Baxter BioScience
Industry: Company
DescriptionBaxalta is a biopharmaceutical company founded on 1 July 2015 after its parent company, Baxter International, spun off biopharmaceutical division. The company began its operation with a revenue of $6 billion. CEO: Ludwig N. Hantson (1 Jul 2015–) Number of employees: 16,000 Founded: 2015 Subsidiaries: Asklepios BioPharmaceutical, Inc., Baxalta US Inc., Parent organization: Shire
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Baxter BioScience Employees
Employee
Years
Job
Industry
Madhavi Thatte Madhavi Thatte's Baxter BioScience Experience April 2013 - Present
Job
Industry Biotechnology
Experience
Baxter Bioscience April 2013 - Present
Amgen July 2009 - April 2013
Amgen Inc April 2006 - July 2009
Mangan Inc.(Contracting in Amgen) 2003 - 2005
paton control (Contracting in Exxon Mobil) April 2002 - April 2003
honeywell, India 1997 - 2000
Skills
Biotechnology, GMP, Operational Excellence, Commercialization, Manufacturing, Leading Projects, Change Control, MS Project, Process Development, Six Sigma, Lean Sigma, PMP, Validation, Protein Purification
Education
University of Pune 1993 — 1997
Bachelor Of Engineering, Instrumentation and Control
Baxter Bioscience April 2013 - Present
Amgen July 2009 - April 2013
Amgen Inc April 2006 - July 2009
Mangan Inc.(Contracting in Amgen) 2003 - 2005
paton control (Contracting in Exxon Mobil) April 2002 - April 2003
honeywell, India 1997 - 2000
Skills
Biotechnology, GMP, Operational Excellence, Commercialization, Manufacturing, Leading Projects, Change Control, MS Project, Process Development, Six Sigma, Lean Sigma, PMP, Validation, Protein Purification
Education
University of Pune 1993 — 1997
Bachelor Of Engineering, Instrumentation and Control
Elfrin Colón-De Jesus Elfrin Colón-De Jesus's Baxter BioScience Experience September 2014 - Present
Job Sr. Validation Engineer at Fresenius Medical Care
Industry Consumer Services
Experience
Fresenius Medical Care January 2015 - Present
Baxter BioScience September 2014 - Present
Johnson & Johnson April 2014 - July 2014
Impax Laboratories June 2013 - February 2014
Actavis, Inc. July 2011 - May 2013
Watson Pharmaceuticals (currently Actavis) June 2009 - June 2010
Watson Pharmaceuticals (currently Actavis) July 2004 - June 2009
Allergan November 2002 - July 2004
Schering-Plough Pharmaceuticals (currently Merck) January 1999 - October 2002
Schering-Plough Pharmaceuticals (currently Merck) January 1997 - January 1999
Skills
Validation, GMP, CAPA, FDA, V&V, Sop, 21 CFR Part 11, Computer System..., Pharmaceutical Industry, Quality Auditing, Manufacturing, Cleaning Validation, Quality Control, Management, Product Development, Team Building, Process Improvement, Project Management, Change Management, Leadership, Pharmaceutics, Regulatory Requirements, Quality Assurance, GAMP, Change Control, Quality Management, Sterilization, LIMS, GLP, Quality System, GxP, Cross-functional Team..., Technology Transfer, Trackwise, Operational Excellence, Analytical Chemistry, HPLC, Deviations, Six Sigma, Root Cause Analysis, SOP
Education
University of Puerto Rico-Rio Piedras 1986 — 1991
Bs, Chemistry
University of Phoenix 2005 — 2008
MBA, Business Administration
Fresenius Medical Care January 2015 - Present
Baxter BioScience September 2014 - Present
Johnson & Johnson April 2014 - July 2014
Impax Laboratories June 2013 - February 2014
Actavis, Inc. July 2011 - May 2013
Watson Pharmaceuticals (currently Actavis) June 2009 - June 2010
Watson Pharmaceuticals (currently Actavis) July 2004 - June 2009
Allergan November 2002 - July 2004
Schering-Plough Pharmaceuticals (currently Merck) January 1999 - October 2002
Schering-Plough Pharmaceuticals (currently Merck) January 1997 - January 1999
Skills
Validation, GMP, CAPA, FDA, V&V, Sop, 21 CFR Part 11, Computer System..., Pharmaceutical Industry, Quality Auditing, Manufacturing, Cleaning Validation, Quality Control, Management, Product Development, Team Building, Process Improvement, Project Management, Change Management, Leadership, Pharmaceutics, Regulatory Requirements, Quality Assurance, GAMP, Change Control, Quality Management, Sterilization, LIMS, GLP, Quality System, GxP, Cross-functional Team..., Technology Transfer, Trackwise, Operational Excellence, Analytical Chemistry, HPLC, Deviations, Six Sigma, Root Cause Analysis, SOP
Education
University of Puerto Rico-Rio Piedras 1986 — 1991
Bs, Chemistry
University of Phoenix 2005 — 2008
MBA, Business Administration
Sam Anderson Sam Anderson's Baxter BioScience Experience October 2010 - June 2011
Job Seasoned IT Pro
Industry Information Technology and Services
Experience
TKMC July 2011 - Present
Sonos, Inc. February 2014 - April 2014
Baxter BioScience October 2010 - June 2011
Fiserv 2004 - September 2009
Amgen Inc. October 1999 - May 2004
Health Net 1993 - 1997
Education
University of Miami
Bachelor of Music, Music Education
TKMC July 2011 - Present
Sonos, Inc. February 2014 - April 2014
Baxter BioScience October 2010 - June 2011
Fiserv 2004 - September 2009
Amgen Inc. October 1999 - May 2004
Health Net 1993 - 1997
Education
University of Miami
Bachelor of Music, Music Education
Rachel Gearig's Baxter BioScience Experience October 2007 - August 2010
Job Quality Control Analyst at Agensys
Industry Biotechnology
Experience
Agensys August 2010 - Present
Baxter BioScience October 2007 - August 2010
Univertical Corp. February 2007 - October 2007
Banfield, The Pet Hospital July 2005 - October 2007
Community Hospitals and Wellness Centers July 2001 - August 2004
Community Hospitals and Wellness Centers October 2000 - July 2001
Skills
GLP, Cross-functional Team..., Sop, GMP, FDA, CAPA, Validation, SOP, Biotechnology, Change Control, Pharmaceutical Industry, 21 CFR Part 11
Education
University of Saint Francis 2004 — 2006
Bachelor's of Science, Chemistry
International Business College 1999 — 2000
Associates, Medical Assisting
Agensys August 2010 - Present
Baxter BioScience October 2007 - August 2010
Univertical Corp. February 2007 - October 2007
Banfield, The Pet Hospital July 2005 - October 2007
Community Hospitals and Wellness Centers July 2001 - August 2004
Community Hospitals and Wellness Centers October 2000 - July 2001
Skills
GLP, Cross-functional Team..., Sop, GMP, FDA, CAPA, Validation, SOP, Biotechnology, Change Control, Pharmaceutical Industry, 21 CFR Part 11
Education
University of Saint Francis 2004 — 2006
Bachelor's of Science, Chemistry
International Business College 1999 — 2000
Associates, Medical Assisting
Denis St-Arnaud Denis St-Arnaud's Baxter BioScience Experience June 2008 - September 2011
Job BioSurgery Specialist at Baxter BioScience
Industry Biotechnology
Experience
Baxter Healthcare July 2008 - September 2011
Baxter BioScience June 2008 - September 2011
Baxter August 2003 - July 2008
Pharmacia January 2001 - August 2003
Skills
Infectious Diseases, Cardiology, Healthcare, Pharmaceutical Industry, Anesthesiology, Pharmaceutical Sales, Gastroenterology, Critical Care, Diabetes, Anesthesia, Medical Devices, Dermatology, Hospital Sales, Market Access, Urology, Sales Effectiveness, Oncology, Nephrology, OB/GYN, Neurology, Endocrinology, Biotechnology, Hospitals, Hematology, Rheumatology, Surgeons, Operating Room, Product Launch, Ophthalmology, Orthopedic, Managed Care, Market Development, Disposables, Capital Equipment, Hypertension, Sales Force Development, Therapeutic Areas
Education
University of Ottawa 1982 — 1986
Bachelor of Commerce
Baxter Healthcare July 2008 - September 2011
Baxter BioScience June 2008 - September 2011
Baxter August 2003 - July 2008
Pharmacia January 2001 - August 2003
Skills
Infectious Diseases, Cardiology, Healthcare, Pharmaceutical Industry, Anesthesiology, Pharmaceutical Sales, Gastroenterology, Critical Care, Diabetes, Anesthesia, Medical Devices, Dermatology, Hospital Sales, Market Access, Urology, Sales Effectiveness, Oncology, Nephrology, OB/GYN, Neurology, Endocrinology, Biotechnology, Hospitals, Hematology, Rheumatology, Surgeons, Operating Room, Product Launch, Ophthalmology, Orthopedic, Managed Care, Market Development, Disposables, Capital Equipment, Hypertension, Sales Force Development, Therapeutic Areas
Education
University of Ottawa 1982 — 1986
Bachelor of Commerce
Betty Tso Betty Tso's Baxter BioScience Experience November 2008 - February 2013
Job Technology Transfer at Bayer Technology Services
Industry Biotechnology
Experience
Bayer Technology Services February 2014 - Present
Bayer Technology Services February 2013 - January 2014
Baxter BioScience November 2008 - February 2013
Baxter BioScience February 2007 - October 2008
Baxter BioScience June 2006 - February 2007
Skills
DeltaV, Validation, Chemical Engineering, GMP, Quality System, Biotechnology, Process Optimization, Change Control, Automation, DMAIC, Protein Purification, Process Improvement, Technical Writing, FDA, Six Sigma, V&V, CAPA, Manufacturing
Education
University of Southern California
MS, Chemical Engineering
University of Wisconsin-Madison
BS, Chemical Engineering
Bayer Technology Services February 2014 - Present
Bayer Technology Services February 2013 - January 2014
Baxter BioScience November 2008 - February 2013
Baxter BioScience February 2007 - October 2008
Baxter BioScience June 2006 - February 2007
Skills
DeltaV, Validation, Chemical Engineering, GMP, Quality System, Biotechnology, Process Optimization, Change Control, Automation, DMAIC, Protein Purification, Process Improvement, Technical Writing, FDA, Six Sigma, V&V, CAPA, Manufacturing
Education
University of Southern California
MS, Chemical Engineering
University of Wisconsin-Madison
BS, Chemical Engineering
Ron Vitales Ron Vitales's Baxter BioScience Experience December 2010 - February 2014
Job Area Sales DirectorOrthobiologics at Baxter International Inc.
Industry Medical Devices
Experience
Baxter International Inc. April 2015 - Present
Baxter International Inc. November 2013 - April 2015
Baxter BioScience December 2010 - February 2014
Baxter BioScience January 2009 - December 2010
Baxter BioScience January 2006 - December 2008
Covidien/Tyco Healthcare/U.S. Surgical November 1994 - January 2006
Skills
Medical Devices, Sales Effectiveness, Market Development, Product Launch, Orthopedic, Surgery, Urology, Hospital Sales, Operating Room, Sales Operations, Capital Equipment, Surgeons, Neurology, Sales Force Development, Managed Care, Disposables, Commercialization, Biotechnology, Spine, Surgical Instruments, Market Access, FDA, Hospitals, Selling Skills, Vascular, Sales, Orthopedics
Education
University of North Carolina at Charlotte 1980 — 1985
B.A., Math
Baxter International Inc. April 2015 - Present
Baxter International Inc. November 2013 - April 2015
Baxter BioScience December 2010 - February 2014
Baxter BioScience January 2009 - December 2010
Baxter BioScience January 2006 - December 2008
Covidien/Tyco Healthcare/U.S. Surgical November 1994 - January 2006
Skills
Medical Devices, Sales Effectiveness, Market Development, Product Launch, Orthopedic, Surgery, Urology, Hospital Sales, Operating Room, Sales Operations, Capital Equipment, Surgeons, Neurology, Sales Force Development, Managed Care, Disposables, Commercialization, Biotechnology, Spine, Surgical Instruments, Market Access, FDA, Hospitals, Selling Skills, Vascular, Sales, Orthopedics
Education
University of North Carolina at Charlotte 1980 — 1985
B.A., Math
Jurea Deloatch Jurea Deloatch's Baxter BioScience Experience July 2009 - January 2011
Job QA Specialist III at AstraZeneca Biologics
Industry Biotechnology
Experience
AstraZeneca Biologics January 2015 - Present
AstraZeneca Biologics June 2012 - January 2015
MedImmune March 2011 - March 2012
Baxter BioScience July 2009 - January 2011
Baxter BioScience July 2005 - July 2009
Baxter BioScience November 2000 - July 2005
Beverage Capital September 1997 - April 2000
Skills
Quality Assurance, Quality Management, CAPA, GMP, Change Control, 21 CFR Part 11, Aseptic Processing, Vaccines, Purification, Manufacturing, Trackwise, Microsoft Office, Biotechnology, Downstream Processing, Supplier Quality, Technology Transfer, Root Cause Analysis, SAP ERP, Patient Safety, Protein Purification, SOP
Education
University of Maryland College Park 1991 — 1996
BS, Chemical Engineering
Milford Mill High School 1988 — 1991
H.S. Diploma, Math & Science
AstraZeneca Biologics January 2015 - Present
AstraZeneca Biologics June 2012 - January 2015
MedImmune March 2011 - March 2012
Baxter BioScience July 2009 - January 2011
Baxter BioScience July 2005 - July 2009
Baxter BioScience November 2000 - July 2005
Beverage Capital September 1997 - April 2000
Skills
Quality Assurance, Quality Management, CAPA, GMP, Change Control, 21 CFR Part 11, Aseptic Processing, Vaccines, Purification, Manufacturing, Trackwise, Microsoft Office, Biotechnology, Downstream Processing, Supplier Quality, Technology Transfer, Root Cause Analysis, SAP ERP, Patient Safety, Protein Purification, SOP
Education
University of Maryland College Park 1991 — 1996
BS, Chemical Engineering
Milford Mill High School 1988 — 1991
H.S. Diploma, Math & Science
Cuong (David) Vo Cuong (David) Vo's Baxter BioScience Experience January 1997 - December 1998
Job Quality System Manager at Smart Source, LLC
Industry Health, Wellness and Fitness
Experience
Smart Source, LLC November 2014 - Present
Pierside Nutrition October 2011 - Present
Baxter Healthcare September 2011 - June 2014
Baxter Healthcare December 2010 - September 2011
Kelly Scientific Resources October 2010 - January 2011
Bioscience, Pharma Continuous Improvement April 2009 - June 2010
Bioscience, Laboratory October 2006 - April 2009
Kids' Camp January 1996 - August 2008
Bioscience, Biochemistry December 1998 - October 2006
Baxter BioScience January 1997 - December 1998
Skills
Project Portfolio..., Lean Sigma, Six Sigma, MS Office Suite, CAPA, Lean Manufacturing, Green Belt, Kaizen, DMAIC, Value Stream Mapping, 5S, Continuous Improvement, Quality Systems, Toyota Production System, SMED, Kanban, Kaizen Facilitation, Operational Excellence, TPM, FMEA, Manufacturing, Process Improvement, Business Process..., ISO 13485, Root Cause Analysis, Lean Initiatives, JIT, Quality Management, OEE, ISO 14971, Value Stream, FDA, Minitab, A3, GMP, cGMP, SOP, Medical Devices, Pharmaceuticals, Poka Yoke, ISO, Quality Assurance, 5 Why, Cross-functional Team..., Metrics, Problem Solving, Process Mapping, Coaching, Team Building, Vietnamese
Education
University of Southern California 1993 — 1997
BS, Biology
Eagle Rock Jr/Sr High School 1987 — 1993
Smart Source, LLC November 2014 - Present
Pierside Nutrition October 2011 - Present
Baxter Healthcare September 2011 - June 2014
Baxter Healthcare December 2010 - September 2011
Kelly Scientific Resources October 2010 - January 2011
Bioscience, Pharma Continuous Improvement April 2009 - June 2010
Bioscience, Laboratory October 2006 - April 2009
Kids' Camp January 1996 - August 2008
Bioscience, Biochemistry December 1998 - October 2006
Baxter BioScience January 1997 - December 1998
Skills
