, Settlement, Account Management, Accounting, Access, Problem Solving, Process Improvement, General Ledger, Investment Banking, Retail Banking, Mortgage Lending, Consumer Lending, Corporate Training, Tax, Portfolio Management

Education
City University of New York-Baruch College - Zicklin School of Business
Master of Science (M.S.), Finance

Nyack College
Bachelor of Science (B.S.), Organizational Management

Donald Sims Donald Sims Greater Philadelphia Area Details
Donald Sims's PharmaDirections Experience 2004 - Present
Job President
Industry Pharmaceuticals
Experience
iCeutica  April 2015 - Present
jdsims & associates   2002 - Present
PharmaDirections   2004 - Present
QSC  2011 - 2014
DSI  2010 - 2012
MDS Pharma Services  2005 - 2006
cima labs  2000 - 2002
solvay  1996 - 2000
apollon   1993 - 1996
Greenwich Pharmaceuticals  1991 - 1993

Skills
Pharmaceuticals, cGMP, Regulatory Affairs, GMP, Validation, Process Validation, Technology Transfer, Quality Auditing, SOP, Pharmaceutical Industry, FDA, Quality System, Sop, V&V, Regulatory Requirements, Quality Control, 21 CFR Part 11, Pharmaceutics, CAPA, Change Control, GLP, Regulatory Submissions

Education
University of North Carolina at Chapel Hill   1975 — 1979
PhD, Medicinal Chemistry

Rice University   1971 — 1975
BA, biochemistry

Julie Kron Julie Kron Raleigh-Durham, North Carolina Area Details
Julie Kron's PharmaDirections Experience August 2006 - October 2008
Job Sr. Project Manager, Technical Development, Vaccines R&D
Industry Pharmaceuticals
Experience
Novartis Vaccines  February 2012 - March 2015
Catalent Pharma Solutions  June 2010 - February 2012
Novo Nordisk  March 2010 - July 2010
AlphaVax  October 2008 - February 2010
PharmaDirections   August 2006 - October 2008
PharmaDirections   2005 - 2006
Magellan Laboratories  1999 - 2005
Cardinal Health  1997 - 2005
Magellan Laboratories  1997 - 1999
Entropy, Inc.   April 1994 - 1997

Skills
GMP, Pharmaceutical Industry, Validation, Six Sigma, Sop, Drug Development, Strategy, Training, CAPA, FDA, Process Improvement, Biotechnology, Leadership, Change Control, Technology Transfer, 21 CFR Part 11, Program Management, Cross-functional Team..., Analytical Chemistry, Management, PMP, CRO, Project Management, Pharmaceutics, Product Development, Manufacturing

Education
North Carolina State University - College of Management   1999 — 2002
MBA, New Product Development

University of North Carolina at Chapel Hill   1990 — 1994
BS, Biology

John Landy John Landy Greater Philadelphia Area Details
John Landy's PharmaDirections Experience 2007 - 2007
Job Team Leader at Pfizer
Industry Pharmaceuticals
Experience
Pfizer  December 2010 - Present
Pfizer (formerly Wyeth)   December 2007 - December 2010
PharmaDirections   2007 - 2007
sanofi-aventis  1984 - 2006

Skills
Validation, GMP, Pharmaceutical Industry, Chemistry, Analytical Chemistry, Quality Assurance, Sop, Quality Control, Strategy, Technology Transfer, Lifesciences, Laboratory, Clinical Development, GLP, Immunology, LIMS, FDA, 21 CFR Part 11, Microbiology, Change Control, CAPA, SOP

Education
University of Florida   1979 — 1983
PhD, Chemistry

New York University   1975 — 1979
BS, Chemistry

Emily Kuykendall Emily Kuykendall Raleigh-Durham, North Carolina Area Details
Emily Kuykendall's PharmaDirections Experience 2005 - 2012
Job President/Owner at ESK Consulting, Inc.
Industry Pharmaceuticals
Experience
ESK Consulting, Inc.   January 2006 - Present
PharmaDirections   2005 - 2012
Cardinal Health Pharmaceutical Development   January 2002 - January 2005
Magellan Laboratories  April 1998 - January 2002
Hospira  1997 - 2000

Skills
Vendor Management, Pharmaceutical Industry, GMP, FDA, Validation, Technology Transfer, Sop, Biotechnology, CAPA, CRO, Change Control, 21 CFR Part 11, Clinical Development, Lifesciences, Clinical Trials

