Synthon Pharmaceuticals, Inc
Industry: Pharmaceutical company
DescriptionFounded: 1997 Parent organization: Synthon Holding B.V. Subsidiary: Synthon Laboratories, Inc.
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Synthon Pharmaceuticals, Inc Employees
Employee
Years
Job
Industry
Mir Mehdi Mir Mehdi's Synthon Pharmaceuticals, Inc Experience May 2010 - Present
Job Quality Assurance Manager at Synthon Pharmaceuticals, Inc
Industry Pharmaceuticals
Experience
Synthon Pharmaceuticals, Inc May 2010 - Present
Synthon 2010 - Present
Forest Laboratories, Inc September 2001 - May 2010
NMC Laboratories, Inc December 1992 - September 2001
Bauch & Lomb January 1985 - December 1992
Skills
CAPA, FDA, Validation, Quality System, Quality Management, GMP, SOP, Regulatory Affairs, Pharmaceutical Industry, Management, Chemistry, Root Cause Analysis, Process Improvement, Document Management, Change Management, Reviews, Risk Management, Data Analysis, Quality Assurance, Customer Service, Site Inspections, Private Investigations, Technology Transfer, Quality Systems, Investigations, Internal and External..., Technology/Product..., Annual Product Review, FDA Submissions, Label Development /..., Manage Plant Training..., Qyality Reports, Quality Manual, Product Specifications, Chemistry Machine and..., Chemistry, Machine and..., Management Training..., Non Sterile..., Sterile Manufacturing..., GLP and Facility Audits, Trending and Analysis...
Education
University of Karachi
Master of Science (MS), Chemistry, 3.6
Synthon Pharmaceuticals, Inc May 2010 - Present
Synthon 2010 - Present
Forest Laboratories, Inc September 2001 - May 2010
NMC Laboratories, Inc December 1992 - September 2001
Bauch & Lomb January 1985 - December 1992
Skills
CAPA, FDA, Validation, Quality System, Quality Management, GMP, SOP, Regulatory Affairs, Pharmaceutical Industry, Management, Chemistry, Root Cause Analysis, Process Improvement, Document Management, Change Management, Reviews, Risk Management, Data Analysis, Quality Assurance, Customer Service, Site Inspections, Private Investigations, Technology Transfer, Quality Systems, Investigations, Internal and External..., Technology/Product..., Annual Product Review, FDA Submissions, Label Development /..., Manage Plant Training..., Qyality Reports, Quality Manual, Product Specifications, Chemistry Machine and..., Chemistry, Machine and..., Management Training..., Non Sterile..., Sterile Manufacturing..., GLP and Facility Audits, Trending and Analysis...
Education
University of Karachi
Master of Science (MS), Chemistry, 3.6
C Wharton C Wharton's Synthon Pharmaceuticals, Inc Experience January 2012 - February 2012
Job Consultant at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL International February 2012 - Present
Synthon Pharmaceuticals, Inc. January 2012 - February 2012
Synthon Pharmaceuticals, Inc. February 2008 - January 2012
Stiefel, a GSK company June 2006 - February 2008
Stiefel Research Institute, Inc. January 2005 - June 2006
Stiefel Research Institute, Inc. June 2001 - January 2005
Skills
Regulatory Affairs..., Regulatory Affairs, Analytical Chemistry, Regulatory Strategy, Regulatory Submissions, GMP, ANDA, HPLC, Pharmaceuticals, Sop, Pharmaceutical Industry, V&V, FDA, 21 CFR Part 11
Education
The College of Saint Rose 1997 — 2001
Bachelor of Arts, Biology
Chatham High School 1992 — 1996
PAREXEL International February 2012 - Present
Synthon Pharmaceuticals, Inc. January 2012 - February 2012
