Atrix Laboratories
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Atrix Laboratories Employees
Employee
Years
Job
Industry
Steve Lohr Steve Lohr's Atrix Laboratories Experience 1994 - 2003
Job Trainer Consultant
Industry Biotechnology
Experience
Independent Contractor Trainer October 2013 - Present
Streffco Consultants, Inc. March 2012 - October 2013
Self employed - corporate trainer February 2011 - March 2012
AlloSource April 2003 - February 2011
Atrix Laboratories 1994 - 2003
Xoma Corporation 1989 - 1992
Skills
Documentation, Medical Devices, cGMP, Staff Training, Process Improvement, Safety Management, Investigations, Pharmaceuticals, GMP, Software Documentation, Training, FDA, Pharmaceutical Industry, Validation, Management, Safety Management..., Sop, Private Investigations, R&D, Manufacturing, Biotechnology
Education
The Ohio State University 1966 — 1976
Bachelor's degree, Biological Science
The Ohio State University 1966 — 1975
B. Sci., Biological Sciences
Independent Contractor Trainer October 2013 - Present
Streffco Consultants, Inc. March 2012 - October 2013
Self employed - corporate trainer February 2011 - March 2012
AlloSource April 2003 - February 2011
Atrix Laboratories 1994 - 2003
Xoma Corporation 1989 - 1992
Skills
Documentation, Medical Devices, cGMP, Staff Training, Process Improvement, Safety Management, Investigations, Pharmaceuticals, GMP, Software Documentation, Training, FDA, Pharmaceutical Industry, Validation, Management, Safety Management..., Sop, Private Investigations, R&D, Manufacturing, Biotechnology
Education
The Ohio State University 1966 — 1976
Bachelor's degree, Biological Science
The Ohio State University 1966 — 1975
B. Sci., Biological Sciences
James Sherman James Sherman's Atrix Laboratories Experience March 1993 - September 1996
Job Senior Scientist, Technical Services at TOLMAR Inc.
Industry Pharmaceuticals
Experience
TOLMAR Inc. April 2014 - Present
Zila Dental May 2012 - March 2014
Integra LifeSciences Corporation May 2010 - November 2011
Dentsply International Professional Division September 1996 - December 2009
Atrix Laboratories March 1993 - September 1996
Atrix Laboratories October 1989 - March 1993
Methodist Hospital of Indiana January 1989 - September 1989
Saint Vincent Hospital October 1987 - January 1989
Skills
Medical Devices, Cross-functional Team..., Validation, Product Development, ISO 13485, Lifesciences, V&V, Program Management, Project Management, Manufacturing, Design Control, FDA, Strategic Planning, CAPA, Product Launch, Clinical Development, ISO, Design of Experiments, Regulatory Affairs, Quality System, GMP, Testing, R&D, Clinical Research, Technology Transfer, 21 CFR Part 11, Commercialization
Education
Regis University 1993 — 1994
MS, Management
Colorado State University 1982 — 1986
BS, Microbiology / Medical Technology
TOLMAR Inc. April 2014 - Present
Zila Dental May 2012 - March 2014
Integra LifeSciences Corporation May 2010 - November 2011
Dentsply International Professional Division September 1996 - December 2009
Atrix Laboratories March 1993 - September 1996
Atrix Laboratories October 1989 - March 1993
Methodist Hospital of Indiana January 1989 - September 1989
Saint Vincent Hospital October 1987 - January 1989
Skills
Medical Devices, Cross-functional Team..., Validation, Product Development, ISO 13485, Lifesciences, V&V, Program Management, Project Management, Manufacturing, Design Control, FDA, Strategic Planning, CAPA, Product Launch, Clinical Development, ISO, Design of Experiments, Regulatory Affairs, Quality System, GMP, Testing, R&D, Clinical Research, Technology Transfer, 21 CFR Part 11, Commercialization
Education
Regis University 1993 — 1994
MS, Management
Colorado State University 1982 — 1986
BS, Microbiology / Medical Technology
Jack Rogers, RAC Jack Rogers, RAC's Atrix Laboratories Experience 1985 - 1991
Job Regulatory Affairs Consultant
Industry Medical Devices
Experience
Polymer Technology Systems, Inc 2012 - 2015
Beckman Coulter 2011 - 2012
Roche Diagnostics 2009 - 2011
Thermo Fisher Scientific 2004 - 2009
Sirna Therapeutics 2000 - 2004
MedLogic Global 1999 - 2000
Valleylab 1997 - 1999
REAADS Medical Products 1994 - 1997
Macleod Pharmaceuticals 1992 - 1993
Atrix Laboratories 1985 - 1991
Skills
FDA, Medical Devices, GMP, cGMP, Regulatory Affairs, Regulatory Submissions, 510 K, PMA, ISO 13485, Quality Systems, Quality Assurance, Diagnostics, Design Control, Regulatory Strategy, Commercialization, Product Development, R&D, QSR, Life Sciences, CE marking, Quality System, ISO 14971, CAPA, Strategy, GLP, Change Control, Sop, Hardware Diagnostics, Lifesciences, Validation, HPLC, Quality Control, Biotechnology, V&V, Pharmaceutical Industry, Analytical Chemistry, Chemistry, Drug Development, Quality Auditing, GxP, Technology Transfer, IVD, Regulatory Requirements, Immunoassays, Clinical Trials, ELISA, GCP, Purification, Assay Development, 21 CFR
Education
Colorado State University 1981 — 1984
M.S., Geology
Fort Hays State University 1977 — 1981
B.S., Geology
Polymer Technology Systems, Inc 2012 - 2015
Beckman Coulter 2011 - 2012
Roche Diagnostics 2009 - 2011
Thermo Fisher Scientific 2004 - 2009
Sirna Therapeutics 2000 - 2004
MedLogic Global 1999 - 2000
Valleylab 1997 - 1999
REAADS Medical Products 1994 - 1997
Macleod Pharmaceuticals 1992 - 1993
Atrix Laboratories 1985 - 1991
Skills
FDA, Medical Devices, GMP, cGMP, Regulatory Affairs, Regulatory Submissions, 510 K, PMA, ISO 13485, Quality Systems, Quality Assurance, Diagnostics, Design Control, Regulatory Strategy, Commercialization, Product Development, R&D, QSR, Life Sciences, CE marking, Quality System, ISO 14971, CAPA, Strategy, GLP, Change Control, Sop, Hardware Diagnostics, Lifesciences, Validation, HPLC, Quality Control, Biotechnology, V&V, Pharmaceutical Industry, Analytical Chemistry, Chemistry, Drug Development, Quality Auditing, GxP, Technology Transfer, IVD, Regulatory Requirements, Immunoassays, Clinical Trials, ELISA, GCP, Purification, Assay Development, 21 CFR
Education
Colorado State University 1981 — 1984
M.S., Geology
Fort Hays State University 1977 — 1981
B.S., Geology
Thaddeus Owen Thaddeus Owen's Atrix Laboratories Experience August 2001 - May 2004
Job Chief Engineer, Sustainability Team at Herman Miller
Industry Furniture
Experience
Otec Performance January 2009 - Present
Herman Miller August 2007 - Present
Perrigo July 2004 - July 2007
Perrigo Pharmaceuticals 2006 - 2007
Atrix Laboratories August 2001 - May 2004
Procter & Gamble December 1998 - July 2001
Skills
Sustainability, Environmental Awareness, Product Design, Life Cycle Assessment, Product Development, Project Management, Continuous Improvement, Lean Manufacturing, Cross-functional Team..., Six Sigma, Project Planning, Manufacturing, Process Simulation, R&D, Technology Transfer, Carbon Footprinting, LEED, Process Engineering
Education
Clayton College of Natural Health 2005 — 2007
MS, Holistic Nutrition
Clarkson University 1994 — 1998
BS, Chemical Engineering
Otec Performance January 2009 - Present
Herman Miller August 2007 - Present
Perrigo July 2004 - July 2007
Perrigo Pharmaceuticals 2006 - 2007
Atrix Laboratories August 2001 - May 2004
Procter & Gamble December 1998 - July 2001
Skills
Sustainability, Environmental Awareness, Product Design, Life Cycle Assessment, Product Development, Project Management, Continuous Improvement, Lean Manufacturing, Cross-functional Team..., Six Sigma, Project Planning, Manufacturing, Process Simulation, R&D, Technology Transfer, Carbon Footprinting, LEED, Process Engineering
Education
Clayton College of Natural Health 2005 — 2007
MS, Holistic Nutrition
Clarkson University 1994 — 1998
BS, Chemical Engineering
Art Tipton Art Tipton's Atrix Laboratories Experience May 1988 - May 1993
Job President and CEO at Southern Research Institute
Industry Pharmaceuticals
Experience
Southern Research Institute July 2013 - Present
Evonik Degussa November 2011 - June 2013
Brookwood Pharmaceuticals January 2005 - June 2013
Brookwood Pharmaceuticals January 2005 - June 2013
DURECT Corporation April 2001 - March 2004
Birmingham Polymers June 1993 - April 2001
Southern BioSystems May 1993 - April 2001
Atrix Laboratories May 1988 - May 1993
Skills
R&D, Technology Transfer, FDA, Biotechnology, Commercialization, Lifesciences, GMP, Medical Devices, Pharmaceutical Industry, Validation, Chemistry, Polymers, Drug Discovery, Quality System, Regulatory Affairs, Analytical Chemistry, GLP, V&V, Drug Development, Life Sciences, Biopharmaceuticals, Polymer Chemistry
Education
University of Massachusetts, Amherst 1983 — 1988
PhD, Polymer Science
Spring Hill College 1977 — 1980
BS, Chemistry
John Carroll
Southern Research Institute July 2013 - Present
Evonik Degussa November 2011 - June 2013
Brookwood Pharmaceuticals January 2005 - June 2013
Brookwood Pharmaceuticals January 2005 - June 2013
DURECT Corporation April 2001 - March 2004
Birmingham Polymers June 1993 - April 2001
Southern BioSystems May 1993 - April 2001
Atrix Laboratories May 1988 - May 1993
Skills
R&D, Technology Transfer, FDA, Biotechnology, Commercialization, Lifesciences, GMP, Medical Devices, Pharmaceutical Industry, Validation, Chemistry, Polymers, Drug Discovery, Quality System, Regulatory Affairs, Analytical Chemistry, GLP, V&V, Drug Development, Life Sciences, Biopharmaceuticals, Polymer Chemistry
Education
University of Massachusetts, Amherst 1983 — 1988
PhD, Polymer Science
Spring Hill College 1977 — 1980
BS, Chemistry
John Carroll
Chris French Chris French's Atrix Laboratories Experience October 2001 - November 2002
Job Vice President, Compliance, Advaxis, Inc.
