Synergen Company
Description
Address: 11750 Katy Fwy #1000, Houston, TX 77079 Hours: Open ⋅ Closes 5PM Martin Luther King Jr. Day might affect these hoursMonday(Martin Luther King Jr. Day)8AM–5PMHours might differTuesday8AM–5PMWednesday8AM–5PMThursday8AM–5PMFriday8AM–5PMSaturdayClosedSundayClosedSuggest an edit Unable to add this file. Please check that it is a valid photo. Phone: (800) 701-4248: : : : Place name: : : Website: Category: Website: https://synergen.com/ Category: Consultant Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Synergen Consulting International Posting publicly on the Web Write a review Reviews Be the first to review
Synergen List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Synergen. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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Synergen Employees
Employee
Years
Job
Industry
Lee Hazzard Lee Hazzard's Synergen Experience 1992 - 1995
Job Manager at SlimGenics
Industry
Experience
SlimGenics June 2012 - Present
Peak to Peak Charter School 2006 - 2012
Weekenders 2002 - 2007
Hazzard Consulting 1997 - 2001
Amgen 1995 - 1997
Synergen 1992 - 1995
Synergen 1990 - 1992
Synergen 1989 - 1990
Synergen 1988 - 1989
Veterinary hospitals 1984 - 1988
Skills
Microsoft Excel, Microsoft Office, Public Speaking, Customer Service, Leadership
Education
Pennsylvania State University 1981 — 1984
Bachelor of Science (B.S.), Animal Sciences
Harcum College 1979 — 1981
Animal Sciences
University of Denver
Environmental policy and management
SlimGenics June 2012 - Present
Peak to Peak Charter School 2006 - 2012
Weekenders 2002 - 2007
Hazzard Consulting 1997 - 2001
Amgen 1995 - 1997
Synergen 1992 - 1995
Synergen 1990 - 1992
Synergen 1989 - 1990
Synergen 1988 - 1989
Veterinary hospitals 1984 - 1988
Skills
Microsoft Excel, Microsoft Office, Public Speaking, Customer Service, Leadership
Education
Pennsylvania State University 1981 — 1984
Bachelor of Science (B.S.), Animal Sciences
Harcum College 1979 — 1981
Animal Sciences
University of Denver
Environmental policy and management
Edward Jennings Edward Jennings's Synergen Experience 1992 - 1994
Job IBRF Pilot Plant Operations Manager at National Renewable Energy Laboratory
Industry Renewables & Environment
Experience
National Renewable Energy Laboratory October 2014 - Present
National Renewable Energy Laboratory July 1995 - Present
National Renewable Energy Laboratory 1995 - 2003
Synergen 1992 - 1994
Skills
Biotechnology, Fermentation, enzymatic hydrolysis, Process Integration, Process Validation, GMPLS, Writing For Publication, Cellulosic Ethanol..., Ethanol, Scalability, Pretreatment of..., Renewable Energy, Biofuels, Biomass, Pilot Plant, Biochemistry, Microbiology
Education
State University of New York College at Plattsburgh
Bachelor's degree, Environmental Science
State University of New York College at Plattsburgh
National Renewable Energy Laboratory October 2014 - Present
National Renewable Energy Laboratory July 1995 - Present
National Renewable Energy Laboratory 1995 - 2003
Synergen 1992 - 1994
Skills
Biotechnology, Fermentation, enzymatic hydrolysis, Process Integration, Process Validation, GMPLS, Writing For Publication, Cellulosic Ethanol..., Ethanol, Scalability, Pretreatment of..., Renewable Energy, Biofuels, Biomass, Pilot Plant, Biochemistry, Microbiology
Education
State University of New York College at Plattsburgh
Bachelor's degree, Environmental Science
State University of New York College at Plattsburgh
Brian C. Finley's Synergen Experience January 1993 - July 1994
Job Vice President of Application Development ■ Director ■ 20+ Years of Experience
Industry Information Technology and Services
Experience
Wells Fargo August 2015 - Present
BSI Group March 2013 - July 2015
Wells Fargo September 2011 - February 2013
Translational Genomics Research Institute (TGen) April 2009 - August 2011
AAA Northern California, Nevada & Utah June 2006 - March 2009
OppenheimerFunds December 1999 - May 2006
OppenheimerFunds December 1997 - December 1999
OppenheimerFunds August 1994 - November 1997
Synergen January 1993 - July 1994
Skills
Program Management, Project Management, Software Development, IT Strategy, Team Leadership, Leadership, Scrum, Management, SaaS, Waterfall, Agile Project Management, SQL, Disaster Recovery, Oracle, Enterprise Software, Integration, SDLC, CRM, Strategy, IT Management, Start-ups, Risk Management, Product Management, Business Analysis, Salesforce.com, Analysis, Agile Methodologies, Vendor Management, Process Improvement, Requirements Analysis, Consulting
Education
University of Oklahoma - Price College of Business 1989 — 1992
BBA, Managment Information Systems
Wells Fargo August 2015 - Present
BSI Group March 2013 - July 2015
Wells Fargo September 2011 - February 2013
Translational Genomics Research Institute (TGen) April 2009 - August 2011
AAA Northern California, Nevada & Utah June 2006 - March 2009
OppenheimerFunds December 1999 - May 2006
OppenheimerFunds December 1997 - December 1999
OppenheimerFunds August 1994 - November 1997
Synergen January 1993 - July 1994
Skills
Program Management, Project Management, Software Development, IT Strategy, Team Leadership, Leadership, Scrum, Management, SaaS, Waterfall, Agile Project Management, SQL, Disaster Recovery, Oracle, Enterprise Software, Integration, SDLC, CRM, Strategy, IT Management, Start-ups, Risk Management, Product Management, Business Analysis, Salesforce.com, Analysis, Agile Methodologies, Vendor Management, Process Improvement, Requirements Analysis, Consulting
Education
University of Oklahoma - Price College of Business 1989 — 1992
BBA, Managment Information Systems
Dean Jannuzzi Dean Jannuzzi's Synergen Experience 1986 - 1994
Job Consultant at Hyde Engineering + Consulting
Industry Biotechnology
Experience
Hyde Engineering + Consulting May 2014 - Present
Amgen April 2013 - April 2014
Merck November 2010 - December 2012
ASDx Biosystems Inc October 2008 - May 2010
Endo Pharmaceuticals April 2007 - April 2008
Insmed January 2006 - March 2007
Amgen June 2003 - January 2006
Baxter November 1998 - December 2002
Synergen 1986 - 1994
Skills
GMP, Biotechnology, HPLC, Chromatography, Biopharmaceuticals, GLP, Protein Chemistry, Pharmaceutical Industry, Validation, Purification, Technology Transfer, 21 CFR Part 11, Assay Development, ELISA, Cell, Sop
Education
Colorado State University 1980 — 1984
Bachelor of Science (BSc), Microbiology
Hyde Engineering + Consulting May 2014 - Present
Amgen April 2013 - April 2014
Merck November 2010 - December 2012
ASDx Biosystems Inc October 2008 - May 2010
Endo Pharmaceuticals April 2007 - April 2008
Insmed January 2006 - March 2007
Amgen June 2003 - January 2006
Baxter November 1998 - December 2002
Synergen 1986 - 1994
Skills
GMP, Biotechnology, HPLC, Chromatography, Biopharmaceuticals, GLP, Protein Chemistry, Pharmaceutical Industry, Validation, Purification, Technology Transfer, 21 CFR Part 11, Assay Development, ELISA, Cell, Sop
Education
Colorado State University 1980 — 1984
Bachelor of Science (BSc), Microbiology
Jim Seely's Synergen Experience September 1992 - January 1995
Job Blues Guitarist
Industry Biotechnology
Experience
Currently guitar player for Papa Juke, 50 Shades of Blue and the CTS Praise Band March 1996 - Present
Self-employed February 2013 - April 2014
Amgen December 2000 - December 2012
Blues Ambassadors 2008 - 2012
Synergen September 1992 - January 1995
Synergen September 1992 - December 1994
Skills
V&V, Protein Purification, Protein Chemistry, Pharmaceutical process..., Biotechnology, Biochemistry, Hydrophobic Interaction..., SDS-PAGE, Process Simulation, Validation, GLP, Purification, LC-MS, Monoclonal Antibodies, GMP, Biopharmaceuticals, Antibodies, Chromatography, Downstream Processing, Technology Transfer, LIMS, Fermentation, Commercialization, Assay Development, HPLC, Blues Guitar, Blues, Slide Guitar, Characterization, Cell Culture, Sop
Education
The University of South Dakota 1976 — 1980
Doctor of Philosophy (Ph.D.), Biochemistry
Buena Vista University 1972 — 1976
Bachelor of Science (BS), Chemistry and Biology
Currently guitar player for Papa Juke, 50 Shades of Blue and the CTS Praise Band March 1996 - Present
Self-employed February 2013 - April 2014
Amgen December 2000 - December 2012
Blues Ambassadors 2008 - 2012
Synergen September 1992 - January 1995
Synergen September 1992 - December 1994
Skills
V&V, Protein Purification, Protein Chemistry, Pharmaceutical process..., Biotechnology, Biochemistry, Hydrophobic Interaction..., SDS-PAGE, Process Simulation, Validation, GLP, Purification, LC-MS, Monoclonal Antibodies, GMP, Biopharmaceuticals, Antibodies, Chromatography, Downstream Processing, Technology Transfer, LIMS, Fermentation, Commercialization, Assay Development, HPLC, Blues Guitar, Blues, Slide Guitar, Characterization, Cell Culture, Sop
Education
The University of South Dakota 1976 — 1980
Doctor of Philosophy (Ph.D.), Biochemistry
Buena Vista University 1972 — 1976
Bachelor of Science (BS), Chemistry and Biology
Richard Beeler Richard Beeler's Synergen Experience March 1999 - October 2006
Job Technical Writer/Editor
Industry Writing and Editing
Experience
Self-employed Chairman, English DepartmentLebanese International University
Lebanese International University (LIU Yemen) October 2009 - September 2010
Oracle November 2006 - October 2007
Synergen March 1999 - October 2006
U.S. Joint Economic Commission September 1985 - December 1997
Colorado State University September 1976 - August 1985
Skills
Technical Writing, Editing, Information Technology, Computer Proficiency, Library Instruction, Library Research, Copy Editing, FrameMaker, Program Management, Content Management, Teaching, Customer Service, Creative Writing
Education
University of California, Berkeley 1997 — 1998
Professional Certificate, Technical Documentation
The University of Texas at Austin 1970 — 1971
Masters of Library and Information Science (M.L.S.), Information Technology
The University of Texas at Austin 1966 — 1968
Bachelor of Arts (B.A.), Economics
Self-employed Chairman, English DepartmentLebanese International University
Lebanese International University (LIU Yemen) October 2009 - September 2010
Oracle November 2006 - October 2007
Synergen March 1999 - October 2006
U.S. Joint Economic Commission September 1985 - December 1997
Colorado State University September 1976 - August 1985
Skills
Technical Writing, Editing, Information Technology, Computer Proficiency, Library Instruction, Library Research, Copy Editing, FrameMaker, Program Management, Content Management, Teaching, Customer Service, Creative Writing
Education
University of California, Berkeley 1997 — 1998
Professional Certificate, Technical Documentation
The University of Texas at Austin 1970 — 1971
Masters of Library and Information Science (M.L.S.), Information Technology
The University of Texas at Austin 1966 — 1968
Bachelor of Arts (B.A.), Economics
Kae Miller Kae Miller's Synergen Experience January 1993 - April 1994
Job
Industry Medical Devices
Experience
Medtronic plc September 2014 - Present
Gambro Renal Products, Inc. March 2002 - August 2014
Fischer Imaging November 2001 - March 2002
Syncor Pharmaceuticals, Inc. January 1996 - September 2001
GEN/Rx, Inc. September 1994 - January 1996
Synergen January 1993 - April 1994
USPCI June 1990 - January 1993
Geneva Pharmaceuticals, Inc. March 1979 - May 1990
Education
University of Denver 1996 — 2002
BBA, Business Administration
Northeastern University
Regulatory Affairs
Medtronic plc September 2014 - Present
Gambro Renal Products, Inc. March 2002 - August 2014
Fischer Imaging November 2001 - March 2002
Syncor Pharmaceuticals, Inc. January 1996 - September 2001
GEN/Rx, Inc. September 1994 - January 1996
Synergen January 1993 - April 1994
USPCI June 1990 - January 1993
Geneva Pharmaceuticals, Inc. March 1979 - May 1990
Education
University of Denver 1996 — 2002
BBA, Business Administration
Northeastern University
Regulatory Affairs
Debra Armentrout's Synergen Experience 1990 - 1993
Job Virtual Executive/Project Administrator at House Property Partners
Industry Executive Office
Experience
House Property Partners 2010 - Present
Debra Armentrout 2006 - Present
House Property Partners 1990 - Present
Mammoth Enterprises 2009 - 2013
DreamCatcher Direct Instruction 1998 - 2004
Ribozyme Pharmaceuticals 1993 - 1996
Synergen 1990 - 1993
Ohmeda, BOC 1984 - 1989
Skills
Painting, Art, Research, Teaching, Editing, Visual Arts, Copy Editing, Project Coordination, Customer Service, Training, Fine Art, Technical Writing, Graphic Design, E-Learning Consulting, Photography, Adobe Creative Suite, Contemporary Art, Requirements Gathering, Books, Illustration, Software Documentation, Museums
Education
University of Colorado Boulder 2000 — 2004
Art History
Lake Zurich High School
House Property Partners 2010 - Present
Debra Armentrout 2006 - Present
House Property Partners 1990 - Present
Mammoth Enterprises 2009 - 2013
DreamCatcher Direct Instruction 1998 - 2004
Ribozyme Pharmaceuticals 1993 - 1996
Synergen 1990 - 1993
Ohmeda, BOC 1984 - 1989
Skills
Painting, Art, Research, Teaching, Editing, Visual Arts, Copy Editing, Project Coordination, Customer Service, Training, Fine Art, Technical Writing, Graphic Design, E-Learning Consulting, Photography, Adobe Creative Suite, Contemporary Art, Requirements Gathering, Books, Illustration, Software Documentation, Museums
Education
University of Colorado Boulder 2000 — 2004
Art History
Lake Zurich High School
Andrew Witt Andrew Witt's Synergen Experience 1993 - 1994
Job Associate Director Quality Assurance at Receptos, Inc.