Education
North Carolina State University   1992 — 1996
BS, Biology, Nutrition

Ralph Horstmann Ralph Horstmann Greensboro/Winston-Salem, North Carolina Area Details
Ralph Horstmann's PharmaDirections Experience September 2006 - May 2008
Job Pharmaceutical Consultant
Industry Pharmaceuticals
Experience
R & D Express Pharmaceutical Consulting   September 2006 - Present
Herbalife  December 2013 - July 2014
Axcentria Pharmaceuticals  October 2010 - November 2013
Pharm Ops, Inc.   March 2010 - October 2010
Frontage Laboratories, Inc  June 2008 - March 2010
PharmaDirections   September 2006 - May 2008
McNeil Consumer Healthcare  May 2005 - September 2006
Teva Pharmaceuticals USA  May 2000 - October 2004
Teva Pharmaceuticals USA  January 2002 - January 2004
Schwarz Pharma  October 1992 - May 2000

Skills
Formulation Development, Product Development, Technology Transfer, Pharmaceuticals, Pharmaceutical Industry, Drug Development, Pharmaceutics, Contract Manufacturing, Validation, CAPA, Heavy Equipment, Sop, Formulation, FDA, GMP, Clinical Development, Lifesciences, R&D, Biotechnology, HPLC, 21 CFR Part 11, UV/Vis, Change Control, Regulatory Submissions, Regulatory Affairs, Biopharmaceuticals, Quality System, LIMS, Process Simulation, Analytical Chemistry, GxP, GLP, CRO, IND, Clinical Trials, Regulatory Requirements, Cleaning Validation, SOP, Life Sciences

Education
ITT Technical Institute-Indianapolis   1998 — 1999
Project Management

Florida State University   1972 — 1975
BS

Sara McKenzie Sara McKenzie Santa Fe, New Mexico Area Details
Sara McKenzie's PharmaDirections Experience October 2012 - Present
Job Principal at PharmaDirections
Industry Biotechnology
Experience
PharmaDirections   October 2012 - Present
Proteostasis Therapeutics, Inc.   July 2011 - December 2012
Independent Biopharmaceutical Consulting   September 2010 - March 2012
NormOxys   April 2008 - September 2010
Synta Pharmaceuticals  December 2006 - March 2008
invivodata  May 2004 - March 2006
Critical Therapeutics  2006 - 2006
Sepracor Pharmaceuticals  1999 - 2004
Genzyme Corporation  1996 - 1999

Skills
Clinical Trials, Biotechnology, Strategic Planning, Program Management, Negotiation, Budgeting, Team Building, Product Development, Planning, Problem Solving, Public Speaking, Team Leadership, CRO, Project Management, Clinical Development, Pharmaceutical Industry, Project Planning, IND, Cross-functional Team..., Budgets

Education
Simmons College - Simmons School of Management   1991 — 1993
Master of Business Administration (MBA), General Management

University of Kansas   1979 — 1984
PhD, Biochemistry, Immunology

Iowa State University   1975 — 1979
BS, Chemistry, Biology

Ron Filipski Ron Filipski Orlando, Florida Area Details
Ron Filipski's PharmaDirections Experience 2004 - 2014
Job Retired at None
Industry Pharmaceuticals
Experience
None  September 2015 - Present
PFP Consultants, Inc   November 2000 - September 2015
PharmaDirections   2004 - 2014
Quantic  2000 - June 2013
Aventis Pasteur  April 1988 - November 2000
Zenith Laboratories   February 1985 - April 1988
Hoffmann-La Roche  January 1973 - February 1985

Skills
GMP, FDA, Validation, Pharmaceutical Industry, Biotechnology, Medical Devices, Product Development, Quality Auditing, Project Management, Manufacturing, Quality Control, Management, LIMS, Technology Transfer, GCP, Computer System..., Regulatory Requirements, Sop, CAPA, Regulatory Affairs, Quality System, GLP, Quality Assurance, Technical Writing, Clinical Trials, Project Planning, Regulatory Submissions, Pharmaceutics, ISO 13485, Vaccines, Leadership, 21 CFR Part 11, Testing, R&D, Commercialization, Change Control, Cross-functional Team..., Auditing, Drug Development, Aseptic Processing, Lifesciences, Clinical Development, Biopharmaceuticals, V&V, GAMP, CRO, Cleaning Validation, Formulation, GxP, Software Documentation