Synthon Pharmaceuticals, Inc. February 2008 - January 2012
Stiefel, a GSK company June 2006 - February 2008
Stiefel Research Institute, Inc. January 2005 - June 2006
Stiefel Research Institute, Inc. June 2001 - January 2005
Skills
Regulatory Affairs..., Regulatory Affairs, Analytical Chemistry, Regulatory Strategy, Regulatory Submissions, GMP, ANDA, HPLC, Pharmaceuticals, Sop, Pharmaceutical Industry, V&V, FDA, 21 CFR Part 11
Education
The College of Saint Rose 1997 — 2001
Bachelor of Arts, Biology
Chatham High School 1992 — 1996
Greg Pate Greg Pate's Synthon Pharmaceuticals, Inc Experience February 2005 - November 2005
Job Manager of Legal Affairs at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences June 2014 - Present
PRA Health Sciences December 2010 - Present
UnitedHealth Group March 2008 - January 2011
CIGNA February 2006 - March 2008
Synthon Pharmaceuticals, Inc. February 2005 - November 2005
IBM June 2001 - January 2005
Wake Forest University School of Medicine May 1994 - May 1998
Skills
Intellectual Property, Member of Toastmasters, Impromptu Speaking, Persuasive Speaker, Influential Communicator, Patents, Licensing, Due Diligence, Contract Negotiation, Healthcare, Biotechnology, Negotiation, Employment Law, Regulatory Affairs, Litigation, Legal Research, Corporate Law, Insurance, Data Privacy, Contract Management, Health Law, Clinical Trials, Legal Writing, Privacy Law, Pharmaceutical Industry, Contract Law, Legal Compliance, Copyright Law, Mediation, Legal Issues, Trademarks, Legal Assistance, International Law, Software Licensing, Management, Leadership
Education
University of North Carolina School of Law 1998 — 2001
JD, Law
University of North Carolina at Greensboro 1990 — 1994
BA, Biology
PRA Health Sciences June 2014 - Present
PRA Health Sciences December 2010 - Present
UnitedHealth Group March 2008 - January 2011
CIGNA February 2006 - March 2008
Synthon Pharmaceuticals, Inc. February 2005 - November 2005
IBM June 2001 - January 2005
Wake Forest University School of Medicine May 1994 - May 1998
Skills
Intellectual Property, Member of Toastmasters, Impromptu Speaking, Persuasive Speaker, Influential Communicator, Patents, Licensing, Due Diligence, Contract Negotiation, Healthcare, Biotechnology, Negotiation, Employment Law, Regulatory Affairs, Litigation, Legal Research, Corporate Law, Insurance, Data Privacy, Contract Management, Health Law, Clinical Trials, Legal Writing, Privacy Law, Pharmaceutical Industry, Contract Law, Legal Compliance, Copyright Law, Mediation, Legal Issues, Trademarks, Legal Assistance, International Law, Software Licensing, Management, Leadership
Education
University of North Carolina School of Law 1998 — 2001
JD, Law
University of North Carolina at Greensboro 1990 — 1994
BA, Biology
Christine Schneider Pope Christine Schneider Pope's Synthon Pharmaceuticals, Inc Experience January 2011 - Present
Job Senior Project Manager Consultant at Eisai
Industry Pharmaceuticals
Experience
Eisai June 2013 - Present
Synthon Pharmaceuticals, Inc. January 2011 - Present
Synthon Pharmaceuticals, Inc. July 2008 - January 2011
Synthon BV August 2007 - July 2008
Synthon Pharmaceuticals, Inc. October 2003 - August 2007
Procter & Gamble July 1996 - September 2003
GlaxoWellcome January 1994 - May 1996
Skills