Industry Pharmaceuticals
Experience
AstraZeneca June 2012 - December 2014
Amylin Pharmaceuticals March 2007 - June 2011
Ligand Pharmaceuticals 2003 - 2007
Isis Pharmaceuticals 2002 - 2003
Nektar Therapeutics 2000 - 2002
PharmComm 1997 - 2000
Ribozyme Pharmaceuticals, Inc. 1995 - 1997
Synergen 1993 - 1994
Skills
Validation, GMP, Pharmaceutical Industry, CAPA, FDA, Change Control, GxP, Sop, Regulatory Affairs, V&V, Biotechnology, Technology Transfer, 21 CFR Part 11, Medical Devices, Regulatory Submissions, Biopharmaceuticals, Computer System..., Project Management, Manufacturing..., Commercial Labeling..., Quality Systems Design..., Risk Management, State Licensing, Serialization, Product Complaint..., 3PL, Product Demonstration, Licensing, ISO 13485, Contract Manufacturing, Lifesciences, Regulatory Requirements, Aseptic Processing, CRO, Commercialization, Quality Auditing, Trackwise, Pharmaceutics, Quality System, Quality Assurance, Clinical Trials, Drug Development, Oncology, CMC
Education
University of Colorado at Boulder 1988 — 1992
Bachelor of Arts (B.A.), Molecular, Cellular, and Developmental Biology
AstraZeneca June 2012 - December 2014
Amylin Pharmaceuticals March 2007 - June 2011
Ligand Pharmaceuticals 2003 - 2007
Isis Pharmaceuticals 2002 - 2003
Nektar Therapeutics 2000 - 2002
PharmComm 1997 - 2000
Ribozyme Pharmaceuticals, Inc. 1995 - 1997
Synergen 1993 - 1994
Skills
Validation, GMP, Pharmaceutical Industry, CAPA, FDA, Change Control, GxP, Sop, Regulatory Affairs, V&V, Biotechnology, Technology Transfer, 21 CFR Part 11, Medical Devices, Regulatory Submissions, Biopharmaceuticals, Computer System..., Project Management, Manufacturing..., Commercial Labeling..., Quality Systems Design..., Risk Management, State Licensing, Serialization, Product Complaint..., 3PL, Product Demonstration, Licensing, ISO 13485, Contract Manufacturing, Lifesciences, Regulatory Requirements, Aseptic Processing, CRO, Commercialization, Quality Auditing, Trackwise, Pharmaceutics, Quality System, Quality Assurance, Clinical Trials, Drug Development, Oncology, CMC
Education
University of Colorado at Boulder 1988 — 1992
Bachelor of Arts (B.A.), Molecular, Cellular, and Developmental Biology
Janet Hill-Aiello Janet Hill-Aiello's Synergen Experience July 1992 - August 1994
Job Business Analyst
Industry Information Services
Experience
Insight Global November 2012 - June 2013
MedImmune (contract) December 2011 - January 2012
Quest Diagnostics (contract) June 2010 - June 2011
Advanced Sterilization Products September 2009 - March 2010
Abbott Vascular Devices April 2008 - June 2009
Novartis October 2000 - April 2008
Solvay Pharmaceuticals, Inc August 1997 - October 2000
Solvay Animal Health October 1994 - March 1997
Synergen July 1992 - August 1994
Dey Laboratories May 1989 - June 1992
Skills
EDMSs, Document Management, Business Process, Documentum, Forms Development, Visio, Microsoft Word, Microsoft Excel, MS Project, PowerPoint, Process Qualification, Qualification Testing, Supervisory Skills, 21 CFR Part 11, Distributed Team..., Access, Quality Assurance, Regulatory Affairs, Validation, Computer System..., GMP, Software Documentation, Pharmaceutical Industry
Education
Buena Vista University
Bachelor's DegreeBA, MIS (Management Information Systems)
Tarrant College
Associate DegreeAA, Chemistry
Insight Global November 2012 - June 2013
MedImmune (contract) December 2011 - January 2012
Quest Diagnostics (contract) June 2010 - June 2011
Advanced Sterilization Products September 2009 - March 2010
Abbott Vascular Devices April 2008 - June 2009
Novartis October 2000 - April 2008
Solvay Pharmaceuticals, Inc August 1997 - October 2000
Solvay Animal Health October 1994 - March 1997
Synergen July 1992 - August 1994
Dey Laboratories May 1989 - June 1992
Skills
EDMSs, Document Management, Business Process, Documentum, Forms Development, Visio, Microsoft Word, Microsoft Excel, MS Project, PowerPoint, Process Qualification, Qualification Testing, Supervisory Skills, 21 CFR Part 11, Distributed Team..., Access, Quality Assurance, Regulatory Affairs, Validation, Computer System..., GMP, Software Documentation, Pharmaceutical Industry
Education
Buena Vista University
Bachelor's DegreeBA, MIS (Management Information Systems)
Tarrant College
Associate DegreeAA, Chemistry
Alex McClung Alex McClung's Synergen Experience October 1988 - December 1994
Job Executive leadership for the pharmaceutical and health science industries
Industry Pharmaceuticals
Experience
Xcelience, LLC April 2014 - Present
Pharmaceutics International, Inc September 2007 - April 2014
BioniCare Medical Technologies, Inc December 2003 - July 2007
Alpharma USHP January 2003 - November 2003
Amgen January 2001 - January 2003
Amgen January 1998 - January 2001
Amgen January 1995 - January 1998
Synergen October 1988 - December 1994
Skills
GMP, Validation, FDA, Cleaning Validation, Regulatory Affairs, Quality Assurance, Biotechnology, Biopharmaceuticals, CAPA, Quality System, 21 CFR Part 11, Sop, Pharmaceutical Industry, Change Control, GxP, Leadership, V&V, GLP, Pharmaceutics, Technology Transfer, Medical Devices, Quality Management, ISO 13485, Clinical Trials, Aseptic Processing, Lifesciences, R&D, Product Development, Clinical Development, Computer System..., Trackwise, Regulatory Submissions, Analytical Chemistry, Quality Auditing, Regulatory Requirements, FDA GMP, Quality Control, HPLC, LIMS, Manufacturing, Sterile fill & packaging, Life Sciences, SOP
Education
Towson University 1984 — 1988
Biology, Chemistry
Xcelience, LLC April 2014 - Present
Pharmaceutics International, Inc September 2007 - April 2014
BioniCare Medical Technologies, Inc December 2003 - July 2007
Alpharma USHP January 2003 - November 2003
Amgen January 2001 - January 2003
Amgen January 1998 - January 2001
Amgen January 1995 - January 1998
Synergen October 1988 - December 1994
Skills
GMP, Validation, FDA, Cleaning Validation, Regulatory Affairs, Quality Assurance, Biotechnology, Biopharmaceuticals, CAPA, Quality System, 21 CFR Part 11, Sop, Pharmaceutical Industry, Change Control, GxP, Leadership, V&V, GLP, Pharmaceutics, Technology Transfer, Medical Devices, Quality Management, ISO 13485, Clinical Trials, Aseptic Processing, Lifesciences, R&D, Product Development, Clinical Development, Computer System..., Trackwise, Regulatory Submissions, Analytical Chemistry, Quality Auditing, Regulatory Requirements, FDA GMP, Quality Control, HPLC, LIMS, Manufacturing, Sterile fill & packaging, Life Sciences, SOP
Education
Towson University 1984 — 1988
Biology, Chemistry
Joe Darrow Joe Darrow's Synergen Experience June 1993 - June 1994
Job Senior Quality Engineer at Sandoz
Industry Biotechnology
Experience
Sandoz October 2013 - Present
Sandoz May 2012 - November 2013
Amgen October 2006 - June 2011
Amgen October 2003 - October 2006
Ancile Pharmaceuticals January 1999 - December 2002
NaPro Biotherapeutics, Inc. December 1995 - December 1999
Synergen June 1993 - June 1994
Synergen, Inc April 1989 - June 1993
Skills
Product Development, Chemistry, Sop, Validation, Lifesciences, GLP, Aseptic Technique, Technology Transfer, V&V, Purification, Protein Purification, Fermentation, CAPA, 21 CFR Part 11, Change Control, SOP, Life Sciences, GMP
Education
University of Colorado at Boulder 1982 — 1988
B.S., Microbiology and Chemistry
Sandoz October 2013 - Present
Sandoz May 2012 - November 2013
Amgen October 2006 - June 2011
Amgen October 2003 - October 2006
Ancile Pharmaceuticals January 1999 - December 2002
NaPro Biotherapeutics, Inc. December 1995 - December 1999
Synergen June 1993 - June 1994
Synergen, Inc April 1989 - June 1993
Skills
Product Development, Chemistry, Sop, Validation, Lifesciences, GLP, Aseptic Technique, Technology Transfer, V&V, Purification, Protein Purification, Fermentation, CAPA, 21 CFR Part 11, Change Control, SOP, Life Sciences, GMP
Education
University of Colorado at Boulder 1982 — 1988
B.S., Microbiology and Chemistry
Bob Harker Bob Harker's Synergen Experience 1992 - 1994
Job Executive Director, Plant Manager
Industry Biotechnology
Experience
Routt County May 2014 - Present
Amgen August 1992 - May 2014
Synergen 1992 - 1994
Genentech 1985 - 1992
Skills
Biopharmaceuticals, Biotechnology, Validation, GLP, GMP, Pharmaceutical Industry, FDA, Aseptic Processing, Lifesciences, CAPA, Technology Transfer, Sop, 21 CFR Part 11, V&V, Change Control, Cross-functional Team..., Quality System, Life Sciences, SOP
Education
San Jose State University 1978 — 1983
BS & BA, Microbiology, Molecular Biology, Biochemistry
Routt County May 2014 - Present
Amgen August 1992 - May 2014
Synergen 1992 - 1994
Genentech 1985 - 1992
Skills
Biopharmaceuticals, Biotechnology, Validation, GLP, GMP, Pharmaceutical Industry, FDA, Aseptic Processing, Lifesciences, CAPA, Technology Transfer, Sop, 21 CFR Part 11, V&V, Change Control, Cross-functional Team..., Quality System, Life Sciences, SOP
Education
San Jose State University 1978 — 1983
BS & BA, Microbiology, Molecular Biology, Biochemistry
Kevin Roberson Kevin Roberson's Synergen Experience 1992 - 1994
Job Senior Director, Quality Assurance
Industry Pharmaceuticals
Experience
Analytical Bio-Chemistry, Inc. March 2001 - Present
PDL BioPharma 1995 - 2001
Synergen 1992 - 1994
Monsanto 1986 - 1988
Skills
Quality Systems, Quality Assurance, Computer System..., 21 CFR Part 11, GxP, GMP, GAMP, CAPA, Validation, FDA, Quality Auditing, Quality Management, Software Validation, cGMP, Change Control, GLP, SOP, LIMS, QC, Pharmaceuticals, Biotechnology, Technology Transfer, Life Sciences, Biopharmaceuticals, Analytical Chemistry, Root Cause Analysis, HPLC, Aseptic Processing, Compliance, Chromatography, Regulatory Requirements, CRO, Change Management, Risk Management, Aseptic Technique, Pharmaceutical Industry, Quality System, Sop, Lifesciences, Quality Control, Testing, Cleaning Validation, Laboratory, Drug Development, V&V, IND, Trackwise, CMC, ELISA, Regulatory Submissions
Education
University of Missouri-Columbia 1973 — 1980
BA/MA
Analytical Bio-Chemistry, Inc. March 2001 - Present
PDL BioPharma 1995 - 2001
Synergen 1992 - 1994
Monsanto 1986 - 1988
Skills
Quality Systems, Quality Assurance, Computer System..., 21 CFR Part 11, GxP, GMP, GAMP, CAPA, Validation, FDA, Quality Auditing, Quality Management, Software Validation, cGMP, Change Control, GLP, SOP, LIMS, QC, Pharmaceuticals, Biotechnology, Technology Transfer, Life Sciences, Biopharmaceuticals, Analytical Chemistry, Root Cause Analysis, HPLC, Aseptic Processing, Compliance, Chromatography, Regulatory Requirements, CRO, Change Management, Risk Management, Aseptic Technique, Pharmaceutical Industry, Quality System, Sop, Lifesciences, Quality Control, Testing, Cleaning Validation, Laboratory, Drug Development, V&V, IND, Trackwise, CMC, ELISA, Regulatory Submissions
Education
University of Missouri-Columbia 1973 — 1980
BA/MA
Ric Buesgen Ric Buesgen's Synergen Experience January 1998 - September 2001
Job Teacher at SCUSD
Industry Education Management
Experience
SCUSD September 2002 - Present
SMF Systems Corporation September 2001 - September 2002
Synergen January 1998 - September 2001
Skills
Certified Dive Master, Golfer, Trap Shooter, Coaching, Teaching, Curriculum Design, Management, Leadership Development, Instructional Design, Educational Leadership, Team Building, Organizational..., Data Analysis, Training, Leadership, Staff Development, Strategic Planning, Program Management
Education
Central Michigan University 1985 — 1987
MA, Business Administration
University of Minnesota Duluth 1971 — 1975
Chemistry, Chemistry
SCUSD September 2002 - Present
SMF Systems Corporation September 2001 - September 2002
Synergen January 1998 - September 2001
Skills
Certified Dive Master, Golfer, Trap Shooter, Coaching, Teaching, Curriculum Design, Management, Leadership Development, Instructional Design, Educational Leadership, Team Building, Organizational..., Data Analysis, Training, Leadership, Staff Development, Strategic Planning, Program Management
Education
Central Michigan University 1985 — 1987
MA, Business Administration
University of Minnesota Duluth 1971 — 1975
Chemistry, Chemistry
Chuck Hannum Chuck Hannum's Synergen Experience 1987 - 1990
Job Senior Director, Protein Sciences at Oxford BioTherapeutics
Industry Biotechnology
Experience
Oxford BioTherapeutics March 2015 - Present
Sea Lane Biotechnologies 2009 - March 2015
Facet Biotech 2008 - June 2010
PDL BioPharma 2004 - 2008
Schering Plough Biopharma/DNAX 1995 - 2003
DNAX Research Institute 1990 - 1995
Synergen 1987 - 1990
National Jewish Medical and Research Center 1983 - 1986
Skills
Antibodies, Monoclonal Antibodies, Assay Development, Immunology, Biotechnology, ELISA, Drug Discovery, Molecular Biology, Lifesciences, Protein Chemistry, Cell Culture, Cell Biology, Biochemistry, Cell, Translational Research, Biopharmaceuticals, Protein Purification, Purification
Education
Northwestern University 1977 — 1983
Ph.D., Biochemistry
University of Illinois at Chicago 1975 — 1977
MS, Biochemistry
Wheaton College 1967 — 1971
BS, Biology
Oxford BioTherapeutics March 2015 - Present
Sea Lane Biotechnologies 2009 - March 2015
Facet Biotech 2008 - June 2010
PDL BioPharma 2004 - 2008
Schering Plough Biopharma/DNAX 1995 - 2003
DNAX Research Institute 1990 - 1995
Synergen 1987 - 1990
National Jewish Medical and Research Center 1983 - 1986
Skills
Antibodies, Monoclonal Antibodies, Assay Development, Immunology, Biotechnology, ELISA, Drug Discovery, Molecular Biology, Lifesciences, Protein Chemistry, Cell Culture, Cell Biology, Biochemistry, Cell, Translational Research, Biopharmaceuticals, Protein Purification, Purification
Education
Northwestern University 1977 — 1983
Ph.D., Biochemistry
University of Illinois at Chicago 1975 — 1977
MS, Biochemistry
Wheaton College 1967 — 1971
BS, Biology
Robert Hageman Robert Hageman's Synergen Experience September 1983 - August 1994
Job Principal at RH Pharma Consulting
Industry Biotechnology
Experience
RH Pharma Consulting August 2015 - Present
Novartis July 2014 - August 2015
Novartis July 2010 - June 2014
Scios October 2006 - December 2007
Scios October 2003 - December 2007
Chiron 2001 - 2003
Chiron Corporation 1998 - 2001
Panvera 1997 - 1998
BioNebraska 1997 - 1998
Synergen September 1983 - August 1994
Skills
Analytical Chemistry, Quality Control, Validation, Pharmaceutical Industry, Technology Transfer, Change Control, GMP, Biotechnology, Biopharmaceuticals, FDA, Quality Operations, Management, CAPA, Formulation, SOP, Regulatory Affairs, Purification, Quality Assurance, Life Sciences
Education
University of Wisconsin-Madison 1974 — 1979
Ph.D., Biochemistry
University of California, Berkeley 1972 — 1974
B.S., Chemistry
RH Pharma Consulting August 2015 - Present
Novartis July 2014 - August 2015
Novartis July 2010 - June 2014
Scios October 2006 - December 2007
Scios October 2003 - December 2007
Chiron 2001 - 2003
Chiron Corporation 1998 - 2001
Panvera 1997 - 1998
BioNebraska 1997 - 1998
Synergen September 1983 - August 1994
Skills
Analytical Chemistry, Quality Control, Validation, Pharmaceutical Industry, Technology Transfer, Change Control, GMP, Biotechnology, Biopharmaceuticals, FDA, Quality Operations, Management, CAPA, Formulation, SOP, Regulatory Affairs, Purification, Quality Assurance, Life Sciences
Education
University of Wisconsin-Madison 1974 — 1979
Ph.D., Biochemistry
University of California, Berkeley 1972 — 1974
B.S., Chemistry
Dot Colagiovanni, PhD (DABT), MT (ASCP)'s Synergen Experience 1994 - 1994
Job Senior Director of Product Development at Nivalis Therapeutics, Inc.