Industry Pharmaceuticals
Experience
Advaxis, Inc. March 2011 - Present
Reach Within Lead Beyond January 2011 - Present
BRISTOL-MYERS SQUIBB COMPANY November 2007 - January 2011
Bristol-Myers Squibb, Princeton, New Jersey June 2006 - October 2007
MGI PHARMA, INC September 2004 - May 2006
AESGEN, INC. November 2002 - September 2004
Atrix Laboratories October 2001 - November 2002
AESGEN, INC March 2001 - October 2001
Scientific and Regulatory Affairs November 1995 - March 2001
MAYO MEDICAL CENTER January 1990 - January 1995
Education
University of St. Thomas 1992 — 1995
Master of Business Administration (M.B.A.), Marketing and Finance
Mayo Graduate School 1980 — 1984
Experimental Pathology/Molecular Biology
Mankato State University
Bachelor of Science, Biology; Chemistry
University of St. Thomas (TX)
Masters of Business Administration, Management Concentration (Marketing and Finance Core)
Advaxis, Inc. March 2011 - Present
Reach Within Lead Beyond January 2011 - Present
BRISTOL-MYERS SQUIBB COMPANY November 2007 - January 2011
Bristol-Myers Squibb, Princeton, New Jersey June 2006 - October 2007
MGI PHARMA, INC September 2004 - May 2006
AESGEN, INC. November 2002 - September 2004
Atrix Laboratories October 2001 - November 2002
AESGEN, INC March 2001 - October 2001
Scientific and Regulatory Affairs November 1995 - March 2001
MAYO MEDICAL CENTER January 1990 - January 1995
Education
University of St. Thomas 1992 — 1995
Master of Business Administration (M.B.A.), Marketing and Finance
Mayo Graduate School 1980 — 1984
Experimental Pathology/Molecular Biology
Mankato State University
Bachelor of Science, Biology; Chemistry
University of St. Thomas (TX)
Masters of Business Administration, Management Concentration (Marketing and Finance Core)
Terry Geiger Terry Geiger's Atrix Laboratories Experience September 2001 - October 2006
Job Instructor of Organic Chemistry at University of Colorado at Colorado Springs
Industry Higher Education
Experience
University of Colorado at Colorado Springs September 2012 - Present
Aims Community College January 2008 - Present
Reckitt Benckiser August 2008 - September 2012
QLT USA October 2006 - August 2008
Atrix Laboratories September 2001 - October 2006
Skills
Analytical Chemistry, Technology Transfer, Biotechnology, LC-MS, Chromatography, Lifesciences, FDA, Purification, GMP, GLP, HPLC, Validation, Chemistry, R&D, Organic Chemistry
Education
Kansas State University 1998 — 2001
MS, Organic Chemistry
University of Utah 1997 — 1998
Transfer, Biological Chemistry
University of Colorado at Colorado Springs 1991 — 1996
BS, Chemistry
University of Colorado at Colorado Springs September 2012 - Present
Aims Community College January 2008 - Present
Reckitt Benckiser August 2008 - September 2012
QLT USA October 2006 - August 2008
Atrix Laboratories September 2001 - October 2006
Skills
Analytical Chemistry, Technology Transfer, Biotechnology, LC-MS, Chromatography, Lifesciences, FDA, Purification, GMP, GLP, HPLC, Validation, Chemistry, R&D, Organic Chemistry
Education
Kansas State University 1998 — 2001
MS, Organic Chemistry
University of Utah 1997 — 1998
Transfer, Biological Chemistry
University of Colorado at Colorado Springs 1991 — 1996
BS, Chemistry
Brian Richmond Brian Richmond's Atrix Laboratories Experience 1980 - 2003
Job TOLMAR, Inc, CSU, Gymnastics Officiating
Industry Accounting
Experience
Tolmar Inc. June 2011 - Present
Sample and Bailey, CPAs 2003 - 2011
Atrix Laboratories 1980 - 2003
Skills
Financial Reporting, Accounting, General Ledger, Account Reconciliation, Financial Analysis, Budgets, Forecasting, Process Improvement, Financial Accounting, Tax, Microsoft Excel, Leadership, Internal Controls, Bookkeeping, QuickBooks, Finance, Strategic Planning, Auditing, Management, Mergers & Acquisitions
Education
Colorado State University 1970 — 1979
Master's degree, Business Administration and Management, General
Tolmar Inc. June 2011 - Present
Sample and Bailey, CPAs 2003 - 2011
Atrix Laboratories 1980 - 2003
Skills
Financial Reporting, Accounting, General Ledger, Account Reconciliation, Financial Analysis, Budgets, Forecasting, Process Improvement, Financial Accounting, Tax, Microsoft Excel, Leadership, Internal Controls, Bookkeeping, QuickBooks, Finance, Strategic Planning, Auditing, Management, Mergers & Acquisitions
Education
Colorado State University 1970 — 1979
Master's degree, Business Administration and Management, General
Rajan Bawa Rajan Bawa's Atrix Laboratories Experience 1997 - 1999
Job CEO & CSO at CHP/CARE Research, LLC
Industry Veterinary
Experience
CARE Research, LLC March 2010 - Present
Colorado Histo-Prep 1999 - Present
Atrix Laboratories 1997 - 1999
Alcon 1994 - 1997
Bausch & Lomb 1984 - 1994
Skills
Biotechnology, R&D, Pharmaceutical Industry, Laboratory, Life Sciences, Drug Delivery, Medical Devices, Clinical Development, FDA, Technology Transfer, Lifesciences, Biopharmaceuticals, Analytical Chemistry, GLP, Validation, CRO, Toxicology, Commercialization, Biomedical Engineering, Science, Regulatory Affairs, Chemistry, Drug Discovery, Product Development, Strategic Planning, Clinical Research, Research, Drug Development, Pharmaceutics, Start-ups, Formulation, Cell Culture, Targeted Drug Delivery, Process Research, Process Simulation, Regulatory Submissions, Preclinical Testing, Clinical Trials, Histopathology, Ocular Drug Delivery, Ocular Disease, GMP, Management, Strategy
Education
University of Rochester 1988 — 1992
Ph.D, Chemical Engineering
Massachusetts Institute of Technology 1978 — 1981
S.M. & S.M., Chemical Engineering & Nutritional Biochemistry & Metabolism
Carnegie Mellon University 1977 — 1978
Biomedical Engineering
Birla Institute of Technology & Science 1972 — 1977
B.E. (Hons), Chemical Engineering
CARE Research, LLC March 2010 - Present
Colorado Histo-Prep 1999 - Present
Atrix Laboratories 1997 - 1999
Alcon 1994 - 1997
Bausch & Lomb 1984 - 1994
Skills
Biotechnology, R&D, Pharmaceutical Industry, Laboratory, Life Sciences, Drug Delivery, Medical Devices, Clinical Development, FDA, Technology Transfer, Lifesciences, Biopharmaceuticals, Analytical Chemistry, GLP, Validation, CRO, Toxicology, Commercialization, Biomedical Engineering, Science, Regulatory Affairs, Chemistry, Drug Discovery, Product Development, Strategic Planning, Clinical Research, Research, Drug Development, Pharmaceutics, Start-ups, Formulation, Cell Culture, Targeted Drug Delivery, Process Research, Process Simulation, Regulatory Submissions, Preclinical Testing, Clinical Trials, Histopathology, Ocular Drug Delivery, Ocular Disease, GMP, Management, Strategy
Education
University of Rochester 1988 — 1992
Ph.D, Chemical Engineering
Massachusetts Institute of Technology 1978 — 1981
S.M. & S.M., Chemical Engineering & Nutritional Biochemistry & Metabolism
Carnegie Mellon University 1977 — 1978
Biomedical Engineering
Birla Institute of Technology & Science 1972 — 1977
B.E. (Hons), Chemical Engineering
Karen Cigliano Karen Cigliano's Atrix Laboratories Experience June 1995 - June 1996
Job Director, Quality Projects at Merck
Industry Pharmaceuticals
Experience
Merck May 2010 - Present
Pfizer (formerly Wyeth) July 2001 - May 2010
Wyeth January 2006 - May 2009
Wyeth January 2004 - December 2005
Wyeth Pharmaceuticals July 2001 - December 2003
PAREXEL International June 1996 - June 2001
Atrix Laboratories June 1995 - June 1996
GENETICS INSTITUTE November 1988 - June 1995
POLAROID-BEHRING DIAGNOSTICS November 1987 - November 1988
Biogen Idec June 1985 - November 1987
Skills
Change Management, Project Management, Manufacturing..., Pharmaceutical Industry, Biotechnology, Validation, FDA, Drug Development, Quality Operations, Change Control, GMP, 21 CFR Part 11, CAPA, Clinical Research, CTMS, Clinical Trials, Cross-functional Team..., Medical Devices, Pharmaceutics, Process Improvement, Product Launch, Regulatory Affairs, SOP, Technology Transfer
Education
Simmons College - Simmons School of Management 1990 — 1993
MBA
Northeastern University 1980 — 1985
Bachelor of Science, Biology
Merck May 2010 - Present
Pfizer (formerly Wyeth) July 2001 - May 2010
Wyeth January 2006 - May 2009
Wyeth January 2004 - December 2005
Wyeth Pharmaceuticals July 2001 - December 2003
PAREXEL International June 1996 - June 2001
Atrix Laboratories June 1995 - June 1996
GENETICS INSTITUTE November 1988 - June 1995
POLAROID-BEHRING DIAGNOSTICS November 1987 - November 1988
Biogen Idec June 1985 - November 1987
Skills