FDA, Pharmaceutical Industry, Technology Transfer, Sop, Change Control, GMP, Project Management, Product Management, MS Project, Project Portfolio..., Problem Solving, Product Launch, Production Planning, Product Marketing, New Business Development, Product Development, Strategic Planning, Business Strategy, Strategic Communications, New Product Ideas, Virtual Teams, Supplier Negotiation, Contract Negotiation, Pricing Strategy, Business Alliances, Cross-cultural Teams, Cross-functional Team..., Demand Forecasting, Product Forecasting, Taking New Products to..., Supply Chain Management, Operations Management, Risk Management, Global Alliance..., P&L Responsibility, OPEX, Operational Efficiency, Operational Strategy, Purchase Management, Procurement Outsourcing, Procurement Contracts, Collaborative Problem..., Validation, DEA, Import/Export Operations, Contract Manufacturing, Change Management, Process Improvement, Business Relationship..., P
Education
North Carolina State University 1991 — 1996
Bachelor of Science (BS), Chemical Engineering
Eisai June 2013 - Present
Synthon Pharmaceuticals, Inc. January 2011 - Present
Synthon Pharmaceuticals, Inc. July 2008 - January 2011
Synthon BV August 2007 - July 2008
Synthon Pharmaceuticals, Inc. October 2003 - August 2007
Procter & Gamble July 1996 - September 2003
GlaxoWellcome January 1994 - May 1996
Skills
FDA, Pharmaceutical Industry, Technology Transfer, Sop, Change Control, GMP, Project Management, Product Management, MS Project, Project Portfolio..., Problem Solving, Product Launch, Production Planning, Product Marketing, New Business Development, Product Development, Strategic Planning, Business Strategy, Strategic Communications, New Product Ideas, Virtual Teams, Supplier Negotiation, Contract Negotiation, Pricing Strategy, Business Alliances, Cross-cultural Teams, Cross-functional Team..., Demand Forecasting, Product Forecasting, Taking New Products to..., Supply Chain Management, Operations Management, Risk Management, Global Alliance..., P&L Responsibility, OPEX, Operational Efficiency, Operational Strategy, Purchase Management, Procurement Outsourcing, Procurement Contracts, Collaborative Problem..., Validation, DEA, Import/Export Operations, Contract Manufacturing, Change Management, Process Improvement, Business Relationship..., P
Education
North Carolina State University 1991 — 1996
Bachelor of Science (BS), Chemical Engineering
Hollie Altice, PHR Hollie Altice, PHR's Synthon Pharmaceuticals, Inc Experience May 2010 - July 2012
Job O&T Operations Leader at ADAMA
Industry Human Resources
Experience
ADAMA USA July 2012 - Present
Synthon Pharmaceuticals, Inc. May 2010 - July 2012
The Greer Group July 2007 - May 2010
Saks Fifth Avenue August 2004 - July 2006
Wake County Schools May 1998 - January 2001
Education
University of North Carolina at Wilmington 1993 — 1998
Bachelor of Arts (B.A.), Elementary Education and Teaching
ADAMA USA July 2012 - Present
Synthon Pharmaceuticals, Inc. May 2010 - July 2012
The Greer Group July 2007 - May 2010
Saks Fifth Avenue August 2004 - July 2006
Wake County Schools May 1998 - January 2001
Education
University of North Carolina at Wilmington 1993 — 1998
Bachelor of Arts (B.A.), Elementary Education and Teaching
Marty Damask's Synthon Pharmaceuticals, Inc Experience January 2008 - January 2011
Job Operations Manager, CTM at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Hospira / Pfizer June 2014 - September 2015
Hospira June 2013 - June 2014
Corning Life Sciences (formerly Becton-Dickenson) September 2012 - June 2013
Absolute Dental Services July 2011 - March 2012
Synthon Pharmaceuticals, Inc January 2008 - January 2011