Project Portfolio..., Lean Sigma, Six Sigma, MS Office Suite, CAPA, Lean Manufacturing, Green Belt, Kaizen, DMAIC, Value Stream Mapping, 5S, Continuous Improvement, Quality Systems, Toyota Production System, SMED, Kanban, Kaizen Facilitation, Operational Excellence, TPM, FMEA, Manufacturing, Process Improvement, Business Process..., ISO 13485, Root Cause Analysis, Lean Initiatives, JIT, Quality Management, OEE, ISO 14971, Value Stream, FDA, Minitab, A3, GMP, cGMP, SOP, Medical Devices, Pharmaceuticals, Poka Yoke, ISO, Quality Assurance, 5 Why, Cross-functional Team..., Metrics, Problem Solving, Process Mapping, Coaching, Team Building, Vietnamese
Education
University of Southern California 1993 — 1997
BS, Biology
Eagle Rock Jr/Sr High School 1987 — 1993
Jeanne M. Pistillo Jeanne M. Pistillo's Baxter BioScience Experience March 2012 - Present
Job Product Stability Specialist, Product Stability at Baxter BioScience
Industry Pharmaceuticals
Experience
Baxter BioScience March 2012 - Present
Amgen January 2009 - December 2011
AMGEN July 1997 - December 2011
Amgen July 1997 - 2009
UC Irvine January 1996 - January 1997
GRANBIO INC January 1993 - January 1996
Specialty labs 1996 - 1996
Skills
Molecular Cloning..., Quantitative protein,..., ELISA, RIA, EIA, IFA,..., Protein, DNA and RNA..., Polymerase chain..., PAGE, Western,..., In vitro..., DNA Sequencing/RFLP, Expression/purification..., Plasmid /DNA preps, Column Chromatography, Raised/purified..., Colony Hybridizations, Analytical chemistry, cDNA..., Viral RNA/DNA isolations, NAB assays/Cell..., TCID50, growth curves, Replication assays,..., Mixed Lymphocyte..., 3H-Thymidine..., HPLC, UV/Vis..., Atomic adsorption,Gas..., Transfections, viral..., Cell culture, Fluorescent, inverted..., Densitometer, UV/Vis spectrophotometer, Scintillation counter, ABI automated sequencer, MSD assays and..., Fluorometer,..., Mini/Midi Macs..., FACS analysis, Antibodies, Drug Discovery, Cell Culture, Cell
Education
University of NE Medical Center, Omaha 1991 — 1993
PHD objective, Pathology/Microbiology
University of NE Medical Center, Omaha 1987 — 1991
M.S, Biochemistry/Molecular Biology
University of Nebraska at Omaha
B.S, Chemistry
Baxter BioScience March 2012 - Present
Amgen January 2009 - December 2011
AMGEN July 1997 - December 2011
Amgen July 1997 - 2009
UC Irvine January 1996 - January 1997
GRANBIO INC January 1993 - January 1996
Specialty labs 1996 - 1996
Skills
Molecular Cloning..., Quantitative protein,..., ELISA, RIA, EIA, IFA,..., Protein, DNA and RNA..., Polymerase chain..., PAGE, Western,..., In vitro..., DNA Sequencing/RFLP, Expression/purification..., Plasmid /DNA preps, Column Chromatography, Raised/purified..., Colony Hybridizations, Analytical chemistry, cDNA..., Viral RNA/DNA isolations, NAB assays/Cell..., TCID50, growth curves, Replication assays,..., Mixed Lymphocyte..., 3H-Thymidine..., HPLC, UV/Vis..., Atomic adsorption,Gas..., Transfections, viral..., Cell culture, Fluorescent, inverted..., Densitometer, UV/Vis spectrophotometer, Scintillation counter, ABI automated sequencer, MSD assays and..., Fluorometer,..., Mini/Midi Macs..., FACS analysis, Antibodies, Drug Discovery, Cell Culture, Cell
Education
University of NE Medical Center, Omaha 1991 — 1993
PHD objective, Pathology/Microbiology
University of NE Medical Center, Omaha 1987 — 1991
M.S, Biochemistry/Molecular Biology
University of Nebraska at Omaha
B.S, Chemistry
Dawn-Amber Straughn Dawn-Amber Straughn's Baxter BioScience Experience August 2009 - January 2011
Job Lead Production Technician at MedImmune
Industry Biotechnology
Experience
MedImmune June 2011 - January 2013
Baxter BioScience August 2009 - January 2011
Skills
GMP, Aseptic Processing, Sop, Trackwise, FDA, 21 CFR Part 11, CAPA, LIMS, Validation, GLP, Change Control, Purification, Aseptic Technique, Biotechnology, Technology Transfer
Education
University of Maryland Eastern Shore 1996 — 2000
BS, Biology
MedImmune June 2011 - January 2013
Baxter BioScience August 2009 - January 2011
Skills
GMP, Aseptic Processing, Sop, Trackwise, FDA, 21 CFR Part 11, CAPA, LIMS, Validation, GLP, Change Control, Purification, Aseptic Technique, Biotechnology, Technology Transfer
Education
University of Maryland Eastern Shore 1996 — 2000
BS, Biology
Nick Bayrakdarian Nick Bayrakdarian's Baxter BioScience Experience April 2002 - April 2004
Job Quality Management Systems Professional in the BioPharmaceutical and Medical Device Industries / Independent Consultant
Industry Biotechnology
Experience
NSBay Consulting 2015 - Present
Amgen June 2013 - December 2014
Amgen January 2012 - June 2013
Amgen May 2004 - January 2012
Baxter BioScience April 2002 - April 2004
Alpha Therapeutics Corp., Grifols Biologicals Inc June 1998 - April 2002
Skills
Quality System, Complaint Management, Quality Assurance, FDA, GMP, CAPA, Exception Management, Root Cause Analysis, Complaint Investigations, Post Market Surveillance, Supplier Quality..., Quality Auditing, Trend Analysis, Metrics Reporting, Contract Manufacturing, Supplier Evaluation, GVP, GxP, Pharmacovigilance, Computer System..., GLP, Sop, Medical Devices, Data Analysis, Corporate Quality, Relational Databases, Regulatory Requirements, Product Complaints, Regulatory Affairs, Cold Chain, Document Management..., Plasma Processing, Pharmaceutical Industry, Biotechnology, Biopharmaceuticals, SOP
Education
University of La Verne
Bachelor of Science (BS)
University, Frederick Cyprus
NSBay Consulting 2015 - Present
Amgen June 2013 - December 2014
Amgen January 2012 - June 2013
Amgen May 2004 - January 2012
Baxter BioScience April 2002 - April 2004
Alpha Therapeutics Corp., Grifols Biologicals Inc June 1998 - April 2002
Skills
Quality System, Complaint Management, Quality Assurance, FDA, GMP, CAPA, Exception Management, Root Cause Analysis, Complaint Investigations, Post Market Surveillance, Supplier Quality..., Quality Auditing, Trend Analysis, Metrics Reporting, Contract Manufacturing, Supplier Evaluation, GVP, GxP, Pharmacovigilance, Computer System..., GLP, Sop, Medical Devices, Data Analysis, Corporate Quality, Relational Databases, Regulatory Requirements, Product Complaints, Regulatory Affairs, Cold Chain, Document Management..., Plasma Processing, Pharmaceutical Industry, Biotechnology, Biopharmaceuticals, SOP
Education
University of La Verne
Bachelor of Science (BS)
University, Frederick Cyprus
Riddhi Patel Riddhi Patel's Baxter BioScience Experience March 2007 - July 2011
Job Quality Design Assurance Engineer at ThermoFisher Scientific
Industry Biotechnology
Experience
ThermoFisher Scientific November 2013 - Present
Baxter Healthcare November 2011 - November 2013
Baxter BioScience March 2007 - July 2011
Genentech 2001 - 2005
National Institute of Health September 1999 - June 2000
Johns Hopkins Hospital May 1998 - September 1999
Suburban Hospital, Bethesda, MD May 1998 - August 1999
National Institute of Health May 1997 - September 1997
Skills
V&V, ELISA, LIMS, Validation, Biotechnology, Quality System, Sop, GMP, FDA, Biopharmaceuticals, CAPA, Assay Development, Quality Control, Medical Devices, GLP, Immunology, Laboratory, HPLC, Pharmaceutical Industry, SOP
Education
University of Maryland School of Medicine 1994 — 1998
B.S, Medical and Research Technology
ThermoFisher Scientific November 2013 - Present
Baxter Healthcare November 2011 - November 2013
Baxter BioScience March 2007 - July 2011
Genentech 2001 - 2005
National Institute of Health September 1999 - June 2000
Johns Hopkins Hospital May 1998 - September 1999
Suburban Hospital, Bethesda, MD May 1998 - August 1999
National Institute of Health May 1997 - September 1997
Skills
V&V, ELISA, LIMS, Validation, Biotechnology, Quality System, Sop, GMP, FDA, Biopharmaceuticals, CAPA, Assay Development, Quality Control, Medical Devices, GLP, Immunology, Laboratory, HPLC, Pharmaceutical Industry, SOP
Education
University of Maryland School of Medicine 1994 — 1998
B.S, Medical and Research Technology
Christof Langer Christof Langer's Baxter BioScience Experience January 2004 - December 2008
Job Managing Director & Founder at OncoQR ML OG
Industry Pharmaceuticals
Experience
OncoQR ML OG March 2013 - Present
OSConsulting November 2009 - Present
S-TARget therapeutics 2009 - Present
Baxter January 2004 - December 2008
Baxter BioScience January 2004 - December 2008
Skills
Operational Excellence, FDA, Biotechnology, Pharmaceuticals, cGMP, Lean Sigma, Quality Systems, Process Validation, GMP, SOP, CAPA, Process Optimization, Lean Manufacturing, Validation, DMAIC, Manufacturing, Kaizen, Six Sigma, Continuous Improvement, Cross-functional Team..., 5S, Quality Management, Quality Assurance, Biopharmaceuticals, Root Cause Analysis, Strategic Planning, Process Improvement, FMEA, Change Management, Technology Transfer, Outsourcing, People Management, Contract Manufacturing, Life Sciences, Manufacturing Operations, Microbiology, Quality System, Lifesciences, Pharmaceutical Industry, V&V, Sop, Management, Commercialization, Leadership, Regulatory Affairs
Education
University of Natural Resources and Life Sciences, Vienna (BOKU) 1987 — 1996
master, biotechnology
OncoQR ML OG March 2013 - Present
OSConsulting November 2009 - Present
S-TARget therapeutics 2009 - Present
Baxter January 2004 - December 2008
Baxter BioScience January 2004 - December 2008
Skills
Operational Excellence, FDA, Biotechnology, Pharmaceuticals, cGMP, Lean Sigma, Quality Systems, Process Validation, GMP, SOP, CAPA, Process Optimization, Lean Manufacturing, Validation, DMAIC, Manufacturing, Kaizen, Six Sigma, Continuous Improvement, Cross-functional Team..., 5S, Quality Management, Quality Assurance, Biopharmaceuticals, Root Cause Analysis, Strategic Planning, Process Improvement, FMEA, Change Management, Technology Transfer, Outsourcing, People Management, Contract Manufacturing, Life Sciences, Manufacturing Operations, Microbiology, Quality System, Lifesciences, Pharmaceutical Industry, V&V, Sop, Management, Commercialization, Leadership, Regulatory Affairs
Education
University of Natural Resources and Life Sciences, Vienna (BOKU) 1987 — 1996
master, biotechnology
Pejman Farivar Pejman Farivar's Baxter BioScience Experience October 2000 - July 2005
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Glidewell Laboratories June 2009 - March 2010
Life Therapeutics July 2006 - May 2008
AMERICAN OPTISURGICAL Inc., July 2005 - July 2006
BAXTER BIOSCIENCE October 2000 - July 2005
AMERICAN RED CROSS, National Genome Testing Laboratory August 1998 - October 2000
Education
University of Phoenix 2000 — 2002
MBA-Tech, Business - Ecommerce
Worcester State University 1991 — 1993
Bachelor, Chemistry
Glidewell Laboratories June 2009 - March 2010
Life Therapeutics July 2006 - May 2008
AMERICAN OPTISURGICAL Inc., July 2005 - July 2006
BAXTER BIOSCIENCE October 2000 - July 2005
AMERICAN RED CROSS, National Genome Testing Laboratory August 1998 - October 2000
Education
University of Phoenix 2000 — 2002
MBA-Tech, Business - Ecommerce
Worcester State University 1991 — 1993
Bachelor, Chemistry
Carlos Landaverde Carlos Landaverde's Baxter BioScience Experience June 2000 - October 2001
Job Specialist QA at Amgen
Industry Biotechnology
Experience
Amgen November 2013 - Present
Amgen June 2004 - November 2013
CimQuest July 2003 - June 2004
Cetan Technologies February 2002 - June 2003
Baxter BioScience June 2000 - October 2001
Baxter BioScience February 1995 - June 2000
Skills
MES, LIMS, FileMaker, SharePoint, GMP, Computer System..., GAMP, Change Control, Validation, Visual Basic, SQL*Plus, Cross-functional Team..., CAPA, Biotechnology, Biopharmaceuticals, GxP, Pharmaceutical Industry, Technology Transfer, Testing, Quality Assurance, 21 CFR Part 11
Education
University of Southern California 1989 — 1995
BS, Chemistry
Amgen November 2013 - Present
Amgen June 2004 - November 2013
CimQuest July 2003 - June 2004
Cetan Technologies February 2002 - June 2003
Baxter BioScience June 2000 - October 2001
Baxter BioScience February 1995 - June 2000
Skills
MES, LIMS, FileMaker, SharePoint, GMP, Computer System..., GAMP, Change Control, Validation, Visual Basic, SQL*Plus, Cross-functional Team..., CAPA, Biotechnology, Biopharmaceuticals, GxP, Pharmaceutical Industry, Technology Transfer, Testing, Quality Assurance, 21 CFR Part 11
Education
University of Southern California 1989 — 1995
BS, Chemistry
Amanda McAllister Amanda McAllister's Baxter BioScience Experience August 2009 - Present
Job Continuous Improvement Leader at Baxter BioScience
Industry Biotechnology
Experience
Baxter BioScience August 2009 - Present
Baxter BioScience August 2007 - August 2009
Altec 2002 - 2007
Starbucks Coffee Company August 1999 - February 2002
Skills
Lean Manufacturing, 5S, Continuous Improvement, Kaizen, Excel, Word, Six Sigma, Problem Solving, Process Improvement, Metrics, PowerPoint, Change Management, Team Building, Coaching, Microsoft Office, Strategic Planning, Operational Excellence, Supply Chain, Public Speaking, Cross-functional Team..., Risk Management, Data Analysis, DMAIC, Management, Microsoft Word, Opera, Singing, Training, Acting, Microsoft Excel, Value Stream Mapping, Project Management, Validation, Quality System, Logistics, Procurement, Quality Assurance, Strategy, GMP, CAPA, FDA, Minitab, Root Cause Analysis, Process Engineering, Quality Management
Education
Scuola Leonardo 2007 — 2007
University of Missouri-Kansas City 1999 — 2003
BM, Vocal Performance
Baxter BioScience August 2009 - Present
Baxter BioScience August 2007 - August 2009
Altec 2002 - 2007
Starbucks Coffee Company August 1999 - February 2002
Skills
Lean Manufacturing, 5S, Continuous Improvement, Kaizen, Excel, Word, Six Sigma, Problem Solving, Process Improvement, Metrics, PowerPoint, Change Management, Team Building, Coaching, Microsoft Office, Strategic Planning, Operational Excellence, Supply Chain, Public Speaking, Cross-functional Team..., Risk Management, Data Analysis, DMAIC, Management, Microsoft Word, Opera, Singing, Training, Acting, Microsoft Excel, Value Stream Mapping, Project Management, Validation, Quality System, Logistics, Procurement, Quality Assurance, Strategy, GMP, CAPA, FDA, Minitab, Root Cause Analysis, Process Engineering, Quality Management
Education
Scuola Leonardo 2007 — 2007
University of Missouri-Kansas City 1999 — 2003
BM, Vocal Performance
Colin Newton Colin Newton's Baxter BioScience Experience April 1998 - September 2007
Job Retired from Pharmaceutical
Industry Pharmaceuticals
Experience
Retired July 2014 - Present
Sanofi Pasteur July 2010 - August 2014
Imclone Systems, subsidiary of Eli Lilly April 2009 - July 2010
Leiner Health Products April 2008 - July 2008
Private Generics Company November 2007 - March 2008
Baxter BioScience April 1998 - September 2007
Alpha Therapeutics August 1996 - April 1998
Various companies July 1994 - February 1996
Molecular BioSystems June 1992 - March 1994
Skills
Biotechnology, Validation, Chromatography, Formulation, Sop, Protein Chemistry, Analytical Chemistry, Pharmaceutical Industry, Quality System, Biochemistry, Assay Development, SOP
Education
University of Southampton 1972 — 1976
Ph. D., Biochemistry
University of Southampton 1969 — 1972