Change Management, Project Management, Manufacturing..., Pharmaceutical Industry, Biotechnology, Validation, FDA, Drug Development, Quality Operations, Change Control, GMP, 21 CFR Part 11, CAPA, Clinical Research, CTMS, Clinical Trials, Cross-functional Team..., Medical Devices, Pharmaceutics, Process Improvement, Product Launch, Regulatory Affairs, SOP, Technology Transfer
Education
Simmons College - Simmons School of Management 1990 — 1993
MBA
Northeastern University 1980 — 1985
Bachelor of Science, Biology
Chip Carnathan Chip Carnathan's Atrix Laboratories Experience January 1998 - October 1999
Job Director of Regulatory Affairs at Impact Pharmaceutical Services
Industry Biotechnology
Experience
Impact Pharmaceutical Services February 2014 - Present
Independent Consultant January 2012 - Present
Aptiv Solutions October 2010 - January 2012
Independent Consultant June 2010 - October 2010
Argos Therapeutics July 2009 - June 2010
SRA International November 2005 - April 2009
Origin USA LLC May 2003 - November 2005
Napro Biotherapeutics 2001 - 2005
IAVI 1999 - 2001
Atrix Laboratories January 1998 - October 1999
Skills
Vaccines, Clinical Development, Drug Development, IND, Toxicology, Biologics, Pharmacology, Biotechnology, Pharmaceutical Industry, Clinical Trials, Oncology, Regulatory Submissions, Medical Writing, Sop, GCP, Infectious Diseases, Clinical Research, Lifesciences, CRO, Therapeutic Areas, R&D, Regulatory Requirements, FDA, In Vivo, Clinical Study Design, GLP, Pharmaceutics, Immunology, Technology Transfer, Drug Discovery, Biopharmaceuticals, Life Sciences, SOP
Education
University of Massachusetts, Amherst 1976 — 1981
MS, PhD, Reproductive Pharmacology/Physiology
Northeastern University 1971 — 1974
BSc, Psychology
Impact Pharmaceutical Services February 2014 - Present
Independent Consultant January 2012 - Present
Aptiv Solutions October 2010 - January 2012
Independent Consultant June 2010 - October 2010
Argos Therapeutics July 2009 - June 2010
SRA International November 2005 - April 2009
Origin USA LLC May 2003 - November 2005
Napro Biotherapeutics 2001 - 2005
IAVI 1999 - 2001
Atrix Laboratories January 1998 - October 1999
Skills
Vaccines, Clinical Development, Drug Development, IND, Toxicology, Biologics, Pharmacology, Biotechnology, Pharmaceutical Industry, Clinical Trials, Oncology, Regulatory Submissions, Medical Writing, Sop, GCP, Infectious Diseases, Clinical Research, Lifesciences, CRO, Therapeutic Areas, R&D, Regulatory Requirements, FDA, In Vivo, Clinical Study Design, GLP, Pharmaceutics, Immunology, Technology Transfer, Drug Discovery, Biopharmaceuticals, Life Sciences, SOP
Education
University of Massachusetts, Amherst 1976 — 1981
MS, PhD, Reproductive Pharmacology/Physiology
Northeastern University 1971 — 1974
BSc, Psychology
Chad Ronholdt's Atrix Laboratories Experience May 1996 - May 1998
Job President and CEO at Subwave Sensing
Industry Medical Devices
Experience
Subwave Sensing LLC. November 2013 - Present
New Vision BioLOGIC Inc. March 2013 - Present
LABS Inc.(wholly owned subsidiary of AlloSource) May 2009 - March 2013
AlloSource February 2002 - May 2009
Sulzer Biologics Inc. May 2000 - October 2001
Ancea Inc. February 1999 - March 2000
Colorado Animal Research Enterprises September 1998 - August 1999
Atrix Laboratories May 1996 - May 1998
Skills
Medical Devices, FDA, Microbiology, Biotechnology, Commercialization, Assay Development, Start-ups, R&D, Stem Cells, Immunology, Laboratory, Strategic Planning, Biologics, Quality System, Project Management, Orthopedic, Cross-functional Team..., Biomedical Engineering, Marketing Strategy, Business Development, Contract Negotiation, Product Development, Leadership, Staff Development, Competitive Analysis, Regulations, Quality Control, Life Sciences
Education
Colorado State University
B.Sc., Microbiology
University of Phoenix
M.B.A., Technology Management
Colorado State University
Certificate, Biotechnology and Industrial Microbiology
Wheat Ridge High School
Subwave Sensing LLC. November 2013 - Present
New Vision BioLOGIC Inc. March 2013 - Present
LABS Inc.(wholly owned subsidiary of AlloSource) May 2009 - March 2013
AlloSource February 2002 - May 2009
Sulzer Biologics Inc. May 2000 - October 2001
Ancea Inc. February 1999 - March 2000
Colorado Animal Research Enterprises September 1998 - August 1999
Atrix Laboratories May 1996 - May 1998
Skills
Medical Devices, FDA, Microbiology, Biotechnology, Commercialization, Assay Development, Start-ups, R&D, Stem Cells, Immunology, Laboratory, Strategic Planning, Biologics, Quality System, Project Management, Orthopedic, Cross-functional Team..., Biomedical Engineering, Marketing Strategy, Business Development, Contract Negotiation, Product Development, Leadership, Staff Development, Competitive Analysis, Regulations, Quality Control, Life Sciences
Education
Colorado State University
B.Sc., Microbiology
University of Phoenix
M.B.A., Technology Management
Colorado State University
Certificate, Biotechnology and Industrial Microbiology
Wheat Ridge High School
Kathleen Thorson Kathleen Thorson's Atrix Laboratories Experience July 1998 - October 1999
Job Specialist QC, Bioanalytical Sciences, Amgen
Industry Biotechnology
Experience
Amgen July 2012 - Present
Amgen June 2002 - June 2012
Amgen March 2000 - May 2002
Atrix Laboratories July 1998 - October 1999
Atrix Laboratories October 1996 - June 1998
Colorado State University January 1994 - September 1996
US Army August 1986 - August 1989
Skills
Validation, LIMS, Aseptic Processing, Technology Transfer, Biotechnology, GMP, Bioassay, Immunoassays, Cell Culture, Protein Chemistry, Life Sciences, SDS-PAGE, Purification, Cell, Microbiology, ELISA, Antibodies, Chromatography
Education
Colorado State University
Bachelor's of Science, Microbiology
Amgen July 2012 - Present
Amgen June 2002 - June 2012
Amgen March 2000 - May 2002
Atrix Laboratories July 1998 - October 1999
Atrix Laboratories October 1996 - June 1998
Colorado State University January 1994 - September 1996
US Army August 1986 - August 1989
Skills
Validation, LIMS, Aseptic Processing, Technology Transfer, Biotechnology, GMP, Bioassay, Immunoassays, Cell Culture, Protein Chemistry, Life Sciences, SDS-PAGE, Purification, Cell, Microbiology, ELISA, Antibodies, Chromatography
Education
Colorado State University
Bachelor's of Science, Microbiology
Jennifer (Vandrilla) Culbertson's Atrix Laboratories Experience March 1999 - June 2000
Job President/Clinical Research Consultant at Acacia Consulting Services, LLC
Industry Pharmaceuticals
Experience
Acacia Consulting Services, LLC March 2013 - Present
Novella Clinical, Inc. February 2010 - March 2013
OSI Pharmaceuticals May 2009 - January 2010
Worldwide Clinical Research October 2007 - March 2009
OSI Pharmaceuticals, Inc. July 2000 - September 2007
Atrix Laboratories March 1999 - June 2000
Merck & Co. December 1995 - March 1999
Merck Research Laboratories July 1992 - December 1995
Skills
Oncology, Clinical Development, Clinical Research, Clinical Trials, Global Drug Development, Project Management, Drug Development, Pharmaceutical Industry, CRO, Clinical Data Management, EDC, GCP, Biotechnology, Regulatory Submissions, Clinical Monitoring, IND, ICH-GCP, Therapeutic Areas, CTMS, Clinical Operations, Sop, Clinical Trial..., Pharmaceuticals, Clinical Data, Data Monitoring, SOP
Education
Franklin & Marshall College 1988 — 1992
BA, Chemistry
Lancaster University 1990 — 1991
Study Abroad Program, Chemistry
Plainville High School 1984 — 1988
Acacia Consulting Services, LLC March 2013 - Present
Novella Clinical, Inc. February 2010 - March 2013
OSI Pharmaceuticals May 2009 - January 2010
Worldwide Clinical Research October 2007 - March 2009
OSI Pharmaceuticals, Inc. July 2000 - September 2007
Atrix Laboratories March 1999 - June 2000
Merck & Co. December 1995 - March 1999
Merck Research Laboratories July 1992 - December 1995
Skills
Oncology, Clinical Development, Clinical Research, Clinical Trials, Global Drug Development, Project Management, Drug Development, Pharmaceutical Industry, CRO, Clinical Data Management, EDC, GCP, Biotechnology, Regulatory Submissions, Clinical Monitoring, IND, ICH-GCP, Therapeutic Areas, CTMS, Clinical Operations, Sop, Clinical Trial..., Pharmaceuticals, Clinical Data, Data Monitoring, SOP
Education
Franklin & Marshall College 1988 — 1992
BA, Chemistry
Lancaster University 1990 — 1991
Study Abroad Program, Chemistry
Plainville High School 1984 — 1988
Susan Moore Susan Moore's Atrix Laboratories Experience 1996 - 1997