Synthon Pharmaceuticals, Inc March 2006 - December 2007
UCB Manufacturing, Inc March 2002 - March 2006
Corning, Inc. October 2000 - February 2001
Iron Mountain 2001 - 2001
Celltech-Medeva Pharmaceuticals October 1999 - October 2000
Skills
Manufacturing..., Department Budgeting, Cross-functional Team..., Root Cause Analysis, Process Improvement, FDA, Lean Manufacturing, Training, Continuous Improvement, Operations Management, Project Management, GMP, Talent Management, Medical Devices, Budgets, Manufacturing, Change Control, Quality Assurance, Change Management, Six Sigma, Mentoring Of Staff, Project Planning, Supply Chain, Supply Chain Management, Validation, 5S, Pharmaceutical Industry, Management, Leadership, Strategic Planning, Performance Reviews, Strategy, Procurement, Quality System, Logistics, Sop, Inventory Management, Process Simulation, Program Management, Product Launch, Kaizen, Team Building, Packaging, V&V, Start-ups, CAPA, Vendor Relationships, SOP
Education
Roberts Wesleyan College 1998 — 1999
Master of Science (M.S.), Organizational Management, 3.8/4.0
Georgia Southern University 1986 — 1988
B.S., Political Science (Minor: international relations), 3.5/4.0
United States Naval Academy 1980 — 1983
Political Science
Hospira / Pfizer June 2014 - September 2015
Hospira June 2013 - June 2014
Corning Life Sciences (formerly Becton-Dickenson) September 2012 - June 2013
Absolute Dental Services July 2011 - March 2012
Synthon Pharmaceuticals, Inc January 2008 - January 2011
Synthon Pharmaceuticals, Inc March 2006 - December 2007
UCB Manufacturing, Inc March 2002 - March 2006
Corning, Inc. October 2000 - February 2001
Iron Mountain 2001 - 2001
Celltech-Medeva Pharmaceuticals October 1999 - October 2000
Skills
Manufacturing..., Department Budgeting, Cross-functional Team..., Root Cause Analysis, Process Improvement, FDA, Lean Manufacturing, Training, Continuous Improvement, Operations Management, Project Management, GMP, Talent Management, Medical Devices, Budgets, Manufacturing, Change Control, Quality Assurance, Change Management, Six Sigma, Mentoring Of Staff, Project Planning, Supply Chain, Supply Chain Management, Validation, 5S, Pharmaceutical Industry, Management, Leadership, Strategic Planning, Performance Reviews, Strategy, Procurement, Quality System, Logistics, Sop, Inventory Management, Process Simulation, Program Management, Product Launch, Kaizen, Team Building, Packaging, V&V, Start-ups, CAPA, Vendor Relationships, SOP
Education
Roberts Wesleyan College 1998 — 1999
Master of Science (M.S.), Organizational Management, 3.8/4.0
Georgia Southern University 1986 — 1988
B.S., Political Science (Minor: international relations), 3.5/4.0
United States Naval Academy 1980 — 1983
Political Science
Dan DeForge's Synthon Pharmaceuticals, Inc Experience August 2011 - February 2012
Job Associate Director, Business Analytics at Ironwood Pharmaceuticals
Industry Pharmaceuticals
Experience
Ironwood Pharmaceuticals April 2013 - Present
Independent Biotech/Pharmaceutical Consultant February 2012 - April 2013
Synthon Pharmaceuticals, Inc. August 2011 - February 2012
Victory Pharma February 2010 - July 2011
GlaxoSmithKline June 2001 - August 2009
GlaxoWellcome - Judges Legal Staffing January 1999 - June 2001
Vanguard Security May 1998 - March 1999
Uncle Louie's Italian Restaurant January 1995 - January 1998
Skills