BSc, Physiology and Biochemistry
Retired July 2014 - Present
Sanofi Pasteur July 2010 - August 2014
Imclone Systems, subsidiary of Eli Lilly April 2009 - July 2010
Leiner Health Products April 2008 - July 2008
Private Generics Company November 2007 - March 2008
Baxter BioScience April 1998 - September 2007
Alpha Therapeutics August 1996 - April 1998
Various companies July 1994 - February 1996
Molecular BioSystems June 1992 - March 1994
Skills
Biotechnology, Validation, Chromatography, Formulation, Sop, Protein Chemistry, Analytical Chemistry, Pharmaceutical Industry, Quality System, Biochemistry, Assay Development, SOP
Education
University of Southampton 1972 — 1976
Ph. D., Biochemistry
University of Southampton 1969 — 1972
BSc, Physiology and Biochemistry
Daniel Lucey's Baxter BioScience Experience September 2014 - July 2015
Job Process Engineer with Hyde Engineering + Consulting
Industry Biotechnology
Experience
Baxter BioScience September 2014 - July 2015
Baxter Bioscience September 2012 - August 2014
Independent Consultant November 2011 - May 2012
Global Pharmaceutical Supply Group, Unit of ALZA Corp., a Johnson & Johnson Company May 2005 - October 2011
Global Pharmaceutical Supply Group (formerly PSGA), Unit of ALZA Corp., a Johnson & Johnson Company March 2004 - April 2005
Global Pharmaceutical Supply Group (formerly PSGA), Unit of ALZA Corp., a Johnson & Johnson Company July 2003 - February 2004
Kelly Scientific Services November 2002 - June 2003
Alpha Therapeutic Corporation May 2001 - September 2001
Skills
Process Development, Validation, GMP, Six Sigma, Quality Systems, Quality System, Technology Transfer, Manufacturing, Lean Manufacturing, Process Improvement, Sop, Biopharmaceuticals, Change Control, Cleaning Validation, Quality Assurance, Process Simulation, FDA
Education
University of Southern California 1998 — 2002
Bachelor of Science, Chemical Engineering (emphasizing biochemical processes)
Baxter BioScience September 2014 - July 2015
Baxter Bioscience September 2012 - August 2014
Independent Consultant November 2011 - May 2012
Global Pharmaceutical Supply Group, Unit of ALZA Corp., a Johnson & Johnson Company May 2005 - October 2011
Global Pharmaceutical Supply Group (formerly PSGA), Unit of ALZA Corp., a Johnson & Johnson Company March 2004 - April 2005
Global Pharmaceutical Supply Group (formerly PSGA), Unit of ALZA Corp., a Johnson & Johnson Company July 2003 - February 2004
Kelly Scientific Services November 2002 - June 2003
Alpha Therapeutic Corporation May 2001 - September 2001
Skills
Process Development, Validation, GMP, Six Sigma, Quality Systems, Quality System, Technology Transfer, Manufacturing, Lean Manufacturing, Process Improvement, Sop, Biopharmaceuticals, Change Control, Cleaning Validation, Quality Assurance, Process Simulation, FDA
Education
University of Southern California 1998 — 2002
Bachelor of Science, Chemical Engineering (emphasizing biochemical processes)
Yani Giraldez's Baxter BioScience Experience June 2005 - November 2007
Job Sales Rep Benzer Specialty Pharmacy
Industry Medical Devices
Experience
Baxter Bioscience June 2005 - November 2007
Professional Detailing Incorporated August 2000 - June 2005
GlaxoSmithKline 1999 - 2000
Parke-Davis Division, Pfizer April 1998 - May 1999
University of Miami January 1996 - April 1998
Skills
MSO Office Suite, Flow Cytometry, Siebel Analytics, Medical Devices, Suite, Pharmaceutical Industry, Healthcare, Immunology, Clinical Research
Education
University of Miami 1992 — 1997
B.S., Microbiology, Chemistry Minor
Baxter Bioscience June 2005 - November 2007
Professional Detailing Incorporated August 2000 - June 2005
GlaxoSmithKline 1999 - 2000
Parke-Davis Division, Pfizer April 1998 - May 1999
University of Miami January 1996 - April 1998
Skills
MSO Office Suite, Flow Cytometry, Siebel Analytics, Medical Devices, Suite, Pharmaceutical Industry, Healthcare, Immunology, Clinical Research
Education
University of Miami 1992 — 1997
B.S., Microbiology, Chemistry Minor
Alison Karoleski's Baxter BioScience Experience February 2009 - Present
Job Biologics specialist at Stryker
Industry Medical Devices
Experience
Stryker 2013 - Present
Baxter BioScience February 2009 - Present
Atrium Medical September 2007 - April 2010
sanofi-aventis April 2005 - September 2007
Education
University of New Hampshire 1996 — 2000
BS, Biochemistry
Stryker 2013 - Present
Baxter BioScience February 2009 - Present
Atrium Medical September 2007 - April 2010
sanofi-aventis April 2005 - September 2007
Education
University of New Hampshire 1996 — 2000
BS, Biochemistry
Louis Lopez's Baxter BioScience Experience December 2011 - January 2015
Job Equipment Maintenance Technician, Powertrain Sustaining Engineering at Tesla Motors
Industry Medical Devices
Experience
Tesla Motors January 2015 - Present
Baxter BioScience December 2011 - January 2015
Medtronic May 2005 - December 2011
Nypro June 2000 - May 2005
Skills
FDA, Medical Devices, Engineering, Manufacturing, Troubleshooting, Automation, Robotics, GMP, Quality System, Six Sigma, Process Improvement, Sop, Product Development, CAPA, Validation, V&V, Design of Experiments, Design Control, ISO 13485, R&D, Change Control, SPC, Root Cause Analysis, 21 CFR Part 11, Lean Manufacturing, Process Simulation, Preventive Maintenance, FMEA, Quality Assurance, Continuous Improvement, DMAIC, ISO, Aseptic Processing, Biomedical Engineering, Calibration, Cross-functional Team..., FDA GMP, Failure Analysis, Injection Molding, Minitab, Process Engineering, Quality Auditing, 5S, Biotechnology, Biopharmaceuticals, Computer System..., Design for Manufacturing, GxP, Kaizen, Manufacturing...
Education
University of Puerto Rico-Aguadilla 1996 — 2001
Bachelor's, Science in Electronic Technology
Tesla Motors January 2015 - Present
Baxter BioScience December 2011 - January 2015
Medtronic May 2005 - December 2011
Nypro June 2000 - May 2005
Skills
FDA, Medical Devices, Engineering, Manufacturing, Troubleshooting, Automation, Robotics, GMP, Quality System, Six Sigma, Process Improvement, Sop, Product Development, CAPA, Validation, V&V, Design of Experiments, Design Control, ISO 13485, R&D, Change Control, SPC, Root Cause Analysis, 21 CFR Part 11, Lean Manufacturing, Process Simulation, Preventive Maintenance, FMEA, Quality Assurance, Continuous Improvement, DMAIC, ISO, Aseptic Processing, Biomedical Engineering, Calibration, Cross-functional Team..., FDA GMP, Failure Analysis, Injection Molding, Minitab, Process Engineering, Quality Auditing, 5S, Biotechnology, Biopharmaceuticals, Computer System..., Design for Manufacturing, GxP, Kaizen, Manufacturing...
Education
University of Puerto Rico-Aguadilla 1996 — 2001
Bachelor's, Science in Electronic Technology
Michael (Mick) Trier Michael (Mick) Trier's Baxter BioScience Experience January 1998 - June 2000
Job Director of Global Product and Distribution Surveillance at Baxter International Inc.
Industry Pharmaceuticals
Experience
Baxter International Inc. 2000 - Present
Baxter BioScience January 1998 - June 2000
Baxter BioScience 1997 - 1998
Skills
Compliance, Quality System, Quality Assurance, Quality Management, Strategic Planning, Project Management, Logistics Management, CAPA, Change Management, Internal Audit, Team Leadership, Cold Chain, Product Management, Post Market Surveillance
Education
University of Phoenix 2000 — 2003
MBA Global Management, June 2003, graduated Summa-Cum Laude, Gobal Business Management
Baxter International Inc. 2000 - Present
Baxter BioScience January 1998 - June 2000
Baxter BioScience 1997 - 1998
Skills
Compliance, Quality System, Quality Assurance, Quality Management, Strategic Planning, Project Management, Logistics Management, CAPA, Change Management, Internal Audit, Team Leadership, Cold Chain, Product Management, Post Market Surveillance
Education
University of Phoenix 2000 — 2003
MBA Global Management, June 2003, graduated Summa-Cum Laude, Gobal Business Management
Gassumu Lahai Gassumu Lahai's Baxter BioScience Experience June 2008 - December 2010
Job Manufacturing Associate II at United Therapeutics
Industry Pharmaceuticals
Experience
United Therapeutics January 2011 - July 2012
Baxter BioScience June 2008 - December 2010
Skills
GMP, Sop, FDA, CAPA, Validation, GLP, LIMS, Biotechnology, Aseptic Processing, Change Control, Technology Transfer, Purification, Vaccines, Pharmaceutical Industry, Quality System, Aseptic Technique, Protein Purification, Cell Culture, Biopharmaceuticals, Deviations, Downstream Processing, Quality Assurance, Cell, Sterilization, cGMP practices, SOP development, cGMP manufacturing, Drug Development, Cleaning Validation, GxP
Education
University of Maryland Eastern Shore 2002 — 2007
Bachelor of Science, Biology
United Therapeutics January 2011 - July 2012
Baxter BioScience June 2008 - December 2010
Skills
GMP, Sop, FDA, CAPA, Validation, GLP, LIMS, Biotechnology, Aseptic Processing, Change Control, Technology Transfer, Purification, Vaccines, Pharmaceutical Industry, Quality System, Aseptic Technique, Protein Purification, Cell Culture, Biopharmaceuticals, Deviations, Downstream Processing, Quality Assurance, Cell, Sterilization, cGMP practices, SOP development, cGMP manufacturing, Drug Development, Cleaning Validation, GxP
Education
University of Maryland Eastern Shore 2002 — 2007
Bachelor of Science, Biology
Frank Marsilio Frank Marsilio's Baxter BioScience Experience February 2002 - January 2003
Job Technical Support & QA Manager
Industry Information Technology and Services
Experience
SmartSound Software November 2008 - Present
FnT Records October 2007 - Present
The Frank & Todd Show August 1998 - Present
No Red Tape Mortgage January 2003 - June 2007
Baxter BioScience February 2002 - January 2003
Skills
Process Improvement, Team Building, Project Management, Product Development, Windows, Team Leadership, Music, Strategic Planning, Training, Six Sigma, Negotiation, Account Management, Sales, Social Media, Start-ups, Salesforce.com, Online Advertising, B2B, Social Media Marketing, Management, Product Management, Online Marketing, E-commerce
Education
University of Missouri-Columbia 1996 — 2000
BS, Biochemistry, Minor in Computer Science
SmartSound Software November 2008 - Present
FnT Records October 2007 - Present
The Frank & Todd Show August 1998 - Present
No Red Tape Mortgage January 2003 - June 2007
Baxter BioScience February 2002 - January 2003
Skills
Process Improvement, Team Building, Project Management, Product Development, Windows, Team Leadership, Music, Strategic Planning, Training, Six Sigma, Negotiation, Account Management, Sales, Social Media, Start-ups, Salesforce.com, Online Advertising, B2B, Social Media Marketing, Management, Product Management, Online Marketing, E-commerce
Education
University of Missouri-Columbia 1996 — 2000
BS, Biochemistry, Minor in Computer Science
Johnathan Maher, PhD's Baxter BioScience Experience July 2010 - July 2011
Job Scientific Director, Oncology Global Medical Affairs
Industry Pharmaceuticals
Experience
AbbVie May 2015 - Present
Dendreon February 2014 - April 2015
Dendreon July 2011 - February 2014
Baxter BioScience July 2010 - July 2011
BlueSpark Healthcare Communications August 2008 - July 2010
Gardiner-Caldwell US August 2006 - July 2008
Institute for Medical Education & Research, Inc. December 2005 - April 2006
Skills
Biotechnology, Clinical Trials, Oncology, Medical Writing, Metabolism, Regulations, Quality Assurance, Pharmaceutical Industry, Infectious Diseases, Immunology, Lifesciences, Clinical Development, Publication Planning, Hematology, Medical Communications, Vaccines, Medical Affairs, Therapeutic Areas, Clinical Research, Cancer, Neurology, Regulatory Affairs, Regulatory Submissions, Drug Development, Medicine, Pharmacovigilance, Biopharmaceuticals, Scientific..., Life Sciences
Education
University of Miami Leonard M. Miller School of Medicine
PhD, Molecular Cell and Developmental Biology
Virginia Polytechnic Institute and State University
BS, Food Science
AbbVie May 2015 - Present
Dendreon February 2014 - April 2015
Dendreon July 2011 - February 2014
Baxter BioScience July 2010 - July 2011
BlueSpark Healthcare Communications August 2008 - July 2010
Gardiner-Caldwell US August 2006 - July 2008
Institute for Medical Education & Research, Inc. December 2005 - April 2006
Skills
Biotechnology, Clinical Trials, Oncology, Medical Writing, Metabolism, Regulations, Quality Assurance, Pharmaceutical Industry, Infectious Diseases, Immunology, Lifesciences, Clinical Development, Publication Planning, Hematology, Medical Communications, Vaccines, Medical Affairs, Therapeutic Areas, Clinical Research, Cancer, Neurology, Regulatory Affairs, Regulatory Submissions, Drug Development, Medicine, Pharmacovigilance, Biopharmaceuticals, Scientific..., Life Sciences
Education
University of Miami Leonard M. Miller School of Medicine
PhD, Molecular Cell and Developmental Biology
Virginia Polytechnic Institute and State University
BS, Food Science
Art Romo Art Romo's Baxter BioScience Experience June 2014 - March 2015
Job
Industry Biotechnology
Experience
Baxalta (Baxter BioScience Spin Off) March 2015 - Present
Baxter BioScience June 2014 - March 2015
Baxter BioScience August 2011 - June 2014
Baxter BioScience January 2011 - August 2011
Baxter BioScience July 2006 - January 2011
Baxter BioScience June 2004 - July 2006
Baxter BioScience July 2002 - June 2004
Baxter International Inc. October 2000 - July 2002
Skills
DMAIC, GMP, Quality System, Sop, Continuous Improvement, Change Control, Pharmaceutical Industry, Manufacturing, CAPA, Six Sigma, Quality Assurance, Process Improvement, Supply Chain, Root Cause Analysis, Value Stream Mapping, Lean Manufacturing, Manufacturing Operations, Pharmaceutical Packaging, Change Management, FDA, Quality Management, V&V, Operational Excellence, Green Belt, Cross-functional Team..., 21 CFR Part 11, ISO, Quality Auditing, 5S, FMEA, Kaizen, SOP
Education
University of Phoenix 2009 — 2010
Master of Management
University of Phoenix 2002 — 2005
Bachelors of Science
Baxalta (Baxter BioScience Spin Off) March 2015 - Present
Baxter BioScience June 2014 - March 2015
Baxter BioScience August 2011 - June 2014
Baxter BioScience January 2011 - August 2011
Baxter BioScience July 2006 - January 2011
Baxter BioScience June 2004 - July 2006
Baxter BioScience July 2002 - June 2004
Baxter International Inc. October 2000 - July 2002
Skills
DMAIC, GMP, Quality System, Sop, Continuous Improvement, Change Control, Pharmaceutical Industry, Manufacturing, CAPA, Six Sigma, Quality Assurance, Process Improvement, Supply Chain, Root Cause Analysis, Value Stream Mapping, Lean Manufacturing, Manufacturing Operations, Pharmaceutical Packaging, Change Management, FDA, Quality Management, V&V, Operational Excellence, Green Belt, Cross-functional Team..., 21 CFR Part 11, ISO, Quality Auditing, 5S, FMEA, Kaizen, SOP
Education
University of Phoenix 2009 — 2010
Master of Management
University of Phoenix 2002 — 2005
Bachelors of Science
Paul Marshall Paul Marshall's Baxter BioScience Experience 2002 - 2005
Job SVP Technical Operations at Heron Therapeutics, Inc.