Industry Biotechnology
Experience
Nivalis Therapeutics, Inc. February 2015 - Present
N30 Pharmaceuticals June 2010 - Present
N30 Pharma May 2008 - June 2010
Replidyne November 2004 - May 2008
OSi Pharmaceuticals January 2001 - November 2004
Gilead Sciences December 1998 - December 2000
Amgen July 1994 - May 1998
Synergen 1994 - 1994
University of Colorado 1989 - 1994
Skills
Toxicology, Pharmaceuticals, Microbiology, Pharmacology, NDA, Regulatory Submissions, GLP, Strategic Consulting, Due Diligence, Biotechnology, Biopharmaceuticals, IND, Pharmaceutical Industry, Drug Discovery, CRO, Drug Development, GMP, Oncology, Lifesciences, Animal Models, Clinical Trials, In Vitro, Protein Chemistry, Assay Development, Biomarker Discovery, Inflammation, Biomarkers, Clinical Development, Cell, Infectious Diseases, In Vivo, ELISA, Pharmacokinetics, Biochemistry, Cell Biology, Life Sciences
Education
University of Colorado Anschutz Medical Campus 1989 — 1994
Ph.D., Molecular Toxicology and Environmental Health Sciences
University of Vermont 1983 — 1987
B.S., Medical Technology
Nivalis Therapeutics, Inc. February 2015 - Present
N30 Pharmaceuticals June 2010 - Present
N30 Pharma May 2008 - June 2010
Replidyne November 2004 - May 2008
OSi Pharmaceuticals January 2001 - November 2004
Gilead Sciences December 1998 - December 2000
Amgen July 1994 - May 1998
Synergen 1994 - 1994
University of Colorado 1989 - 1994
Skills
Toxicology, Pharmaceuticals, Microbiology, Pharmacology, NDA, Regulatory Submissions, GLP, Strategic Consulting, Due Diligence, Biotechnology, Biopharmaceuticals, IND, Pharmaceutical Industry, Drug Discovery, CRO, Drug Development, GMP, Oncology, Lifesciences, Animal Models, Clinical Trials, In Vitro, Protein Chemistry, Assay Development, Biomarker Discovery, Inflammation, Biomarkers, Clinical Development, Cell, Infectious Diseases, In Vivo, ELISA, Pharmacokinetics, Biochemistry, Cell Biology, Life Sciences
Education
University of Colorado Anschutz Medical Campus 1989 — 1994
Ph.D., Molecular Toxicology and Environmental Health Sciences
University of Vermont 1983 — 1987
B.S., Medical Technology
Guy Vigers Guy Vigers's Synergen Experience September 1991 - March 1994
Job Senior Research Investigator at Array BioPharma
Industry Pharmaceuticals
Experience
Array BioPharma August 1998 - Present
Amgen March 1994 - June 1998
Synergen September 1991 - March 1994
Skills
X-ray crystallography, Computational Chemistry, Programming, Drug Discovery, Drug Design, Kinases, Biochemistry, Life Sciences, Medicinal Chemistry, Protein Chemistry, Chromatography, Biotechnology, Drug Development, Chemistry
Education
University of Colorado at Boulder 1986 — 1988
Postdoctoral studies, Cell Biology
University of Cambridge 1979 — 1986
BA, MA and PhD, Physics and Molecular Biology
Array BioPharma August 1998 - Present
Amgen March 1994 - June 1998
Synergen September 1991 - March 1994
Skills
X-ray crystallography, Computational Chemistry, Programming, Drug Discovery, Drug Design, Kinases, Biochemistry, Life Sciences, Medicinal Chemistry, Protein Chemistry, Chromatography, Biotechnology, Drug Development, Chemistry
Education
University of Colorado at Boulder 1986 — 1988
Postdoctoral studies, Cell Biology
University of Cambridge 1979 — 1986
BA, MA and PhD, Physics and Molecular Biology
Luis Bloise Luis Bloise's Synergen Experience 1992 - 1994
Job Experienced Biopharmaceuticals Operations Professional
Industry Biotechnology
Experience
BioMarin 2010 - 2015
Genentech 1997 - 2010
Protein Design Labs 1994 - 1997
Synergen 1992 - 1994
Baxter BioScience 1980 - 1992
Skills
Biotechnology, Biopharmaceuticals, GMP, Technology Transfer, FDA, Pharmaceutical Industry, 21 CFR Part 11, Validation, Change Control, Lifesciences, IND, Sop, CAPA, Clinical Development, CMC, Lean Tools, Six Sigma, Cross-functional Team..., Quality System, Computer System..., Project Management, Fermentation, Business Process..., Purification, GxP, Monoclonal Antibodies, SOP, Life Sciences
Education
University of California, Davis - Graduate School of Management 1998 — 2001
MBA, Management of Science & Technology
University of Southern California - Marshall School of Business 1987 — 1992
B.S, Decision Systems & Operations
Villanova University
Certified Black Belt, Lean Six Sigma
Hammer & Co
Certificate of Process Mastery
BioMarin 2010 - 2015
Genentech 1997 - 2010
Protein Design Labs 1994 - 1997
Synergen 1992 - 1994
Baxter BioScience 1980 - 1992
Skills
Biotechnology, Biopharmaceuticals, GMP, Technology Transfer, FDA, Pharmaceutical Industry, 21 CFR Part 11, Validation, Change Control, Lifesciences, IND, Sop, CAPA, Clinical Development, CMC, Lean Tools, Six Sigma, Cross-functional Team..., Quality System, Computer System..., Project Management, Fermentation, Business Process..., Purification, GxP, Monoclonal Antibodies, SOP, Life Sciences
Education
University of California, Davis - Graduate School of Management 1998 — 2001
MBA, Management of Science & Technology
University of Southern California - Marshall School of Business 1987 — 1992
B.S, Decision Systems & Operations
Villanova University
Certified Black Belt, Lean Six Sigma
Hammer & Co
Certificate of Process Mastery
Bruce Grieshaber Jr., PMP's Synergen Experience 1993 - 1995
Job Business Analyst | Project Management | Laboratory Informatics Professional
Industry Biotechnology
Experience
Amgen August 2007 - Present
Amgen January 2003 - August 2007
Amgen June 1999 - June 2003
Quark, Inc. March 1998 - June 1999
Amgen May 1996 - March 1998
Softworks, Inc. 1992 - 1996
Synergen 1993 - 1995
Clebern 1990 - 1993
Skills
Validation, Biotechnology, Quality System, Process Improvement, Quality Control, GMP, FDA, Pharmaceutical Industry, 21 CFR Part 11, LIMS, Change Control, Business Process, Management, Technology Transfer, Product Management, Computer System..., Start-ups, Product Development, Analysis, Software Development, Risk Management
Education
Colorado State University
BS, Computer Science
Amgen August 2007 - Present
Amgen January 2003 - August 2007
Amgen June 1999 - June 2003
Quark, Inc. March 1998 - June 1999
Amgen May 1996 - March 1998
Softworks, Inc. 1992 - 1996
Synergen 1993 - 1995
Clebern 1990 - 1993
Skills
Validation, Biotechnology, Quality System, Process Improvement, Quality Control, GMP, FDA, Pharmaceutical Industry, 21 CFR Part 11, LIMS, Change Control, Business Process, Management, Technology Transfer, Product Management, Computer System..., Start-ups, Product Development, Analysis, Software Development, Risk Management
Education
Colorado State University
BS, Computer Science
Lydia Willing Lydia Willing's Synergen Experience June 1985 - May 1987
Job Director of Sales North America GeneChips at Affymetrix
Industry Biotechnology
Experience
Affymetrix January 2014 - Present
Affymetrix July 2013 - January 2014
Affymetrix March 2005 - June 2013
Affymetrix March 2001 - February 2005
Equifax March 2000 - March 2001
Bio-Rad Laboratories January 1996 - March 2000
bio rad laboratories 1987 - 2000
Bio-Rad Laboratories January 1990 - March 1996
Bio-Rad Laboratories May 1987 - March 1990
Synergen June 1985 - May 1987
Skills
Biotechnology, Lifesciences, Genomics, Sequencing, Genetics, Hardware Diagnostics, Commercialization, DNA, Proteomics, Oncology, Immunology, PCR, DNA sequencing, qPCR, Laboratory Automation, Bioinformatics, Molecular Diagnostics, Molecular Biology, Microarray, Immunoassays, Infectious Diseases, DNA Sequencing
Education
University of Colorado Boulder 1979 — 1985
BA, Molecular, Cellular and Developmental Biology
Affymetrix January 2014 - Present
Affymetrix July 2013 - January 2014
Affymetrix March 2005 - June 2013
Affymetrix March 2001 - February 2005
Equifax March 2000 - March 2001
Bio-Rad Laboratories January 1996 - March 2000
bio rad laboratories 1987 - 2000
Bio-Rad Laboratories January 1990 - March 1996
Bio-Rad Laboratories May 1987 - March 1990
Synergen June 1985 - May 1987
Skills
Biotechnology, Lifesciences, Genomics, Sequencing, Genetics, Hardware Diagnostics, Commercialization, DNA, Proteomics, Oncology, Immunology, PCR, DNA sequencing, qPCR, Laboratory Automation, Bioinformatics, Molecular Diagnostics, Molecular Biology, Microarray, Immunoassays, Infectious Diseases, DNA Sequencing
Education
University of Colorado Boulder 1979 — 1985
BA, Molecular, Cellular and Developmental Biology
John A Bennan John A Bennan's Synergen Experience December 1987 - November 1994
Job President, ComplianceNet
Industry Biotechnology
Experience
ComplianceNet November 1995 - Present
Amgen December 1994 - February 1995
Synergen December 1987 - November 1994
Geneva Pharmaceuticals 1985 - 1986
Skills
GMP, Validation, FDA, Biotechnology, Technology Transfer, Biopharmaceuticals, Quality Assurance, Regulatory Affairs, Change Control, Pharmaceutical Industry, Quality System, Auditing, Quality Systems, Reprocessing, Compliance Training..., Process Validation, Regulatory Submissions, Pharmaceutics, Quality Control, V&V, Lifesciences, FDA GMP, Aseptic Processing, Laboratory, CAPA, GLP, Contract Manufacturing, 21 CFR Part 11, Sop, Vaccines, Manufacturing, Chromatography, Analytical Chemistry, Drug Development, Regulatory Requirements, HPLC, Commercialization, CMC, Quality Auditing, SOP, Life Sciences
Education
University of Colorado at Denver
MBA
Northern Arizona University
BS, Analytical Chemistry ACS
ComplianceNet November 1995 - Present
Amgen December 1994 - February 1995
Synergen December 1987 - November 1994
Geneva Pharmaceuticals 1985 - 1986
Skills
GMP, Validation, FDA, Biotechnology, Technology Transfer, Biopharmaceuticals, Quality Assurance, Regulatory Affairs, Change Control, Pharmaceutical Industry, Quality System, Auditing, Quality Systems, Reprocessing, Compliance Training..., Process Validation, Regulatory Submissions, Pharmaceutics, Quality Control, V&V, Lifesciences, FDA GMP, Aseptic Processing, Laboratory, CAPA, GLP, Contract Manufacturing, 21 CFR Part 11, Sop, Vaccines, Manufacturing, Chromatography, Analytical Chemistry, Drug Development, Regulatory Requirements, HPLC, Commercialization, CMC, Quality Auditing, SOP, Life Sciences
Education
University of Colorado at Denver
MBA
Northern Arizona University
BS, Analytical Chemistry ACS
Hugh Donovan Hugh Donovan's Synergen Experience 1992 - 1994
Job Corporate Vice President, Global Data Operations at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL April 2010 - Present
Accenture June 2007 - March 2010
Siemens Medical Solutions January 2005 - April 2007
Aventis Pharmaceuticals February 1998 - December 2004
SCDM 2000 - 2003
Hoechst Marion Roussel 1998 - 1999
Amgen 1995 - 1997
Synergen 1992 - 1994
GD Searle 1988 - 1992
GD Searle 1981 - 1988
Skills
Clinical Trials, Clinical Development, CRO, Clinical Data Management, CTMS, Pharmaceutical Industry, SAS, GCP, 21 CFR Part 11, Drug Development, Data Management, EDC, Oncology, Pharmacovigilance, Biotechnology, Sop, Regulatory Submissions, Biopharmaceuticals, FDA
Education
University College London, U. of London 1972 — 1975
B. Sc., Statistics
King Edward VI, Southampton 1965 — 1972
PAREXEL April 2010 - Present
Accenture June 2007 - March 2010
Siemens Medical Solutions January 2005 - April 2007
Aventis Pharmaceuticals February 1998 - December 2004
SCDM 2000 - 2003
Hoechst Marion Roussel 1998 - 1999
Amgen 1995 - 1997
Synergen 1992 - 1994
GD Searle 1988 - 1992
GD Searle 1981 - 1988
Skills
Clinical Trials, Clinical Development, CRO, Clinical Data Management, CTMS, Pharmaceutical Industry, SAS, GCP, 21 CFR Part 11, Drug Development, Data Management, EDC, Oncology, Pharmacovigilance, Biotechnology, Sop, Regulatory Submissions, Biopharmaceuticals, FDA
Education
University College London, U. of London 1972 — 1975
B. Sc., Statistics
King Edward VI, Southampton 1965 — 1972
Les Noe Les Noe's Synergen Experience September 1992 - August 1994
Job Executive VP, Health Economics & Outcomes Research at Continuum Clinical
Industry Research
Experience
Continuum Clinical July 2014 - Present
CorEvidence Research & Consulting LLC February 2014 - Present
inVentiv Health Clinical August 2013 - January 2014
inVentiv Health Clinical May 2012 - August 2013
ICON Clinical Research July 2006 - May 2012
Ovation Research Group February 1995 - July 2006
Synergen September 1992 - August 1994
Marion Merrell Dow 1989 - 1992
Marion Laboratories 1987 - 1989
Skills
Outcomes Research, Health Economics, HEOR, Clinical Research, Clinical Trials, Clinical Development, Oncology, CRO, Pharmaceutical Industry, CTMS, GCP, Biotechnology, Infectious Diseases, Medical Writing, EDC, Drug Development, Therapeutic Areas, Market Access, Epidemiology, Lifesciences
Education
University of Missouri-Kansas City 1983 — 1985
MPA
University of Missouri-Kansas City 1977 — 1980
BS, Pharmacy
Missouri State University 1973 — 1977
BS, Biology
Continuum Clinical July 2014 - Present
CorEvidence Research & Consulting LLC February 2014 - Present
inVentiv Health Clinical August 2013 - January 2014
inVentiv Health Clinical May 2012 - August 2013
ICON Clinical Research July 2006 - May 2012
Ovation Research Group February 1995 - July 2006
Synergen September 1992 - August 1994
Marion Merrell Dow 1989 - 1992
Marion Laboratories 1987 - 1989
Skills
Outcomes Research, Health Economics, HEOR, Clinical Research, Clinical Trials, Clinical Development, Oncology, CRO, Pharmaceutical Industry, CTMS, GCP, Biotechnology, Infectious Diseases, Medical Writing, EDC, Drug Development, Therapeutic Areas, Market Access, Epidemiology, Lifesciences
Education
University of Missouri-Kansas City 1983 — 1985
MPA
University of Missouri-Kansas City 1977 — 1980
BS, Pharmacy
Missouri State University 1973 — 1977
BS, Biology
Rod Connolly Rod Connolly's Synergen Experience 1991 - 1991
Job Founder & CEO of Dogma Athletica and Live It Cycling
Industry Health, Wellness and Fitness
Experience
Live It Cycling April 2013 - Present
Dogma Athletica June 2006 - Present
Mapei Clinic 1994 - 1994
Western Orthopaedic and Sports Medicine 1992 - 1993
Synergen 1991 - 1991
Skills
Yoga Alliance, USA Cycling, Cycling Fitting:..., Venture Capital, Public Speaking, Cycling, Personal Training, Nutrition, Exercise Physiology, Fitness, Yoga, Coaching, Fitness Training, Wellness, Sports Nutrition, Wellness Coaching, Strength Training, Lifestyle Coaching, Strategic Planning
Education
Colorado State University
Bachelor of Science (B.S.), Kinesiology
Colorado State University
Master of Science (M.S.), Exercise Physiology
Live It Cycling April 2013 - Present
Dogma Athletica June 2006 - Present
Mapei Clinic 1994 - 1994
Western Orthopaedic and Sports Medicine 1992 - 1993
Synergen 1991 - 1991
Skills
Yoga Alliance, USA Cycling, Cycling Fitting:..., Venture Capital, Public Speaking, Cycling, Personal Training, Nutrition, Exercise Physiology, Fitness, Yoga, Coaching, Fitness Training, Wellness, Sports Nutrition, Wellness Coaching, Strength Training, Lifestyle Coaching, Strategic Planning
Education
Colorado State University
Bachelor of Science (B.S.), Kinesiology
Colorado State University
Master of Science (M.S.), Exercise Physiology
Ellen Johnson Ellen Johnson's Synergen Experience 1992 - 1994
Job Bioprocess Solutions Architect at GE Healthcare
Industry Biotechnology
Experience
GE Healthcare 2015 - Present
Amgen 2008 - 2014
Amgen 2006 - 2008
Amgen 2004 - 2006
Amgen 2001 - 2004
Amgen 1999 - 2001
Amgen 1998 - 1999
Synergen 1992 - 1994
Skills
Biotechnology, Process Engineering, Process Development, Leadership, Management, Cell Culture, Fermentation, Manufacturing..., Validation, Microbiology, Biopharmaceuticals, Technology Transfer, GMP, Commercialization, Platform Development, Equipment Design, Data Analysis, Process Monitoring, Project Management, Technical Writing, Organization Skills, Pharmaceutical Industry, Process Simulation, Life Sciences, Characterization, Chromatography, R&D, FDA, Purification
Education
Colorado State University
M.S., Chemical Engineering
Colorado State University
B.S., Double Major: Microbiology, Biochemistry, Minor: Chemistry
GE Healthcare 2015 - Present
Amgen 2008 - 2014
Amgen 2006 - 2008
Amgen 2004 - 2006
Amgen 2001 - 2004
Amgen 1999 - 2001
Amgen 1998 - 1999
Synergen 1992 - 1994
Skills
Biotechnology, Process Engineering, Process Development, Leadership, Management, Cell Culture, Fermentation, Manufacturing..., Validation, Microbiology, Biopharmaceuticals, Technology Transfer, GMP, Commercialization, Platform Development, Equipment Design, Data Analysis, Process Monitoring, Project Management, Technical Writing, Organization Skills, Pharmaceutical Industry, Process Simulation, Life Sciences, Characterization, Chromatography, R&D, FDA, Purification
Education
Colorado State University
M.S., Chemical Engineering
Colorado State University
B.S., Double Major: Microbiology, Biochemistry, Minor: Chemistry
George Bonano George Bonano's Synergen Experience October 2000 - January 2005
Job
Industry Computer Software
Experience
Wells Fargo December 2012 - Present
Pacific Gas and Electric Company July 2012 - December 2012
Wells Fargo October 2010 - April 2012
Oracle December 2006 - March 2010
SPL WorldGroup January 2005 - December 2006
Synergen October 2000 - January 2005
HealthCentral.com May 2000 - October 2000
AirTouch Communications February 2000 - May 2000
Pacific Telesis/SBC March 1999 - February 2000
Hewlett-Packard May 1998 - March 1999
Skills
PL/SQL, SQL, Access, Excel, Documentation, Troubleshooting, Business Intelligence, Visual Basic, Software Development, Databases, Problem Solving, Data Analysis, Application Development, Windows, Integration
Education
California State University-Hayward - School of Business and Economics 1986 — 1989
Bachelor of Science (BS), Business Administration
Chabot College 1983 — 1986
Associate of Arts (A.A.), Business Administration and Management, General
Alameda High 1979 — 1983
Wells Fargo December 2012 - Present
Pacific Gas and Electric Company July 2012 - December 2012
Wells Fargo October 2010 - April 2012
Oracle December 2006 - March 2010
SPL WorldGroup January 2005 - December 2006
Synergen October 2000 - January 2005
HealthCentral.com May 2000 - October 2000
AirTouch Communications February 2000 - May 2000
Pacific Telesis/SBC March 1999 - February 2000
Hewlett-Packard May 1998 - March 1999
Skills