Job Founder and Principal Consultant at GLM Quality Research Consulting, LLC
Industry Medical Devices
Experience
GLM Quality Research Consulting, LLC June 2013 - Present
Terumo BCT June 2011 - June 2013
Colorado Quality Research, Inc. January 2011 - June 2011
Elanco Animal Health September 2004 - August 2010
Elanco Animal Health November 2002 - September 2004
SomaLogic April 2001 - April 2002
ThermoBiostar 1997 - 2001
Atrix Laboratories 1996 - 1997
Atrix Laboratories 1993 - 1996
Inhausen Research 1992 - 1993
Skills
FDA, Regulatory Affairs, GLP, Pharmaceutical Industry, Biotechnology, Clinical Trials, Lifesciences, Project Management, CTMS, Clinical Data Management, Regulatory Submissions, Sop, GMP, Regulatory Requirements, Medical Writing, Cross-functional Team..., Laboratory, GCP, Clinical Study Design, Clinical Development, Quality Assurance, Clinical Monitoring, Training, Validation, Infectious Diseases, Protocol, Medical Devices, Clinical Research, Quality System, Software Documentation, R&D, CRO, Pharmaceutics, Vaccines, Immunology, Life Sciences, SOP
Education
Colorado State University 1981 — 1985
BS, Animal Science
GLM Quality Research Consulting, LLC June 2013 - Present
Terumo BCT June 2011 - June 2013
Colorado Quality Research, Inc. January 2011 - June 2011
Elanco Animal Health September 2004 - August 2010
Elanco Animal Health November 2002 - September 2004
SomaLogic April 2001 - April 2002
ThermoBiostar 1997 - 2001
Atrix Laboratories 1996 - 1997
Atrix Laboratories 1993 - 1996
Inhausen Research 1992 - 1993
Skills
FDA, Regulatory Affairs, GLP, Pharmaceutical Industry, Biotechnology, Clinical Trials, Lifesciences, Project Management, CTMS, Clinical Data Management, Regulatory Submissions, Sop, GMP, Regulatory Requirements, Medical Writing, Cross-functional Team..., Laboratory, GCP, Clinical Study Design, Clinical Development, Quality Assurance, Clinical Monitoring, Training, Validation, Infectious Diseases, Protocol, Medical Devices, Clinical Research, Quality System, Software Documentation, R&D, CRO, Pharmaceutics, Vaccines, Immunology, Life Sciences, SOP
Education
Colorado State University 1981 — 1985
BS, Animal Science
Kathy Coressel Kathy Coressel's Atrix Laboratories Experience 2002 - 2004
Job Senior Regulatory Manager
Industry Pharmaceuticals
Experience
CHD Bioscience, Inc. January 2014 - June 2015
RMRAS 1996 - 2015
Terumo BCT December 2006 - December 2013
Atrix Laboratories 2002 - 2004
Sandoz August 1988 - December 2002
Skills
FDA, ISO 13485, Regulatory Affairs, Medical Devices, Design Control, CAPA, ISO 14971, Regulations, Regulatory Submissions, CE marking, Cross-functional Team..., Biotechnology, Quality System, GMP, V&V, Validation, Pharmaceutical Industry
Education
Regis University (Loretto Heights) 1984 — 1988
Bachelor of Applied Science (B.A.Sc.), Major Biology and Minor Chemistry, 3.84 GPA Magna Cum Laude
Erie High School
CHD Bioscience, Inc. January 2014 - June 2015
RMRAS 1996 - 2015
Terumo BCT December 2006 - December 2013
Atrix Laboratories 2002 - 2004
Sandoz August 1988 - December 2002
Skills
FDA, ISO 13485, Regulatory Affairs, Medical Devices, Design Control, CAPA, ISO 14971, Regulations, Regulatory Submissions, CE marking, Cross-functional Team..., Biotechnology, Quality System, GMP, V&V, Validation, Pharmaceutical Industry
Education
Regis University (Loretto Heights) 1984 — 1988
Bachelor of Applied Science (B.A.Sc.), Major Biology and Minor Chemistry, 3.84 GPA Magna Cum Laude
Erie High School
Thomas Walker's Atrix Laboratories Experience June 2000 - June 2001
Job
Industry Pharmaceuticals
Experience
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
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
Cindy Croissant's Atrix Laboratories Experience December 1993 - August 2000
Job
Industry Biotechnology
Experience
LumiThera, Inc. September 2015 - Present
LumiThera, Inc. April 2013 - September 2015
Vital Therapies, Inc. January 2013 - September 2015
Aeolus Pharmaceuticals, Inc. July 2012 - March 2014
PhotoThera January 2006 - September 2012
PAREXEL December 2002 - January 2006
PAREXEL August 2000 - December 2002
Atrix Laboratories December 1993 - August 2000
Atrix Laboratories June 1991 - December 1993
Skills
FDA, Oncology, Clinical Operations, Medical Devices, Lifesciences, Data Management, Biotechnology, Regulatory Affairs, Protocol, Clinical Development, Regulatory Submissions, Pharmaceutical Industry, Clinical Research, EDC, CRO, GCP, Life Sciences, ICH-GCP, Clinical Trials, CTMS
Education
Regis University 1998 — 2000
MBA, International Business
Colorado State University 1986 — 1991
BS, Business Administration
Colorado State University 1986 — 1991
BS, Psychology
LumiThera, Inc. September 2015 - Present
LumiThera, Inc. April 2013 - September 2015
Vital Therapies, Inc. January 2013 - September 2015
Aeolus Pharmaceuticals, Inc. July 2012 - March 2014
PhotoThera January 2006 - September 2012
PAREXEL December 2002 - January 2006
PAREXEL August 2000 - December 2002
Atrix Laboratories December 1993 - August 2000
Atrix Laboratories June 1991 - December 1993
Skills
FDA, Oncology, Clinical Operations, Medical Devices, Lifesciences, Data Management, Biotechnology, Regulatory Affairs, Protocol, Clinical Development, Regulatory Submissions, Pharmaceutical Industry, Clinical Research, EDC, CRO, GCP, Life Sciences, ICH-GCP, Clinical Trials, CTMS
Education
Regis University 1998 — 2000
MBA, International Business
Colorado State University 1986 — 1991
BS, Business Administration
Colorado State University 1986 — 1991
BS, Psychology
Jason Modest's Atrix Laboratories Experience May 2001 - June 2002
Job Director of Technical Services at TOLMAR Inc.
Industry Pharmaceuticals
Experience
TOLMAR Inc. June 2015 - Present
Sandoz March 2013 - May 2015
Sandoz May 2012 - March 2013
Sandoz January 2012 - May 2012
Paddock Laboratories March 2010 - December 2011
Paddock Laboratories January 2007 - March 2010
Patheon Inc. August 2004 - January 2007
Mikart Inc. August 2002 - August 2004
Atrix Laboratories May 2001 - June 2002
Paragon Analytics August 1998 - May 2001
Skills
Pharmaceuticals, Formulation Development, cGMP, GMP, Technology Transfer, Validation, Formulation, Analytical Chemistry, Product Development, Protein Chemistry, Regulatory Affairs, Generic Programming, Regulatory Submissions, CAPA, Pharmaceutical Industry, Change Control, FDA, Sop, GLP, Pharmaceutics, Quality System, V&V, Quality Assurance, HPLC
Education
Fort Lewis College 1992 — 1996
B.S., Biochemistry/Chemistry
TOLMAR Inc. June 2015 - Present
Sandoz March 2013 - May 2015
Sandoz May 2012 - March 2013
Sandoz January 2012 - May 2012
Paddock Laboratories March 2010 - December 2011
Paddock Laboratories January 2007 - March 2010
Patheon Inc. August 2004 - January 2007
Mikart Inc. August 2002 - August 2004
Atrix Laboratories May 2001 - June 2002
Paragon Analytics August 1998 - May 2001
Skills
Pharmaceuticals, Formulation Development, cGMP, GMP, Technology Transfer, Validation, Formulation, Analytical Chemistry, Product Development, Protein Chemistry, Regulatory Affairs, Generic Programming, Regulatory Submissions, CAPA, Pharmaceutical Industry, Change Control, FDA, Sop, GLP, Pharmaceutics, Quality System, V&V, Quality Assurance, HPLC
Education
Fort Lewis College 1992 — 1996
B.S., Biochemistry/Chemistry
Robert Tyler's Atrix Laboratories Experience 2001 - 2004
Job Director Clinical Research at Janssen
Industry Pharmaceuticals
Experience
Janssen October 2014 - Present
Dendreon-Seattle, WA November 2013 - October 2014
Dendreon March 2010 - October 2013
Cenotor Ortho BioTech August 2006 - February 2010
sanofi-aventis August 2004 - August 2006
Sanofi-Synthelabo 2003 - 2006
Atrix Laboratories 2001 - 2004
University of Coclrado 1998 - 2001
University of Colorado School of Medicine 1993 - 1998
Skills
Cardiology, Urology, Oncology, Clinical Trials, Clinical Research, Medicine, Nephrology, Neurology, Endocrinology, Lifesciences, Infectious Diseases, Immunology, Biotechnology, Rheumatology, Pharmaceutical Industry, Drug Development, Dermatology, Medical Affairs, GCP, Clinical Development, Medical Writing, Diabetes, Gastroenterology, Cancer, Pharmacovigilance, Hematology, CTMS, Vaccines, Therapeutic Areas, Managed Care, CRO, Pharmacology, Biopharmaceuticals, Market Access, Biologics, Translational Medicine, Hypertension, Regulatory Affairs, Pulmonology
Education
Colorado State University 1986 — 1992
Ph.D., Physiology-Cardiovascular
Janssen October 2014 - Present