Industry Biotechnology
Experience
Heron Therapeutics, Inc. 2013 - Present
Marshall Biopharm Associates, LLC 2013 - Present
Amylin Pharmaceuticals 2008 - January 2013
Amylin Pharmaceuticals 2006 - 2008
Amgen 2005 - 2006
Baxter BioScience 2002 - 2005
Baxter BioScience 1999 - 2002
Creative BioMolecules, Inc 1992 - 1999
Repligen Corporation 1992 - 1992
WelGen Manufacturing Partnership (BWMI) 1990 - 1992
Skills
Biotechnology, FDA, Validation, Pharmaceutical Industry, Biopharmaceuticals, GMP, Quality System..., Manufacturing Operations, Operational Excellence, Change Control, Protein Chemistry, Cross-functional Team..., Cell Culture, Driving Operational..., ISO 13485, Medical Devices, CAPA, Aseptic Processing, Quality System, Sop, Technology Transfer, Vaccines, Lifesciences, Manufacturing, Drug Development, GxP, Clinical Development, Commercialization, Regulatory Affairs, Clinical Trials, Oncology, 21 CFR Part 11, Contract Manufacturing, HPLC, CRO, Regulatory Submissions, IND, LIMS, R&D, Life Sciences, SOP
Education
University of Massachusetts Dartmouth
BS, Biology
University of Massachusetts Dartmouth
MS, Biology
New Bedford High School
Heron Therapeutics, Inc. 2013 - Present
Marshall Biopharm Associates, LLC 2013 - Present
Amylin Pharmaceuticals 2008 - January 2013
Amylin Pharmaceuticals 2006 - 2008
Amgen 2005 - 2006
Baxter BioScience 2002 - 2005
Baxter BioScience 1999 - 2002
Creative BioMolecules, Inc 1992 - 1999
Repligen Corporation 1992 - 1992
WelGen Manufacturing Partnership (BWMI) 1990 - 1992
Skills
Biotechnology, FDA, Validation, Pharmaceutical Industry, Biopharmaceuticals, GMP, Quality System..., Manufacturing Operations, Operational Excellence, Change Control, Protein Chemistry, Cross-functional Team..., Cell Culture, Driving Operational..., ISO 13485, Medical Devices, CAPA, Aseptic Processing, Quality System, Sop, Technology Transfer, Vaccines, Lifesciences, Manufacturing, Drug Development, GxP, Clinical Development, Commercialization, Regulatory Affairs, Clinical Trials, Oncology, 21 CFR Part 11, Contract Manufacturing, HPLC, CRO, Regulatory Submissions, IND, LIMS, R&D, Life Sciences, SOP
Education
University of Massachusetts Dartmouth
BS, Biology
University of Massachusetts Dartmouth
MS, Biology
New Bedford High School
Katie M. Smith Katie M. Smith's Baxter BioScience Experience 2005 - 2013
Job Clinical and Regulatory Affairs
Industry Pharmaceuticals
Experience
Katie Smith Consulting 2009 - Present
Ridge Diagnostics 2012 - 2015
Ridge Diagnostics 2012 - 2015
Baxter Bioscience 2005 - 2013
Biogen Idec 2004 - 2009
Prometheus Laboratories Inc 2001 - 2004
Gen Probe 1996 - 2001
Hybritech 1986 - 1996
Skills
Clinical Trials, Clinical Development, Regulatory Affairs, FDA, Biotechnology, Pharmaceutical Industry, Oncology, Lifesciences, Regulatory Submissions, Laboratory, IND, Medical Devices, Clinical Operations, Biopharmaceuticals, Clinical Research, Regulatory Requirements, Medicine, Vaccines, Therapeutic Areas, Immunology, Clinical Monitoring, CRO, GMP, Biochemistry, Validation, GCP, ELISA, Infectious Diseases, Drug Development, GLP, R&D, Molecular Biology, Life Sciences
Education
Un of Arizona College of Medicine, Tucson, AZ
PhD, Biochemistry
University of Oregon
Bachelor of Arts (BA), Chemistry
Katie Smith Consulting 2009 - Present
Ridge Diagnostics 2012 - 2015
Ridge Diagnostics 2012 - 2015
Baxter Bioscience 2005 - 2013
Biogen Idec 2004 - 2009
Prometheus Laboratories Inc 2001 - 2004
Gen Probe 1996 - 2001
Hybritech 1986 - 1996
Skills
Clinical Trials, Clinical Development, Regulatory Affairs, FDA, Biotechnology, Pharmaceutical Industry, Oncology, Lifesciences, Regulatory Submissions, Laboratory, IND, Medical Devices, Clinical Operations, Biopharmaceuticals, Clinical Research, Regulatory Requirements, Medicine, Vaccines, Therapeutic Areas, Immunology, Clinical Monitoring, CRO, GMP, Biochemistry, Validation, GCP, ELISA, Infectious Diseases, Drug Development, GLP, R&D, Molecular Biology, Life Sciences
Education
Un of Arizona College of Medicine, Tucson, AZ
PhD, Biochemistry
University of Oregon
Bachelor of Arts (BA), Chemistry
Patrick J Maher's Baxter BioScience Experience September 2011 - Present
Job Research Associate III at Baxter BioScience
Industry Pharmaceuticals
Experience
Baxter BioScience September 2011 - Present
Baxter BioScience June 2006 - September 2011
Digene Corporation September 2000 - March 2006
Skills
GMP, FDA, Molecular Biology, Sop, Six Sigma, Six Sigma Green Belt..., Multivariate Data..., Statistics, Change Control, Biotechnology, Protein Purification, DNA, Validation, CAPA, Lifesciences, PCR, Technology Transfer, Manufacturing Control, Quality System, R&D, Biopharmaceuticals
Education
University of Maryland Baltimore 1999 — 2000
none, Molecular and Cellular Biology
University of Scranton 1995 — 1998
BS, Biology
Baxter BioScience September 2011 - Present
Baxter BioScience June 2006 - September 2011
Digene Corporation September 2000 - March 2006
Skills
GMP, FDA, Molecular Biology, Sop, Six Sigma, Six Sigma Green Belt..., Multivariate Data..., Statistics, Change Control, Biotechnology, Protein Purification, DNA, Validation, CAPA, Lifesciences, PCR, Technology Transfer, Manufacturing Control, Quality System, R&D, Biopharmaceuticals
Education
University of Maryland Baltimore 1999 — 2000
none, Molecular and Cellular Biology
University of Scranton 1995 — 1998
BS, Biology
Nicole Nalley-Stoddard Nicole Nalley-Stoddard's Baxter BioScience Experience June 2008 - August 2012
Job GMP Manufacturing Associate at Paragon Bioservices
Industry Biotechnology
Experience
Paragon Bioservices, Inc. August 2012 - Present
Baxter Bioscience June 2008 - August 2012
Baxter Bioscience November 2007 - June 2008
Baxter Bioscience November 2006 - November 2007
Baxter Bioscience February 2002 - November 2006
Skills
GMP, LIMS, 5S, Six Sigma, CAPA, FDA, Aseptic Processing, Lean Manufacturing, Validation, Change Control, Purification, 21 CFR Part 11, GLP, Manufacturing, Biotechnology, cGMP manufacturing, Chromatography, Protein Purification, Aseptic Technique, Deviations, Sterilization
Education
University of Maryland Baltimore County 1996 — 2000
Bachelors of Science, Biological Sciences
Paragon Bioservices, Inc. August 2012 - Present
Baxter Bioscience June 2008 - August 2012
Baxter Bioscience November 2007 - June 2008
Baxter Bioscience November 2006 - November 2007
Baxter Bioscience February 2002 - November 2006
Skills
GMP, LIMS, 5S, Six Sigma, CAPA, FDA, Aseptic Processing, Lean Manufacturing, Validation, Change Control, Purification, 21 CFR Part 11, GLP, Manufacturing, Biotechnology, cGMP manufacturing, Chromatography, Protein Purification, Aseptic Technique, Deviations, Sterilization
Education
University of Maryland Baltimore County 1996 — 2000
Bachelors of Science, Biological Sciences
Devapriya Mandal Devapriya Mandal's Baxter BioScience Experience March 2011 - July 2012
Job Engineer II, Process at Baxter Healthcare
Industry Chemicals
Experience
Baxter Healthcare July 2012 - Present
Baxter BioScience March 2011 - July 2012
The Dow Chemical Company May 2009 - August 2009
The Dow Chemical Company March 2007 - September 2007
Skills
Reliability, cGMP, Process Validation, JD Edwards, Ariba, Crystal Reports, Matlab, Materials Science, GMP, V&V, Chemical Engineering, Validation, R&D, Materials, Manufacturing, Polymers, Characterization
Education
University of Southern California 2008 — 2010
Masters, Material Science
Institute of Chemical Technology 2004 — 2008
Bachelors, Polymer Science & Engineering
Maneckji Cooper
Baxter Healthcare July 2012 - Present
Baxter BioScience March 2011 - July 2012
The Dow Chemical Company May 2009 - August 2009
The Dow Chemical Company March 2007 - September 2007
Skills
Reliability, cGMP, Process Validation, JD Edwards, Ariba, Crystal Reports, Matlab, Materials Science, GMP, V&V, Chemical Engineering, Validation, R&D, Materials, Manufacturing, Polymers, Characterization
Education
University of Southern California 2008 — 2010
Masters, Material Science
Institute of Chemical Technology 2004 — 2008
Bachelors, Polymer Science & Engineering
Maneckji Cooper
Dean Arnold's Baxter BioScience Experience November 2006 - July 2014
Job Director HR at Solid Concepts Inc.
Industry Human Resources
Experience
Solid Concepts Inc. July 2014 - Present
Baxter Bioscience November 2006 - July 2014
Skills
Employee Relations, Talent Management, Succession Planning, Talent Acquisition, HRIS, Onboarding, Workforce Planning, Human Resources, Organizational..., Employee Engagement, Leadership, Performance Management, Deferred Compensation, Team Building, HR Policies, Applicant Tracking..., Employee Benefits, New Hire Orientations, Personnel Management, FMLA, Benefits Administration, College Recruiting, Labor Relations, PeopleSoft, Interviews, Organizational Design, Job Descriptions, Organizational..., HR Consulting, Recruiting, Employee Training, Hiring, Performance Appraisal, Sourcing
Education
University of Phoenix 1994 — 1996
Solid Concepts Inc. July 2014 - Present
Baxter Bioscience November 2006 - July 2014
Skills
Employee Relations, Talent Management, Succession Planning, Talent Acquisition, HRIS, Onboarding, Workforce Planning, Human Resources, Organizational..., Employee Engagement, Leadership, Performance Management, Deferred Compensation, Team Building, HR Policies, Applicant Tracking..., Employee Benefits, New Hire Orientations, Personnel Management, FMLA, Benefits Administration, College Recruiting, Labor Relations, PeopleSoft, Interviews, Organizational Design, Job Descriptions, Organizational..., HR Consulting, Recruiting, Employee Training, Hiring, Performance Appraisal, Sourcing
Education
University of Phoenix 1994 — 1996
Darren Golomb's Baxter BioScience Experience August 2001 - July 2004
Job Sr. Process Engineer at Haskell Construction Co
Industry Biotechnology
Experience
Seiberling Associates, a Haskell Company May 2015 - Present
Novartis Pharmaceuticals July 2004 - September 2014
Baxter BioScience August 2001 - July 2004
Education
University of Michigan 1996 — 2000
Seiberling Associates, a Haskell Company May 2015 - Present
Novartis Pharmaceuticals July 2004 - September 2014
Baxter BioScience August 2001 - July 2004
Education
University of Michigan 1996 — 2000
Doug Gorman's Baxter BioScience Experience April 2002 - September 2005
Job Manager Of Mobile App Development
Industry Entertainment
Experience
Paramount Pictures December 2012 - Present
Creative Artists Agency September 2005 - December 2012
Baxter Bioscience April 2002 - September 2005
SharedGreetings.com February 2001 - August 2001
SpeedyClick.com November 1999 - December 2000
USC Software Systems January 1994 - November 1999
Skills
Software Project..., Software Development, Software Quality..., Agile Methodologies, Git, jQuery, SQL, Windows Azure, Powershell, Release Management, Test Automation, C#, Java, JavaScript, node.js, PHP, HTML, HTML5, XML, MySQL, System Center Service..., Selenium, Ant, Jenkins, Microsoft Operations..., ITIL, Change Management, Incident Management, Team Foundation Server, Visual Studio, Software Training, Localization Testing, Website Development, Website Testing, iOS development, Swift, Objective-C, Android Development, Agile Project Management, CSS
Education
University of Southern California 1992 — 1994
Folsom High School 1987 — 1990
Paramount Pictures December 2012 - Present
Creative Artists Agency September 2005 - December 2012
Baxter Bioscience April 2002 - September 2005
SharedGreetings.com February 2001 - August 2001
SpeedyClick.com November 1999 - December 2000
USC Software Systems January 1994 - November 1999
Skills
Software Project..., Software Development, Software Quality..., Agile Methodologies, Git, jQuery, SQL, Windows Azure, Powershell, Release Management, Test Automation, C#, Java, JavaScript, node.js, PHP, HTML, HTML5, XML, MySQL, System Center Service..., Selenium, Ant, Jenkins, Microsoft Operations..., ITIL, Change Management, Incident Management, Team Foundation Server, Visual Studio, Software Training, Localization Testing, Website Development, Website Testing, iOS development, Swift, Objective-C, Android Development, Agile Project Management, CSS
Education
University of Southern California 1992 — 1994
Folsom High School 1987 — 1990
Henry Eran's Baxter BioScience Experience 2004 - 2007
Job Pharmaceutical Quality
Industry Pharmaceuticals
Experience
C3 Jian March 2013 - Present
Solvay (Peptisyntha) 2008 - 2013
Pharmaceutical Quality 2007 - 2008
Amgen January 2007 - November 2007
Baxter BioScience 2004 - 2007
Grifols 2002 - 2004
Alpha Therapeutic 1990 - 2002
Skills
GMP, Biotechnology, GLP, Pharmaceutical Industry, Validation, Regulatory Affairs, Analytical Chemistry, FDA, Management, Quality Control, Quality Assurance, Interdepartmental..., Departmental Development, Consulting, Biopharmaceuticals, Calibration, GxP, Chromatography, HPLC, Chemistry, Purification, V&V, 21 CFR Part 11
Education
University of Southern California
Ph.D.