PL/SQL, SQL, Access, Excel, Documentation, Troubleshooting, Business Intelligence, Visual Basic, Software Development, Databases, Problem Solving, Data Analysis, Application Development, Windows, Integration
Education
California State University-Hayward - School of Business and Economics 1986 — 1989
Bachelor of Science (BS), Business Administration
Chabot College 1983 — 1986
Associate of Arts (A.A.), Business Administration and Management, General
Alameda High 1979 — 1983
Jill Heller Jill Heller's Synergen Experience April 1998 - December 1999
Job Curriculum Developer at Ellie Mae
Industry Education Management
Experience
Ellie Mae December 2013 - Present
Academy of Art University June 2011 - December 2013
PxJ Studios September 2003 - May 2011
AT&T November 2010 - March 2011
San Francisco State University September 2001 - December 2003
E-LOAN January 2000 - September 2003
Synergen April 1998 - December 1999
ASCAP January 1995 - April 1998
Skills
E-Learning, Instructional Design, Coaching, Training, Instructor-led Training, Adult Education, Blended Learning, Change Management, Learning Management..., Needs Analysis, Customer Service, Team Building, Program Management, Workshop Facilitation, Leadership, Software Documentation, Editing, Curriculum Design, Captivate, Project Management, Management, Interviews, Distance Learning, Technical Writing, Camtasia, ADDIE, Adobe Connect, Content Development, Curriculum Development, Document Management, Employee Training, Instructional Technology, Jing, Learning Management, Project Planning, SnagIt, Staff Development, Teaching, Training Delivery, Public Speaking, Adobe Audition, Human Resources, Technical Training
Education
San Francisco State University 2001 — 2002
MEd, Instructional Technology, A
State University of New York at Oswego
BA, Communications
LearnIT 2013 — 2013
Certificate, Project Management
University of California, Berkeley
Human Resources, A
Ellie Mae December 2013 - Present
Academy of Art University June 2011 - December 2013
PxJ Studios September 2003 - May 2011
AT&T November 2010 - March 2011
San Francisco State University September 2001 - December 2003
E-LOAN January 2000 - September 2003
Synergen April 1998 - December 1999
ASCAP January 1995 - April 1998
Skills
E-Learning, Instructional Design, Coaching, Training, Instructor-led Training, Adult Education, Blended Learning, Change Management, Learning Management..., Needs Analysis, Customer Service, Team Building, Program Management, Workshop Facilitation, Leadership, Software Documentation, Editing, Curriculum Design, Captivate, Project Management, Management, Interviews, Distance Learning, Technical Writing, Camtasia, ADDIE, Adobe Connect, Content Development, Curriculum Development, Document Management, Employee Training, Instructional Technology, Jing, Learning Management, Project Planning, SnagIt, Staff Development, Teaching, Training Delivery, Public Speaking, Adobe Audition, Human Resources, Technical Training
Education
San Francisco State University 2001 — 2002
MEd, Instructional Technology, A
State University of New York at Oswego
BA, Communications
LearnIT 2013 — 2013
Certificate, Project Management
University of California, Berkeley
Human Resources, A
Maurits Trouerbach Maurits Trouerbach's Synergen Experience 1992 - 1994
Job Associate Director at Genentech
Industry Biotechnology
Experience
Genentech October 1994 - Present
Synergen 1992 - 1994
Centocor 1989 - 1992
Skills
Biopharmaceuticals, Biotechnology, Pharmaceutical Industry, GMP, FDA, Technology Transfer, Clinical Development, Life Sciences, Cross-functional Team..., Validation, IND, Oncology, Drug Development, SOP
Education
Universiteit Utrecht 1987 — 1989
DPharm, Pharmacy
Leiden University 1982 — 1989
Master’s Degree, Pharmacy
Genentech October 1994 - Present
Synergen 1992 - 1994
Centocor 1989 - 1992
Skills
Biopharmaceuticals, Biotechnology, Pharmaceutical Industry, GMP, FDA, Technology Transfer, Clinical Development, Life Sciences, Cross-functional Team..., Validation, IND, Oncology, Drug Development, SOP
Education
Universiteit Utrecht 1987 — 1989
DPharm, Pharmacy
Leiden University 1982 — 1989
Master’s Degree, Pharmacy
Gordon Link Gordon Link's Synergen Experience June 1990 - August 1993
Job CFO at NewLink Genetics
Industry Biotechnology
Experience
NewLink Genetics 2008 - Present
NaPro BioTherapeutics 1993 - 2008
Synergen June 1990 - August 1993
Deloitte & Touche December 1985 - June 1990
Spicer & Oppenheim International October 1983 - December 1985
US Army July 1976 - November 1980
Skills
Accounts Payable, Financial Reporting, Managerial Finance, Lifesciences, Biotechnology, Pharmaceutical Industry, Due Diligence, Life Sciences, Venture Capital, Data Analysis, Financial Modeling, Management, Mergers & Acquisitions, Corporate Finance, Auditing, Strategy, Financial Analysis, Start-ups
Education
Metropolitan State University of Denver 1981 — 1982
Bachelor's Degree, Accounting
University of Denver 1980 — 1982
Executive MPA
Rensselaer Polytechnic Institute 1972 — 1976
Bachelor's Degree, Chemistry-minor in Art
NewLink Genetics 2008 - Present
NaPro BioTherapeutics 1993 - 2008
Synergen June 1990 - August 1993
Deloitte & Touche December 1985 - June 1990
Spicer & Oppenheim International October 1983 - December 1985
US Army July 1976 - November 1980
Skills
Accounts Payable, Financial Reporting, Managerial Finance, Lifesciences, Biotechnology, Pharmaceutical Industry, Due Diligence, Life Sciences, Venture Capital, Data Analysis, Financial Modeling, Management, Mergers & Acquisitions, Corporate Finance, Auditing, Strategy, Financial Analysis, Start-ups
Education
Metropolitan State University of Denver 1981 — 1982
Bachelor's Degree, Accounting
University of Denver 1980 — 1982
Executive MPA
Rensselaer Polytechnic Institute 1972 — 1976
Bachelor's Degree, Chemistry-minor in Art
Walter Steele Walter Steele's Synergen Experience October 2000 - October 2005
Job Owner/Consultant at Stretto Technologies
Industry Utilities
Experience
Stretto Technologies January 2014 - Present
Steele Business Consulting, LLC March 2012 - Present
Process Solutions Assurance, LLC September 2012 - December 2013
Oracle October 2007 - September 2012
Oracle March 2008 - March 2010
San Jose Water Company 2005 - 2007
Synergen October 2000 - October 2005
NASA Glenn Research Center July 1990 - October 1999
US Navy 1983 - 1989
Skills
Requirements Analysis, Business Process, Business Process..., Integration, Business Analysis, Data Conversion, Strategic Planning, Project Planning, Pre-sales, Enterprise Software, Program Management, Enterprise Architecture, Oracle, Solution Architecture, Business Intelligence, Project Management, IT Strategy, Consulting, Business Process Design, Software Project..., Professional Services, ERP, Software Implementation, Visio, Systems Analysis, Oracle E-Business Suite, Business Process..., UPK (User Productivity..., Oracle WAM, Management, Testing, SDLC, Process Improvement, Resource Management
Education
US Navy Nuclear Power Program 1983 — 1989
Old Dominion University 1987 — 1987
Cleveland State University 1983 — 1983
The Ohio State University 1980 — 1982
Cleveland State University
Stretto Technologies January 2014 - Present
Steele Business Consulting, LLC March 2012 - Present
Process Solutions Assurance, LLC September 2012 - December 2013
Oracle October 2007 - September 2012
Oracle March 2008 - March 2010
San Jose Water Company 2005 - 2007
Synergen October 2000 - October 2005
NASA Glenn Research Center July 1990 - October 1999
US Navy 1983 - 1989
Skills
Requirements Analysis, Business Process, Business Process..., Integration, Business Analysis, Data Conversion, Strategic Planning, Project Planning, Pre-sales, Enterprise Software, Program Management, Enterprise Architecture, Oracle, Solution Architecture, Business Intelligence, Project Management, IT Strategy, Consulting, Business Process Design, Software Project..., Professional Services, ERP, Software Implementation, Visio, Systems Analysis, Oracle E-Business Suite, Business Process..., UPK (User Productivity..., Oracle WAM, Management, Testing, SDLC, Process Improvement, Resource Management
Education
US Navy Nuclear Power Program 1983 — 1989
Old Dominion University 1987 — 1987
Cleveland State University 1983 — 1983
The Ohio State University 1980 — 1982
Cleveland State University
Nancy Mezo Nancy Mezo's Synergen Experience January 1992 - April 1993
Job Quality and Audit
Industry Defense & Space
Experience
Lockheed Martin Aeronautics February 2012 - Present
Lockheed Martin Space Systems Company September 2003 - November 2012
Sievers Instruments January 1996 - September 1998
National Jewish Health April 1993 - April 1995
Synergen January 1992 - April 1993
Skills
AS9100, CMMI, Supplier Quality...
Education
University of Colorado Boulder 1998 — 2002
B.S. Applied Mathematics, Mechanical Engineering
Colorado State University 1988 — 1992
B.S., Microbiology
Lockheed Martin Aeronautics February 2012 - Present
Lockheed Martin Space Systems Company September 2003 - November 2012
Sievers Instruments January 1996 - September 1998
National Jewish Health April 1993 - April 1995
Synergen January 1992 - April 1993
Skills
AS9100, CMMI, Supplier Quality...
Education
University of Colorado Boulder 1998 — 2002
B.S. Applied Mathematics, Mechanical Engineering
Colorado State University 1988 — 1992
B.S., Microbiology
Duane Bloedow Duane Bloedow's Synergen Experience 1990 - 1994
Job Retired Pharmaceutical Scientist, Educator & Pharmacist
Industry Pharmaceuticals
Experience
University of Washington 2004 - 2011
Genentech 1994 - 2003
Synergen 1990 - 1994
University of Colorado 1979 - 1990
University of Washington 1976 - 1978
South Dakota State University 1974 - 1976
Community Pharmacy 1968 - 1970
Skills
Pharmacokinetics, Biotechnology, Pharmacology, Protein Chemistry, Lifesciences, Biochemistry, Cell, Drug Discovery, Life Sciences, Clinical Trials, Cell Culture
Education
Washington State University 1970 — 1974
Ph.D., Pharmaceutical Science
South Dakota State University 1963 — 1968
B.S., Pharmacy
University of Washington 2004 - 2011
Genentech 1994 - 2003
Synergen 1990 - 1994
University of Colorado 1979 - 1990
University of Washington 1976 - 1978
South Dakota State University 1974 - 1976
Community Pharmacy 1968 - 1970
Skills
Pharmacokinetics, Biotechnology, Pharmacology, Protein Chemistry, Lifesciences, Biochemistry, Cell, Drug Discovery, Life Sciences, Clinical Trials, Cell Culture
Education
Washington State University 1970 — 1974
Ph.D., Pharmaceutical Science
South Dakota State University 1963 — 1968
B.S., Pharmacy
Jeanne De Long Jeanne De Long's Synergen Experience 1992 - 1994
Job Independent Biotechnology Professional
Industry Biotechnology
Experience
De Long Quality and Compliance Services, Ltd. November 2007 - Present
Merck&Co 2010 - 2011
Amgen, Inc. June 1994 - November 2007
Synergen 1992 - 1994
Skills
21 CFR Part 11, Internal Audit, CAPA, Quality System, Biotechnology, Validation, Sop, Regulatory Requirements, V&V, Change Control, HPLC, GMP, Biopharmaceuticals, Technology Transfer, FDA, Pharmaceutical Industry, GxP, LIMS, GLP, Laboratory, ELISA, Biochemistry, Lifesciences, Regulatory Affairs, Computer System..., Drug Development, SOP, Life Sciences
Education
University of Colorado at Boulder 1987 — 1991
BA, Molecular, Cellular and Developmental Biology
Carleton College 1985 — 1986
Math, Science
Villanova University 2008 — 2008
Lean Six Sigma Certification
De Long Quality and Compliance Services, Ltd. November 2007 - Present
Merck&Co 2010 - 2011
Amgen, Inc. June 1994 - November 2007
Synergen 1992 - 1994
Skills
21 CFR Part 11, Internal Audit, CAPA, Quality System, Biotechnology, Validation, Sop, Regulatory Requirements, V&V, Change Control, HPLC, GMP, Biopharmaceuticals, Technology Transfer, FDA, Pharmaceutical Industry, GxP, LIMS, GLP, Laboratory, ELISA, Biochemistry, Lifesciences, Regulatory Affairs, Computer System..., Drug Development, SOP, Life Sciences
Education
University of Colorado at Boulder 1987 — 1991
BA, Molecular, Cellular and Developmental Biology
Carleton College 1985 — 1986
Math, Science
Villanova University 2008 — 2008
Lean Six Sigma Certification
Ann Suding Ann Suding's Synergen Experience 1992 - 1994
Job CoOwner, ComplianceNet, LLC
Industry Biotechnology
Experience
ComplianceNet, LLC 1995 - Present
Synergen 1992 - 1994
Skills
Biotechnology, R&D, Technology Transfer, Process Engineering, Validation, GMP, Quality System, Product Development
Education
University of Colorado at Denver
MBA
University of Colorado at Boulder
BS
ComplianceNet, LLC 1995 - Present
Synergen 1992 - 1994
Skills
Biotechnology, R&D, Technology Transfer, Process Engineering, Validation, GMP, Quality System, Product Development
Education
University of Colorado at Denver
MBA
University of Colorado at Boulder
BS
Mark Tomusiak Mark Tomusiak's Synergen Experience 1991 - 1995
Job Principal Consultant at RMC Pharmaceutical Solutions
Industry Biotechnology
Experience
RMC Pharmaceutical Solutions, Inc. July 2014 - Present
Tomusiak Bioseparations Consulting LLC November 2009 - Present
Amgen 2004 - 2007
Amgen 2002 - 2003
Amgen 1995 - 2001
Synergen 1991 - 1995
Skills
Purification, Validation, Process Simulation, Biopharmaceuticals, Biotechnology, Technology Transfer, Fermentation, Biochemistry, GMP, Pharmaceutical Industry, Centrifugation, Facility Start-up, Plant Design, Process Engineering
Education
Caltech 1987 — 1989
MSc, Biochemical Engineering
University of Saskatchewan 1983 — 1987
BSc, Chemical Engineering
RMC Pharmaceutical Solutions, Inc. July 2014 - Present
Tomusiak Bioseparations Consulting LLC November 2009 - Present
Amgen 2004 - 2007
Amgen 2002 - 2003
Amgen 1995 - 2001
Synergen 1991 - 1995
Skills
Purification, Validation, Process Simulation, Biopharmaceuticals, Biotechnology, Technology Transfer, Fermentation, Biochemistry, GMP, Pharmaceutical Industry, Centrifugation, Facility Start-up, Plant Design, Process Engineering
Education
Caltech 1987 — 1989
MSc, Biochemical Engineering
University of Saskatchewan 1983 — 1987
BSc, Chemical Engineering
Thale Jarvis's Synergen Experience July 1992 - September 1993
Job
Industry Biotechnology
Experience
Crestone, Inc. February 2009 - Present
SomaLogic January 2009 - May 2012
Replidyne, Inc. July 2002 - October 2008
Impact Biosciences 2000 - 2002
Atugen 1999 - 2000
Ribozyme Pharmaceuticals, Inc 1993 - 1999
Synergen July 1992 - September 1993
Skills
Molecular Biology, Biochemistry, Life Sciences, Biotechnology, Infectious Diseases, Cell Culture, Microbiology, Drug Discovery, Protein Purification, Technology Transfer, Genomics, R&D, Diagnostics, HPLC, Pharmaceuticals, Research, Biopharmaceuticals, Protein Chemistry, Start-ups, Clinical Development, Pharmacology, Cell Based Assays, Cell Biology, Science, Cross-functional Team..., Drug Development, Assay Development
Education
University of Colorado at Boulder 1989 — 1992
postdoc, Molecular Virology
University of Oregon 1984 — 1989
Ph.D., Chemistry
Carleton College 1980 — 1984
B.A., Chemistry
Crestone, Inc. February 2009 - Present
SomaLogic January 2009 - May 2012
Replidyne, Inc. July 2002 - October 2008
Impact Biosciences 2000 - 2002
Atugen 1999 - 2000
Ribozyme Pharmaceuticals, Inc 1993 - 1999
Synergen July 1992 - September 1993
Skills
Molecular Biology, Biochemistry, Life Sciences, Biotechnology, Infectious Diseases, Cell Culture, Microbiology, Drug Discovery, Protein Purification, Technology Transfer, Genomics, R&D, Diagnostics, HPLC, Pharmaceuticals, Research, Biopharmaceuticals, Protein Chemistry, Start-ups, Clinical Development, Pharmacology, Cell Based Assays, Cell Biology, Science, Cross-functional Team..., Drug Development, Assay Development
Education
University of Colorado at Boulder 1989 — 1992
postdoc, Molecular Virology
University of Oregon 1984 — 1989
Ph.D., Chemistry
Carleton College 1980 — 1984
B.A., Chemistry
Jonathan Ferras's Synergen Experience May 1999 - December 2004
Job Senior WAM Consultant
Industry Computer Software
Experience
Centric Consulting March 2011 - Present
Oracle America January 2007 - December 2010
SPL Worldgroup/Synergen January 2005 - December 2006
Synergen May 1999 - December 2004
Indus International May 1995 - May 1999
Pacific Bell directory 1988 - 1992
Skills
Training, Program Management, Requirements Analysis, Business Process, Enterprise Software, Business Analysis, Integration, Oracle, Software Implementation, ERP, Oracle Applications, Business Process..., Software Project..., Project Management, Software Documentation, Training Delivery, Solution Architecture, Requirements Gathering, Oracle E-Business Suite, Enterprise Asset..., Oracle Work and Asset..., Software support, Education..., Business Process Design, Consulting, SDLC, IT Strategy, PMO, Data Warehousing, SaaS, Technical Support, Project Portfolio..., Professional Services, SharePoint, PMP, CRM, Business Transformation, Visio, Cloud Computing, Vendor Management, Process Improvement, Management Consulting, Project Delivery, Testing, Teacher Training, Change Management, Instructor-led Training, Governance
Education
St. Mary's College of California
MBA
Centric Consulting March 2011 - Present
Oracle America January 2007 - December 2010
SPL Worldgroup/Synergen January 2005 - December 2006
Synergen May 1999 - December 2004
Indus International May 1995 - May 1999
Pacific Bell directory 1988 - 1992
Skills
Training, Program Management, Requirements Analysis, Business Process, Enterprise Software, Business Analysis, Integration, Oracle, Software Implementation, ERP, Oracle Applications, Business Process..., Software Project..., Project Management, Software Documentation, Training Delivery, Solution Architecture, Requirements Gathering, Oracle E-Business Suite, Enterprise Asset..., Oracle Work and Asset..., Software support, Education..., Business Process Design, Consulting, SDLC, IT Strategy, PMO, Data Warehousing, SaaS, Technical Support, Project Portfolio..., Professional Services, SharePoint, PMP, CRM, Business Transformation, Visio, Cloud Computing, Vendor Management, Process Improvement, Management Consulting, Project Delivery, Testing, Teacher Training, Change Management, Instructor-led Training, Governance
Education
St. Mary's College of California
MBA
Susan Eustes's Synergen Experience 1989 - 1994
Job Director, Global Mobility and Stock Plan Services, IHS Inc.