Dendreon-Seattle, WA November 2013 - October 2014
Dendreon March 2010 - October 2013
Cenotor Ortho BioTech August 2006 - February 2010
sanofi-aventis August 2004 - August 2006
Sanofi-Synthelabo 2003 - 2006
Atrix Laboratories 2001 - 2004
University of Coclrado 1998 - 2001
University of Colorado School of Medicine 1993 - 1998
Skills
Cardiology, Urology, Oncology, Clinical Trials, Clinical Research, Medicine, Nephrology, Neurology, Endocrinology, Lifesciences, Infectious Diseases, Immunology, Biotechnology, Rheumatology, Pharmaceutical Industry, Drug Development, Dermatology, Medical Affairs, GCP, Clinical Development, Medical Writing, Diabetes, Gastroenterology, Cancer, Pharmacovigilance, Hematology, CTMS, Vaccines, Therapeutic Areas, Managed Care, CRO, Pharmacology, Biopharmaceuticals, Market Access, Biologics, Translational Medicine, Hypertension, Regulatory Affairs, Pulmonology
Education
Colorado State University 1986 — 1992
Ph.D., Physiology-Cardiovascular
Molly Vardas's Atrix Laboratories Experience January 2001 - April 2004
Job Quality Assurance
Industry Pharmaceuticals
Experience
Sandoz April 2012 - Present
Amgen January 2011 - June 2011
Amgen March 2006 - January 2011
Sirna Therapeutics May 2004 - February 2006
Atrix Laboratories January 2001 - April 2004
Geneva Pharmaceuticals November 1998 - December 2000
Skills
HPLC, FDA, Validation, Chromatography, Technology Transfer, Analytical Chemistry, LIMS, UV/Vis, Chemistry, Purification, ELISA, 21 CFR Part 11, Biopharmaceuticals, Quality System, Medical Devices, Quality Assurance, GxP, Trackwise, Quality Auditing, Regulatory Requirements, cGMP practices, CAPA, Sop, Aseptic Processing, Cleaning Validation, FDA GMP, GLP, Quality Control, V&V, Computer System..., Lifesciences, Life Sciences, SOP, TrackWise
Education
University of Arizona 1994 — 1998
BS, Chemistry
Sandoz April 2012 - Present
Amgen January 2011 - June 2011
Amgen March 2006 - January 2011
Sirna Therapeutics May 2004 - February 2006
Atrix Laboratories January 2001 - April 2004
Geneva Pharmaceuticals November 1998 - December 2000
Skills
HPLC, FDA, Validation, Chromatography, Technology Transfer, Analytical Chemistry, LIMS, UV/Vis, Chemistry, Purification, ELISA, 21 CFR Part 11, Biopharmaceuticals, Quality System, Medical Devices, Quality Assurance, GxP, Trackwise, Quality Auditing, Regulatory Requirements, cGMP practices, CAPA, Sop, Aseptic Processing, Cleaning Validation, FDA GMP, GLP, Quality Control, V&V, Computer System..., Lifesciences, Life Sciences, SOP, TrackWise
Education
University of Arizona 1994 — 1998
BS, Chemistry
Cheri Jones's Atrix Laboratories Experience February 2003 - November 2004
Job Vice President Regulatory Affairs at Peplin
Industry Pharmaceuticals
Experience
Peplin Vice President Regulatory AffairsQLT Inc.November 2004 - February 2006
Atrix Laboratories February 2003 - November 2004
Obagi Medical Products July 1998 - June 2002
Alpharma July 1988 - January 1992
Education
Saint John's University 1983 — 1985
M.S., Pharmaceutical Marketing, Allied Health
St. Joseph's College 1981 — 1983
B.S., Health Care Administration
Elizabeth Seton College 1976 — 1978
AAS, General Business
Peplin Vice President Regulatory AffairsQLT Inc.November 2004 - February 2006
Atrix Laboratories February 2003 - November 2004
Obagi Medical Products July 1998 - June 2002
Alpharma July 1988 - January 1992
Education
Saint John's University 1983 — 1985
M.S., Pharmaceutical Marketing, Allied Health
St. Joseph's College 1981 — 1983
B.S., Health Care Administration
Elizabeth Seton College 1976 — 1978
AAS, General Business
Cynthia Venendaal, PhD, MPH, CCRA's Atrix Laboratories Experience January 2003 - November 2004
Job Senior Director, Project Management at Clinipace Worldwide
Industry Biotechnology
Experience
Clinipace Worldwide April 2013 - Present
Clinipace Worldwide October 2012 - Present
Clinipace Worldwide September 2011 - October 2012
Clinipace Worldwide May 2008 - September 2011
Array BioPharma July 2006 - May 2008
Array BioPharma July 2006 - October 2007
QLT Inc. (formerly Atrix Laboratories) November 2004 - December 2006
QLT Inc. 2004 - 2006
Atrix Laboratories January 2003 - November 2004
Atrix Laboratories June 2001 - January 2003
Skills
Clinical Development, Clinical Trials, Oncology, Infectious Diseases, Medical Writing, Clinical Research, Dermatology, Endocrinology, Clinical Operations, CTMS, CRO, GCP, Clinical Monitoring, EDC, Phase I, ICH-GCP, Therapeutic Areas, Drug Development, Protocol, Clinical Data Management, Regulatory Submissions, Regulatory Affairs, Sop, Pharmacovigilance, IND, Clinical Study Design, Vaccines, Inform, Data Management, Biotechnology, FDA, Pharmaceutical Industry, 21 CFR Part 11, Neurology, Lifesciences, Diabetes, Immunology, Oracle Clinical, Pharmacology, IRB, Hematology, Cardiology, Drug Discovery, Cancer, Biopharmaceuticals, Patient Recruitment, Clinical Pharmacology, CRF design, Medical Affairs
Education
University of Colorado Anschutz Medical Campus 2004 — 2007
PhD, Clinical Science
University of Northern Colorado 2000 — 2002
MPH, Public Health
University of Massachusetts, Amherst 1995 — 1999
BS, Biology
Clinipace Worldwide April 2013 - Present
Clinipace Worldwide October 2012 - Present
Clinipace Worldwide September 2011 - October 2012
Clinipace Worldwide May 2008 - September 2011
Array BioPharma July 2006 - May 2008
Array BioPharma July 2006 - October 2007
QLT Inc. (formerly Atrix Laboratories) November 2004 - December 2006
QLT Inc. 2004 - 2006
Atrix Laboratories January 2003 - November 2004
Atrix Laboratories June 2001 - January 2003
Skills
Clinical Development, Clinical Trials, Oncology, Infectious Diseases, Medical Writing, Clinical Research, Dermatology, Endocrinology, Clinical Operations, CTMS, CRO, GCP, Clinical Monitoring, EDC, Phase I, ICH-GCP, Therapeutic Areas, Drug Development, Protocol, Clinical Data Management, Regulatory Submissions, Regulatory Affairs, Sop, Pharmacovigilance, IND, Clinical Study Design, Vaccines, Inform, Data Management, Biotechnology, FDA, Pharmaceutical Industry, 21 CFR Part 11, Neurology, Lifesciences, Diabetes, Immunology, Oracle Clinical, Pharmacology, IRB, Hematology, Cardiology, Drug Discovery, Cancer, Biopharmaceuticals, Patient Recruitment, Clinical Pharmacology, CRF design, Medical Affairs
Education
University of Colorado Anschutz Medical Campus 2004 — 2007
PhD, Clinical Science
University of Northern Colorado 2000 — 2002
MPH, Public Health
University of Massachusetts, Amherst 1995 — 1999
BS, Biology
Elyse Wolff's Atrix Laboratories Experience January 1988 - November 2004
Job Owner/Consultant at Dawn Research Solutions, LLC
Industry Pharmaceuticals
Experience
Dawn Research Solutions, LLC April 2014 - Present
Reckitt Benckiser Pharmaceuticals August 2008 - April 2014
QLT USA November 2004 - August 2008
Atrix Laboratories January 1988 - November 2004
Skills
Biotechnology, Technology Transfer, FDA, GMP, Regulatory Affairs, Validation
Education
Colorado State University
BS, Medical Technology & Microbiology
Dawn Research Solutions, LLC April 2014 - Present
Reckitt Benckiser Pharmaceuticals August 2008 - April 2014
QLT USA November 2004 - August 2008
Atrix Laboratories January 1988 - November 2004
Skills
Biotechnology, Technology Transfer, FDA, GMP, Regulatory Affairs, Validation
Education
Colorado State University
BS, Medical Technology & Microbiology
Paul Welk's Atrix Laboratories Experience July 1991 - February 1992
Job Sr Manager at Amgen
Industry Pharmaceuticals
Experience
Amgen Inc. July 1997 - Present
Novartis(Geneva Pharmaceuticals) March 1995 - June 1997
American Veterinary Products January 1994 - March 1995
Synergen Inc. February 1992 - April 1994
Atrix Laboratories July 1991 - February 1992
Dr. Mike Elliott, Colorado State University, Fort Collins, Colorado May 1990 - July 1991
Skills
GMP
Education
Colorado State University 1990 — 1992
BS, chemistry
Fort Lewis College 1987 — 1989
BS, Chemistry
Amgen Inc. July 1997 - Present
Novartis(Geneva Pharmaceuticals) March 1995 - June 1997
American Veterinary Products January 1994 - March 1995
Synergen Inc. February 1992 - April 1994
Atrix Laboratories July 1991 - February 1992
Dr. Mike Elliott, Colorado State University, Fort Collins, Colorado May 1990 - July 1991
Skills
GMP
Education
Colorado State University 1990 — 1992
BS, chemistry
Fort Lewis College 1987 — 1989
BS, Chemistry
Kasey Kravig's Atrix Laboratories Experience January 2003 - July 2003
Job Quality Engineer at Tolmar Inc.