C3 Jian March 2013 - Present
Solvay (Peptisyntha) 2008 - 2013
Pharmaceutical Quality 2007 - 2008
Amgen January 2007 - November 2007
Baxter BioScience 2004 - 2007
Grifols 2002 - 2004
Alpha Therapeutic 1990 - 2002
Skills
GMP, Biotechnology, GLP, Pharmaceutical Industry, Validation, Regulatory Affairs, Analytical Chemistry, FDA, Management, Quality Control, Quality Assurance, Interdepartmental..., Departmental Development, Consulting, Biopharmaceuticals, Calibration, GxP, Chromatography, HPLC, Chemistry, Purification, V&V, 21 CFR Part 11
Education
University of Southern California
Ph.D.
Doug Hunt's Baxter BioScience Experience March 2008 - Present
Job Vice President, Regulatory Affairs
Industry Biotechnology
Experience
Baxter Bioscience March 2008 - Present
Amgen Inc January 2000 - March 2008
Quintiles, Inc. 1994 - 2000
Skills
21 CFR Part 11, Biopharmaceuticals, Biotechnology, CAPA, CRO, Change Control, Clinical Development, Clinical Trials, Cross-functional Team..., Drug Development, FDA, GCP, GLP, GMP, IND, Infectious Diseases, Life Sciences, Lifesciences, Medical Devices, Oncology, Pharmaceutical Industry, Pharmaceutics, Pharmacovigilance, Product Development, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Sop, Technology Transfer, Validation
Education
University of Portsmouth 1981 — 1984
Bachelor of Applied Science (B.A.Sc.), Biology, General, 2(1)
Baxter Bioscience March 2008 - Present
Amgen Inc January 2000 - March 2008
Quintiles, Inc. 1994 - 2000
Skills
21 CFR Part 11, Biopharmaceuticals, Biotechnology, CAPA, CRO, Change Control, Clinical Development, Clinical Trials, Cross-functional Team..., Drug Development, FDA, GCP, GLP, GMP, IND, Infectious Diseases, Life Sciences, Lifesciences, Medical Devices, Oncology, Pharmaceutical Industry, Pharmaceutics, Pharmacovigilance, Product Development, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Sop, Technology Transfer, Validation
Education
University of Portsmouth 1981 — 1984
Bachelor of Applied Science (B.A.Sc.), Biology, General, 2(1)
Ravi Samavedam's Baxter BioScience Experience August 2000 - June 2003
Job General Manager at Azzur Group
Industry Biotechnology
Experience
Azzur Group May 2014 - Present
BioSPEQ July 2012 - Present
Shire HGT December 2008 - June 2012
Amgen August 2003 - December 2008
Baxter BioScience August 2000 - June 2003
Skills
Process Validation, cGMP, Disposables, Cleaning Validation, CMC, Biotech Manufacturing, Aseptic Processing, Technology Transfer, Regulatory Submissions, Extractables and..., Cold Chain..., Validation Maintenance, Validation, V&V, Biotechnology, GMP, Quality Control, Biopharmaceuticals, 21 CFR Part 11, Change Control, FDA, Computer System..., CAPA, Pharmaceutics, Sop, Pharmaceutical Industry, LIMS, SOP
Education
University of Minnesota-Twin Cities 1997 — 2000
HBTI, Kanpur 1993 — 1997
B. Tech, Biochemical Engineering
BJB College 1990 — 1993
Azzur Group May 2014 - Present
BioSPEQ July 2012 - Present
Shire HGT December 2008 - June 2012
Amgen August 2003 - December 2008
Baxter BioScience August 2000 - June 2003
Skills
Process Validation, cGMP, Disposables, Cleaning Validation, CMC, Biotech Manufacturing, Aseptic Processing, Technology Transfer, Regulatory Submissions, Extractables and..., Cold Chain..., Validation Maintenance, Validation, V&V, Biotechnology, GMP, Quality Control, Biopharmaceuticals, 21 CFR Part 11, Change Control, FDA, Computer System..., CAPA, Pharmaceutics, Sop, Pharmaceutical Industry, LIMS, SOP
Education
University of Minnesota-Twin Cities 1997 — 2000
HBTI, Kanpur 1993 — 1997
B. Tech, Biochemical Engineering
BJB College 1990 — 1993
Deborah Harrison-Fazzio's Baxter BioScience Experience 2002 - 2002
Job Compliance Auditor at ISO Auditor Certification Program
Industry Medical Devices
Experience
ISO Auditor Certification Program March 2011 - Present
Volcano Corporation December 2008 - Present
Dey/Mylan June 2004 - December 2008
Baxter Bioscience 2002 - 2002
Aerojet 1995 - 2002
Skills
CAPA, Quality Systems, Quality Assurance, Process Improvement, Budgeting, GMP, Sop, Quality Auditing, Training, FDA, Quality System, Pharmaceutical Industry, Validation, Budgets, Change Control, V&V, ISO 13485, Trackwise, 21 CFR Part 11, Software Documentation, Medical Devices, ISO, Quality Control, Root Cause Analysis, Six Sigma, Regulatory Requirements, Continuous Improvement, Auditing, Design Control, ISO 14971, Internal Audit, Regulatory Affairs, GxP, Computer System..., Iso 9000, DMAIC, Regulatory Submissions, Quality Management, Supplier Quality, R&D, Process Simulation, FMEA, LIMS, SPC, Pharmaceutics, Cross-functional Team..., Manufacturing
Education
University of Phoenix 2006 — 2008
Bachelor's Degree, Management Science, Highest Honors. 3.90
GenCorp Leadership 1999 — 2000
Certificate Program, Organizational Leadership
Cosumnes River College 1996 — 1999
Associate's Degree, Chemistry and Mathematics, 3.85
ISO Auditor Certification Program March 2011 - Present
Volcano Corporation December 2008 - Present
Dey/Mylan June 2004 - December 2008
Baxter Bioscience 2002 - 2002
Aerojet 1995 - 2002
Skills
CAPA, Quality Systems, Quality Assurance, Process Improvement, Budgeting, GMP, Sop, Quality Auditing, Training, FDA, Quality System, Pharmaceutical Industry, Validation, Budgets, Change Control, V&V, ISO 13485, Trackwise, 21 CFR Part 11, Software Documentation, Medical Devices, ISO, Quality Control, Root Cause Analysis, Six Sigma, Regulatory Requirements, Continuous Improvement, Auditing, Design Control, ISO 14971, Internal Audit, Regulatory Affairs, GxP, Computer System..., Iso 9000, DMAIC, Regulatory Submissions, Quality Management, Supplier Quality, R&D, Process Simulation, FMEA, LIMS, SPC, Pharmaceutics, Cross-functional Team..., Manufacturing
Education
University of Phoenix 2006 — 2008
Bachelor's Degree, Management Science, Highest Honors. 3.90
GenCorp Leadership 1999 — 2000
Certificate Program, Organizational Leadership
Cosumnes River College 1996 — 1999
Associate's Degree, Chemistry and Mathematics, 3.85
John McMican's Baxter BioScience Experience February 2001 - September 2003
Job Senior Engineer Viral Vaccine Technology and Engineering at Merck
Industry Pharmaceuticals
Experience
Merck July 2011 - Present
JHP Pharmaceuticals January 2008 - July 2011
Pfizer PGRD October 2006 - January 2008
King Pharmaceuticals September 2003 - October 2006
Baxter BioScience February 2001 - September 2003
Skills
Validation, Cleaning Validation, Vaccines, GMP, Aseptic Processing, Sterility Assurance, Pharmaceutical Industry, Trackwise, Aseptic Technique, Sop, FDA, Change Control, V&V, GxP, 21 CFR Part 11, CAPA, Quality System, GLP, Contract Manufacturing, Computer System..., LIMS, Biopharmaceuticals, Technology Transfer
Education
University of Michigan-Flint 1995 — 2000
BS, Biology
Merck July 2011 - Present
JHP Pharmaceuticals January 2008 - July 2011
Pfizer PGRD October 2006 - January 2008
King Pharmaceuticals September 2003 - October 2006
Baxter BioScience February 2001 - September 2003
Skills
Validation, Cleaning Validation, Vaccines, GMP, Aseptic Processing, Sterility Assurance, Pharmaceutical Industry, Trackwise, Aseptic Technique, Sop, FDA, Change Control, V&V, GxP, 21 CFR Part 11, CAPA, Quality System, GLP, Contract Manufacturing, Computer System..., LIMS, Biopharmaceuticals, Technology Transfer
Education
University of Michigan-Flint 1995 — 2000
BS, Biology
Nicole Kurz's Baxter BioScience Experience February 2007 - February 2009
Job Territory Manager at Actelion Pharmaceuticals
Industry Pharmaceuticals
Experience
Actelion February 2009 - Present
Baxter BioScience February 2007 - February 2009
Skills
Pharmaceutical Sales, Pharmaceutical Industry, Pulmonology, Cardiology, Hospital Sales, Sales Effectiveness, Rheumatology
Education
University of Scranton 1995 — 1999
Actelion February 2009 - Present
Baxter BioScience February 2007 - February 2009
Skills
Pharmaceutical Sales, Pharmaceutical Industry, Pulmonology, Cardiology, Hospital Sales, Sales Effectiveness, Rheumatology
Education
University of Scranton 1995 — 1999
James Yakel's Baxter BioScience Experience March 2002 - Present
Job Project Manager II at Baxter
Industry Pharmaceuticals
Experience
Baxter BioScience March 2002 - Present
TXU May 2000 - November 2001
University of Oklahoma April 1999 - August 1999
Skills
21 CFR Part 11, Business Analysis, Change Control, Computer System..., Cross-functional Team..., FDA, GMP, LIMS, Pharmaceutical Industry, Quality Assurance, SDLC, Software Documentation, Validation, CAPA, Quality System
Education
University of Oklahoma - Price College of Business
BA, MIS with minors in Psychology and Sociology
Baxter BioScience March 2002 - Present
TXU May 2000 - November 2001
University of Oklahoma April 1999 - August 1999
Skills
21 CFR Part 11, Business Analysis, Change Control, Computer System..., Cross-functional Team..., FDA, GMP, LIMS, Pharmaceutical Industry, Quality Assurance, SDLC, Software Documentation, Validation, CAPA, Quality System
Education
University of Oklahoma - Price College of Business
BA, MIS with minors in Psychology and Sociology
Thang Ngo's Baxter BioScience Experience October 2005 - Present
Job QA Inspector at Baxter BioScience
Industry Biotechnology
Experience
Baxter BioScience October 2005 - Present
Thermo Fisher Scientific September 1995 - July 2005
Skills
GMP, FDA, Quality System, Change Control, CAPA, 21 CFR Part 11, Sop, ISO 13485, Quality Auditing, GxP, GLP, Quality Control, ISO, Regulatory Affairs, Pharmaceutical Industry, Quality Management, Biopharmaceuticals, Biotechnology, Root Cause Analysis, Trackwise
Education
University of La Verne
Bachelor of Science (BS), Mathematics
Baxter BioScience October 2005 - Present
Thermo Fisher Scientific September 1995 - July 2005
Skills
GMP, FDA, Quality System, Change Control, CAPA, 21 CFR Part 11, Sop, ISO 13485, Quality Auditing, GxP, GLP, Quality Control, ISO, Regulatory Affairs, Pharmaceutical Industry, Quality Management, Biopharmaceuticals, Biotechnology, Root Cause Analysis, Trackwise
Education
University of La Verne
Bachelor of Science (BS), Mathematics
Allen Fogle's Baxter BioScience Experience August 1999 - November 2005
Job Sr. Client Services Manager at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical June 2012 - Present
St. Jude Medical November 2005 - June 2012
Baxter BioScience August 1999 - November 2005
Skills
21 CFR Part 11, Medical Devices, Computer System..., Cross-functional Team..., Software Documentation, Change Control, Validation, Vendor Management, Process Improvement, CAPA, FDA, IT Strategy, Quality System, IT Management, SDLC, Quality Assurance, Six Sigma, ISO 13485, Troubleshooting, Market Development, Global Marketing, V&V, Active Directory, Product Launch, GMP, Root Cause Analysis, Commercialization, Cardiology, Biomedical Engineering, Design Control, Design of Experiments, Minitab, R&D, Capital Equipment, Continuous Improvement, Pharmaceutical Industry, Regulatory Affairs, Quality Auditing, Biotechnology, Sop, FMEA, LIMS, Medical Imaging, Product Development, Hardware Diagnostics, System Deployment, Collaborative Problem...
Education
University of Phoenix 2007 — 2012
Bachelor of Science (B.S.), Business Administration, Management and Operations, 3.74
Ameritech College of Technology 1997 — 1999
St. Jude Medical June 2012 - Present
St. Jude Medical November 2005 - June 2012
Baxter BioScience August 1999 - November 2005
Skills
21 CFR Part 11, Medical Devices, Computer System..., Cross-functional Team..., Software Documentation, Change Control, Validation, Vendor Management, Process Improvement, CAPA, FDA, IT Strategy, Quality System, IT Management, SDLC, Quality Assurance, Six Sigma, ISO 13485, Troubleshooting, Market Development, Global Marketing, V&V, Active Directory, Product Launch, GMP, Root Cause Analysis, Commercialization, Cardiology, Biomedical Engineering, Design Control, Design of Experiments, Minitab, R&D, Capital Equipment, Continuous Improvement, Pharmaceutical Industry, Regulatory Affairs, Quality Auditing, Biotechnology, Sop, FMEA, LIMS, Medical Imaging, Product Development, Hardware Diagnostics, System Deployment, Collaborative Problem...