Market Research, Data Analysis, Cross-functional Team..., Pharmaceutical Industry, Analytics, Analysis, Competitive Intelligence, Biotechnology, Strategic Planning, Management, Business Development, Project Management, Clinical Research, Data Management, Project Portfolio..., Product Launch, Business Analysis, Qualitative Research, Microsoft Excel, Secondary Research, Marketing Strategy, Pharmaceuticals, Research Project..., PowerPoint, Primary Research, Segmentation, Strategy, Forecasting
Education
Catawba College 1991 — 1996
Bachelor of Science Degree, Political Science (Public Administration)
Ironwood Pharmaceuticals April 2013 - Present
Independent Biotech/Pharmaceutical Consultant February 2012 - April 2013
Synthon Pharmaceuticals, Inc. August 2011 - February 2012
Victory Pharma February 2010 - July 2011
GlaxoSmithKline June 2001 - August 2009
GlaxoWellcome - Judges Legal Staffing January 1999 - June 2001
Vanguard Security May 1998 - March 1999
Uncle Louie's Italian Restaurant January 1995 - January 1998
Skills
Market Research, Data Analysis, Cross-functional Team..., Pharmaceutical Industry, Analytics, Analysis, Competitive Intelligence, Biotechnology, Strategic Planning, Management, Business Development, Project Management, Clinical Research, Data Management, Project Portfolio..., Product Launch, Business Analysis, Qualitative Research, Microsoft Excel, Secondary Research, Marketing Strategy, Pharmaceuticals, Research Project..., PowerPoint, Primary Research, Segmentation, Strategy, Forecasting
Education
Catawba College 1991 — 1996
Bachelor of Science Degree, Political Science (Public Administration)
Craig Mead's Synthon Pharmaceuticals, Inc Experience October 2007 - June 2009
Job Regulatory Affairs
Industry Pharmaceuticals
Experience
Kimberly-Clark July 2013 - May 2014
Upsher-Smith Laboratories October 2011 - June 2013
Synthon Pharmaceuticals, Inc. October 2007 - June 2009
Synthon Pharmaceuticals, Inc. April 2003 - September 2007
Covance Biotechnology Services 1998 - 2001
Skills
Pharmaceuticals, Regulatory Affairs, GMP, SOP, Regulatory Submissions, Regulatory Strategy, Quality Assurance, cGMP, Change Control, Generics, FDA, GxP, Sop, Pharmacovigilance, Pharmaceutical Industry, Laboratory, Regulatory Requirements, Quality Management, Technology Transfer, GCP, 21 CFR Part 11, Drug Discovery, GLP, CAPA, Validation, Quality Auditing, Lifesciences, R&D, Chromatography, Computer System..., Drug Development, Generic Programming, eCTD, Cross-functional Team..., CRO, Analytical Chemistry, HPLC, Biotechnology, Six Sigma, Biopharmaceuticals, Quality Control, Pharmaceutics, Quality System, SOP development, Dissolution, V&V, Clinical Trials, Clinical Development, Strategy, Chemistry
Education
University of North Carolina at Chapel Hill 1993 — 1997
Kimberly-Clark July 2013 - May 2014
Upsher-Smith Laboratories October 2011 - June 2013
Synthon Pharmaceuticals, Inc. October 2007 - June 2009
Synthon Pharmaceuticals, Inc. April 2003 - September 2007
Covance Biotechnology Services 1998 - 2001
Skills
Pharmaceuticals, Regulatory Affairs, GMP, SOP, Regulatory Submissions, Regulatory Strategy, Quality Assurance, cGMP, Change Control, Generics, FDA, GxP, Sop, Pharmacovigilance, Pharmaceutical Industry, Laboratory, Regulatory Requirements, Quality Management, Technology Transfer, GCP, 21 CFR Part 11, Drug Discovery, GLP, CAPA, Validation, Quality Auditing, Lifesciences, R&D, Chromatography, Computer System..., Drug Development, Generic Programming, eCTD, Cross-functional Team..., CRO, Analytical Chemistry, HPLC, Biotechnology, Six Sigma, Biopharmaceuticals, Quality Control, Pharmaceutics, Quality System, SOP development, Dissolution, V&V, Clinical Trials, Clinical Development, Strategy, Chemistry