Industry Biotechnology
Experience
Tolmar Inc. November 2011 - Present
Amgen March 2011 - July 2011
Amgen July 2003 - February 2011
Atrix Laboratories January 2003 - July 2003
Atrix Laboratories July 2001 - December 2002
Geneva Pharmaceuticals 1997 - 2001
Geneva Pharmaceuticals 1992 - 1997
Education
University of Colorado at Boulder
Bachelors, Chemical Engineering, Biochemistry, Biology
Tolmar Inc. November 2011 - Present
Amgen March 2011 - July 2011
Amgen July 2003 - February 2011
Atrix Laboratories January 2003 - July 2003
Atrix Laboratories July 2001 - December 2002
Geneva Pharmaceuticals 1997 - 2001
Geneva Pharmaceuticals 1992 - 1997
Education
University of Colorado at Boulder
Bachelors, Chemical Engineering, Biochemistry, Biology
Craig Wesselman's Atrix Laboratories Experience 2003 - 2005
Job Associate Director of Biostatistics at CPC Research
Industry Pharmaceuticals
Experience
CPC Research January 2014 - Present
CPC Research September 2013 - January 2014
TOLMAR July 2003 - September 2013
QLT Inc. 2003 - 2006
Atrix Laboratories 2003 - 2005
i3 Statprobe October 1998 - July 2003
Skills
Clinical Trials, Biostatistics, Data Management, Protocol, SAS, Clinical Study Design, Pharmaceutical Industry, Clinical Development, GCP, Oncology, Validation, Regulatory Submissions, Sop, Data Analysis, Statistical Programming, EDC, Statistical Modeling, ICH-GCP, Statistical Consulting, Pharmacokinetics, Dermatology, Biotechnology, CRO, Clinical Data Management, Clinical Research, FDA, Life Sciences, Drug Development
Education
Brigham Young University 1993 — 2000
MS, Statistics
CPC Research January 2014 - Present
CPC Research September 2013 - January 2014
TOLMAR July 2003 - September 2013
QLT Inc. 2003 - 2006
Atrix Laboratories 2003 - 2005
i3 Statprobe October 1998 - July 2003
Skills
Clinical Trials, Biostatistics, Data Management, Protocol, SAS, Clinical Study Design, Pharmaceutical Industry, Clinical Development, GCP, Oncology, Validation, Regulatory Submissions, Sop, Data Analysis, Statistical Programming, EDC, Statistical Modeling, ICH-GCP, Statistical Consulting, Pharmacokinetics, Dermatology, Biotechnology, CRO, Clinical Data Management, Clinical Research, FDA, Life Sciences, Drug Development
Education
Brigham Young University 1993 — 2000
MS, Statistics
Rick Holl's Atrix Laboratories Experience August 2000 - February 2003
Job Director, Development Operations
Industry Pharmaceuticals
Experience
Lupin Pharmaceuticals, Inc February 2015 - Present
Catalent Pharma Solutions February 2012 - February 2015
Aptuit April 2008 - February 2012
Cephalon September 2003 - March 2008
Atrix Laboratories August 2000 - February 2003
Southern BioSystems 1994 - 1999
Skills
Clinical Development, Research, Film, Group Management, Pharmaceutical...
Education
Auburn University 1982 — 1989
PhD, Chemical Engineering
University of Florida 1978 — 1982
BSChE, Chemical Engineering
Lupin Pharmaceuticals, Inc February 2015 - Present
Catalent Pharma Solutions February 2012 - February 2015
Aptuit April 2008 - February 2012
Cephalon September 2003 - March 2008
Atrix Laboratories August 2000 - February 2003
Southern BioSystems 1994 - 1999
Skills
Clinical Development, Research, Film, Group Management, Pharmaceutical...
Education
Auburn University 1982 — 1989
PhD, Chemical Engineering
University of Florida 1978 — 1982
BSChE, Chemical Engineering
Cody Yarborough's Atrix Laboratories Experience 1998 - April 2004
Job Managing Member at Lifecycle Biotechnologies L.P.
Industry Biotechnology
Experience
CHATA Biosystems, LLC June 2011 - Present
Boval BioSolutions, LLC. October 2004 - Present
Lifecycle Biotechnologies, LP October 2004 - Present
Atrix Laboratories 1998 - April 2004
Alcon Laboratories, Inc. 1992 - 1998
ScanRoad, Inc. 1987 - 1992
Skills
Biotechnology, Technology Transfer, Pharmaceutical Industry, Validation, FDA, GMP, Lifesciences, Product Development, R&D, HPLC, Medical Devices, Continuous Improvement, V&V, Manufacturing, Strategic Planning, Sop, Clinical Development, Project Management, Chromatography, Market Development
Education
The University of Texas at Arlington 1994 — 1996
MBA, Marketing
Tarleton State University 1983 — 1987
BS Chemistry, Chemistry, International Business
CHATA Biosystems, LLC June 2011 - Present
Boval BioSolutions, LLC. October 2004 - Present
Lifecycle Biotechnologies, LP October 2004 - Present
Atrix Laboratories 1998 - April 2004
Alcon Laboratories, Inc. 1992 - 1998
ScanRoad, Inc. 1987 - 1992
Skills
Biotechnology, Technology Transfer, Pharmaceutical Industry, Validation, FDA, GMP, Lifesciences, Product Development, R&D, HPLC, Medical Devices, Continuous Improvement, V&V, Manufacturing, Strategic Planning, Sop, Clinical Development, Project Management, Chromatography, Market Development
Education
The University of Texas at Arlington 1994 — 1996
MBA, Marketing
Tarleton State University 1983 — 1987
BS Chemistry, Chemistry, International Business
Brent Coonts's Atrix Laboratories Experience July 1992 - November 2004
Job Director CMC Operations at Indivior Inc.
Industry Pharmaceuticals
Experience
Indivior Inc. January 2015 - Present
Reckitt Benckiser Pharmaceuticals February 2014 - January 2015
Reckitt Benckiser Pharmaceuticals August 2008 - February 2014
QLT USA, Inc November 2004 - August 2008
Atrix Laboratories July 1992 - November 2004
Skills
Technology Transfer, GLP, Analytical Chemistry, Pharmaceutical Industry, GMP, Sop, Regulatory Affairs, R&D, CAPA, HPLC, Validation, FDA, V&V, Change Control, Medical Devices, CMC
Education
Colorado State University 1984 — 1988
B.S.
Indivior Inc. January 2015 - Present
Reckitt Benckiser Pharmaceuticals February 2014 - January 2015
Reckitt Benckiser Pharmaceuticals August 2008 - February 2014
QLT USA, Inc November 2004 - August 2008
Atrix Laboratories July 1992 - November 2004
Skills
Technology Transfer, GLP, Analytical Chemistry, Pharmaceutical Industry, GMP, Sop, Regulatory Affairs, R&D, CAPA, HPLC, Validation, FDA, V&V, Change Control, Medical Devices, CMC
Education
Colorado State University 1984 — 1988
B.S.
Roy Wren's Atrix Laboratories Experience June 1998 - January 2000
Job Automations Engineer at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company May 2012 - Present
St. Jude Medical August 2011 - May 2012
Multivac September 2009 - October 2010
Atrix Laboratories June 1998 - January 2000
Skills
Machinery, Automation, Manufacturing, Packaging, Product Development, Medical Devices, Lean Manufacturing, Process Improvement, Engineering Management, ISO, Engineering, Thermoforming, Project Management, Continuous Improvement, FDA, Management, Solidworks, Kaizen, Machining, Troubleshooting, 5S, Project Engineering, Plastics, Process Engineering, Manufacturing..., R&D, Maintenance Management, V&V, Root Cause Analysis, GMP, Design for Manufacturing, Validation, Manufacturing..., Design of Experiments, Quality System, FMEA, CAPA, Six Sigma, Cross-functional Team..., SPC, Design Control, ISO 13485
Education
Regis University 1988 — 1991
AGS MCSE, computer science
Frontrange community College 1985 — 1987
MCSE, Computer Science
Eli Lilly and Company May 2012 - Present
St. Jude Medical August 2011 - May 2012
Multivac September 2009 - October 2010
Atrix Laboratories June 1998 - January 2000
Skills
Machinery, Automation, Manufacturing, Packaging, Product Development, Medical Devices, Lean Manufacturing, Process Improvement, Engineering Management, ISO, Engineering, Thermoforming, Project Management, Continuous Improvement, FDA, Management, Solidworks, Kaizen, Machining, Troubleshooting, 5S, Project Engineering, Plastics, Process Engineering, Manufacturing..., R&D, Maintenance Management, V&V, Root Cause Analysis, GMP, Design for Manufacturing, Validation, Manufacturing..., Design of Experiments, Quality System, FMEA, CAPA, Six Sigma, Cross-functional Team..., SPC, Design Control, ISO 13485
Education
Regis University 1988 — 1991
AGS MCSE, computer science
Frontrange community College 1985 — 1987
MCSE, Computer Science
Edward Adrian's Atrix Laboratories Experience 2001 - 2004
Job Vice President of Production Operations at Tolmar Inc.