Industry Information Services
Experience
IHS Inc. June 2006 - March 2012
Sun Microsystems, Inc. 2005 - 2006
Storage Technology Corporation 1995 - 2005
Synergen 1989 - 1994
Skills
Process Improvement, Mergers & Acquisitions, Project Management, Management, Program Management, Strategy, Vendor Management, Cross-functional Team..., Product Management, Analysis, Strategic Planning, Leadership, Performance Management, Employee Benefits, Start-ups, Business Strategy, Onboarding, Employee Relations, Immigration Policy, Global Mobility, Corporate Relocation, International..., Tax Equalization, Stock Management, Compensation & Benefits, Executive Compensation..., equity compensation, Stock Plan..., Proxy Statements, Proxy Voting
Education
University of Kentucky 1979 — 1983
BA, Journalism
IHS Inc. June 2006 - March 2012
Sun Microsystems, Inc. 2005 - 2006
Storage Technology Corporation 1995 - 2005
Synergen 1989 - 1994
Skills
Process Improvement, Mergers & Acquisitions, Project Management, Management, Program Management, Strategy, Vendor Management, Cross-functional Team..., Product Management, Analysis, Strategic Planning, Leadership, Performance Management, Employee Benefits, Start-ups, Business Strategy, Onboarding, Employee Relations, Immigration Policy, Global Mobility, Corporate Relocation, International..., Tax Equalization, Stock Management, Compensation & Benefits, Executive Compensation..., equity compensation, Stock Plan..., Proxy Statements, Proxy Voting
Education
University of Kentucky 1979 — 1983
BA, Journalism
Kay Sanders's Synergen Experience September 1990 - July 1994
Job Principal, Kay Sanders Consulting
Industry Biotechnology
Experience
Kay Sanders Consulting February 2008 - Present
Novartis (formerly Chiron) April 2006 - February 2007
Chiron Corporation April 2000 - April 2006
Chiron Corporation February 1999 - April 2000
PanVera Corp. 1998 - 1998
Heska Corporation April 1996 - November 1997
Synergen September 1990 - July 1994
Skills
GMP, Validation, Quality Assurance, Pharmaceutical Industry, Biopharmaceuticals, Vaccines, FDA, Analytical Chemistry, Regulatory Affairs, R&D, Technical Writing, Software Documentation, Biotechnology, Process Simulation, Quality Control
Education
Goethe Institute: Berlin, Göttingen, Munich, San Francisco 2007 — 2015
C1/C2 Level Certification, German language
University of California, Berkeley 1998 — 2003
Certification, Technical Writing
San Francisco State University
BS, Cell Biology, Minor in Chemistry
Kay Sanders Consulting February 2008 - Present
Novartis (formerly Chiron) April 2006 - February 2007
Chiron Corporation April 2000 - April 2006
Chiron Corporation February 1999 - April 2000
PanVera Corp. 1998 - 1998
Heska Corporation April 1996 - November 1997
Synergen September 1990 - July 1994
Skills
GMP, Validation, Quality Assurance, Pharmaceutical Industry, Biopharmaceuticals, Vaccines, FDA, Analytical Chemistry, Regulatory Affairs, R&D, Technical Writing, Software Documentation, Biotechnology, Process Simulation, Quality Control
Education
Goethe Institute: Berlin, Göttingen, Munich, San Francisco 2007 — 2015
C1/C2 Level Certification, German language
University of California, Berkeley 1998 — 2003
Certification, Technical Writing
San Francisco State University
BS, Cell Biology, Minor in Chemistry
Jean Yager's Synergen Experience 1991 - 1995
Job Independent Contractor
Industry Pharmaceuticals
Experience
BioPharm People, LLC September 2009 - December 2014
Drug Information Association April 2009 - January 2010
Pfizer, Inc. January 2002 - September 2009
Pfizer Global R&D 2002 - 2009
Food & Drug Administration July 1995 - January 2002
Synergen 1991 - 1995
Schering Plough 1978 - 1990
Skills
Regulatory Affairs, Drug Development, Operations Management, Strategic Planning, FDA, High Performance Teams, Lifesciences, Strategy, Pharmaceutics, Drug Discovery, Pharmaceutical Industry, Clinical Trials, Oncology, Clinical Development, Biotechnology, Life Sciences
Education
Saint John's University 1992 — 2002
Ph.D., Microbiology/Physiology
Fordham University 1971 — 1973
M.S., Physiology
Manhattanville College 1967 — 1971
B.A., Biology/Chemistry
BioPharm People, LLC September 2009 - December 2014
Drug Information Association April 2009 - January 2010
Pfizer, Inc. January 2002 - September 2009
Pfizer Global R&D 2002 - 2009
Food & Drug Administration July 1995 - January 2002
Synergen 1991 - 1995
Schering Plough 1978 - 1990
Skills
Regulatory Affairs, Drug Development, Operations Management, Strategic Planning, FDA, High Performance Teams, Lifesciences, Strategy, Pharmaceutics, Drug Discovery, Pharmaceutical Industry, Clinical Trials, Oncology, Clinical Development, Biotechnology, Life Sciences
Education
Saint John's University 1992 — 2002
Ph.D., Microbiology/Physiology
Fordham University 1971 — 1973
M.S., Physiology
Manhattanville College 1967 — 1971
B.A., Biology/Chemistry
Mary Ann Rheinberger's Synergen Experience 1991 - 1992
Job Strategic Market Planning/Marketing Research/Commercial Due Diligence Consultant
Industry Biotechnology
Experience
MarGoMar Medical Marketing Solutions 2000 - Present
Berlex Laboratories 1997 - 2000
Self-employed 1994 - 1997
Somatogen 1992 - 1993
Synergen 1991 - 1992
Searle (Div. of Monsanto) 1991 - 1991
Abbott Laboratories 1989 - 1991
Skills
Pharmaceutical Industry, Product Management, Lifesciences, Biotechnology, Market Access, Product Launch, Strategic Partnerships, Strategy, Market Research, Medical Devices, Marketing Research, Diabetes, Marketing, Life Sciences, Cardiology, Oncology, Cross-functional Team...
Education
University of Minnesota-Twin Cities
BA, Microbiology
University of Wisconsin-Madison
MBA, Marketing
University of Wisconsin-Madison - School of Business
Ph.D. (course work completed), Marketing Focus, Minors in Psychology and Research Design
MarGoMar Medical Marketing Solutions 2000 - Present
Berlex Laboratories 1997 - 2000
Self-employed 1994 - 1997
Somatogen 1992 - 1993
Synergen 1991 - 1992
Searle (Div. of Monsanto) 1991 - 1991
Abbott Laboratories 1989 - 1991
Skills
Pharmaceutical Industry, Product Management, Lifesciences, Biotechnology, Market Access, Product Launch, Strategic Partnerships, Strategy, Market Research, Medical Devices, Marketing Research, Diabetes, Marketing, Life Sciences, Cardiology, Oncology, Cross-functional Team...
Education
University of Minnesota-Twin Cities
BA, Microbiology
University of Wisconsin-Madison
MBA, Marketing
University of Wisconsin-Madison - School of Business
Ph.D. (course work completed), Marketing Focus, Minors in Psychology and Research Design
Darla Landfair's Synergen Experience 1986 - 1992
Job Scientific Researcher
Industry Pharmaceuticals
Experience
FSBiT, Inc. March 2001 - December 2013
Astellas Pharma US June 2010 - December 2012
OSI Pharmaceuticals July 2002 - June 2010
Gilead Sciences March 1999 - July 2002
NeXstar Pharmaceuticals May 1996 - March 1999
Biostar Pharmaceuticals Inc August 1993 - May 1996
Synergen 1986 - 1992
Skills
Biotechnology, Technology Transfer, IND, GLP, Sop, High Throughput..., GMP, Drug Discovery, Pharmacology, Validation, In Vivo, Pharmaceutical Industry, Oncology, Lifesciences, SOP, Assay Development, Cell, Drug Development, Life Sciences, Project Management
Education
University of Phoenix 2002 — 2004
Master of Business Administration (M.B.A.), Business Administration and Management, General
University of Colorado Boulder 1982 — 1983
Bachelor of Applied Science (BASc), Molecular, Cellular and Developmental Biology
The Ohio State University 1979 — 1981
Zoology/Animal Biology
FSBiT, Inc. March 2001 - December 2013
Astellas Pharma US June 2010 - December 2012
OSI Pharmaceuticals July 2002 - June 2010
Gilead Sciences March 1999 - July 2002
NeXstar Pharmaceuticals May 1996 - March 1999
Biostar Pharmaceuticals Inc August 1993 - May 1996
Synergen 1986 - 1992
Skills
Biotechnology, Technology Transfer, IND, GLP, Sop, High Throughput..., GMP, Drug Discovery, Pharmacology, Validation, In Vivo, Pharmaceutical Industry, Oncology, Lifesciences, SOP, Assay Development, Cell, Drug Development, Life Sciences, Project Management
Education
University of Phoenix 2002 — 2004
Master of Business Administration (M.B.A.), Business Administration and Management, General
University of Colorado Boulder 1982 — 1983
Bachelor of Applied Science (BASc), Molecular, Cellular and Developmental Biology
The Ohio State University 1979 — 1981
Zoology/Animal Biology
Doug Daiss's Synergen Experience July 1992 - July 1994
Job Senior Controls Engineer
Industry Biotechnology
Experience
Mangan Inc. November 2007 - Present
Amgen February 2002 - November 2007
Amgen July 1995 - February 2002
Sandoz July 1994 - July 1995
Synergen July 1992 - July 1994
Skills
Process Automation, Quality System, Validation, FDA, GMP, Computer System..., SCADA, Automation, Process Simulation, V&V, Biopharmaceuticals, Biotechnology, Pharmaceutical Industry, Manufacturing, CAPA, Commissioning, Process Control, Change Control
Education
Front Range Community College
Mangan Inc. November 2007 - Present
Amgen February 2002 - November 2007
Amgen July 1995 - February 2002
Sandoz July 1994 - July 1995
Synergen July 1992 - July 1994
Skills
Process Automation, Quality System, Validation, FDA, GMP, Computer System..., SCADA, Automation, Process Simulation, V&V, Biopharmaceuticals, Biotechnology, Pharmaceutical Industry, Manufacturing, CAPA, Commissioning, Process Control, Change Control
Education
Front Range Community College
Terri Kurtz's Synergen Experience February 1992 - August 1994
Job Medical Device and Pharmaceutical Consultant
Industry Medical Devices
Experience
TLK Consulting February 2005 - Present
FeRx Incorporated May 1998 - May 2004
Geneva Pharmaceuticals September 1994 - May 1998
Geneva Pharmaceuticals (a Novartis company) 1994 - 1998
Synergen February 1992 - August 1994
Skills
GMP, FDA, V&V, Validation, ISO 13485, Quality System, Pharmaceutical Industry, Process Simulation, Medical Devices, Design Control, Sop, Manufacturing, Quality Control, ISO 14971, FMEA, SOP
Education
Regis University
MBA, Business
University of Colorado Boulder
BS, Chemical Engineering
TLK Consulting February 2005 - Present
FeRx Incorporated May 1998 - May 2004
Geneva Pharmaceuticals September 1994 - May 1998
Geneva Pharmaceuticals (a Novartis company) 1994 - 1998
Synergen February 1992 - August 1994
Skills
GMP, FDA, V&V, Validation, ISO 13485, Quality System, Pharmaceutical Industry, Process Simulation, Medical Devices, Design Control, Sop, Manufacturing, Quality Control, ISO 14971, FMEA, SOP
Education
Regis University
MBA, Business
University of Colorado Boulder
BS, Chemical Engineering
Kristi Vrkljan's Synergen Experience 1993 - 1994
Job Quality Assurance Manager at Clovis Oncology
Industry Biotechnology
Experience
Clovis Oncology November 2012 - Present
ChromaDex October 2009 - October 2012
ARCA Biopharma November 2008 - May 2009
Hospira Boulder September 2007 - April 2008
Lancaster LAbs September 2004 - July 2007
Lancaster Labs (Amgen) 2004 - 2007
Proligo 2000 - 2004
Nexstar Pharmaceuticals 1994 - 1998
Synergen 1993 - 1994
Education
Metropolitan State University of Denver 1990 — 1992
Clovis Oncology November 2012 - Present
ChromaDex October 2009 - October 2012
ARCA Biopharma November 2008 - May 2009
Hospira Boulder September 2007 - April 2008
Lancaster LAbs September 2004 - July 2007
Lancaster Labs (Amgen) 2004 - 2007
Proligo 2000 - 2004
Nexstar Pharmaceuticals 1994 - 1998
Synergen 1993 - 1994
Education
Metropolitan State University of Denver 1990 — 1992
LeAnn (Taylor) Selby's Synergen Experience June 1992 - July 1994
Job Lab Services Supervisor at Array Biopharma
Industry Pharmaceuticals
Experience
Array Biopharma August 2007 - Present
Array BioPharma July 2002 - August 2007
Seagate Technology 1999 - July 2002
Amgen July 1994 - July 1998
Synergen June 1992 - July 1994
Skills
PCR, Molecular Biology, Lifesciences, Drug Discovery, Oncology, CAPA, 21 CFR Part 11, ELISA, LIMS, HPLC, Fermentation, Protein Chemistry, Biochemistry, GMP, GLP, Laboratory, Cell Culture, Management, Sop, Technology Transfer, FDA, Protein Purification, Biopharmaceuticals, Chromatography, Analytical Chemistry, Validation, Pharmaceutical Industry, Biotechnology, SOP, GxP, Life Sciences, Purification, Drug Development
Education
University of Colorado at Boulder 1985 — 1990
BA, Environmental Biology
Array Biopharma August 2007 - Present
Array BioPharma July 2002 - August 2007
Seagate Technology 1999 - July 2002
Amgen July 1994 - July 1998
Synergen June 1992 - July 1994
Skills
PCR, Molecular Biology, Lifesciences, Drug Discovery, Oncology, CAPA, 21 CFR Part 11, ELISA, LIMS, HPLC, Fermentation, Protein Chemistry, Biochemistry, GMP, GLP, Laboratory, Cell Culture, Management, Sop, Technology Transfer, FDA, Protein Purification, Biopharmaceuticals, Chromatography, Analytical Chemistry, Validation, Pharmaceutical Industry, Biotechnology, SOP, GxP, Life Sciences, Purification, Drug Development
Education
University of Colorado at Boulder 1985 — 1990
BA, Environmental Biology
Tina Jacobson's Synergen Experience July 1992 - February 1995
Job QC Supervisor at Hospira
Industry Biotechnology
Experience
Hospira April 2012 - Present
Hospira April 2011 - April 2012
Independent January 2007 - May 2011
Hospira November 2009 - April 2011
Amgen February 1995 - January 2007
Synergen July 1992 - February 1995
Skills
Quality Control, Quality System, Analytical Chemistry, Laboratory, GMP, Management, Biopharmaceuticals, Project Management, Science, CAPA, Trackwise, HPLC, Biotechnology, Chromatography, Quality Assurance, Change Control, TrackWise, Sop, SOP, Team Leadership
Education
University of Colorado Boulder 1987 — 1991
Hospira April 2012 - Present
Hospira April 2011 - April 2012
Independent January 2007 - May 2011
Hospira November 2009 - April 2011
Amgen February 1995 - January 2007
Synergen July 1992 - February 1995
Skills
Quality Control, Quality System, Analytical Chemistry, Laboratory, GMP, Management, Biopharmaceuticals, Project Management, Science, CAPA, Trackwise, HPLC, Biotechnology, Chromatography, Quality Assurance, Change Control, TrackWise, Sop, SOP, Team Leadership
Education
University of Colorado Boulder 1987 — 1991
Glenn Achziger's Synergen Experience 1990 - 1995
Job
Industry Biotechnology
Experience
Agilent Technologies September 2014 - Present
Amgen January 1995 - April 2014
Synergen 1990 - 1995
Skills
Biotechnology, Protein Chemistry, Analytical Chemistry, Raw Materials, Cell Biology, GMP, Quality Control, Validation, Gas Chromatography, Purification, UV-Vis-NIR, Bioassay, Wet Chemistry, LAL, TOC, Moisture Analysis, USP/NF, FTIR, Quality Assurance, Laboratory, Biopharmaceuticals, SOP, 21 CFR Part 11, Pharmaceutical Industry, FDA
Education
Colorado State University 1985 — 1990
Bachelor's of Science, Biological Science and Zoology; minor in Anatomy and Physiology
Poudre High School 1982 — 1985
Agilent Technologies September 2014 - Present
Amgen January 1995 - April 2014
Synergen 1990 - 1995
Skills
Biotechnology, Protein Chemistry, Analytical Chemistry, Raw Materials, Cell Biology, GMP, Quality Control, Validation, Gas Chromatography, Purification, UV-Vis-NIR, Bioassay, Wet Chemistry, LAL, TOC, Moisture Analysis, USP/NF, FTIR, Quality Assurance, Laboratory, Biopharmaceuticals, SOP, 21 CFR Part 11, Pharmaceutical Industry, FDA
Education
Colorado State University 1985 — 1990
Bachelor's of Science, Biological Science and Zoology; minor in Anatomy and Physiology
Poudre High School 1982 — 1985
Monica Eris, B.S., M.B.A's Synergen Experience 1992 - 1994
Job Associate Director, Clinical Drug Supply at Pharmacyclics
Industry Biotechnology
Experience
Pharmacyclics July 2015 - Present
Dynavax Technologies February 2015 - May 2015
Amgen January 2007 - October 2014
Amgen 2004 - 2007
Amgen 2000 - 2004
Amgen 1995 - 2000
Synergen 1992 - 1994
Skills
Process Improvement, GMP, Biotechnology, Validation, Pharmaceutical Industry, Supply Chain Management, Strategic Planning, Cross-functional Team..., SOP, Manufacturing, Strategy, Supply Chain, Change Control, Biopharmaceuticals, Quality Assurance, FDA, Forecasting, SAP, CAPA, Life Sciences
Education
California Lutheran University 1999 — 2003
Master of Business Administration (M.B.A.)
Metropolitan State University of Denver 1989 — 1994
Bachelor's Degree, Biology, General
Pharmacyclics July 2015 - Present
Dynavax Technologies February 2015 - May 2015
Amgen January 2007 - October 2014
Amgen 2004 - 2007
Amgen 2000 - 2004
Amgen 1995 - 2000
Synergen 1992 - 1994
Skills
Process Improvement, GMP, Biotechnology, Validation, Pharmaceutical Industry, Supply Chain Management, Strategic Planning, Cross-functional Team..., SOP, Manufacturing, Strategy, Supply Chain, Change Control, Biopharmaceuticals, Quality Assurance, FDA, Forecasting, SAP, CAPA, Life Sciences
Education
California Lutheran University 1999 — 2003
Master of Business Administration (M.B.A.)