Education
Fairleigh Dickinson University-Florham Campus   1975 — 1980
MBA, Management

University of Cincinnati   1968 — 1972
BS, Biology/Chemistry

Judi Lay, PMP Judi Lay, PMP Greater Chicago Area Details
Judi Lay, PMP's PharmaDirections Experience December 2005 - May 2008
Job Sr. Development Services Manager One2One Global Contract Manufacturing Services at Hospira
Industry Pharmaceuticals
Experience
Hospira  August 2011 - Present
Novartis  April 2011 - August 2011
Alcon Laboratories, Inc.   April 2009 - April 2011
Lord & Lay   December 2005 - March 2009
PharmaDirections   December 2005 - May 2008
The Dow Chemical Company  September 1983 - January 2003

Skills
Vendor Management, Project Management, Pharmaceutical Industry, Leadership, Cross-functional Team..., Program Management, Pharmaceutics, Biotechnology, Process Improvement, Strategy, Clinical Trials, Negotiation, Product Development, GMP, Change Management, Strategic Planning, Technology Transfer, Change Control, Drug Development, EHS, Continuous Improvement, Supply Chain Management, Contract Negotiation, PMP, Budgets, R&D, FDA, Manufacturing, Regulatory Submissions, Management, Validation, 21 CFR Part 11, Clinical Development, Sop, SOP

Education
Texas A&M University   1979 — 1983
BS, Chemistry

Trinity University   1978 — 1979
Biology

Crockett HS   1974 — 1978

Jeanette Konicki Jeanette Konicki Greater Atlanta Area Details
Jeanette Konicki's PharmaDirections Experience August 2006 - December 2008
Job Director, Global Process Management at Carter's | OshKosh B'gosh
Industry Apparel & Fashion
Experience
Carter's OshKosh B'gosh   November 2011 - Present
Carter's OshKosh B'gosh   January 2010 - November 2011
Tickled Lime Design   January 2009 - April 2010
PharmaDirections   August 2006 - December 2008
Target  May 2004 - July 2006
Target  March 2003 - May 2004
Hartstrings  April 2002 - December 2002
Michael Simon  June 2001 - April 2002
Eagle's Eye  September 1999 - May 2001
Eagle's Eye  January 1998 - September 1999

Skills
Apparel, Fashion, Creative Direction, Strategic Planning, Marketing, Illustrator, Brand Management, Leadership, Product Development, Management, Textiles, Graphic Design, Trend, Team Building, Trend Analysis, Fashion Design, Merchandising

Education
Drexel University   1988 — 1992
B.S., Design Arts-earned degree in 1992

Mary Tichi PhD, MBA Mary Tichi PhD, MBA Greater San Diego Area Details
Mary Tichi PhD, MBA's PharmaDirections Experience 2007 - August 2008
Job ***
Industry Biotechnology
Experience
Affymetrix  January 2013 - July 2013
Affymetrix  January 2012 - December 2012
Affymetrix  August 2010 - January 2012
Catalent  December 2008 - April 2010
PharmaDirections   2007 - August 2008
Independent Consultant  2006 - 2007
Ambion  2004 - 2006
Invitrogen  2001 - 2004

Skills
Pharmaceutical Industry, Biotechnology, Business Development, Oncology, Molecular Diagnostics, Molecular Biology, Clinical Development, Toxicology, Infectious Diseases, Immunoassays, Cancer, Technology Transfer, Pharmaceutics, FDA, Biomarker Discovery, Strategy, Cell Biology, Vaccines, Biochemistry, R&D, Cell, DNA sequencing

Education
The Ohio State University
Ph.D.