Industry Pharmaceuticals
Experience
Tolmar Inc. October 2012 - Present
Tolmar 2004 - October 2012
Atrix Laboratories 2001 - 2004
Schering-Plough November 1995 - June 2001
Springs Industries June 1992 - November 1995
Education
Louisiana State University 1988 — 1992
MS, Industrial Engineering
Colorado State University 1983 — 1988
BS, Industrial Technology
Tolmar Inc. October 2012 - Present
Tolmar 2004 - October 2012
Atrix Laboratories 2001 - 2004
Schering-Plough November 1995 - June 2001
Springs Industries June 1992 - November 1995
Education
Louisiana State University 1988 — 1992
MS, Industrial Engineering
Colorado State University 1983 — 1988
BS, Industrial Technology
Kate Norton's Atrix Laboratories Experience August 1997 - December 2001
Job Regulatory Affairs Consultant
Industry Pharmaceuticals
Experience
KHN Consulting, LLC September 2009 - Present
Clovis Oncology March 2010 - September 2011
Array Biopharma June 2008 - May 2009
PR Pharmaceuticals January 2002 - April 2008
Atrix Laboratories August 1997 - December 2001
Skills
GMP, Oncology, Sop, Clinical Development, Lifesciences, GLP, Regulatory Submissions, Biotechnology, FDA, Validation, Clinical Trials, GCP, Regulatory Affairs, Clinical Research, Drug Development, CAPA, Analytical Chemistry, Medical Writing, Technology Transfer, Biopharmaceuticals, V&V, IND, Chromatography
Education
University of Cincinnati 1990 — 1997
PhD, Developmental Biology
Indiana University Bloomington 1986 — 1990
BS, Biology
KHN Consulting, LLC September 2009 - Present
Clovis Oncology March 2010 - September 2011
Array Biopharma June 2008 - May 2009
PR Pharmaceuticals January 2002 - April 2008
Atrix Laboratories August 1997 - December 2001
Skills
GMP, Oncology, Sop, Clinical Development, Lifesciences, GLP, Regulatory Submissions, Biotechnology, FDA, Validation, Clinical Trials, GCP, Regulatory Affairs, Clinical Research, Drug Development, CAPA, Analytical Chemistry, Medical Writing, Technology Transfer, Biopharmaceuticals, V&V, IND, Chromatography
Education
University of Cincinnati 1990 — 1997
PhD, Developmental Biology
Indiana University Bloomington 1986 — 1990
BS, Biology
Sherry Palmateer's Atrix Laboratories Experience 1991 - 1998
Job Associate Director of Clinical Operations, Training and Education at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences January 2014 - Present
PRA International April 2013 - January 2014
PRA International November 2005 - April 2013
PRA International January 1999 - November 2005
Atrix Laboratories 1991 - 1998
Skills
CTMS, CRO, EDC, Clinical Monitoring, ICH-GCP, GCP, Clinical Trials, Clinical Operations, Therapeutic Areas, Clinical Development, Oncology, Pharmaceutical Industry, Training, Performance Improvement, Program Management, Curriculum Design, Leadership, Resource Management, Management, Process Improvement, Training Needs Analysis, Mentoring, Protocol, SOP, Clinical Research, FDA, Clinical Data Management, Regulatory Submissions, Data Management, Biotechnology, Drug Development, Life Sciences, Cross-functional Team..., IND
Education
Capella University 2001 — 2005
MS Adult Education, Training and Development
Bloomsburg University of Pennsylvania 1981 — 1985
BSN, Nursing
PRA Health Sciences January 2014 - Present
PRA International April 2013 - January 2014
PRA International November 2005 - April 2013
PRA International January 1999 - November 2005
Atrix Laboratories 1991 - 1998
Skills
CTMS, CRO, EDC, Clinical Monitoring, ICH-GCP, GCP, Clinical Trials, Clinical Operations, Therapeutic Areas, Clinical Development, Oncology, Pharmaceutical Industry, Training, Performance Improvement, Program Management, Curriculum Design, Leadership, Resource Management, Management, Process Improvement, Training Needs Analysis, Mentoring, Protocol, SOP, Clinical Research, FDA, Clinical Data Management, Regulatory Submissions, Data Management, Biotechnology, Drug Development, Life Sciences, Cross-functional Team..., IND
Education
Capella University 2001 — 2005
MS Adult Education, Training and Development
Bloomsburg University of Pennsylvania 1981 — 1985
BSN, Nursing
Joseph Raciti's Atrix Laboratories Experience 1999 - 2000
Job Director of Quality:Administration and SelfInjection Systems at West Pharmaceutical Services
Industry Pharmaceuticals
Experience
West Pharmaceutical Services July 2011 - Present
West Pharmaceutical Services July 2009 - July 2011
Wyeth Pharmaceuticals March 2002 - July 2009
Sulzer Biologics 2000 - 2001
Atrix Laboratories 1999 - 2000
Rosemont Pharmaceuticals 1994 - 1998
Pharmaceutical Basics 1994 - 1998
PBI 1994 - 1998
DuPont Merck Pharmaceuticls 1988 - 1994
Dupont Pharmaceuticals 1988 - 1994
Education
University of Delaware 1981 — 1987
BA/BS, Chemistry
West Pharmaceutical Services July 2011 - Present
West Pharmaceutical Services July 2009 - July 2011
Wyeth Pharmaceuticals March 2002 - July 2009
Sulzer Biologics 2000 - 2001
Atrix Laboratories 1999 - 2000
Rosemont Pharmaceuticals 1994 - 1998
Pharmaceutical Basics 1994 - 1998
PBI 1994 - 1998
DuPont Merck Pharmaceuticls 1988 - 1994
Dupont Pharmaceuticals 1988 - 1994
Education
University of Delaware 1981 — 1987
BA/BS, Chemistry
Graham Carron's Atrix Laboratories Experience 1997 - 2003
Job AD Biostatistics at PPD
Industry Biotechnology
Experience
PPD May 2012 - Present
Adolor Corporation February 2010 - May 2012
ZARS Pharma 2007 - 2009
Myriad Genetics May 2005 - August 2007
NPS Pharmaceuticals May 2003 - May 2005
NPS Pharmaceuticals 2003 - 2005
NPS 2003 - 2005
Atrix laboratories 1997 - 2003
Novartis 1989 - 2003
Sandoz 1989 - 1993
Skills
Clinical Trials, Experimental Design, Mixed Model, Biostatistics, CRO, Clinical Research, Data Management, Pharmaceutical Industry, Clinical Development, Biotechnology, Statistics, Oncology, Life Sciences, Clinical Data Management, SAS, Pharmacology, CDISC
Education
Brigham Young University 1982 — 1989
MS, Statistics
PPD May 2012 - Present
Adolor Corporation February 2010 - May 2012
ZARS Pharma 2007 - 2009
Myriad Genetics May 2005 - August 2007
NPS Pharmaceuticals May 2003 - May 2005
NPS Pharmaceuticals 2003 - 2005
NPS 2003 - 2005
Atrix laboratories 1997 - 2003
Novartis 1989 - 2003
Sandoz 1989 - 1993
Skills
Clinical Trials, Experimental Design, Mixed Model, Biostatistics, CRO, Clinical Research, Data Management, Pharmaceutical Industry, Clinical Development, Biotechnology, Statistics, Oncology, Life Sciences, Clinical Data Management, SAS, Pharmacology, CDISC
Education
Brigham Young University 1982 — 1989
MS, Statistics
David Bethune's Atrix Laboratories Experience 1999 - 2005
Job Strategic Alliances Manager at TOLMAR Inc.
Industry Pharmaceuticals
Experience
TOLMAR Inc. March 2014 - Present
Zila Inc. February 2012 - Present
Zila, Inc. October 2008 - May 2012
Tolmar Inc. October 2007 - October 2008
QLT Inc. January 2006 - September 2007
Atrix Laboratories 1999 - 2005
ACNielsen 1993 - 1999
Skills
Pharmaceutical Industry, Pharmaceutical Sales, Medical Devices, Marketing Strategy, Product Development, Sales Operations, Product Launch, FDA, Cardiology, Sales Force Development, Business Development, Biotechnology, Strategic Planning, Product Management, Capital Equipment, Cross-functional Team..., Oncology, Management, Sales Management, Lifesciences, Dermatology, Sales, Account Management, Leadership
Education
Lenoir-Rhyne College 1985 — 1991
Bachelor of Arts (B.A.), International Relations and Affairs
TOLMAR Inc. March 2014 - Present
Zila Inc. February 2012 - Present
Zila, Inc. October 2008 - May 2012
Tolmar Inc. October 2007 - October 2008
QLT Inc. January 2006 - September 2007
Atrix Laboratories 1999 - 2005
ACNielsen 1993 - 1999
Skills
Pharmaceutical Industry, Pharmaceutical Sales, Medical Devices, Marketing Strategy, Product Development, Sales Operations, Product Launch, FDA, Cardiology, Sales Force Development, Business Development, Biotechnology, Strategic Planning, Product Management, Capital Equipment, Cross-functional Team..., Oncology, Management, Sales Management, Lifesciences, Dermatology, Sales, Account Management, Leadership
Education
Lenoir-Rhyne College 1985 — 1991
Bachelor of Arts (B.A.), International Relations and Affairs
Elaine Gazdeck's Atrix Laboratories Experience 1988 - 2001
Job Director QA/Reg Compliance at ArrayBioPharma Inc
Industry Pharmaceuticals
Experience
ArrayBioPharma Inc. April 2013 - Present
ArrayBioPharma Inc January 2007 - March 2013
Gazdeck/Taylor & Associates, LLC July 2001 - December 2006
Atrix Laboratories 1988 - 2001
Genentech January 1983 - June 1987
Burroughs Wellcome October 1972 - December 1982
Skills
FDA, GMP, Regulatory Affairs, Validation, CAPA, Product Development, Quality Assurance, GLP, Regulatory Submissions, Pharmaceutical Industry, Regulatory Requirements, V&V, Medical Devices, 21 CFR Part 11, Technology Transfer, Sop
Education
Southern Illinois University, Carbondale 1968 — 1972
BS, Community Recreation/Botany
ArrayBioPharma Inc. April 2013 - Present
ArrayBioPharma Inc January 2007 - March 2013
Gazdeck/Taylor & Associates, LLC July 2001 - December 2006
Atrix Laboratories 1988 - 2001
Genentech January 1983 - June 1987
Burroughs Wellcome October 1972 - December 1982
Skills
FDA, GMP, Regulatory Affairs, Validation, CAPA, Product Development, Quality Assurance, GLP, Regulatory Submissions, Pharmaceutical Industry, Regulatory Requirements, V&V, Medical Devices, 21 CFR Part 11, Technology Transfer, Sop
Education
Southern Illinois University, Carbondale 1968 — 1972