Metropolitan State University of Denver 1989 — 1994
Bachelor's Degree, Biology, General
Bobbie Covert's Synergen Experience 1992 - 1995
Job Master Nutrition Therapist, Natural Foods Chef, Personal Trainer
Industry Health, Wellness and Fitness
Experience
Self Employed December 2012 - Present
Beautycounter December 2014 - Present
Amgen April 2009 - May 2010
Amgen June 2005 - April 2009
Amgen April 2003 - June 2005
Amgen June 1999 - April 2003
Synergen 1992 - 1995
Skills
Biotechnology, GMP, Biopharmaceuticals, FDA, Pharmaceutical Industry, Quality Control, Sop, 21 CFR Part 11, Lifesciences, Validation, LIMS, CAPA, Clinical Research, Change Control, Nutrition, Quality Assurance, Nutritional Counseling, Healthy Lifestyle, Healthy Eating, Wellness, Health & Wellness, Wellness Coaching
Education
Nutrition Therapy Institute 2012 — 2014
Master Nutrition Therapy, Nutrition
Bauman College 2011 — 2012
Natural Foods Chef
Colorado State University 1995 — 1999
Lehigh University 1986 — 1990
BA, Biology
Newburgh Free Academy
Self Employed December 2012 - Present
Beautycounter December 2014 - Present
Amgen April 2009 - May 2010
Amgen June 2005 - April 2009
Amgen April 2003 - June 2005
Amgen June 1999 - April 2003
Synergen 1992 - 1995
Skills
Biotechnology, GMP, Biopharmaceuticals, FDA, Pharmaceutical Industry, Quality Control, Sop, 21 CFR Part 11, Lifesciences, Validation, LIMS, CAPA, Clinical Research, Change Control, Nutrition, Quality Assurance, Nutritional Counseling, Healthy Lifestyle, Healthy Eating, Wellness, Health & Wellness, Wellness Coaching
Education
Nutrition Therapy Institute 2012 — 2014
Master Nutrition Therapy, Nutrition
Bauman College 2011 — 2012
Natural Foods Chef
Colorado State University 1995 — 1999
Lehigh University 1986 — 1990
BA, Biology
Newburgh Free Academy
Heidi Reno's Synergen Experience September 1992 - December 1994
Job QA Specialist with US Tech Solutions; currently with Amgen
Industry Biotechnology
Experience
US Tech Solutions April 2015 - Present
Agensys October 2009 - April 2015
Amgen December 1999 - July 2009
Somatogen 1994 - 1996
Synergen September 1992 - December 1994
Skills
Validation, 21 CFR Part 11, GMP, CAPA, Lean Manufacturing, Change Control, Manufacturing, Purification, Biopharmaceuticals, Product Development, Quality Assurance, Aseptic Processing, Clean Rooms, Leadership, Sop, Fermentation, Pharmaceutical Industry, Cell Culture, Biotechnology
Education
The University of Kansas 1981 — 1985
US Tech Solutions April 2015 - Present
Agensys October 2009 - April 2015
Amgen December 1999 - July 2009
Somatogen 1994 - 1996
Synergen September 1992 - December 1994
Skills
Validation, 21 CFR Part 11, GMP, CAPA, Lean Manufacturing, Change Control, Manufacturing, Purification, Biopharmaceuticals, Product Development, Quality Assurance, Aseptic Processing, Clean Rooms, Leadership, Sop, Fermentation, Pharmaceutical Industry, Cell Culture, Biotechnology
Education
The University of Kansas 1981 — 1985
Brian Governson's Synergen Experience December 1992 - December 1994
Job Certified Personal Trainer: National Academy of Sports Medicine (NASM)
Industry Health, Wellness and Fitness
Experience
Box gym QC Assay SpecialistGlobeImmune, Inc.August 2011 - April 2015
GlobeImmune August 2007 - August 2011
Act I January 2006 - July 2006
Dharmacon May 2003 - April 2005
Amgen September 2001 - April 2003
Amgen January 1995 - September 2001
Synergen December 1992 - December 1994
Skills
GMP, Biotechnology, FDA, Validation, Sop, CAPA, LIMS, Biopharmaceuticals, Technology Transfer, HPLC, 21 CFR Part 11, SDS-PAGE, Aseptic Technique, Change Control, ELISA, Assay Development, Protein Chemistry, Lifesciences, Pharmaceutical Industry, Chromatography, Microbiology, Laboratory
Education
National Personal Training Institute of Colorado 2014 — 2015
Certified Personal Training Diploma, Fitness and Personal Training
University of Phoenix-Colorado Campus 2005 — 2007
Masters in Education, Secondary Science
University of Colorado at Boulder 1985 — 1992
Bachelor of Arts (B.A.), Molecular, Cellular & Developmental Biology
Box gym QC Assay SpecialistGlobeImmune, Inc.August 2011 - April 2015
GlobeImmune August 2007 - August 2011
Act I January 2006 - July 2006
Dharmacon May 2003 - April 2005
Amgen September 2001 - April 2003
Amgen January 1995 - September 2001
Synergen December 1992 - December 1994
Skills
GMP, Biotechnology, FDA, Validation, Sop, CAPA, LIMS, Biopharmaceuticals, Technology Transfer, HPLC, 21 CFR Part 11, SDS-PAGE, Aseptic Technique, Change Control, ELISA, Assay Development, Protein Chemistry, Lifesciences, Pharmaceutical Industry, Chromatography, Microbiology, Laboratory
Education
National Personal Training Institute of Colorado 2014 — 2015
Certified Personal Training Diploma, Fitness and Personal Training
University of Phoenix-Colorado Campus 2005 — 2007
Masters in Education, Secondary Science
University of Colorado at Boulder 1985 — 1992
Bachelor of Arts (B.A.), Molecular, Cellular & Developmental Biology
Jean Yager's Synergen Experience 1991 - 1995
Job Director, Infectious Disease at Pfizer
Industry Pharmaceuticals
Experience
Pfizer Director, Infectious DiseasesPfizer2002 - 2008
Drug Information Association 1995 - 2003
Food & Drug Administration 1995 - 2002
Synergen 1991 - 1995
Education
Saint John's University 1978 — 1989
Ph.D., Microbiology, physiology
Fordham University
M.S., Microbiology, Physiology
Manhattanville College 1967 — 1971
B.A., Biology
Pfizer Director, Infectious DiseasesPfizer2002 - 2008
Drug Information Association 1995 - 2003
Food & Drug Administration 1995 - 2002
Synergen 1991 - 1995
Education
Saint John's University 1978 — 1989
Ph.D., Microbiology, physiology
Fordham University
M.S., Microbiology, Physiology
Manhattanville College 1967 — 1971
B.A., Biology
Dominic DeMuro's Synergen Experience July 1992 - December 1994
Job Site Quality Operations Leader at Pfizer
Industry Biotechnology
Experience
Pfizer February 2011 - Present
Pfizer April 2008 - January 2011
Amgen December 2005 - April 2008
Amgen October 2002 - November 2005
Amgen April 1999 - September 2002
Amgen November 1997 - March 1999
Amgen January 1995 - October 1997
Synergen July 1992 - December 1994
Skills
Manufacturing, GMP, Quality Assurance, 21 CFR Part 11, Vaccines, Biotechnology, Change Control, Biopharmaceuticals, Pharmaceutical Industry, FDA, Validation, Leadership, CAPA, Sop, V&V, Manufacturing Operations, Aseptic Processing, Continuous Improvement, Six Sigma, Quality System, GxP, Cell Culture, Technology Transfer
Education
University of Denver 1996 — 1999
Masters, Business Administration
University of Colorado Boulder 1988 — 1992
BA, Molecular, Cellular & Developmental Biology
Pfizer February 2011 - Present
Pfizer April 2008 - January 2011
Amgen December 2005 - April 2008
Amgen October 2002 - November 2005
Amgen April 1999 - September 2002
Amgen November 1997 - March 1999
Amgen January 1995 - October 1997
Synergen July 1992 - December 1994
Skills
Manufacturing, GMP, Quality Assurance, 21 CFR Part 11, Vaccines, Biotechnology, Change Control, Biopharmaceuticals, Pharmaceutical Industry, FDA, Validation, Leadership, CAPA, Sop, V&V, Manufacturing Operations, Aseptic Processing, Continuous Improvement, Six Sigma, Quality System, GxP, Cell Culture, Technology Transfer
Education
University of Denver 1996 — 1999
Masters, Business Administration
University of Colorado Boulder 1988 — 1992
BA, Molecular, Cellular & Developmental Biology
Mark Passamaneck, PE's Synergen Experience 1992 - 1995
Job President at Carbon Arms Corp
Industry Mechanical or Industrial Engineering
Experience
Carbon Arms Corp January 2011 - Present
Entropy Engineering Corp June 2008 - Present
Western Engineering & Research Corporation 1997 - 2008
Analytical Engineering Inc. May 1995 - October 1997
Synergen 1992 - 1995
Skills
Engineering, Strategic Planning, Construction, CAD, Structural Engineering, Failure Analysis, Program Management, Project Engineering, Forensic Engineering, Engineering Management, Mechanical Engineering, Testing, Solidworks, Manufacturing, Product Development, Materials, Product Design, Analysis, Machining, SolidWorks
Education
University of Colorado Denver 1997 — 1999
Master's level coursework, Mechanical Engineering
University of Colorado Denver 1995 — 1997
BS, Mechanical Engineering
Colorado School of Mines 1985 — 1988
BS, Mechanical Engineering
Carbon Arms Corp January 2011 - Present
Entropy Engineering Corp June 2008 - Present
Western Engineering & Research Corporation 1997 - 2008
Analytical Engineering Inc. May 1995 - October 1997
Synergen 1992 - 1995
Skills
Engineering, Strategic Planning, Construction, CAD, Structural Engineering, Failure Analysis, Program Management, Project Engineering, Forensic Engineering, Engineering Management, Mechanical Engineering, Testing, Solidworks, Manufacturing, Product Development, Materials, Product Design, Analysis, Machining, SolidWorks
Education
University of Colorado Denver 1997 — 1999
Master's level coursework, Mechanical Engineering
University of Colorado Denver 1995 — 1997
BS, Mechanical Engineering
Colorado School of Mines 1985 — 1988
BS, Mechanical Engineering
Julie Ross-Kramer's Synergen Experience 1991 - 1994
Job Associate Director, Manufacturing at Pharmatek
Industry Biotechnology
Experience
Pharmatek August 2014 - Present
Pharmatek December 2011 - Present
REVA Medical, Inc. October 2010 - December 2011
Eurogentec May 2009 - October 2010
Illumina February 2008 - May 2009
Amgen April 1994 - February 2008
BioSource International January 2002 - July 2002
Synergen 1991 - 1994
Cell Technology, Inc. 1988 - 1990
Cell Technology 1987 - 1988
Skills
GMP, Production Management, Business Analysis, DNA, Requirements Analysis, solid oral dosage..., materials management, cold chain management, Manufacturing Operations, Quality Management, ISO 13485, Business Process..., Business Development, Materials Management, Production Managment, Molecular Biology, Biotechnology, Pharmaceutical Industry, Oligonucleotides, Lifesciences, Validation, Quality Control, CAPA, Technology Transfer, Manufacturing, FDA, Purification, GLP, Sop, Laboratory, LIMS, Medical Devices, Change Control, Quality System, Chemistry, R&D, Biopharmaceuticals, V&V, Life Sciences, SOP
Education
Regis University 1998 — 2004
MS, Computer Information Systems
University of Colorado at Boulder 1984 — 1989
Bachelor of Arts, Molecular, Cellular and Developmental Biology
Pharmatek August 2014 - Present
Pharmatek December 2011 - Present
REVA Medical, Inc. October 2010 - December 2011
Eurogentec May 2009 - October 2010
Illumina February 2008 - May 2009
Amgen April 1994 - February 2008
BioSource International January 2002 - July 2002
Synergen 1991 - 1994
Cell Technology, Inc. 1988 - 1990
Cell Technology 1987 - 1988
Skills
GMP, Production Management, Business Analysis, DNA, Requirements Analysis, solid oral dosage..., materials management, cold chain management, Manufacturing Operations, Quality Management, ISO 13485, Business Process..., Business Development, Materials Management, Production Managment, Molecular Biology, Biotechnology, Pharmaceutical Industry, Oligonucleotides, Lifesciences, Validation, Quality Control, CAPA, Technology Transfer, Manufacturing, FDA, Purification, GLP, Sop, Laboratory, LIMS, Medical Devices, Change Control, Quality System, Chemistry, R&D, Biopharmaceuticals, V&V, Life Sciences, SOP
Education
Regis University 1998 — 2004
MS, Computer Information Systems
University of Colorado at Boulder 1984 — 1989
Bachelor of Arts, Molecular, Cellular and Developmental Biology
Vishwas Gaitonde's Synergen Experience 1995 - 1995
Job Founder & Principal, Quill & Pill LLC
Industry Pharmaceuticals
Experience
Quill & Pill 2005 - Present
independent writing and editing professional January 1995 - Present
Pharmaceutical & Health-Sciences Research 2000 - 2005
Dura Pharmaceuticals 1996 - 1999
Synergen 1995 - 1995
Bristol-Myers Squibb 1990 - 1994
Skills
Medical Writing, Publications, Regulatory Submissions, Editing, Oncology, Content Development, Infectious Diseases, FDA, Feature Articles, Freelance Writing, Clinical Research, Journalism, Creative Writing, Web Content, Publishing, Immunology, Copy Editing, Pharmaceutical Industry, Neurology, Writing, Non-fiction, Literature, Proofreading, Ghostwriting, Research, Medical Microbiology, Essays, Gastroenterology, Marketing Communications, IND, Medicine, Editorial, Blogging, Books, NDA, Fiction Writing
Education
University of Iowa
MA, Journalism
University of Madras
MD, (Medicine)
Quill & Pill 2005 - Present
independent writing and editing professional January 1995 - Present
Pharmaceutical & Health-Sciences Research 2000 - 2005
Dura Pharmaceuticals 1996 - 1999
Synergen 1995 - 1995
Bristol-Myers Squibb 1990 - 1994
Skills
Medical Writing, Publications, Regulatory Submissions, Editing, Oncology, Content Development, Infectious Diseases, FDA, Feature Articles, Freelance Writing, Clinical Research, Journalism, Creative Writing, Web Content, Publishing, Immunology, Copy Editing, Pharmaceutical Industry, Neurology, Writing, Non-fiction, Literature, Proofreading, Ghostwriting, Research, Medical Microbiology, Essays, Gastroenterology, Marketing Communications, IND, Medicine, Editorial, Blogging, Books, NDA, Fiction Writing
Education
University of Iowa
MA, Journalism
University of Madras
MD, (Medicine)
RaJean Tiffany's Synergen Experience 1992 - 1995
Job Independant Biotechnology Professional
Industry Biotechnology
Experience
Self Employed November 2007 - Present
Amgen 1992 - November 2007
Synergen 1992 - 1995
Skills
Biopharmaceuticals, Validation, Biotechnology
Education
University of Northern Colorado 1984 — 1988
Self Employed November 2007 - Present
Amgen 1992 - November 2007
Synergen 1992 - 1995
Skills
Biopharmaceuticals, Validation, Biotechnology
Education
University of Northern Colorado 1984 — 1988
Andrea Curry's Synergen Experience 1993 - 1998
Job Principal Product Quality Leader Chief of Staff at Amgen
Industry Biotechnology
Dave Tillett's Synergen Experience 1992 - 1994
Job President at Berea Consulting
Industry Biotechnology
Experience
Berea Consulting January 2010 - Present
Amgen 1992 - 2007
Synergen 1992 - 1994
Skills
Biotechnology, Pharmaceutical Industry, GMP, Validation, Project Planning, Software Lifecycle, Sop, FDA, Quality System, Technology Transfer, Process Simulation, Biopharmaceuticals, Regulatory Affairs, Quality Assurance, Manufacturing, Lifesciences, V&V, Cross-functional Team..., 21 CFR Part 11, Change Control, CAPA, Clinical Development, Life Sciences, SOP
Education
Georgia Institute of Technology 1982 — 1988
PhD, Chemical Engineering
University of Delaware 1977 — 1982
BSChE, Chemical Engineering
Berea Consulting January 2010 - Present
Amgen 1992 - 2007
Synergen 1992 - 1994
Skills
Biotechnology, Pharmaceutical Industry, GMP, Validation, Project Planning, Software Lifecycle, Sop, FDA, Quality System, Technology Transfer, Process Simulation, Biopharmaceuticals, Regulatory Affairs, Quality Assurance, Manufacturing, Lifesciences, V&V, Cross-functional Team..., 21 CFR Part 11, Change Control, CAPA, Clinical Development, Life Sciences, SOP
Education
Georgia Institute of Technology 1982 — 1988
PhD, Chemical Engineering
University of Delaware 1977 — 1982
BSChE, Chemical Engineering
Patricia Catalano MD's Synergen Experience 1993 - 1995
Job Independent Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Eyetech Pharmaceuticals 2003 - 2007
Amgen 1995 - 1999
Amgen 1995 - 1999
Synergen 1993 - 1995
Skills
Biotechnology
Education
Albany Medical College 1967 — 1971
Eyetech Pharmaceuticals 2003 - 2007
Amgen 1995 - 1999
Amgen 1995 - 1999
Synergen 1993 - 1995
Skills
Biotechnology
Education
Albany Medical College 1967 — 1971
Koleen Green's Synergen Experience November 1992 - September 1994
Job Senior Manager, Training and Technical Development
Industry Biotechnology
Experience
Oso BioPharmaceuticals Manufacturing, LLC August 2014 - Present
Amgen May 1997 - June 2014
Synergen November 1992 - September 1994
Skills