Education
University of Phoenix 2007 — 2012
Bachelor of Science (B.S.), Business Administration, Management and Operations, 3.74
Ameritech College of Technology 1997 — 1999
Jonelle Chapman's Baxter BioScience Experience June 2003 - June 2007
Job Global Program Regulatory Director for Cell & Gene Therapy at Novartis
Industry Pharmaceuticals
Experience
Novartis February 2015 - Present
Novartis October 2013 - Present
Novartis October 2011 - October 2013
Novartis April 2009 - October 2011
Rutgers University July 2007 - April 2009
Baxter Bioscience June 2003 - June 2007
National Cancer Institute - NIH September 2001 - August 2003
Skills
Regulatory Affairs, Clinical Trials, Clinical Research, Pharmaceutical Industry, Regulatory Submissions
Education
University of Maryland Baltimore
Pharm.D
University of Minnesota-Twin Cities
BSc, Biochemistry
Novartis February 2015 - Present
Novartis October 2013 - Present
Novartis October 2011 - October 2013
Novartis April 2009 - October 2011
Rutgers University July 2007 - April 2009
Baxter Bioscience June 2003 - June 2007
National Cancer Institute - NIH September 2001 - August 2003
Skills
Regulatory Affairs, Clinical Trials, Clinical Research, Pharmaceutical Industry, Regulatory Submissions
Education
University of Maryland Baltimore
Pharm.D
University of Minnesota-Twin Cities
BSc, Biochemistry
James Rouhani's Baxter BioScience Experience August 2008 - Present
Job Technical Specialist at Baxter BioScience
Industry Pharmaceuticals
Experience
Baxter BioScience August 2008 - Present
University of Mobile January 2003 - July 2008
Tech Advanced Computers November 1999 - December 2001
Skills
Testing, SQL, Microsoft Office, Data Analysis, Servers, Process Improvement, Networking, Business Analysis, Windows, Software Documentation, Windows Server, VMware, Public Speaking, Security, Hardware, Technical Support, Troubleshooting, Data Center, Firewalls, Customer Service, Leadership, VMware ESX, Routers, Information Technology, Strategic Planning, Team Building, Infrastructure, Teaching, Microsoft Excel, Event Planning, Project Management, Cisco Routers, Microsoft Word, SharePoint, Management, Documentation, Social Media, PowerPoint, Strategy, Problem Solving, Active Directory, System Administration, Microsoft SQL Server
Education
University of Mobile 2001 — 2005
Bachelor's of Science, Religion/Religious Studies
Campbell High School 1995 — 1999
Baxter BioScience August 2008 - Present
University of Mobile January 2003 - July 2008
Tech Advanced Computers November 1999 - December 2001
Skills
Testing, SQL, Microsoft Office, Data Analysis, Servers, Process Improvement, Networking, Business Analysis, Windows, Software Documentation, Windows Server, VMware, Public Speaking, Security, Hardware, Technical Support, Troubleshooting, Data Center, Firewalls, Customer Service, Leadership, VMware ESX, Routers, Information Technology, Strategic Planning, Team Building, Infrastructure, Teaching, Microsoft Excel, Event Planning, Project Management, Cisco Routers, Microsoft Word, SharePoint, Management, Documentation, Social Media, PowerPoint, Strategy, Problem Solving, Active Directory, System Administration, Microsoft SQL Server
Education
University of Mobile 2001 — 2005
Bachelor's of Science, Religion/Religious Studies
Campbell High School 1995 — 1999
Christopher Hafner's Baxter BioScience Experience October 2009 - September 2010
Job Manager, Clinical Affairs at Ellipse Technologies, Inc.
Industry Biotechnology
Experience
Ellipse Technologies, Inc. October 2011 - Present
AqueSys, Inc. August 2010 - October 2011
Baxter BioScience October 2009 - September 2010
NeuroSystec Corporation August 2008 - October 2009
Boston Scientific Corporation June 2005 - August 2008
Medtronic Corporation January 2004 - June 2005
Skills
Neurology, Orthopedic, Medical Devices, Cardiology, Psychiatry, FDA, CRO, CTMS, Clinical Development, Clinical Research, Clinical Trials, GCP
Education
University of Minnesota-Twin Cities 1998 — 2003
BA, Physiology
University of Minnesota-Twin Cities 1998 — 2003
BA, Psychology
Ellipse Technologies, Inc. October 2011 - Present
AqueSys, Inc. August 2010 - October 2011
Baxter BioScience October 2009 - September 2010
NeuroSystec Corporation August 2008 - October 2009
Boston Scientific Corporation June 2005 - August 2008
Medtronic Corporation January 2004 - June 2005
Skills
Neurology, Orthopedic, Medical Devices, Cardiology, Psychiatry, FDA, CRO, CTMS, Clinical Development, Clinical Research, Clinical Trials, GCP
Education
University of Minnesota-Twin Cities 1998 — 2003
BA, Physiology
University of Minnesota-Twin Cities 1998 — 2003
BA, Psychology
Elyssa Peskin's Baxter BioScience Experience 2005 - Present
Job Regulatory Affairs Manager at Baxter
Industry Biotechnology
Experience
Baxter March 2005 - Present
Baxter Healthcare Corp 2005 - Present
Baxter Healthcare (now Baxter BioScience) 2005 - Present
Baxter Bioscience 2005 - Present
Baxter International Inc. 2005 - Present
Baxter 2005 - 2009
Amgen Inc 2000 - 2005
Skills
Regulatory Affairs, Pharmaceutical Industry, Regulatory Requirements, Regulatory Submissions, GMP, Sop, CAPA
Education
University of Southern California 2001 — 2003
Baxter March 2005 - Present
Baxter Healthcare Corp 2005 - Present
Baxter Healthcare (now Baxter BioScience) 2005 - Present
Baxter Bioscience 2005 - Present
Baxter International Inc. 2005 - Present
Baxter 2005 - 2009
Amgen Inc 2000 - 2005
Skills
Regulatory Affairs, Pharmaceutical Industry, Regulatory Requirements, Regulatory Submissions, GMP, Sop, CAPA
Education
University of Southern California 2001 — 2003
Jennifer Bushey's Baxter BioScience Experience October 2007 - December 2010
Job Technical Specialist at Meridian BioGroup
Industry Pharmaceuticals
Experience
Meridian BioGroup, LLC September 2011 - Present
Baxter BioScience October 2007 - December 2010
Baxter Pharmaceutical Solutions (BPS) June 2006 - June 2007
Baxter November 2005 - June 2006
QC Microbiology August 2004 - June 2006
Baxter September 2003 - November 2005
Barkn' Buddies January 2003 - September 2003
Southern Indiana Scuba May 2002 - January 2003
Skills
LIMS, Continuous Improvement, Materials Management, Auditing, Management, Sop, GMP, CAPA, GLP, Quality Assurance, Manufacturing, 21 CFR Part 11, Quality System, Quality Control, Veterinary Medicine, Change Control, SOP, Life Sciences, Pharmaceutical Industry, Swing Trading, Microbiology, Relationship Management
Education
Indiana University 2006 — 2006
Certificate, Mangement in the Life Sciences Industry
Indiana University 1999 — 2002
Bachelor of Arts, Biology
University of Southern California 1998 — 1999
Theatre
Meridian BioGroup, LLC September 2011 - Present
Baxter BioScience October 2007 - December 2010
Baxter Pharmaceutical Solutions (BPS) June 2006 - June 2007
Baxter November 2005 - June 2006
QC Microbiology August 2004 - June 2006
Baxter September 2003 - November 2005
Barkn' Buddies January 2003 - September 2003
Southern Indiana Scuba May 2002 - January 2003
Skills
LIMS, Continuous Improvement, Materials Management, Auditing, Management, Sop, GMP, CAPA, GLP, Quality Assurance, Manufacturing, 21 CFR Part 11, Quality System, Quality Control, Veterinary Medicine, Change Control, SOP, Life Sciences, Pharmaceutical Industry, Swing Trading, Microbiology, Relationship Management
Education
Indiana University 2006 — 2006
Certificate, Mangement in the Life Sciences Industry
Indiana University 1999 — 2002
Bachelor of Arts, Biology
University of Southern California 1998 — 1999
Theatre
Joan Fusco's Baxter BioScience Experience 2000 - 2004
Job VP Product Development at BioProtection Systems / NewLink Genetics Corp.
Industry Biotechnology
Experience
BioProtection Systems / NewLink Genetics Corp. March 2015 - Present
Vaccinologist October 2010 - Present
CBR International Corp. November 2013 - February 2015
PharmAthene February 2008 - September 2010
Acambis 2004 - 2008
Baxter BioScience 2000 - 2004
North American Vaccine 1991 - 2001
University of Pittsurgh 1978 - 1987
Skills
Biotechnology, Technology Transfer, Vaccines, Life Sciences, GMP, CAPA, Aseptic Processing, Lifesciences, Biopharmaceuticals, Quality System, Pharmaceutical Industry, Commercialization, 21 CFR Part 11, Clinical Development, Oncology, FDA, Regulatory Affairs, Validation
Education
University of Pittsburgh
Ph.D., Microbiology/Biological Sciences
BioProtection Systems / NewLink Genetics Corp. March 2015 - Present
Vaccinologist October 2010 - Present
CBR International Corp. November 2013 - February 2015
PharmAthene February 2008 - September 2010
Acambis 2004 - 2008
Baxter BioScience 2000 - 2004
North American Vaccine 1991 - 2001
University of Pittsurgh 1978 - 1987
Skills
Biotechnology, Technology Transfer, Vaccines, Life Sciences, GMP, CAPA, Aseptic Processing, Lifesciences, Biopharmaceuticals, Quality System, Pharmaceutical Industry, Commercialization, 21 CFR Part 11, Clinical Development, Oncology, FDA, Regulatory Affairs, Validation
Education
University of Pittsburgh
Ph.D., Microbiology/Biological Sciences
Eric Schlauch's Baxter BioScience Experience February 2001 - July 2003
Job Laboratory Technologist IV Laboratory Information System Specialist
Industry Hospital & Health Care
Experience
Memorial Sloan-Kettering Cancer Center May 2006 - Present
Baxter BioScience February 2001 - July 2003
American Red Cross Blood Services 1997 - 2001
Skills
Clinical Chemistry, Laboratory Medicine, Hematology, Cancer, Blood Bank, Immunology, Coagulation, Laboratory, Healthcare Information..., Healthcare, Medical Technology, LIS, Immunoassays
Education
The University of Montana 1992 — 1997
B.S., Medical Technology
The University of Montana 1992 — 1997
Bachelor of Applied Science (BASc), Microbiology
Memorial Sloan-Kettering Cancer Center May 2006 - Present
Baxter BioScience February 2001 - July 2003
American Red Cross Blood Services 1997 - 2001
Skills
Clinical Chemistry, Laboratory Medicine, Hematology, Cancer, Blood Bank, Immunology, Coagulation, Laboratory, Healthcare Information..., Healthcare, Medical Technology, LIS, Immunoassays
Education
The University of Montana 1992 — 1997
B.S., Medical Technology
The University of Montana 1992 — 1997
Bachelor of Applied Science (BASc), Microbiology
Antonieta Sosa's Baxter BioScience Experience 1998 - 2006
Job Director, Clinical Program Leader
Industry Pharmaceuticals
Experience
The Janssen Pharmaceutical Companies of Johnson & Johnson March 2015 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson June 2009 - Present
Johnson & Johnson March 2008 - Present
Cougar Biotechnology 2008 - Present
Ortho Biotech Oncology R&D, Unit of Cougar Biotechnology, Inc. 2008 - 2009
Grifols August 2006 - March 2008
Cougar Biotechnology 2008 - 2008
Baxter Healthcare, Inc. 2000 - 2006
Baxter BioScience 1998 - 2006
Baxter 1998 - 2006
Skills
GCP, Clinical Development, Clinical Research, CTMS, CRO, Pharmaceutical Industry, Clinical Trials, Sop, Oncology, EDC, FDA, Regulatory Submissions, Biotechnology, Urology, Regulatory Affairs, Global Recruitment, Vendor Relationship..., Vendor Management, Global Clinical Trial...
Education
USC
Master of Science (MSc)
The Janssen Pharmaceutical Companies of Johnson & Johnson March 2015 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson June 2009 - Present
Johnson & Johnson March 2008 - Present
Cougar Biotechnology 2008 - Present
Ortho Biotech Oncology R&D, Unit of Cougar Biotechnology, Inc. 2008 - 2009
Grifols August 2006 - March 2008
Cougar Biotechnology 2008 - 2008
Baxter Healthcare, Inc. 2000 - 2006
Baxter BioScience 1998 - 2006
Baxter 1998 - 2006
Skills
GCP, Clinical Development, Clinical Research, CTMS, CRO, Pharmaceutical Industry, Clinical Trials, Sop, Oncology, EDC, FDA, Regulatory Submissions, Biotechnology, Urology, Regulatory Affairs, Global Recruitment, Vendor Relationship..., Vendor Management, Global Clinical Trial...
Education
USC
Master of Science (MSc)
Monette Inumerable's Baxter BioScience Experience February 2008 - Present
Job Manager, Quality and Regulatory Compliance at Baxter Healthcare Corp Bioscience Division
Industry Biotechnology
Experience
Baxter Bioscience February 2008 - Present
Baxter Healthcare Corporation 2007 - Present
Baxter Healthcare Corp 2008 - 2010
Quest Diagnostics 2005 - 2008
United Laboratories, Inc. 1988 - 1990
United Laboratories, Inc. 1988 - 1990
Skills
CAPA, Validations, FDA, cGMP, Regulatory Requirements, GMP, 21 CFR Part 11, GxP, Regulatory Affairs, LIMS, QC, ISO 13485, Quality Control, V&V, Computer System..., Validation, Pharmaceutical Industry, Quality System, Sop, Microbiology, Change Control, Aseptic Processing, Biopharmaceuticals, GLP, Technology Transfer, Medical Devices, Cleaning Validation, Trackwise, Quality Auditing, Regulatory Submissions, HPLC, Biotechnology, SOP, Quality Assurance, Life Sciences
Education
Glendale University College of Law 1998 — 2002
Juris Doctor (Law), Law
University of Santo Tomas
Bachelor's Degree, Biochemistry
Baxter Bioscience February 2008 - Present
Baxter Healthcare Corporation 2007 - Present
Baxter Healthcare Corp 2008 - 2010
Quest Diagnostics 2005 - 2008
United Laboratories, Inc. 1988 - 1990
United Laboratories, Inc. 1988 - 1990
Skills
CAPA, Validations, FDA, cGMP, Regulatory Requirements, GMP, 21 CFR Part 11, GxP, Regulatory Affairs, LIMS, QC, ISO 13485, Quality Control, V&V, Computer System..., Validation, Pharmaceutical Industry, Quality System, Sop, Microbiology, Change Control, Aseptic Processing, Biopharmaceuticals, GLP, Technology Transfer, Medical Devices, Cleaning Validation, Trackwise, Quality Auditing, Regulatory Submissions, HPLC, Biotechnology, SOP, Quality Assurance, Life Sciences
Education
Glendale University College of Law 1998 — 2002
Juris Doctor (Law), Law
University of Santo Tomas
Bachelor's Degree, Biochemistry
Randy Bradshaw's Baxter BioScience Experience May 2002 - September 2006
Job Director of Facilities and Engineering at MacroGenics, Inc.