University of California, San Diego - The Rady School of Management
MBA

University of Washington
BS

Cathi Rogers Cathi Rogers Cary, North Carolina Details
Cathi Rogers's PharmaDirections Experience Business Operations Manager and Business DevelpmentPharmaDirections$
Job Business Operations Manager at PharmaDirections
Industry Pharmaceuticals
Experience
PharmaDirections   Business Operations Manager and Business DevelpmentPharmaDirections$

Skills
Biotechnology, Life Sciences, Clinical Trials, Clinical Research, GMP, Technology Transfer, Pharmaceutical Industry

Education
Eastern Kentucky University

Johnna Sloop Johnna Sloop Rochester, Minnesota Area Details
Johnna Sloop's PharmaDirections Experience 2007 - 2009
Job Audit Coordinator at Mayo Clinic
Industry Hospital & Health Care
Experience
Home  August 2010 - Present
Mayo Clinic  October 2008 - Present
PharmaDirections   2007 - 2009
PharmaDirections   July 2007 - August 2008
The Weatherhills Group   December 2006 - July 2007
Salix Pharmaceuticals  April 2005 - July 2006
Mayne Pharma Inc   April 1999 - March 2005
aaipharma  August 1996 - January 1999

Education
High Point University   1992 — 1996
BS, Chemistry

Bethany Leins Bethany Leins Raleigh-Durham, North Carolina Area Details
Bethany Leins's PharmaDirections Experience June 2004 - May 2008
Job JCL Consulting LLC; Project Manager for PharmaDirections Inc
Industry Pharmaceuticals
Experience
JCL Consulting LLC   April 2010 - Present
bioMerieux Inc  June 2008 - March 2010
PharmaDirections   June 2004 - May 2008
Rhone-Poulenc Rorer  March 1997 - January 2000
Rhone Poulenc Rorer  March 1994 - February 1997
Cedars-Sinai Medical Center  March 1993 - March 1994

Skills
Pharmaceutical Industry, Validation, FDA, Biotechnology, Lifesciences, GMP, Project Management, Technology Transfer, Sop, Quality Assurance, 21 CFR Part 11, GLP, Clinical Development, CAPA, Regulatory Affairs, Drug Development, CRO, Clinical Trials, Biopharmaceuticals, V&V, GxP, Computer System..., Regulatory Submissions, Change Control, Life Sciences, SOP, Management, Medical Devices, Cross-functional Team..., Quality System, R&D, Product Development, Oncology, Leadership, Pharmaceutics, Drug Discovery, Clinical Research, Manufacturing, Consulting

Education
Duquesne University
Bachelor of Science (B.S.), Biology

NCPMI Leadership Committee

Maureen McBride-Simonds Maureen McBride-Simonds Raleigh-Durham, North Carolina Area Details
Maureen McBride-Simonds's PharmaDirections Experience 2006 - 2008
Job Director, Product Development EDIS Solutions at Allscripts
Industry Computer Software
Experience
Allscripts  2011 - Present
AllscriptsMisys Healthcare Solutions   2006 - September 2011
PharmaDirections   2006 - 2008
Icoria (a Clinical Data company)   2000 - 2006
Icoria  2000 - 2006
Paradigm Genetics  2000 - 2003
A4 Health Systems  1997 - 2000

Skills
Healthcare Information..., Informatics, Health Information..., Agile Methodologies, EHR, HL7, Software Development, EMR, Healthcare

Education
Swarthmore College   1976 — 1980
BA

Georgetown University
MPP

Roberta Susnow, PhD Roberta Susnow, PhD Greater New York City Area Details
Roberta Susnow, PhD's PharmaDirections Experience 2008 - 2011
Job Principal Medical Writer Developer at Sanofi
Industry Pharmaceuticals
Experience
Sanofi  2015 - Present
Nth Analytics   2008 - Present
Daiichi Sankyo, Inc.   2014 - 2014
Bristol-Myers Squibb  2011 - 2012
PharmaDirections   2008 - 2011
Johnson & Johnson  2006 - 2007
Pharmacopeia-Accelrys   2001 - 2002

Skills
Statistics, Clinical Trials, Clinical Study Design, Pharmaceutical Industry, Drug Discovery, SAS, Clinical Development, CRO, Drug Development, Lifesciences, Data Management, Oncology, Biotechnology, Regulatory Submissions, Life Sciences, Clinical Research, Protocol

Education
Princeton University   1986 — 1991
PhD, Physical Chemistry

Jay Breaux Jay Breaux Raleigh-Durham, North Carolina Area Details
Jay Breaux's PharmaDirections Experience January 2008 - November 2008
Job Pharmaceutical Development and Regulatory Affairs Consultant
Industry Pharmaceuticals
Experience
JB Life Sciences   January 2008 - Present
PharmaDirections   January 2008 - November 2008
King Pharmaceuticals  January 2007 - December 2007
Cato Research  July 2004 - January 2007
AAI Pharma  May 2001 - July 2003
Aventis Life Sciences   1999 - 2001
Rhone-Poulenc  1987 - 2001
Monsanto  1976 - 1986