Education
University of North Carolina at Chapel Hill 1993 — 1997
Lisa Bonsor, CPA's Synthon Pharmaceuticals, Inc Experience May 2011 - February 2012
Job Experienced Finance & Accounting Professional
Industry Accounting
Experience
Kellogg Company May 2012 - Present
Synthon Pharmaceuticals Inc. May 2011 - February 2012
Eisai Inc. August 2003 - May 2011
Biovail Pharmaceuticals February 2002 - August 2003
Midway Airlines October 1998 - December 2001
Skills
Budgets, Financial Reporting, Process Improvement, Internal Controls, Forecasting, Cost Accounting, Accounting, General Ledger, Leadership, Internal Audit, Finance, Sarbanes-Oxley Act, Auditing, US GAAP, Variance Analysis, Financial Analysis
Education
Augusta State University
BBA
Kellogg Company May 2012 - Present
Synthon Pharmaceuticals Inc. May 2011 - February 2012
Eisai Inc. August 2003 - May 2011
Biovail Pharmaceuticals February 2002 - August 2003
Midway Airlines October 1998 - December 2001
Skills
Budgets, Financial Reporting, Process Improvement, Internal Controls, Forecasting, Cost Accounting, Accounting, General Ledger, Leadership, Internal Audit, Finance, Sarbanes-Oxley Act, Auditing, US GAAP, Variance Analysis, Financial Analysis
Education
Augusta State University
BBA
Richard Almond's Synthon Pharmaceuticals, Inc Experience Research ChemistEnsys1992 - 1996
Job Director, Regulatory Affairs at Synthon Pharmaceuticals, Inc
Industry Pharmaceuticals
Experience
Synthon Pharmaceuticals, Inc Research ChemistEnsys1992 - 1996
Education
King University 2004 — 2005
Synthon Pharmaceuticals, Inc Research ChemistEnsys1992 - 1996
Education
King University 2004 — 2005
David Loar's Synthon Pharmaceuticals, Inc Experience January 2004 - December 2004
Job at
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions General ManagerPharmadyne, LLC2013 - Present
Catalent 2006 - Present
Catalent Pharma Solutions Inc 2005 - Present
Catalent Pharma Solutions, Inc 2005 - Present
Synthon Pharmaceuticals Inc January 2004 - December 2004
Purdue Pharma January 1999 - January 2004
GlaxoSmithKline January 1984 - January 1999
GSK 1984 - 1999
Skills
21 CFR Part 11, Aseptic Processing, Biotechnology, Automation, Change Control, CAPA, Calibration, Continuous Improvement, Contract Manufacturing, Cross-functional Team..., FDA, Engineering, GMP, GxP, LIMS, Lean Manufacturing, Manufacturing, Medical Devices, Operational Excellence, Pharmaceutical Industry, Project Management, Quality Assurance, R, Quality System, Six Sigma, Software Documentation, Sop, Technical Writing, V, Validation, SOP
Education
Varies over the years 1990 — 2000
No, Mechanical
North Carolina State University
Catalent Pharma Solutions General ManagerPharmadyne, LLC2013 - Present
Catalent 2006 - Present
Catalent Pharma Solutions Inc 2005 - Present
Catalent Pharma Solutions, Inc 2005 - Present
Synthon Pharmaceuticals Inc January 2004 - December 2004
Purdue Pharma January 1999 - January 2004
GlaxoSmithKline January 1984 - January 1999
GSK 1984 - 1999
Skills
21 CFR Part 11, Aseptic Processing, Biotechnology, Automation, Change Control, CAPA, Calibration, Continuous Improvement, Contract Manufacturing, Cross-functional Team..., FDA, Engineering, GMP, GxP, LIMS, Lean Manufacturing, Manufacturing, Medical Devices, Operational Excellence, Pharmaceutical Industry, Project Management, Quality Assurance, R, Quality System, Six Sigma, Software Documentation, Sop, Technical Writing, V, Validation, SOP
Education
Varies over the years 1990 — 2000
No, Mechanical
North Carolina State University
Dawn Anders's Synthon Pharmaceuticals, Inc Experience February 2006 - Present
Job Analytical Chemist at Synthon
Industry Pharmaceuticals
Experience
Synthon February 2008 - Present
Synthon Pharmaceuticals, Inc February 2006 - Present
Cardinal Health 2000 - 2006
Skills
Analytical Chemistry, HPLC, UV-Vis, GLP, Dissolution, cGMP, Chromatography, GMP, SOP
Education
University of North Carolina at Wilmington 1994 — 1999
Synthon February 2008 - Present
Synthon Pharmaceuticals, Inc February 2006 - Present
Cardinal Health 2000 - 2006
Skills
Analytical Chemistry, HPLC, UV-Vis, GLP, Dissolution, cGMP, Chromatography, GMP, SOP
Education
University of North Carolina at Wilmington 1994 — 1999
Fred Bangert's Synthon Pharmaceuticals, Inc Experience September 2008 - Present
Job Associate Director Quality Assurance at Synthon Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
Synthon Pharmaceuticals, Inc. September 2008 - Present
Bristol-Myers Squibb Consumer Products September 1998 - March 2002
Bristol-Myers Squibb 1999 - 2002
Education
Syracuse University 1966 — 1970
Synthon Pharmaceuticals, Inc. September 2008 - Present
Bristol-Myers Squibb Consumer Products September 1998 - March 2002
Bristol-Myers Squibb 1999 - 2002
Education
Syracuse University 1966 — 1970
Mary Kelly-Crapse's Synthon Pharmaceuticals, Inc Experience 2009 - 2011
Job Quality Assurance at Eisai Pharmaceuticals
Industry Pharmaceuticals
Experience
Eisai Pharmaceuticals 2012 - Present
Hospira Project through Kelly Scientific 2011 - 2012
Synthon Pharmaceuticals Inc. 2009 - 2011
Synthon Pharmaceuticals Inc 2009 - 2009
Talecris Plasma Resources 2007 - 2009
Wyeth Biotech 2002 - 2006
Wyeth (formerly American Home Products) 2001 - 2002
Covidien Healthcare (formerly Mallinckrodt) 1994 - 2001
Bristol-Myers Squibb 1993 - 1994
Skills
Controlled..., Document Review /..., SOP Development &..., Batch Record Review /..., Internal / External..., Change Control..., Deviation Investigations, CAPA Planning / Closure, Continuous Process..., Staff Training &..., Regulatory Compliance, Data Collection &..., Quality Metrics (KPIs), SOP Gap Analysis, Gap Analysis, Closure, Reviews, GMP, CAPA, Revision, Sop, Compliance, Document Review, SOP development, Change Control, Quality Assurance, Controlled, Continuous Improvement, Deviations, Quality System, Quality Control, Root Cause Analysis, Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, Validation, GLP, FDA, 21 CFR Part 11, Software Documentation, FDA GMP, LIMS, V&V, GxP, Quality Auditing, Technology Transfer, Analytical Chemistry, Equipment Qualification, Cleaning Validation, Biopharmaceuticals
Education
Boston University
North Carolina State University
Temple University
MS, Quality Assurance and Regulatory Affairs
Eisai Pharmaceuticals 2012 - Present
Hospira Project through Kelly Scientific 2011 - 2012
Synthon Pharmaceuticals Inc. 2009 - 2011
Synthon Pharmaceuticals Inc 2009 - 2009
Talecris Plasma Resources 2007 - 2009
Wyeth Biotech 2002 - 2006
Wyeth (formerly American Home Products) 2001 - 2002
Covidien Healthcare (formerly Mallinckrodt) 1994 - 2001
Bristol-Myers Squibb 1993 - 1994
Skills
Controlled..., Document Review /..., SOP Development &..., Batch Record Review /..., Internal / External..., Change Control..., Deviation Investigations, CAPA Planning / Closure, Continuous Process..., Staff Training &..., Regulatory Compliance, Data Collection &..., Quality Metrics (KPIs), SOP Gap Analysis, Gap Analysis, Closure, Reviews, GMP, CAPA, Revision, Sop, Compliance, Document Review, SOP development, Change Control, Quality Assurance, Controlled, Continuous Improvement, Deviations, Quality System, Quality Control, Root Cause Analysis, Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, Validation, GLP, FDA, 21 CFR Part 11, Software Documentation, FDA GMP, LIMS, V&V, GxP, Quality Auditing, Technology Transfer, Analytical Chemistry, Equipment Qualification, Cleaning Validation, Biopharmaceuticals
Education
Boston University
North Carolina State University
Temple University
MS, Quality Assurance and Regulatory Affairs
Angelita Ng's Synthon Pharmaceuticals, Inc Experience 2006 - 2011
Job Chemist at Micell Technologies
Industry Pharmaceuticals
Experience
Micell Technologies February 2012 - Present
SYNTHON PHARMACEUTICALS, INC 2006 - 2011
CARDINAL HEALTH (now CATALENT) 2002 - 2006
ARCADIS G&M of North Carolina 1991 - 2001
Skills
Dissolution, HPLC, Sop, Analytical Chemistry, Gas Chromatography, UV/Vis, GMP, Cleaning Validation, Method Transfer, LIMS, Validation, FDA, Quality Assurance, Regulatory Affairs, V&V, Technology Transfer, Quality Control, Method Development, TLC, FTIR, GLP, Chromatography, Titration, Chemstation, UV, Empower, Chemistry, Karl Fisher, 21 CFR Part 11, CAPA, Change Control, GxP, USP, Pharmaceutics, Raw Materials, Pharmaceutical Industry, SOP development, R&D, Mass Spectrometry, GC-MS, Quality System, Regulatory Requirements, Computer System..., Wet Chemistry, IR, SOP, Regulatory Submissions
Education
North Carolina State University
M. S., Organic Chemistry
Micell Technologies February 2012 - Present
SYNTHON PHARMACEUTICALS, INC 2006 - 2011
CARDINAL HEALTH (now CATALENT) 2002 - 2006
ARCADIS G&M of North Carolina 1991 - 2001
Skills
Dissolution, HPLC, Sop, Analytical Chemistry, Gas Chromatography, UV/Vis, GMP, Cleaning Validation, Method Transfer, LIMS, Validation, FDA, Quality Assurance, Regulatory Affairs, V&V, Technology Transfer, Quality Control, Method Development, TLC, FTIR, GLP, Chromatography, Titration, Chemstation, UV, Empower, Chemistry, Karl Fisher, 21 CFR Part 11, CAPA, Change Control, GxP, USP, Pharmaceutics, Raw Materials, Pharmaceutical Industry, SOP development, R&D, Mass Spectrometry, GC-MS, Quality System, Regulatory Requirements, Computer System..., Wet Chemistry, IR, SOP, Regulatory Submissions
Education
North Carolina State University
M. S., Organic Chemistry
Christa Donofrio's Synthon Pharmaceuticals, Inc Experience June 2006 - February 2011
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
SYNTHON PHARMACEUTICALS, INC June 2006 - February 2011
CARDINAL HEALTH PHARMACEUTICAL DEVELOPMENT January 2000 - January 2006
AAI, INC January 1999 - June 2000
Education
East Carolina University
MS, Biology; Cell and Molecular Biology
North Carolina Wesleyan College
BS / BA, Biology / Psychology
SYNTHON PHARMACEUTICALS, INC June 2006 - February 2011
CARDINAL HEALTH PHARMACEUTICAL DEVELOPMENT January 2000 - January 2006
AAI, INC January 1999 - June 2000
Education
East Carolina University
MS, Biology; Cell and Molecular Biology
North Carolina Wesleyan College
BS / BA, Biology / Psychology
Merck
Johnson & Johnson
GlaxoSmithKline
Bristol Myers Squibb
Eli Lilly and Company
Novartis
Abbott Laboratories
AstraZeneca