Industry Biotechnology
Experience
MacroGenics, Inc. January 2015 - Present
MacroGenics July 2011 - Present
MacroGenics Inc. September 2006 - Present
Baxter Bioscience May 2002 - September 2006
Skills
GMP, Validation, Manufacturing, Six Sigma, Kaizen, Sop, FDA, Troubleshooting, Pharmaceutical Industry, CAPA, Commissioning, DMAIC, Engineering, Quality Assurance, Change Control, 21 CFR Part 11, SOP
Education
University of Maryland - Robert H. Smith School of Business 1981 — 1985
BS, Business and Management
Oxon Hill High School
MacroGenics, Inc. January 2015 - Present
MacroGenics July 2011 - Present
MacroGenics Inc. September 2006 - Present
Baxter Bioscience May 2002 - September 2006
Skills
GMP, Validation, Manufacturing, Six Sigma, Kaizen, Sop, FDA, Troubleshooting, Pharmaceutical Industry, CAPA, Commissioning, DMAIC, Engineering, Quality Assurance, Change Control, 21 CFR Part 11, SOP
Education
University of Maryland - Robert H. Smith School of Business 1981 — 1985
BS, Business and Management
Oxon Hill High School
Roshani Modha's Baxter BioScience Experience April 2007 - November 2009
Job Process Lead at CelSci
Industry Biotechnology
Experience
Cel-sci Corporation September 2014 - Present
Cel-Sci Corporation September 2011 - September 2014
Cel-Sci Corporation December 2009 - September 2011
Baxter Bioscience April 2007 - November 2009
Osiris Therapeutics, Inc. July 2006 - April 2007
Skills
Immunology, cGMP practices, Deviations, Laboratory, Tissue Culture, Protocol, Microscopy, Mammalian Cell Culture, Immunoassays, Assay Development, Biopharmaceuticals, Biotechnology, DNA extraction, Software Documentation
Education
University of Maryland Baltimore County
Cel-sci Corporation September 2014 - Present
Cel-Sci Corporation September 2011 - September 2014
Cel-Sci Corporation December 2009 - September 2011
Baxter Bioscience April 2007 - November 2009
Osiris Therapeutics, Inc. July 2006 - April 2007
Skills
Immunology, cGMP practices, Deviations, Laboratory, Tissue Culture, Protocol, Microscopy, Mammalian Cell Culture, Immunoassays, Assay Development, Biopharmaceuticals, Biotechnology, DNA extraction, Software Documentation
Education
University of Maryland Baltimore County
Wolf Justin's Baxter BioScience Experience July 2012 - Present
Job Lead at Baxter Bioscience
Industry Biotechnology
Experience
Baxter Bioscience July 2012 - Present
Baxter BioScience October 2010 - July 2012
Skills
GMP, Sop, Aseptic Processing, Protein Purification, Aseptic Technique, Purification
Education
University of Phoenix-Southern California Campus 2004 — 2007
Bachelor of Science (B.S.), Information Technology
Baxter Bioscience July 2012 - Present
Baxter BioScience October 2010 - July 2012
Skills
GMP, Sop, Aseptic Processing, Protein Purification, Aseptic Technique, Purification
Education
University of Phoenix-Southern California Campus 2004 — 2007
Bachelor of Science (B.S.), Information Technology
John C. Bourg's Baxter BioScience Experience December 2001 - June 2008
Job Sr. Nuclear Project Manager at Exelon
Industry Oil & Energy
Experience
Exelon Nuclear May 2013 - Present
Entergy May 2012 - May 2013
Entergy October 2011 - May 2012
Life Technologies June 2008 - October 2011
Baxter BioScience December 2001 - June 2008
Pacific Gas and Electric Company January 2000 - April 2007
Pfizer Pharmaceuticals January 1993 - December 1999
Skills
Quality System, DCS, Nuclear, Steam, Instrumentation, Factory, Project Management, Engineering, Reactor, GMP, Automation, Manufacturing, Petrochemical, Power Plants, Pumps, FDA, Validation, Energy, Engineering Management, Gas Turbines, Power Generation, Process Control, Electricians, Quality Assurance, Maintenance & Repair, Construction, Inspection, Root Cause Analysis, Quality Control, Project Engineering, Calibration, ISO, Commissioning, Supervisory Skills, Maintenance Management, Preventive Maintenance, Process Engineering, PLC, Nuclear Engineering, MS Project, Metal Fabrication, Steam Turbines, Turbines, Electrical Engineering, Boilers, EPC, Project Control, Process Simulation, Piping, Pressure Vessels
Education
Allen Bradley
Course Completion, Programmable Logic Controller programming (PLC)
Detroit Edison - Nuclear Power
Entergy Nuclear
Pacific Gas and Electric - Nuclear Power
IAS Technical
Industrial Instrumentation / Process Control
ITV, Inc.
Industrial Instrumentation / Electrical Control
University of New Orleans
Electrical and Electronics Engineering
Exelon Nuclear May 2013 - Present
Entergy May 2012 - May 2013
Entergy October 2011 - May 2012
Life Technologies June 2008 - October 2011
Baxter BioScience December 2001 - June 2008
Pacific Gas and Electric Company January 2000 - April 2007
Pfizer Pharmaceuticals January 1993 - December 1999
Skills
Quality System, DCS, Nuclear, Steam, Instrumentation, Factory, Project Management, Engineering, Reactor, GMP, Automation, Manufacturing, Petrochemical, Power Plants, Pumps, FDA, Validation, Energy, Engineering Management, Gas Turbines, Power Generation, Process Control, Electricians, Quality Assurance, Maintenance & Repair, Construction, Inspection, Root Cause Analysis, Quality Control, Project Engineering, Calibration, ISO, Commissioning, Supervisory Skills, Maintenance Management, Preventive Maintenance, Process Engineering, PLC, Nuclear Engineering, MS Project, Metal Fabrication, Steam Turbines, Turbines, Electrical Engineering, Boilers, EPC, Project Control, Process Simulation, Piping, Pressure Vessels
Education
Allen Bradley
Course Completion, Programmable Logic Controller programming (PLC)
Detroit Edison - Nuclear Power
Entergy Nuclear
Pacific Gas and Electric - Nuclear Power
IAS Technical
Industrial Instrumentation / Process Control
ITV, Inc.
Industrial Instrumentation / Electrical Control
University of New Orleans
Electrical and Electronics Engineering
Eric Dawkins's Baxter BioScience Experience September 2008 - December 2008
Job Entertainer at Movement Talent Agency (MTA)
Industry Entertainment
Experience
Movement Talent Agency (MTA) August 2012 - Present
IDA Hollywood October 2011 - October 2012
DDO Artists Agency June 2009 - August 2012
Amgen September 2010 - June 2011
LabCorp February 2009 - July 2010
Baxter BioScience September 2008 - December 2008
DuPont August 2007 - August 2008
Skills
Electromagnetics, Materials Science, Manufacturing, Electronics, Excel, Street Dance, Breakdance, Choreography, Dance Education, Microsoft Excel, Dance, Performing Arts, Entertainment, Television, Film, Theatre, Event Management, Public Speaking
Education
University of North Carolina at Chapel Hill 2003 — 2007
Bachlor of Science, Applied Sciences: Biomedical Engineering
Movement Talent Agency (MTA) August 2012 - Present
IDA Hollywood October 2011 - October 2012
DDO Artists Agency June 2009 - August 2012
Amgen September 2010 - June 2011
LabCorp February 2009 - July 2010
Baxter BioScience September 2008 - December 2008
DuPont August 2007 - August 2008
Skills
Electromagnetics, Materials Science, Manufacturing, Electronics, Excel, Street Dance, Breakdance, Choreography, Dance Education, Microsoft Excel, Dance, Performing Arts, Entertainment, Television, Film, Theatre, Event Management, Public Speaking
Education
University of North Carolina at Chapel Hill 2003 — 2007
Bachlor of Science, Applied Sciences: Biomedical Engineering
Himmatkumar Shetty's Baxter BioScience Experience 2005 - 2010
Job Project Manager
Industry Information Technology and Services
Experience
Amgen 2012 - June 2013
Amgen 2010 - 2011
Baxter BioScience 2005 - 2010
Baxter Bioscience 2005 - 2010
Extrand Ltd. 2005 - 2006
Pfizer 1999 - 2004
IGATE - Consulting for The Hartford 1997 - 1999
Skills
Project Management, Oracle, PL/SQL, Business Analysis, LIMS, Databases, Unix, Microsoft SQL Server, SQL, Database Administration, Visio, Crystal Reports, Oracle RAC, RMAN
Education
Training
University of Mumbai
B.S, Physics, Mathematics
Amgen 2012 - June 2013
Amgen 2010 - 2011
Baxter BioScience 2005 - 2010
Baxter Bioscience 2005 - 2010
Extrand Ltd. 2005 - 2006
Pfizer 1999 - 2004
IGATE - Consulting for The Hartford 1997 - 1999
Skills
Project Management, Oracle, PL/SQL, Business Analysis, LIMS, Databases, Unix, Microsoft SQL Server, SQL, Database Administration, Visio, Crystal Reports, Oracle RAC, RMAN
Education
Training
University of Mumbai
B.S, Physics, Mathematics
Ellyn Sharkey's Baxter BioScience Experience January 2010 - Present
Job Manufacturing Manager at Baxter BioScience
Industry Pharmaceuticals
Experience
Baxter BioScience January 2010 - Present
Baxter 2007 - Present
BioVeris Corporation March 2004 - March 2007
Education
University of Maryland Baltimore County 1994 — 1996
BS, Biocehmistry and Molecular Biology
Baxter BioScience January 2010 - Present
Baxter 2007 - Present
BioVeris Corporation March 2004 - March 2007
Education
University of Maryland Baltimore County 1994 — 1996
BS, Biocehmistry and Molecular Biology
Patricia Sutton's Baxter BioScience Experience 2000 - 2003
Job VP, Human Resources @ Commuter Air Technology
Industry Human Resources
Experience
Commuter Air Technology October 2013 - Present
United Orthopedic Group May 2009 - October 2013
Universal Instruments July 2007 - November 2008
Nomaco 2004 - 2007
Baxter BioScience 2000 - 2003
Skills
Employee Relations, Onboarding, Talent Acquisition, Talent Management, Recruiting, Change Management, Performance Management, Employment Law, Deferred Compensation, Applicant Tracking..., Leadership Development, HRIS, Benefits Administration, Human Resources, Organizational..., Succession Planning, Executive Search, Management, Team Building, HR Policies, Personnel Management, Employee Benefits, Process Improvement, Training, Leadership, Employee Engagement, Coaching, FMLA, Internet Recruiting, College Recruiting, Sourcing, Labor Relations, Hiring, Workforce Planning, Career Development, Organizational..., Temporary Placement, ADP Payroll, New Hire Orientations, Technical Recruiting, Employer Branding, Interviews, Compensation & Benefit, Employee Training, Payroll, Taleo, Benefits Negotiation, Organizational Design, Conflict Resolution, HR Consulting
Education
University of Oklahoma 1988 — 1992
BA, Political Science/Public Administration
Commuter Air Technology October 2013 - Present
United Orthopedic Group May 2009 - October 2013
Universal Instruments July 2007 - November 2008
Nomaco 2004 - 2007
Baxter BioScience 2000 - 2003
Skills
Employee Relations, Onboarding, Talent Acquisition, Talent Management, Recruiting, Change Management, Performance Management, Employment Law, Deferred Compensation, Applicant Tracking..., Leadership Development, HRIS, Benefits Administration, Human Resources, Organizational..., Succession Planning, Executive Search, Management, Team Building, HR Policies, Personnel Management, Employee Benefits, Process Improvement, Training, Leadership, Employee Engagement, Coaching, FMLA, Internet Recruiting, College Recruiting, Sourcing, Labor Relations, Hiring, Workforce Planning, Career Development, Organizational..., Temporary Placement, ADP Payroll, New Hire Orientations, Technical Recruiting, Employer Branding, Interviews, Compensation & Benefit, Employee Training, Payroll, Taleo, Benefits Negotiation, Organizational Design, Conflict Resolution, HR Consulting
Education
University of Oklahoma 1988 — 1992
BA, Political Science/Public Administration
Jennifer Pennington's Baxter BioScience Experience August 2007 - August 2012
Job Senior Manager, Global Sales Training Baxter BioSurgery
Industry Medical Devices
Experience
Baxter Health Care February 2015 - Present
Baxter Healthcare August 2012 - Present
Baxter BioScience August 2007 - August 2012
Skills
Capital Equipment, Medical Devices, Market Development, Pharmaceutical Sales, Pharmaceutical Industry, Time Management, Sales, Product Launch, Urology, Cardiology, Training, Sales Effectiveness, Oncology, Orthopedic, Biotechnology, Market Access, Surgeons, Neurology, Operating Room, Hospital Sales, OB/GYN, Global Marketing, Disposables, Managed Care, Neurosurgery, Sales Force Development
Education
University of Minnesota-Twin Cities 1990 — 1994
BS, Biology
Baxter Health Care February 2015 - Present
Baxter Healthcare August 2012 - Present
Baxter BioScience August 2007 - August 2012
Skills
Capital Equipment, Medical Devices, Market Development, Pharmaceutical Sales, Pharmaceutical Industry, Time Management, Sales, Product Launch, Urology, Cardiology, Training, Sales Effectiveness, Oncology, Orthopedic, Biotechnology, Market Access, Surgeons, Neurology, Operating Room, Hospital Sales, OB/GYN, Global Marketing, Disposables, Managed Care, Neurosurgery, Sales Force Development
Education
University of Minnesota-Twin Cities 1990 — 1994
BS, Biology
Kenneth Mingus's Baxter BioScience Experience January 2009 - December 2009
Job Territory Sales Manager at Astute Medical, INC.