CAPA, GMP, Biotechnology, Quality Control, Purification, Fermentation, Manufacturing, Biopharmaceuticals, Aseptic Processing, Change Control, FDA, Validation, Sop, 21 CFR Part 11, Technology Transfer, Analytical Chemistry, Aseptic Technique, Cell Culture, Clinical Development, Commercialization, Cross-functional Team..., Deviations, Downstream Processing, ELISA, FDA GMP, Filtration, GLP, LIMS, Laboratory, Manufacturing Operations, Medical Devices, Microbiology, Pharmaceutical Industry, Pharmaceutics, Quality Assurance, Quality System, Regulatory Requirements, Root Cause Analysis, SOP, Trackwise, TrackWise, Regulatory Affairs
Education
University of Colorado Boulder 1988 — 2002
BA, Biology
Oso BioPharmaceuticals Manufacturing, LLC August 2014 - Present
Amgen May 1997 - June 2014
Synergen November 1992 - September 1994
Skills
CAPA, GMP, Biotechnology, Quality Control, Purification, Fermentation, Manufacturing, Biopharmaceuticals, Aseptic Processing, Change Control, FDA, Validation, Sop, 21 CFR Part 11, Technology Transfer, Analytical Chemistry, Aseptic Technique, Cell Culture, Clinical Development, Commercialization, Cross-functional Team..., Deviations, Downstream Processing, ELISA, FDA GMP, Filtration, GLP, LIMS, Laboratory, Manufacturing Operations, Medical Devices, Microbiology, Pharmaceutical Industry, Pharmaceutics, Quality Assurance, Quality System, Regulatory Requirements, Root Cause Analysis, SOP, Trackwise, TrackWise, Regulatory Affairs
Education
University of Colorado Boulder 1988 — 2002
BA, Biology
Erwin Freund's Synergen Experience 1987 - 1995
Job Exec Director at Amgen
Industry Biotechnology
Experience
Amgen March 1996 - Present
Selective Genetics 1995 - 1996
Synergen 1987 - 1995
Hoffmann La-Roche 1985 - 1987
Skills
Biochemistry, Machine vision, Drug Product Inspection..., Drug Delivery, Injection devices, Automation inspection, protein formulation
Education
University of Florida 1980 — 1984
Doctor of Philosophy (Ph.D.), Molecular Biology
Christelijk Lyceum, Zeist
Universiteit Utrecht / University of Utrecht
Masters Degree, Biochemistry
Amgen March 1996 - Present
Selective Genetics 1995 - 1996
Synergen 1987 - 1995
Hoffmann La-Roche 1985 - 1987
Skills
Biochemistry, Machine vision, Drug Product Inspection..., Drug Delivery, Injection devices, Automation inspection, protein formulation
Education
University of Florida 1980 — 1984
Doctor of Philosophy (Ph.D.), Molecular Biology
Christelijk Lyceum, Zeist
Universiteit Utrecht / University of Utrecht
Masters Degree, Biochemistry
Saundra Lewis (Kochersperger)'s Synergen Experience August 1991 - February 1995
Job Research Support Manager at Janus Capital Group
Industry Investment Management
Experience
Janus Capital Group April 2010 - Present
Synergen August 1991 - February 1995
Skills
Process Improvement, Asset Management, Vendor Management, Visio, Management
Education
Front Range Community College 1988 — 1990
Janus Capital Group April 2010 - Present
Synergen August 1991 - February 1995
Skills
Process Improvement, Asset Management, Vendor Management, Visio, Management
Education
Front Range Community College 1988 — 1990
Celeste Ramsey's Synergen Experience October 1992 - August 1994
Job Regulatory Affairs CMC Professional
Industry Biotechnology
Experience
Self Employed Consultant May 2013 - Present
Merck April 2009 - April 2013
Insmed May 2006 - March 2009
Chiron Corporation January 2003 - May 2006
Chiron Corporation September 1996 - December 2002
Synergen October 1992 - August 1994
Cetus Corp 1987 - 1992
Medi-Physics 1979 - 1987
Skills
Biopharmaceuticals, FDA, GMP, Biotechnology, Sop, Regulatory Affairs, Pharmaceutical Industry, Change Control, CMC, Medical Devices, Validation, CRO, Technology Transfer, Quality System, Regulatory Submissions, Manufacturing, Quality Assurance, Drug Development, GxP, Protocol, NDA, Regulatory Requirements, eCTD, Aseptic Processing, SOP
Education
Humboldt State University
B.A., Chemistry
Self Employed Consultant May 2013 - Present
Merck April 2009 - April 2013
Insmed May 2006 - March 2009
Chiron Corporation January 2003 - May 2006
Chiron Corporation September 1996 - December 2002
Synergen October 1992 - August 1994
Cetus Corp 1987 - 1992
Medi-Physics 1979 - 1987
Skills
Biopharmaceuticals, FDA, GMP, Biotechnology, Sop, Regulatory Affairs, Pharmaceutical Industry, Change Control, CMC, Medical Devices, Validation, CRO, Technology Transfer, Quality System, Regulatory Submissions, Manufacturing, Quality Assurance, Drug Development, GxP, Protocol, NDA, Regulatory Requirements, eCTD, Aseptic Processing, SOP
Education
Humboldt State University
B.A., Chemistry
Kristen Schomer's Synergen Experience 1995 - 1997
Job Director, Quality Control Chemistry
Industry Pharmaceuticals
Experience
Celgene Corporation October 2010 - Present
Abraxis BioScience 2007 - 2010
Watson Pharmaceuticals 2004 - 2007
Geneva Pharmaceuticals, Inc. May 1995 - May 2003
Synergen 1995 - 1997
Skills
GMP, CAPA, Sop
Education
Colorado State University
BS, Microbiology
Celgene Corporation October 2010 - Present
Abraxis BioScience 2007 - 2010
Watson Pharmaceuticals 2004 - 2007
Geneva Pharmaceuticals, Inc. May 1995 - May 2003
Synergen 1995 - 1997
Skills
GMP, CAPA, Sop
Education
Colorado State University
BS, Microbiology
Cathy Kroskey's Synergen Experience 1983 - 1994
Job Specialist Quality Assurance at Amgen
Industry Biotechnology
Experience
Amgen April 2014 - Present
Amgen June 2006 - April 2014
Amgen July 1994 - June 2006
Synergen 1983 - 1994
Skills
GMP, Quality Systems, Technical Writing, Root Cause Analysis, CAPA, Investigation, Project Management, Quality System, Biopharmaceuticals, FDA, Quality Control, Change Control, 21 CFR Part 11, Lifesciences, HPLC, Aseptic Processing, GLP, Validation, Biotechnology, Chromatography, Pharmaceutical Industry, Filtration, Cell Culture, LIMS, Sop, Technology Transfer, Fermentation, V&V, Aseptic Technique, Purification, Cleaning Validation, GxP, Computer System..., Clean Rooms, Sterilization, cGMP manufacturing, cGMP practices, SOP, Life Sciences, Quality Assurance, Manufacturing, TrackWise
Education
Colorado State University 1977 — 1979
BS, Botany & Plant Pathology
North Dakota State University 1975 — 1977
AAS, Wildlife Bioloty
Amgen April 2014 - Present
Amgen June 2006 - April 2014
Amgen July 1994 - June 2006
Synergen 1983 - 1994
Skills
GMP, Quality Systems, Technical Writing, Root Cause Analysis, CAPA, Investigation, Project Management, Quality System, Biopharmaceuticals, FDA, Quality Control, Change Control, 21 CFR Part 11, Lifesciences, HPLC, Aseptic Processing, GLP, Validation, Biotechnology, Chromatography, Pharmaceutical Industry, Filtration, Cell Culture, LIMS, Sop, Technology Transfer, Fermentation, V&V, Aseptic Technique, Purification, Cleaning Validation, GxP, Computer System..., Clean Rooms, Sterilization, cGMP manufacturing, cGMP practices, SOP, Life Sciences, Quality Assurance, Manufacturing, TrackWise
Education
Colorado State University 1977 — 1979
BS, Botany & Plant Pathology
North Dakota State University 1975 — 1977
AAS, Wildlife Bioloty
Lara Maloney's Synergen Experience 1992 - 1994
Job Director, Clinical Development at Clovis Oncology
Industry Biotechnology
Experience
Clovis Oncology March 2015 - Present
Clovis Oncology August 2013 - March 2015
Array BioPharma January 2011 - August 2013
Array BioPharma January 2009 - January 2011
Array BioPharma September 2004 - October 2008
AstraZeneca 2003 - 2004
sirna 2002 - 2003
Sirna Therapeutics 2001 - 2003
Ribozyme 1994 - 2003
Synergen 1992 - 1994
Skills
CTMS, CRO, EDC, Drug Discovery, Regulatory Submissions, Lifesciences, Sop, Clinical Data Management
Education
University of Colorado Boulder 1988 — 1991
BA, Biochemistry and Molecular, Cellular, and Developmental Biology
University of Wisconsin-Madison 1986 — 1987
Liberal Arts
Clovis Oncology March 2015 - Present
Clovis Oncology August 2013 - March 2015
Array BioPharma January 2011 - August 2013
Array BioPharma January 2009 - January 2011
Array BioPharma September 2004 - October 2008
AstraZeneca 2003 - 2004
sirna 2002 - 2003
Sirna Therapeutics 2001 - 2003
Ribozyme 1994 - 2003
Synergen 1992 - 1994
Skills
CTMS, CRO, EDC, Drug Discovery, Regulatory Submissions, Lifesciences, Sop, Clinical Data Management
Education
University of Colorado Boulder 1988 — 1991
BA, Biochemistry and Molecular, Cellular, and Developmental Biology
University of Wisconsin-Madison 1986 — 1987
Liberal Arts
Corey Merritt's Synergen Experience March 1992 - August 1994
Job Facilities Coordinator/Planner at BioMarin Pharmaceutical Inc.
Industry Pharmaceuticals
Experience
BioMarin Pharmaceutical Inc. July 2014 - Present
Bio-Rad Laboratories January 2011 - January 2014
Cell Genesys December 2003 - October 2008
Inhale 2000 - 2003
Aviron 1998 - 2000
Scios 1994 - 1998
Synergen March 1992 - August 1994
Some additional Information January 1984 - December 1984
Skills
Validation, Documentation, cGMP, Biotechnology, Quality Systems, Pharmaceuticals, Quality Assurance, Change Management, SOP, FDA, GLP, CAPA, Troubleshooting, Problem Solving, Program Management, Medical Devices, Scheduling, Software Documentation, Manufacturing, Testing, Sop, Quality System, Process Improvement, Pharmaceutical Industry, Automation, Calibration, Process Scheduler, GMP, Laboratory, Change Control
Education
Laney College 2012 — 2014
Machine Tool Technology/Machinist
Monterey Peninsula College 1981 — 1984
General Studies
BioMarin Pharmaceutical Inc. July 2014 - Present
Bio-Rad Laboratories January 2011 - January 2014
Cell Genesys December 2003 - October 2008
Inhale 2000 - 2003
Aviron 1998 - 2000
Scios 1994 - 1998
Synergen March 1992 - August 1994
Some additional Information January 1984 - December 1984
Skills
Validation, Documentation, cGMP, Biotechnology, Quality Systems, Pharmaceuticals, Quality Assurance, Change Management, SOP, FDA, GLP, CAPA, Troubleshooting, Problem Solving, Program Management, Medical Devices, Scheduling, Software Documentation, Manufacturing, Testing, Sop, Quality System, Process Improvement, Pharmaceutical Industry, Automation, Calibration, Process Scheduler, GMP, Laboratory, Change Control
Education
Laney College 2012 — 2014
Machine Tool Technology/Machinist
Monterey Peninsula College 1981 — 1984
General Studies
Patricia Caffes's Synergen Experience 1984 - 1994
Job Sr. Research Associate at mayoclinic
Industry Hospital & Health Care
Experience
Mayo Clinic 1997 - Present
Amgen 1994 - 1997
Synergen 1984 - 1994
Skills
Protein Chemistry, Biotechnology, Cell Culture, Cell, Research, ELISA, Chromatography, Tissue Culture
Education
Augsburg College 2007 — 2009
MBA
University of MN
Bachelor's degree, Chemistry
Mayo Clinic 1997 - Present
Amgen 1994 - 1997
Synergen 1984 - 1994
Skills
Protein Chemistry, Biotechnology, Cell Culture, Cell, Research, ELISA, Chromatography, Tissue Culture
Education
Augsburg College 2007 — 2009
MBA
University of MN
Bachelor's degree, Chemistry
Louis Junker's Synergen Experience 1993 - 1994
Job Principal Consultant at Solutions Biologic, Inc.
Industry Biotechnology
Experience
Solutions Biologic, Inc. 2004 - Present
Coragen Biologics, Inc. 2002 - 2004
Sulzer Biologics, Inc. 1996 - 2002
Synergen 1993 - 1994
Somatogen 1989 - 1993
Skills
Biotechnology, Protein Chemistry, Validation, Purification, Commercialization, FDA, Program Management, Manufacturing, SOP, Clinical Development, Process Simulation, Medical Devices, Product Development, Biopharmaceuticals, GMP
Education
University of Colorado Health Sciences Center 1986 — 1989
Post Doctoral/Faculty
Purdue University 1980 — 1986
Ph.D., Biochemical Nutrition
Solutions Biologic, Inc. 2004 - Present
Coragen Biologics, Inc. 2002 - 2004
Sulzer Biologics, Inc. 1996 - 2002
Synergen 1993 - 1994
Somatogen 1989 - 1993
Skills
Biotechnology, Protein Chemistry, Validation, Purification, Commercialization, FDA, Program Management, Manufacturing, SOP, Clinical Development, Process Simulation, Medical Devices, Product Development, Biopharmaceuticals, GMP
Education
University of Colorado Health Sciences Center 1986 — 1989
Post Doctoral/Faculty
Purdue University 1980 — 1986
Ph.D., Biochemical Nutrition
Donna Darner's Synergen Experience 1992 - 1995
Job Global Regulatory Intelligence Director
Industry Pharmaceuticals
Experience
Alcon, a Novartis company February 2009 - Present
Alcon Laboratories, Inc. March 2006 - January 2009
Alcon Laboratories, Inc. June 2000 - February 2006
Anesta Corp June 1995 - December 1999
Synergen 1992 - 1995
Covance (G.H. Besselaar Associates) 1985 - 1991
Skills
Clinical, Regulatory Affairs, Clinical Trials, Quality Systems, Regulatory Requirements, R&D, FDA, Medical Devices, Pharmaceuticals, GCP, GxP, Clinical Research, Quality System, Pharmaceutical Industry, GMP, Clinical Development, 21 CFR Part 11, Quality Assurance, GLP, Biotechnology, Regulatory Submissions, Drug Development, Data Management, CAPA, Quality Auditing, Clinical Data Management, Protocol, CTMS, Validation, Change Control, Computer System..., Sop, Lifesciences, Pharmaceutics, V&V, Technology Transfer, CRO, Oncology, ISO 13485, Design Control, Biopharmaceuticals, Infectious Diseases, Aseptic Processing, Immunology, Pharmacology, Microbiology, Drug Discovery, Analytical Chemistry, ICH-GCP, Pharmacovigilance
Education
University of Florida 2009 — 2011
MS Pharm, Pharmaceutical Outcomes and Policy
Lipscomb University 1977 — 1981
BS, MT, Medical Technology
Alcon, a Novartis company February 2009 - Present
Alcon Laboratories, Inc. March 2006 - January 2009
Alcon Laboratories, Inc. June 2000 - February 2006
Anesta Corp June 1995 - December 1999
Synergen 1992 - 1995
Covance (G.H. Besselaar Associates) 1985 - 1991
Skills
Clinical, Regulatory Affairs, Clinical Trials, Quality Systems, Regulatory Requirements, R&D, FDA, Medical Devices, Pharmaceuticals, GCP, GxP, Clinical Research, Quality System, Pharmaceutical Industry, GMP, Clinical Development, 21 CFR Part 11, Quality Assurance, GLP, Biotechnology, Regulatory Submissions, Drug Development, Data Management, CAPA, Quality Auditing, Clinical Data Management, Protocol, CTMS, Validation, Change Control, Computer System..., Sop, Lifesciences, Pharmaceutics, V&V, Technology Transfer, CRO, Oncology, ISO 13485, Design Control, Biopharmaceuticals, Infectious Diseases, Aseptic Processing, Immunology, Pharmacology, Microbiology, Drug Discovery, Analytical Chemistry, ICH-GCP, Pharmacovigilance
Education
University of Florida 2009 — 2011
MS Pharm, Pharmaceutical Outcomes and Policy
Lipscomb University 1977 — 1981
BS, MT, Medical Technology
Carol Croft's Synergen Experience 1990 - 1995
Job Senior Exchange Officer at 1031 Corporation
Industry Accounting
Experience
1031 Corporation 1995 - Present
Synergen 1990 - 1995
Education
Colorado State University
BA, Political Science
1031 Corporation 1995 - Present
Synergen 1990 - 1995
Education
Colorado State University
BA, Political Science
Robert Kuhn's Synergen Experience 1992 - 1995
Job Director Process Development at Amgen
Industry Biotechnology
Experience
Amgen 1995 - Present
Synergen 1992 - 1995
Skills
GMP, Biopharmaceuticals, Biotechnology, Technology Transfer, Chromatography, Change Control, Validation, FDA, Purification, Fermentation, Aseptic Processing, V&V
Education
North Carolina State University 1986 — 1992
PhD, Chemical Engineering, Biochemical Engineering Emphasis
Colorado State University 1984 — 1986
MS, Chemical Engineering, Biochemistry Minor
Rutgers, The State University of New Jersey-New Brunswick 1979 — 1983
BS, Chemical Engineering, Biochemical Engineering Minor
Amgen 1995 - Present
Synergen 1992 - 1995
Skills
GMP, Biopharmaceuticals, Biotechnology, Technology Transfer, Chromatography, Change Control, Validation, FDA, Purification, Fermentation, Aseptic Processing, V&V
Education
North Carolina State University 1986 — 1992
PhD, Chemical Engineering, Biochemical Engineering Emphasis
Colorado State University 1984 — 1986
MS, Chemical Engineering, Biochemistry Minor
Rutgers, The State University of New Jersey-New Brunswick 1979 — 1983
BS, Chemical Engineering, Biochemical Engineering Minor
Denise Elliott's Synergen Experience 1992 - December 1994
Job Manager, Data Management
Industry Pharmaceuticals
Experience
Onyx Pharmaceuticals, an Amgen Subsidiary September 2012 - Present