BS, Community Recreation/Botany
Pamela Sklanka's Atrix Laboratories Experience February 2001 - October 2001
Job Regional Director Consulting ServicesQuality Compliance Development
Industry Biotechnology
Experience
Life Technologies August 2009 - February 2012
CV Partners / XenoPort October 2008 - July 2009
Atos Origin August 2007 - July 2008
Scientific Careers January 2007 - July 2008
Quality Compliance Partners June 2007 - September 2007
Averent July 2006 - September 2006
Genentech August 2004 - July 2006
IT&E Consulting May 2004 - August 2004
Quintiles Consulting June 2002 - April 2004
Atrix Laboratories February 2001 - October 2001
Skills
Validation, 21 CFR Part 11, CAPA, Change Control, Computer System..., Cross-functional Team..., FDA, Medical Devices, Process Improvement, Quality Assurance, Quality Control, Quality System, Software Documentation, Sop, Testing, Quality Management, ISO, Biotechnology, Life Sciences, Pharmaceutical Industry, GMP, Management, Quality Auditing
Education
Metro State College 1984 — 1988
BA, Athletic Training (Sports Medicine)
Fort Lewis College 1982 — 1983
Business Management
Aims Community College 1982 — 1982
Chemical Testing Technology
Life Technologies August 2009 - February 2012
CV Partners / XenoPort October 2008 - July 2009
Atos Origin August 2007 - July 2008
Scientific Careers January 2007 - July 2008
Quality Compliance Partners June 2007 - September 2007
Averent July 2006 - September 2006
Genentech August 2004 - July 2006
IT&E Consulting May 2004 - August 2004
Quintiles Consulting June 2002 - April 2004
Atrix Laboratories February 2001 - October 2001
Skills
Validation, 21 CFR Part 11, CAPA, Change Control, Computer System..., Cross-functional Team..., FDA, Medical Devices, Process Improvement, Quality Assurance, Quality Control, Quality System, Software Documentation, Sop, Testing, Quality Management, ISO, Biotechnology, Life Sciences, Pharmaceutical Industry, GMP, Management, Quality Auditing
Education
Metro State College 1984 — 1988
BA, Athletic Training (Sports Medicine)
Fort Lewis College 1982 — 1983
Business Management
Aims Community College 1982 — 1982
Chemical Testing Technology
Brad Thomson's Atrix Laboratories Experience December 1995 - August 2003
Job Experienced Sales Representative
Industry Biotechnology
Experience
VWR International, LLC January 2005 - December 2012
Atrix Laboratories December 1995 - August 2003
Skills
Lifesciences, Sales Management, Direct Sales, Account Management, Key Account Management, CRM, Selling, Product Development, Sales Operations, Management, FDA, Sales Process, Biotechnology
Education
University of Northern Colorado 1984 — 1988
Bachelor of Arts (B.A.), Biological Sciences/Chemistry
VWR International, LLC January 2005 - December 2012
Atrix Laboratories December 1995 - August 2003
Skills
Lifesciences, Sales Management, Direct Sales, Account Management, Key Account Management, CRM, Selling, Product Development, Sales Operations, Management, FDA, Sales Process, Biotechnology
Education
University of Northern Colorado 1984 — 1988
Bachelor of Arts (B.A.), Biological Sciences/Chemistry
Elizabeth Colello's Atrix Laboratories Experience 2000 - 2001
Job Sr Manager, Clinical Monitoring at inVentiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health Clinical April 2015 - Present
inVentiv Health Clinical July 2013 - Present
inVentiv Health Clinical August 2003 - Present
Atrix Laboratories 2000 - 2001
Skills
Project Management, CRO, Clinical Research, Clinical Trials, Pharmaceutical Industry, Clinical Monitoring, Clinical Operations, Phase I, Vendor Management, Cross-functional Team..., Project Plans, Resource Management, Diabetes, Vaccines, GCP, Clinical Data Management, CTMS, Clinical Development, EDC
Education
Cabrini College 1995 — 1998
Bachelor of Science (BSc), Biology, General, Summa Cumme Laude
School name:
inVentiv Health Clinical April 2015 - Present
inVentiv Health Clinical July 2013 - Present
inVentiv Health Clinical August 2003 - Present
Atrix Laboratories 2000 - 2001
Skills
Project Management, CRO, Clinical Research, Clinical Trials, Pharmaceutical Industry, Clinical Monitoring, Clinical Operations, Phase I, Vendor Management, Cross-functional Team..., Project Plans, Resource Management, Diabetes, Vaccines, GCP, Clinical Data Management, CTMS, Clinical Development, EDC
Education
Cabrini College 1995 — 1998
Bachelor of Science (BSc), Biology, General, Summa Cumme Laude
School name:
Cherylyn Mecca's Atrix Laboratories Experience 1989 - 2000
Job Quality Systems Management
Industry Management Consulting
Experience
RES Americas September 2012 - Present
Schott Solar Inc. August 2009 - April 2012
Schott Solar, Inc. August 2008 - August 2009
Emcore 2006 - 2008
Hewlett-Packard 2000 - 2006
Atrix Laboratories 1989 - 2000
Sandoz, Inc. 1981 - 1989
Skills
Lean Manufacturing, Solar Energy, Manufacturing, Renewable Energy, Continuous Improvement, Engineering, Engineering Management, Cross-functional Team..., Six Sigma, Semiconductors, Photovoltaics, Process Improvement, SPC, Quality Assurance, Quality System, Quality Auditing, Quality Control, Supply Chain Management, Customer Service, Quality Management
Education
Regis University
MBA, International Marketing
Regis University
BS, Business Adminstration
RES Americas September 2012 - Present
Schott Solar Inc. August 2009 - April 2012
Schott Solar, Inc. August 2008 - August 2009
Emcore 2006 - 2008
Hewlett-Packard 2000 - 2006
Atrix Laboratories 1989 - 2000
Sandoz, Inc. 1981 - 1989
Skills
Lean Manufacturing, Solar Energy, Manufacturing, Renewable Energy, Continuous Improvement, Engineering, Engineering Management, Cross-functional Team..., Six Sigma, Semiconductors, Photovoltaics, Process Improvement, SPC, Quality Assurance, Quality System, Quality Auditing, Quality Control, Supply Chain Management, Customer Service, Quality Management
Education
Regis University
MBA, International Marketing
Regis University
BS, Business Adminstration
Sue Schaedle's Atrix Laboratories Experience 2004 - 2014
Job Founder and Medical Writer, Peak One Medical Writing, LLC
Industry Pharmaceuticals
Experience
Peak One Medical Writing, LLC January 2002 - Present
Atrix Laboratories 2004 - 2014
Genomica Corporation 2001 - 2002
Valleylab 1998 - 2001
Hauser, Inc. 1996 - 1998
Bristol-Myers Squibb 1988 - 1992
Skills
Pharmaceutical Industry, Biotechnology, SOP, FDA, GCP, Regulatory Submissions, GMP, Medical Devices, User Manual Development, Clinical Study Design, Protocol Development, Study Reports, CMC, ICH Guidelines, Writing, Editing, Marketing Communications, Dermatology, Oncology, Consulting, Medical Writing, Teaching
Education
University of Colorado Boulder 1992 — 1995
M.A., Journalism
Quinnipiac University - School of Business 1990 — 1991
Business Management
Emerson College 1985 — 1987
B.S., Communication Science
Peak One Medical Writing, LLC January 2002 - Present
Atrix Laboratories 2004 - 2014
Genomica Corporation 2001 - 2002
Valleylab 1998 - 2001
Hauser, Inc. 1996 - 1998
Bristol-Myers Squibb 1988 - 1992
Skills
Pharmaceutical Industry, Biotechnology, SOP, FDA, GCP, Regulatory Submissions, GMP, Medical Devices, User Manual Development, Clinical Study Design, Protocol Development, Study Reports, CMC, ICH Guidelines, Writing, Editing, Marketing Communications, Dermatology, Oncology, Consulting, Medical Writing, Teaching
Education
University of Colorado Boulder 1992 — 1995
M.A., Journalism
Quinnipiac University - School of Business 1990 — 1991
Business Management
Emerson College 1985 — 1987
B.S., Communication Science
Aaron R. Goerke's Atrix Laboratories Experience June 2000 - October 2000
Job GBMSAT Purification Sr. Group Leader at Genentech
Industry Biotechnology
Experience
Genentech August 2013 - Present
Genentech November 2012 - August 2013
Merck Research Labs October 2007 - November 2012
Stanford University 2004 - 2007
Merck Research Labs 2001 - 2004
Atrix Laboratories June 2000 - October 2000
COBE Cardiovascular June 1999 - June 2000
Skills
Biochemical Engineering, Process Validation, Fermentation, cGMP, Vaccines, Harvest, Separations, GMP, Filtration, Technology Transfer, Chromatography, Purification, Process Development, Chemical Engineering, Pharmaceuticals, Biotechnology, Validation, Protein Purification, HPLC, Downstream Processing, Life Sciences, Protein Chemistry, SDS-PAGE, Molecular Biology, R&D, Cell Biology, Clinical Development, Biopharmaceuticals, FDA, GLP
Education
Stanford University 2004 — 2007
Ph.D., Chemical Engineering
Baylor University
BS, ACS Honors in Chemistry
Colorado State University
MS, Chemical Engineering
Genentech August 2013 - Present
Genentech November 2012 - August 2013
Merck Research Labs October 2007 - November 2012
Stanford University 2004 - 2007
Merck Research Labs 2001 - 2004
Atrix Laboratories June 2000 - October 2000
COBE Cardiovascular June 1999 - June 2000
Skills
Biochemical Engineering, Process Validation, Fermentation, cGMP, Vaccines, Harvest, Separations, GMP, Filtration, Technology Transfer, Chromatography, Purification, Process Development, Chemical Engineering, Pharmaceuticals, Biotechnology, Validation, Protein Purification, HPLC, Downstream Processing, Life Sciences, Protein Chemistry, SDS-PAGE, Molecular Biology, R&D, Cell Biology, Clinical Development, Biopharmaceuticals, FDA, GLP
Education
Stanford University 2004 — 2007
Ph.D., Chemical Engineering
Baylor University
BS, ACS Honors in Chemistry
Colorado State University
MS, Chemical Engineering