Skills
Drug Development, Drug Discovery, Pharmaceutical Industry, Regulatory Affairs, CRO, CMC, Regulatory Submissions, FDA, Clinical Development, Lifesciences, R&D, CMC Regulatory Affairs, CMC development, Analytical Chemistry, Medicinal Chemistry, IND, GLP

Education
Northwestern University   1975 — 1976
Post Doctoral, Medicinal Chemsitry, Biochemistry

The Johns Hopkins University   1971 — 1975
Ph.D., Chemistry

John Jushchyshyn John Jushchyshyn Greater Philadelphia Area Details
John Jushchyshyn's PharmaDirections Experience 2003 - 2008
Job Independant Pharmaceutical Consultant
Industry Pharmaceuticals
Experience
Hyde-EC Consulting   November 2010 - Present
John M. Jushchyshyn,LLC   September 2002 - Present
PharmaDirections   2003 - 2008
GlaxoSmithKline  June 1971 - December 2002

Skills
Technical Transfer, Clin. Trial Supplies, Regulatory Compliance

Education
University of the Sciences in Philadelphia   1966 — 1969
BS, Chemistry

Marshall University
ms, Physical Organic Chemistry

David Houck David Houck Raleigh-Durham, North Carolina Area Details
David Houck's PharmaDirections Experience 2007 - 2008
Job Pharmaceutical Developer
Industry Pharmaceuticals
Experience
Pharmakey, LLC   January 2008 - Present
Naurex Inc.  January 2012 - August 2015
Summit Drug Development Services   January 2008 - April 2009
PharmaDirections   2007 - 2008
Scynexis  2003 - 2006
Phytera   2000 - 2003
ExSAR Corporation  2001 - 2002
OSI Pharmaceuticals  1994 - 1998
Sterling Winthrop  1989 - 1994
Sterling Winthrop Pharmaceuticals (Sterling Drug)   1989 - 1994

Education
The Ohio State University   1984 — 1987

Purdue University

Steve Gordziel Steve Gordziel Raleigh-Durham, North Carolina Area Details
Steve Gordziel's PharmaDirections Experience 2007 - Present
Job Practice Head at PharmaDirections
Industry Pharmaceuticals
Experience
PharmaDirections   2007 - Present
Hollis Eden Pharmaceutrical   September 2004 - May 2007
Penwest Pharmaceuticals  July 2002 - September 2004
Carter Wallace  October 1979 - May 2002
Ortho Pharmaceutical  1977 - 1979
Wyeth Laboratories  1974 - 1977

Education
University of Connecticut   1970 — 1974
PhD, Pharmaceutical Sciences

George Lukas George Lukas Greater New York City Area Details
George Lukas's PharmaDirections Experience 1995 - 2014
Job Owner, George Lukas Associates, Inc.
Industry Pharmaceuticals
Experience
George Lukas Associates, Inc.   March 1995 - Present
PharmaDirections   1995 - 2014
Ciba-Geigy Corp.  August 1964 - December 1994

Skills
Pharmaceutical Industry, Independent technical..., Drug Development, Pharmaceutics, FDA, Clinical Trials, Biotechnology, GMP, Clinical Research, Validation, Technology Transfer, Clinical Development, Life Sciences, SOP, Regulatory Submissions, Regulatory Affairs, GLP, Change Control, Biopharmaceuticals

Education
Massachusetts Institute of Technology   1959 — 1963
Doctor of Philosophy (Ph.D.), Organic Chemistry

Julie Sims Julie Sims Greater Philadelphia Area Details
Julie Sims's PharmaDirections Experience December 2004 - May 2008
Job Sr. Manager, Regulatory Affairs, CMC at Endo Pharmaceuticals
Industry Pharmaceuticals
Experience
Endo Pharmaceuticals  October 2012 - Present
Endo Pharmaceuticals  October 2009 - Present
jdsims & associates   January 1996 - October 2009
PharmaDirections   December 2004 - May 2008
Mead Johnson Nutritionals  January 1982 - February 1987

Skills
Validation, CMC Regulatory Affairs, Stability, Sop, Technical Writing, Pharmaceutical Industry, Quality Assurance, Document Management, Laboratory, Quality System, Quality Control, Regulatory Affairs, FDA, CAPA, Change Control, GMP, GxP, 21 CFR Part 11

Education
Temple University School of Pharmacy
Master of Science (MS), Quality Assurance and Regulatory Affairs

Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Science (B.S.), Environmental Chemistry

Kris Swackhammer Kris Swackhammer Greater Boston Area Details
Kris Swackhammer's PharmaDirections Experience January 2007 - May 2008
Job Associate Director Investigational Quality Assurance at Takeda International Pharmaceutical Co.
Industry Pharmaceuticals
Experience
Millennium Pharmaceuticals  October 2012 - Present
--  July 2011 - October 2012
OREXIGEN THERAPEUTICS INC   October 2008 - July 2011
PharmaDirections   January 2007 - May 2008
CARDINAL HEALTH INC  December 2003 - January 2007
Quantitative Technologies Inc   June 1995 - November 2003

Education
SUNY College of Environmental Science and Forestry   1993 — 1995
BS, Chemistry

Broome Community College   1991 — 1993
AAS, Industrial Technology (Chemical Emphesis)

Thomas Colatsky Thomas Colatsky Washington D.C. Metro Area Details
Thomas Colatsky's PharmaDirections Experience May 2006 - December 2008
Job Director, Division of Applied Regulatory Science at FDA
Industry Pharmaceuticals
Experience
FDA/CDER/OTS/OCP   September 2013 - Present
FDA  February 2011 - September 2013
FDA  July 2009 - February 2011
FDA  July 2009 - February 2011
GainStage Biosciences   January 2009 - July 2009
Alte Biosciences   May 2006 - January 2009
PharmaDirections   May 2006 - December 2008
Icoria (a Clinical Data company)   August 2002 - May 2006
Argolyn Biosciences   September 2001 - August 2002
Physiome Sciences  February 1999 - August 2001

Skills
Drug Discovery, Pharmacology, Clinical Development, Toxicology, Biomarkers, Computational Biology, Systems Biology, Technology Development, Computational Modeling, Ion Channels, Cardiovascular Medicine, Metabolic Diseases, Biomarker Discovery, Drug Development, Pharmacogenomics, Electrophysiology, Regulatory Science, Technology Evaluation, Pharmaceutical Research, Pharmaceutical..., Lifesciences, Biotechnology, FDA, IND, Pharmaceutical Industry, R, Translational Medicine, Clinical Trials, Pharmacokinetics, Life Sciences, Oncology, In Vitro, Assay Development, Pharmaceutics, Product Development, CRO, Medicine, Immunology, Science, Genomics, Metabolism, In Vivo, GCP, ADME, Cell, Biopharmaceuticals, Clinical Research, R&D

Education
Yale University School of Medicine   1977 — 1979
Post-doctoral

State University of New York at Buffalo - School of Medicine & Biomedical Sciences   1972 — 1977
Ph.D.

Georgetown University   1967 — 1972
B.S.

Christy Damphousse Christy Damphousse Greater Boston Area Details
Christy Damphousse's PharmaDirections Experience May 2013 - Present
Job Pharmaceutical Professional
Industry Pharmaceuticals
Experience
PharmaDirections   May 2013 - Present
Proteome Systems, Inc.   November 2006 - September 2008
Wyeth Research  March 2001 - March 2006
Eukarion, Inc.   October 1995 - March 2001

Skills
Pharmacology, Drug Discovery, Drug Development, Biomarkers, Pharmaceutical Industry, Biotechnology, Animal Models, In Vivo, Lifesciences, Assay Development

Education
Northeastern University   1999 — 2003
MS, Pharmacology

University of New Hampshire   1991 — 1995
BS, Biochemistry, Cum Laude; Honors in Major Distinction

Bruce Rehlaender Bruce Rehlaender Portland, Oregon Area Details
Bruce Rehlaender's PharmaDirections Experience November 2012 - Present
Job Principal, Formulation Development at PharmaDirections
Industry Pharmaceuticals
Experience
PharmaDirections   November 2012 - Present
PharmaDirections   September 2007 - November 2012
Cirrus Pharmaceuticals  March 2000 - August 2007
Pharmacia  February 1988 - May 1995

Skills
Drug Delivery, Formulation Development, Pharmacokinetics, Lyophilization, Pharmaceutical..., Pharmaceuticals, Pharmaceutical Industry, Drug Development, Technology Transfer, GMP, Dry Powder Inhalers, Validation, Analytical Chemistry, Product Development, Formulation, Lifesciences, Biotechnology, Clinical Trials, Protein Chemistry, Regulatory Affairs, Differential Scanning..., CMC, GLP, Aseptic Processing, Patents, HPLC, Spectroscopy, Pharmaceutics, CRO, Sop, FDA, IND

Education
University of North Carolina at Chapel Hill   1995 — 2000
Ph.D., Pharmaceutical Sciences

University of California, Berkeley   1978 — 1983
BA, Biochemistry

Steven Gordziel Steven Gordziel Orange Beach, Alabama Details
Steven Gordziel's PharmaDirections Experience September 2007 - December 2008
Job Owner of SG Pharma CMC Consulting, LLC
Industry Pharmaceuticals
Experience
SG Pharma CMC Consulting, LLC   January 2009 - Present
Tunnell Consulting  2009 - Present
HHS/BARDA   2009 - 2015
HHS/BARDA   2009 - 2015
HHS/BARDA   2009 - 2015
PharmaDirections   September 2007 - December 2008
Hollis Eden Pharmaceuticals  2004 - 2007
Carter-Wallace Inc.  1979 - 2002

Skills
Pharmaceutical Industry, Technology Transfer, GMP, Validation, FDA, Pharmaceutics, Regulatory Affairs, Drug Development, Sop, CAPA, Analytical Chemistry, Drug Delivery, Change Control, Formulation

Education
University of Connecticut   1970 — 1976
Ph.D., Pharmaceutics

Philadelphia Col. of Pharm. & Sci.   1965 — 1970
BS, Pharmacy

Bridget Smith Bridget Smith Raleigh, North Carolina Details
Bridget Smith's PharmaDirections Experience June 2013 - March 2014
Job Sales Consultant at IntegraLabs, Inc.
Industry Pharmaceuticals
Experience
IntegraLabs, Inc.   March 2014 - Present
PharmaDirections   June 2013 - March 2014
Merck -via TSS   September 2008 - March 2012
United Therapeutics  2006 - 2007
Covance  2006 - 2007
Cumberland Pharmacal Co.   2001 - 2007
Chiltern International  2005 - 2006
Novartis  2001 - 2003
GlaxoSmithKline  1991 - 2001

Skills
Pharmaceutical Sales, Pharmaceutical Industry, Product Management, Product Marketing, New Business Development, Biotechnology, CRO, Marketing Strategy, Successful Business..., Specialty Pharmaceutical, Product Launch, Website Development, Website Promotion, Patient Advocacy, Patient Education, Sales Effectiveness, Dermatology, Neurology, Sales

Education
University of Maryland College Park

E Dunzo E Dunzo Raleigh-Durham, North Carolina Area Details
E Dunzo's PharmaDirections Experience June 2008 - August 2010
Job Director at Applied Biopharmaceutics
Industry Pharmaceuticals
Experience
Applied Biopharmaceutics   August 2010 - Present
PharmaDirections   June 2008 - August 2010

Education
University of California, Berkeley   1993 — 1995
BS, Chemistry

Brooke Moody Brooke Moody Raleigh-Durham, North Carolina Area Details
Brooke Moody's PharmaDirections Experience February 2011 - Present
Job Quality Assurance Professional
Industry Pharmaceuticals
Experience
Polaris Compliance Consultants, Inc.   April 2012 - Present
Independent Quality Consultant   January 2011 - Present
PharmaDirections   February 2011 - Present
Whitsell Innovations, Inc.   2012 - 2013
Brooke Moody, L.L.C.   2011 - 2012
AlphaVax  March 2009 - February 2010
Qualicaps  June 2008 - March 2009
Amylin Pharmaceuticals  September 2006 - February 2008
Althea Technologies  February 2005 - September 2006
Isis Pharmaceuticals  November 2003 - February 2005

Skills
cGMP, Quality Auditing, Quality Systems, SOP, FDA, CAPA, Quality Assurance, Pharmaceuticals, Clinical Trials, Pharmaceutical..., Quality System, GMP

Education
Florida Atlantic University   1995 — 1999
Bachelor of Science, Chemistry