Project Manager, Data Management April 2012 - September 2012
PRA International September 2006 - April 2012
Amgen November 1997 - August 2005
Amgen January 1995 - November 1997
Synergen 1992 - December 1994
Skills
Data Management, Oncology, Clinical Data Management, CRO, ICH-GCP, CTMS, Clinical Development, Clinical Trials, Pharmaceutical Industry, GCP, 21 CFR Part 11, EDC, Clinical Research, Inform, CDISC, Biotechnology, Protocol, Sop, Therapeutic Areas, FDA, SOP
Education
University of North Texas
B.A., Marketing
Onyx Pharmaceuticals, an Amgen Subsidiary September 2012 - Present
Project Manager, Data Management April 2012 - September 2012
PRA International September 2006 - April 2012
Amgen November 1997 - August 2005
Amgen January 1995 - November 1997
Synergen 1992 - December 1994
Skills
Data Management, Oncology, Clinical Data Management, CRO, ICH-GCP, CTMS, Clinical Development, Clinical Trials, Pharmaceutical Industry, GCP, 21 CFR Part 11, EDC, Clinical Research, Inform, CDISC, Biotechnology, Protocol, Sop, Therapeutic Areas, FDA, SOP
Education
University of North Texas
B.A., Marketing
Randy Hassler's Synergen Experience April 1983 - January 1995
Job Senior Vice President at Alder Biopharmaceuticals Inc. (Nasdaq: ALDR)
Industry Research
Experience
Alder Biopharmaceuticals Inc. (Nasdaq: ALDR) August 2014 - Present
Seattle Biomedical Research Institute December 2011 - July 2014
Seattle Biomedical Research Institute January 2008 - November 2011
Amgen January 1995 - November 2007
Synergen April 1983 - January 1995
Skills
Quality Assurance, Regulatory Affairs, Technology Transfer, Biotechnology, GLP, Lifesciences, GMP, Biopharmaceuticals, Change Management, Medical Devices, Cross-functional Team..., Pharmaceutical Industry, Sop, Strategic Planning, Oncology, FDA, Cell Culture, Immunology, Molecular Biology, Organizational..., Clinical Trials, Infectious Diseases, Clinical Development, Program Management, Protein Chemistry, Life Sciences, SOP
Education
Colorado State University
M.S., Microbiology
Indiana University Bloomington
B.S., Microbiology
Alder Biopharmaceuticals Inc. (Nasdaq: ALDR) August 2014 - Present
Seattle Biomedical Research Institute December 2011 - July 2014
Seattle Biomedical Research Institute January 2008 - November 2011
Amgen January 1995 - November 2007
Synergen April 1983 - January 1995
Skills
Quality Assurance, Regulatory Affairs, Technology Transfer, Biotechnology, GLP, Lifesciences, GMP, Biopharmaceuticals, Change Management, Medical Devices, Cross-functional Team..., Pharmaceutical Industry, Sop, Strategic Planning, Oncology, FDA, Cell Culture, Immunology, Molecular Biology, Organizational..., Clinical Trials, Infectious Diseases, Clinical Development, Program Management, Protein Chemistry, Life Sciences, SOP
Education
Colorado State University
M.S., Microbiology
Indiana University Bloomington
B.S., Microbiology
Dawn Cherico's Synergen Experience 1992 - 1994
Job Chemist
Industry Primary/Secondary Education
Experience
Array BioPharma January 2000 - October 2004
NaPro BioTherapeutics, Inc August 1997 - December 1999
Synergen 1992 - 1994
Geneva Pharmaceuticals 1989 - 1992
Skills
HPLC, Analytical Chemistry, Chromatography, Mass Spectrometry, GLP
Education
University of Colorado Denver 1993 — 1996
MS, Chemistry
Central Methodist College 1984 — 1987
BA, Major - Chemistry Minor Biology
University of Missouri-Columbia 1982 — 1987
Array BioPharma January 2000 - October 2004
NaPro BioTherapeutics, Inc August 1997 - December 1999
Synergen 1992 - 1994
Geneva Pharmaceuticals 1989 - 1992
Skills
HPLC, Analytical Chemistry, Chromatography, Mass Spectrometry, GLP
Education
University of Colorado Denver 1993 — 1996
MS, Chemistry
Central Methodist College 1984 — 1987
BA, Major - Chemistry Minor Biology
University of Missouri-Columbia 1982 — 1987
Shane Haft's Synergen Experience 1991 - 1994
Job Validation and Compliance Biotechnology Professional
Industry Biotechnology
Experience
Rocky Mountain Compliance Specialists, Inc. 1995 - Present
Synergen 1991 - 1994
Skills
Aseptic Processing, Biotechnology, Validation, V&V, FDA, Quality System, GMP, Cleaning Validation, Quality Assurance, Sterilization, Technology Transfer, Change Control, Sop, FDA GMP, CAPA, Chromatography, Biopharmaceuticals, Medical Devices, Vaccines, Filtration, 21 CFR Part 11, SOP
Education
Montana State University-Bozeman
Rocky Mountain Compliance Specialists, Inc. 1995 - Present
Synergen 1991 - 1994
Skills
Aseptic Processing, Biotechnology, Validation, V&V, FDA, Quality System, GMP, Cleaning Validation, Quality Assurance, Sterilization, Technology Transfer, Change Control, Sop, FDA GMP, CAPA, Chromatography, Biopharmaceuticals, Medical Devices, Vaccines, Filtration, 21 CFR Part 11, SOP
Education
Montana State University-Bozeman
Donna Ferber's Synergen Experience 1982 - 1986
Job patent agent and quilter
Industry Legal Services
Experience
Greenlee Sullivan P.C. 1989 - December 2012
synergen 1982 - 1986
Skills
Patents, Patentability, Prosecution, Intellectual Property, Patent Prosecution
Education
Cornell University 1970 — 1974
BS, Biology
Michigan State University
Doctor of Philosophy (PhD), Microbiology
Greenlee Sullivan P.C. 1989 - December 2012
synergen 1982 - 1986
Skills
Patents, Patentability, Prosecution, Intellectual Property, Patent Prosecution
Education
Cornell University 1970 — 1974
BS, Biology
Michigan State University
Doctor of Philosophy (PhD), Microbiology
R. Michael Smullen's Synergen Experience January 1992 - May 1994
Job CoFounder and Executive Chairman
Industry Pharmaceuticals
Experience
AltMed March 2014 - Present
MedImmune, Inc. May 1994 - July 2007
Synergen January 1992 - May 1994
Fujisawa December 1984 - January 1992
SmithKline & French May 1978 - December 1984
Boehringer Ingelheim September 1976 - May 1978
Skills
Biotechnology, Medical Devices, Pharmaceutical Industry, Hospital Sales, Buy & Bill, Healthcare, Pharmaceutical Sales, Lifesciences, Account Management, Start-ups, Product Launch, Cross-functional Team..., Leadership, Infectious Diseases, Cardiology, Strategic Planning, Vaccines, Clinical Research, Managed Care, Training, Sales Management, Sales Operations, Team Leadership, Mergers & Acquisitions, Negotiation, Pulmonology, Hospitals, Biopharmaceuticals, Business Development, Neurology, Diabetes, Immunology, Clinical Trials, Clinical Development, Gastroenterology, FDA, Sales Effectiveness, Drug Development, Regulatory Affairs, Endocrinology, CTMS, Technology Transfer, Market Access, Oncology, Commercialization, Regulatory Requirements
Education
Norwich University 1972 — 1976
BA, History
South Burlington High school 1971 — 1972
AltMed March 2014 - Present
MedImmune, Inc. May 1994 - July 2007
Synergen January 1992 - May 1994
Fujisawa December 1984 - January 1992
SmithKline & French May 1978 - December 1984
Boehringer Ingelheim September 1976 - May 1978
Skills
Biotechnology, Medical Devices, Pharmaceutical Industry, Hospital Sales, Buy & Bill, Healthcare, Pharmaceutical Sales, Lifesciences, Account Management, Start-ups, Product Launch, Cross-functional Team..., Leadership, Infectious Diseases, Cardiology, Strategic Planning, Vaccines, Clinical Research, Managed Care, Training, Sales Management, Sales Operations, Team Leadership, Mergers & Acquisitions, Negotiation, Pulmonology, Hospitals, Biopharmaceuticals, Business Development, Neurology, Diabetes, Immunology, Clinical Trials, Clinical Development, Gastroenterology, FDA, Sales Effectiveness, Drug Development, Regulatory Affairs, Endocrinology, CTMS, Technology Transfer, Market Access, Oncology, Commercialization, Regulatory Requirements
Education
Norwich University 1972 — 1976
BA, History
South Burlington High school 1971 — 1972
Kris Picher's Synergen Experience 1992 - 1994
Job Claims Examiner at U.S. Department of Labor
Industry Government Administration
Experience
U.S. Department of Labor October 2005 - Present
Picher & Assoc September 1995 - November 2002
Synergen 1992 - 1994
Skills
Health, Research, Writing, Teaching, Case Management, Coaching, Negotiation, Microsoft Office, Policy, Counseling, Healthcare, Case Managment, Program Development
Education
University of Northern Colorado 1991 — 1995
Master's degree, Counseling Psychology
University of Southern Colorado 1970 — 1974
Bachelor of Science (BS), Pre-Medicine/Pre-Medical Studies/medical technology
U.S. Department of Labor October 2005 - Present
Picher & Assoc September 1995 - November 2002
Synergen 1992 - 1994
Skills
Health, Research, Writing, Teaching, Case Management, Coaching, Negotiation, Microsoft Office, Policy, Counseling, Healthcare, Case Managment, Program Development
Education
University of Northern Colorado 1991 — 1995
Master's degree, Counseling Psychology
University of Southern Colorado 1970 — 1974
Bachelor of Science (BS), Pre-Medicine/Pre-Medical Studies/medical technology
Christine Roberson's Synergen Experience August 1990 - August 1994
Job Laboratory Technology Instructor
Industry Primary/Secondary Education
Experience
Columbia Public Schools August 2005 - Present
Lifecore Biomedical August 1995 - November 1997
Geneva Pharmacueticals October 1994 - February 1995
Synergen August 1990 - August 1994
Skills
Clinical Development, Biotechnology, Teaching, HPLC, Science, Clinical Trials, Laboratory, Analytical Chemistry, Research, Science Education, USP
Education
University of Missouri-Columbia 2004 — 2005
M. Ed, Curriculum and Instruction, science education
Colorado College 1986 — 1990
BA, Biology
Columbia Public Schools August 2005 - Present
Lifecore Biomedical August 1995 - November 1997
Geneva Pharmacueticals October 1994 - February 1995
Synergen August 1990 - August 1994
Skills
Clinical Development, Biotechnology, Teaching, HPLC, Science, Clinical Trials, Laboratory, Analytical Chemistry, Research, Science Education, USP
Education
University of Missouri-Columbia 2004 — 2005
M. Ed, Curriculum and Instruction, science education
Colorado College 1986 — 1990
BA, Biology
Therese Herzog's Synergen Experience February 1990 - January 1993
Job Self Employed
Industry Biotechnology
Experience
Amgen February 2006 - May 2014
Amgen January 2000 - February 2006
Amgen January 1995 - January 2000
Synergen became Amgen in 1995 January 1993 - January 1995
Synergen February 1990 - January 1993
Skills
Biotechnology, Biopharmaceuticals, Aseptic Processing, Sop, GMP, CAPA, FDA, Validation, Purification, Fermentation, 21 CFR Part 11, Technology Transfer, Cross-functional Team..., LIMS, Pharmaceutical Industry, GLP, Quality System, Change Control, Lifesciences, Quality Control, Quality Assurance, Cell Culture, Chromatography, Aseptic Technique, SAP ERP
Education
Colorado State University 1987 — 1989
BS, Microbiology
Amgen February 2006 - May 2014
Amgen January 2000 - February 2006
Amgen January 1995 - January 2000
Synergen became Amgen in 1995 January 1993 - January 1995
Synergen February 1990 - January 1993
Skills
Biotechnology, Biopharmaceuticals, Aseptic Processing, Sop, GMP, CAPA, FDA, Validation, Purification, Fermentation, 21 CFR Part 11, Technology Transfer, Cross-functional Team..., LIMS, Pharmaceutical Industry, GLP, Quality System, Change Control, Lifesciences, Quality Control, Quality Assurance, Cell Culture, Chromatography, Aseptic Technique, SAP ERP
Education
Colorado State University 1987 — 1989
BS, Microbiology
Adrienne Hanagan's Synergen Experience 1991 - 1993
Job Biology Instructor at Crossroads Christian Academy
Industry Higher Education
Experience
Crossroads Christian Academy August 2011 - Present
University of Colorado Health Sciences Center School of Pharmacy 1995 - 1997
Supragen, Inc 1993 - 1995
Synergen 1991 - 1993
Education
San Francisco State University 1988 — 1991
M. A. Biology, Cell and Molecular Biology, Protein Biochemistry, 3.5
Colorado School of Mines 1980 — 1983
B. S. Chemical and Petroleum Refining Engineering, Chemical Engineering
Crossroads Christian Academy August 2011 - Present
University of Colorado Health Sciences Center School of Pharmacy 1995 - 1997
Supragen, Inc 1993 - 1995
Synergen 1991 - 1993
Education
San Francisco State University 1988 — 1991
M. A. Biology, Cell and Molecular Biology, Protein Biochemistry, 3.5
Colorado School of Mines 1980 — 1983
B. S. Chemical and Petroleum Refining Engineering, Chemical Engineering
Kathy Cunningham's Synergen Experience 1985 - 1986
Job Production Assistant at CJ Roofing
Industry Information Services
Experience
CJ Roofing November 2014 - Present
CJ Roofing November 2014 - Present
Corinthian Colleges, Inc. July 2013 - November 2014
Staffing Agencies November 2012 - July 2013
Add a Concierge July 2012 - November 2012
Oxford West May 2005 - April 2012
C & C Couriers, Inc. November 1989 - May 2006
Aries Art Forms 1987 - 1989
Synergen 1985 - 1986
Downtown Boulder Partnership 1984 - 1985
Skills
Administrative &..., Customer Service, Office Management, Accounts Payable, Accounts Receivable, Microsoft Outlook, Word, Excel, PowerPoint, Adobe, LaCert Tax Program, Peachtree Accounting, Wordperfect, Outlook, Adobe Acrobat
Education
Front Range Community College
Applied Science/Horticulture
CJ Roofing November 2014 - Present
CJ Roofing November 2014 - Present
Corinthian Colleges, Inc. July 2013 - November 2014
Staffing Agencies November 2012 - July 2013
Add a Concierge July 2012 - November 2012
Oxford West May 2005 - April 2012
C & C Couriers, Inc. November 1989 - May 2006
Aries Art Forms 1987 - 1989
Synergen 1985 - 1986
Downtown Boulder Partnership 1984 - 1985
Skills
Administrative &..., Customer Service, Office Management, Accounts Payable, Accounts Receivable, Microsoft Outlook, Word, Excel, PowerPoint, Adobe, LaCert Tax Program, Peachtree Accounting, Wordperfect, Outlook, Adobe Acrobat
Education
Front Range Community College
Applied Science/Horticulture
Katie Kaulbach's Synergen Experience May 1984 - October 1993
Job Facilities Management
Industry Biotechnology
Experience
Self-employed January 1987 - Present
Various Biotech and Pharmaceutical companies January 1996 - January 2011
Water For People July 1994 - June 1996
Synergen May 1984 - October 1993
Colorado State University 1980 - 1984
Skills
Laboratory, Facilities Management, Biotechnology, Construction, Protein Purification, Tissue Culture, Construction Management, Management, Quality Control, Process Scheduler, Proposal Writing, GLP
Education
Bel-Rea Institute of Animal Technology 1978 — 1979
Associate of Science (AS), Veterinary/Animal Health Technology/Technician and Veterinary Assistant
Colorado State University 1975 — 1976
Wildlife Biology
Self-employed January 1987 - Present
Various Biotech and Pharmaceutical companies January 1996 - January 2011
Water For People July 1994 - June 1996
Synergen May 1984 - October 1993
Colorado State University 1980 - 1984
Skills
Laboratory, Facilities Management, Biotechnology, Construction, Protein Purification, Tissue Culture, Construction Management, Management, Quality Control, Process Scheduler, Proposal Writing, GLP
Education
Bel-Rea Institute of Animal Technology 1978 — 1979
Associate of Science (AS), Veterinary/Animal Health Technology/Technician and Veterinary Assistant
Colorado State University 1975 — 1976
Wildlife Biology
Suzanne Pyle's Synergen Experience April 1990 - July 1994
Job Associate Scientist at Amgen
Industry Biotechnology
Experience
Amgen July 1994 - Present
Synergen April 1990 - July 1994
Skills
Mammalian Cell Culture, Bacterial Cell Culture, Pharmaceutical process..., Protein Purification, Cryopreservation, Biopharmaceuticals, GLP, Validation, Chromatography, Biotechnology, Cell Culture, FDA, Life Sciences, SOP, Protein Chemistry, GMP, Technology Transfer
Education
University of Colorado Boulder
Chemical Engineering
Amgen July 1994 - Present
Synergen April 1990 - July 1994
Skills
Mammalian Cell Culture, Bacterial Cell Culture, Pharmaceutical process..., Protein Purification, Cryopreservation, Biopharmaceuticals, GLP, Validation, Chromatography, Biotechnology, Cell Culture, FDA, Life Sciences, SOP, Protein Chemistry, GMP, Technology Transfer
Education
University of Colorado Boulder
Chemical Engineering