Industry Medical Devices
Experience
Teleflex December 2011 - August 2012
Baxter Healthcare January 2010 - December 2011
Baxter BioScience January 2009 - December 2009
Baxter BioScience January 2006 - December 2008
Genzyme August 1999 - January 2006
American Medical Systems January 1998 - August 1999
Skills
Capital Equipment, Operating Room, Urology, Medical Devices, Heart Valves, Hemostasis, Biotechnology, Regenerative Medicine, Cardiac Surgery, Blood Management, Valve Repair, Hospital Sales, Surgeons, Thoracic, Vascular Surgery, Perfusion, Market Development, Orthopedic, Disposables, ENT, Gynecologic Surgery, Minimally Invasive..., Robotics, Pharmaceutical Sales, Plastic Surgery, Cardiology, Selling, Spine, Surgery, Clinical Research, Hospitals, Neurosurgery, Interventional..., Cross-functional Team..., Sales Effectiveness, Neurology, Cath Lab, Medical Sales, Interventional Radiology, Biologics, Product Launch, Sales
Education
University of Phoenix
BS, Business Mangment
Teleflex December 2011 - August 2012
Baxter Healthcare January 2010 - December 2011
Baxter BioScience January 2009 - December 2009
Baxter BioScience January 2006 - December 2008
Genzyme August 1999 - January 2006
American Medical Systems January 1998 - August 1999
Skills
Capital Equipment, Operating Room, Urology, Medical Devices, Heart Valves, Hemostasis, Biotechnology, Regenerative Medicine, Cardiac Surgery, Blood Management, Valve Repair, Hospital Sales, Surgeons, Thoracic, Vascular Surgery, Perfusion, Market Development, Orthopedic, Disposables, ENT, Gynecologic Surgery, Minimally Invasive..., Robotics, Pharmaceutical Sales, Plastic Surgery, Cardiology, Selling, Spine, Surgery, Clinical Research, Hospitals, Neurosurgery, Interventional..., Cross-functional Team..., Sales Effectiveness, Neurology, Cath Lab, Medical Sales, Interventional Radiology, Biologics, Product Launch, Sales
Education
University of Phoenix
BS, Business Mangment
Minal Ashtekar, Ph.D's Baxter BioScience Experience September 2006 - April 2011
Job Consultant, Clinical Research & Regulatory Affairs
Industry Biotechnology
Experience
Independant June 2011 - Present
Innovis Inc 2012 - 2012
Baxter BioScience September 2006 - April 2011
Dynport Vaccine Company April 2003 - August 2006
Quintiles Inc 2002 - 2003
Skills
Clinical Research, Regulatory Affairs, Clinical Development, GCP, Clinical Trials, FDA, Regulatory Submissions, IND, 21 CFR Part 11, 510 K, Vaccines, Clinical Trial..., Protocol Development, Medical Writing, Life Sciences, Clinical, Medical Devices, Biotechnology, Science, Infectious Diseases, Clinical Operations, Sop, Protocol
Education
University of Mumbai
PhD, Applied Biology
Independant June 2011 - Present
Innovis Inc 2012 - 2012
Baxter BioScience September 2006 - April 2011
Dynport Vaccine Company April 2003 - August 2006
Quintiles Inc 2002 - 2003
Skills
Clinical Research, Regulatory Affairs, Clinical Development, GCP, Clinical Trials, FDA, Regulatory Submissions, IND, 21 CFR Part 11, 510 K, Vaccines, Clinical Trial..., Protocol Development, Medical Writing, Life Sciences, Clinical, Medical Devices, Biotechnology, Science, Infectious Diseases, Clinical Operations, Sop, Protocol
Education
University of Mumbai
PhD, Applied Biology
Anita Kijak's Baxter BioScience Experience 2001 - April 2011
Job Manufacturing Production Planner at Hydrasearch
Industry Biotechnology
Experience
Hydrasearch February 2011 - Present
Baxter BioScience 2001 - April 2011
North American Vaccine 1998 - 2001
American Environmental Network 1994 - 1998
Biospherics Incorporated 1987 - 1994
Skills
Manufacturing, Production Planning, Six Sigma, CAPA, Quality Assurance, 21 CFR Part 11, FDA, Forecasting, MRP, Purchasing, ERP, Continuous Improvement, Process Improvement, Sop, Change Control, Software Documentation, Materials Management, GMP, Quality System, Team Leadership, Analysis, Management, Root Cause Analysis, Project Planning, Pharmaceutical Industry, Biotechnology, SOP
Education
University of Maryland College Park 1982 — 1987
Master of Science (M.S.), Analytical Chemistry
Hydrasearch February 2011 - Present
Baxter BioScience 2001 - April 2011
North American Vaccine 1998 - 2001
American Environmental Network 1994 - 1998
Biospherics Incorporated 1987 - 1994
Skills
Manufacturing, Production Planning, Six Sigma, CAPA, Quality Assurance, 21 CFR Part 11, FDA, Forecasting, MRP, Purchasing, ERP, Continuous Improvement, Process Improvement, Sop, Change Control, Software Documentation, Materials Management, GMP, Quality System, Team Leadership, Analysis, Management, Root Cause Analysis, Project Planning, Pharmaceutical Industry, Biotechnology, SOP
Education
University of Maryland College Park 1982 — 1987
Master of Science (M.S.), Analytical Chemistry
Gurpreet Saran's Baxter BioScience Experience July 2010 - December 2010
Job at Medimmune
Industry Pharmaceuticals
Experience
Medimmune February 2011 - Present
Baxter BioScience July 2010 - December 2010
Skills
Validation, FDA, GMP, Biotechnology, CAPA, Aseptic Processing
Education
University of Maryland College Park 2006 — 2010
BS, Chemical Engineering
Medimmune February 2011 - Present
Baxter BioScience July 2010 - December 2010
Skills
Validation, FDA, GMP, Biotechnology, CAPA, Aseptic Processing
Education
University of Maryland College Park 2006 — 2010
BS, Chemical Engineering
Elizabeth (Lisa) Cotten's Baxter BioScience Experience June 2005 - September 2009
Job Quality System NuSil Technology
Industry Chemicals
Experience
NuSil Technology March 2013 - March 2015
NuSil Technology January 2010 - March 2013
Baxter BioScience June 2005 - September 2009
Skills
Microsoft Office, Strategic Planning, Customer Service, Project Management, Process Improvement, Cross-functional Team..., Microsoft Excel, Manufacturing
Education
University of Phoenix 2008 — 2010
Associate of Arts (AA), Business, 3.6 GPA
NuSil Technology March 2013 - March 2015
NuSil Technology January 2010 - March 2013
Baxter BioScience June 2005 - September 2009
Skills
Microsoft Office, Strategic Planning, Customer Service, Project Management, Process Improvement, Cross-functional Team..., Microsoft Excel, Manufacturing
Education
University of Phoenix 2008 — 2010
Associate of Arts (AA), Business, 3.6 GPA
Lisa Yap's Baxter BioScience Experience 2001 - 2003
Job Senior Technical Manager Global Change Control (Biologics) at Genentech
Industry Biotechnology
Experience
Genentech July 2014 - Present
Genentech 2011 - 2014
Genentech 2010 - 2011
Genentech 2003 - 2010
Baxter BioScience 2001 - 2003
Baxter BioScience 1998 - 2001
3M Pharmaceuticals 1997 - 1998
Skills
Biotechnology, Validation, Biopharmaceuticals, GMP, Change Control, CAPA, Computer System..., FDA, Pharmaceutical Industry, Sop, Technology Transfer, GxP, Aseptic Processing
Education
University of Miami
Genentech July 2014 - Present
Genentech 2011 - 2014
Genentech 2010 - 2011
Genentech 2003 - 2010
Baxter BioScience 2001 - 2003
Baxter BioScience 1998 - 2001
3M Pharmaceuticals 1997 - 1998
Skills
Biotechnology, Validation, Biopharmaceuticals, GMP, Change Control, CAPA, Computer System..., FDA, Pharmaceutical Industry, Sop, Technology Transfer, GxP, Aseptic Processing
Education
University of Miami
LaKisha Lavender's Baxter BioScience Experience Department SpecialistBaxter BioScienceNovember 2007 - August 2010
Job Manufacturing Supervisor at Baxter BioScience
Industry Biotechnology
Experience
Baxter BioScience Department SpecialistBaxter BioScienceNovember 2007 - August 2010
Baxter BioScience July 2000 - November 2007
acambis 2002 - 2003
Skills
GMP
Education
University of Maryland Eastern Shore 1996 — 2000
BS, Biology
Baxter BioScience Department SpecialistBaxter BioScienceNovember 2007 - August 2010
Baxter BioScience July 2000 - November 2007
acambis 2002 - 2003
Skills
GMP
Education
University of Maryland Eastern Shore 1996 — 2000
BS, Biology
Hirut Bikila's Baxter BioScience Experience July 2007 - December 2010
Job Director of Quality and Regulatory Compliance at NovaSom, Inc.
Industry Biotechnology
Experience
NovaSom, Inc. May 2011 - Present
Baxter BioScience July 2007 - December 2010
Sera Care Bioservices September 2006 - 2007
University of Maryland Baltimore County 2004 - 2006
Skills
GMP, Process Improvement, Validation, Cross-functional Team..., Quality Assurance, FDA, Quality System, SOP, Six Sigma, Leadership, CAPA, Quality Management, Quality Auditing, Internal Audit, External Audit, Product Complaints, Joint Commission, Cornerstone-Training...
Education
University of Maryland University College
Master of Business Administration (M.B.A.)
University of Maryland University College
Master's degree, Biotechnology
University of Maryland Baltimore County
Bachelor of Science (BS), Biochemistry and Molecular Biology
NovaSom, Inc. May 2011 - Present
Baxter BioScience July 2007 - December 2010
Sera Care Bioservices September 2006 - 2007
University of Maryland Baltimore County 2004 - 2006
Skills
GMP, Process Improvement, Validation, Cross-functional Team..., Quality Assurance, FDA, Quality System, SOP, Six Sigma, Leadership, CAPA, Quality Management, Quality Auditing, Internal Audit, External Audit, Product Complaints, Joint Commission, Cornerstone-Training...
Education
University of Maryland University College
Master of Business Administration (M.B.A.)
University of Maryland University College
Master's degree, Biotechnology
University of Maryland Baltimore County
Bachelor of Science (BS), Biochemistry and Molecular Biology
Sheree Ting-Berreth's Baxter BioScience Experience May 2011 - Present
Job Scientist
Industry Biotechnology
Experience
Baxter BioScience May 2011 - Present
Life Technologies May 2009 - December 2010
Life Technologies October 2007 - May 2009
Amgen 2005 - 2007
UCLA Medical Center 1998 - 2003
Skills
Western Blotting, Immunohistochemistry, Immunoassays, In Situ Hybridization, Customer Interface, Cell Culture, Cell, in Situ Hybridization, Technology Transfer, Antibodies, Assay Development, R&D, Mammalian Cell Culture, Stem Cells, Biopharmaceuticals, Purification, Lifesciences, Biotechnology, Cell Biology, GLP, GMP, DNA, Life Sciences
Education
University of Southern California
Ph.D, Pathbiology
University of Southern California
MS, Pathobiology
University of Southern California
B.S., Biological Sciences
Baxter BioScience May 2011 - Present
Life Technologies May 2009 - December 2010
Life Technologies October 2007 - May 2009
Amgen 2005 - 2007
UCLA Medical Center 1998 - 2003
Skills
Western Blotting, Immunohistochemistry, Immunoassays, In Situ Hybridization, Customer Interface, Cell Culture, Cell, in Situ Hybridization, Technology Transfer, Antibodies, Assay Development, R&D, Mammalian Cell Culture, Stem Cells, Biopharmaceuticals, Purification, Lifesciences, Biotechnology, Cell Biology, GLP, GMP, DNA, Life Sciences
Education
University of Southern California
Ph.D, Pathbiology
University of Southern California
MS, Pathobiology
University of Southern California
B.S., Biological Sciences
Ryan Preslar's Baxter BioScience Experience December 2004 - June 2012
Job Ethicon Endo Surgery at Ethicon EndoSurgery
Industry Medical Devices
Experience
Ethicon Endo-Surgery June 2012 - Present
Ethicon Surgical Care June 2012 - Present
Baxter Biosurgery December 2004 - June 2012
Baxter Bioscience December 2004 - June 2012
Baxter Biosurgery December 2004 - June 2012
SouthTech Orthopedics, Inc December 2001 - December 2004
Wachovia Bank July 1997 - December 2001
Wachovia Bank July 1997 - December 2001
Wachovia Bank July 1997 - December 2001
Skills
Sales, Sales Presentations, Case Managment, Surgery, Supply Chain, Surgeons, Vascular Surgery, Cardiac Surgery, Laparoscopic Surgery, Reconstructive Surgery, Surgical Instruments, Contract Negotiation, Contract Management, Financial Analysis, Financial Reporting, Materials, Cath Lab, Cardiac Cath, Wound Care, Plastic Surgery, Orthopedic, General Surgery, Building Relationships, Team Leadership, Educational Leadership, Technical Leadership, Product Launch
Education
University of North Carolina 1992 — 1996
B.A, Psychology
University of North Carolina at Chapel Hill 1992 — 1996
Bachelor of Arts (BA), Psychology
Ethicon Endo-Surgery June 2012 - Present
Ethicon Surgical Care June 2012 - Present
Baxter Biosurgery December 2004 - June 2012
Baxter Bioscience December 2004 - June 2012
Baxter Biosurgery December 2004 - June 2012
SouthTech Orthopedics, Inc December 2001 - December 2004
Wachovia Bank July 1997 - December 2001
Wachovia Bank July 1997 - December 2001
Wachovia Bank July 1997 - December 2001
Skills
Sales, Sales Presentations, Case Managment, Surgery, Supply Chain, Surgeons, Vascular Surgery, Cardiac Surgery, Laparoscopic Surgery, Reconstructive Surgery, Surgical Instruments, Contract Negotiation, Contract Management, Financial Analysis, Financial Reporting, Materials, Cath Lab, Cardiac Cath, Wound Care, Plastic Surgery, Orthopedic, General Surgery, Building Relationships, Team Leadership, Educational Leadership, Technical Leadership, Product Launch
Education
University of North Carolina 1992 — 1996
B.A, Psychology
University of North Carolina at Chapel Hill 1992 — 1996
Bachelor of Arts (BA), Psychology
Bill Glaser's Baxter BioScience Experience 1998 - 2002
Job Quality Assurance Associate at Breckenridge Pharmaceutical, Inc.
Industry Biotechnology
Experience
Breckenridge Pharmaceutical, Inc. April 2015 - Present
Leidos Biomedical (formerly SAIC) 2011 - 2014
SAIC 2003 - 2011
BioReliance 2002 - 2003
Baxter Bioscience 1998 - 2002
American Environment Network 1993 - 1998
Skills
Quality Assurance, SOP, Calibration, Quality Auditing, Manufacturing, GMP, Biotechnology, Corrective Actions, Preventive Actions, SOP authoring, Validation, Compliance Audits, Training, FDA, Requirements Analysis, Batch Record Review, Engineering, Quality Control, Management, Process Improvement, Pharmaceutical Industry, Auditing, Reviews, CAPA, Change Control, Total Quality..., Corrective and..., Audit Compliance, Deviation Review and..., Good Manufacturing..., Good Laboratory..., Standard Operating..., CFR 210/211, Soil Evaluation, Structurally-Safe Design, Environmental Sampling, Slope Stability Analysis, Mechanics of Materials, Fluid Mechanics and..., Environmental..., Structural Geology
Education
University of Notre Dame
Bachelor's degree, Civil Engineering and Geology
Breckenridge Pharmaceutical, Inc. April 2015 - Present
Leidos Biomedical (formerly SAIC) 2011 - 2014
SAIC 2003 - 2011
BioReliance 2002 - 2003
Baxter Bioscience 1998 - 2002
American Environment Network 1993 - 1998
Skills
Quality Assurance, SOP, Calibration, Quality Auditing, Manufacturing, GMP, Biotechnology, Corrective Actions, Preventive Actions, SOP authoring, Validation, Compliance Audits, Training, FDA, Requirements Analysis, Batch Record Review, Engineering, Quality Control, Management, Process Improvement, Pharmaceutical Industry, Auditing, Reviews, CAPA, Change Control, Total Quality..., Corrective and..., Audit Compliance, Deviation Review and..., Good Manufacturing..., Good Laboratory..., Standard Operating..., CFR 210/211, Soil Evaluation, Structurally-Safe Design, Environmental Sampling, Slope Stability Analysis, Mechanics of Materials, Fluid Mechanics and..., Environmental..., Structural Geology
Education
University of Notre Dame
Bachelor's degree, Civil Engineering and Geology
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY