Copley Pharmaceutical
Industry: Pharmaceutical company
DescriptionFounded: 1972 Parent organization: Teva Pharmaceuticals USA, Inc.
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Copley Pharmaceutical Employees
Employee
Years
Job
Industry
Sean Jordan Sean Jordan's Copley Pharmaceutical Experience 1994 - 1997
Job Business Development, Product Launches, Sales and Marketing Executive looking for new opportunity
Industry Hospital & Health Care
Experience
Jordan Consulting January 2015 - Present
Jordan Consulting January 2015 - Present
Johnson & Johnson October 2012 - December 2014
Cardinal Health August 2009 - September 2012
Cardinal Health August 2007 - August 2009
Actuant Corporation June 2004 - June 2006
The Gillette Company June 2003 - November 2003
The Gillette Company June 2000 - June 2003
Johnson & Johnson 1997 - 2000
Copley Pharmaceutical 1994 - 1997
Skills
Relationship-focused..., Product Development, Leadership, Lean Manufacturing, Supply Chain..., Product Launch, Business Acumen, Cross-functional Team..., Strategy, New Business Development, Project Management, Sales Operations, Medical Devices, Contract Negotiation, Manufacturing, Pricing, Supply Chain, Process Improvement, Management, Negotiation, Marketing Strategy, Marketing, Business Strategy, Strategic Planning, Sales, Six Sigma, FDA, Healthcare, Global Business..., Market Research, Operations Management, Budgets, Supply Chain Management, Competitive Analysis, Forecasting, Product Management, Business Process..., Data Analysis, P&L Management, Operational Excellence, Change Management, Vendor Management, Program Management, Team Building, Product Marketing, Business Development, Business Planning, Start-ups, Process Engineering, CRM
Education
Suffolk University 2001 — 2003
Master of Business Administration (MBA), Marketing
Purdue University 1992 — 1993
Master of Science (MS), Industrial Engineering
Fitchburg State University 1988 — 1992
Bachelor of Science (BS), Industrial Technology
Jordan Consulting January 2015 - Present
Jordan Consulting January 2015 - Present
Johnson & Johnson October 2012 - December 2014
Cardinal Health August 2009 - September 2012
Cardinal Health August 2007 - August 2009
Actuant Corporation June 2004 - June 2006
The Gillette Company June 2003 - November 2003
The Gillette Company June 2000 - June 2003
Johnson & Johnson 1997 - 2000
Copley Pharmaceutical 1994 - 1997
Skills
Relationship-focused..., Product Development, Leadership, Lean Manufacturing, Supply Chain..., Product Launch, Business Acumen, Cross-functional Team..., Strategy, New Business Development, Project Management, Sales Operations, Medical Devices, Contract Negotiation, Manufacturing, Pricing, Supply Chain, Process Improvement, Management, Negotiation, Marketing Strategy, Marketing, Business Strategy, Strategic Planning, Sales, Six Sigma, FDA, Healthcare, Global Business..., Market Research, Operations Management, Budgets, Supply Chain Management, Competitive Analysis, Forecasting, Product Management, Business Process..., Data Analysis, P&L Management, Operational Excellence, Change Management, Vendor Management, Program Management, Team Building, Product Marketing, Business Development, Business Planning, Start-ups, Process Engineering, CRM
Education
Suffolk University 2001 — 2003
Master of Business Administration (MBA), Marketing
Purdue University 1992 — 1993
Master of Science (MS), Industrial Engineering
Fitchburg State University 1988 — 1992
Bachelor of Science (BS), Industrial Technology
Sharon Colacino's Copley Pharmaceutical Experience 1994 - 1997
Job Scientist II, QC Microbiology at Genzyme
Industry Biotechnology
Experience
Genzyme (A Sanofi Company) 2012 - Present
Genzyme 1997 - 2012
Copley Pharmaceutical 1994 - 1997
Microtest Laboratories November 1992 - February 1994
Springborn Laboratories May 1991 - November 1992
Skills
Bioburden Method..., Microbial Investigations, Microbiology, Quality Control, Assay Development, cGMP practices, Photography, Pharmaceutical Industry, Bioburden, GMP, Wildlife Photography, Process Simulation, Medical Devices, Testing, FDA GMP, Sterilization, Endotoxin, Pharmaceutics, Product Development, Analytical Method..., cGMP manufacturing, 21 CFR Part 11, Biotechnology, CAPA, Change Control, FDA, GLP, SOP, Validation
Education
Quinnipiac University 1986 — 1991
B.S., Microbiology/Biotechnology
Genzyme (A Sanofi Company) 2012 - Present
Genzyme 1997 - 2012
Copley Pharmaceutical 1994 - 1997
Microtest Laboratories November 1992 - February 1994
Springborn Laboratories May 1991 - November 1992
Skills
Bioburden Method..., Microbial Investigations, Microbiology, Quality Control, Assay Development, cGMP practices, Photography, Pharmaceutical Industry, Bioburden, GMP, Wildlife Photography, Process Simulation, Medical Devices, Testing, FDA GMP, Sterilization, Endotoxin, Pharmaceutics, Product Development, Analytical Method..., cGMP manufacturing, 21 CFR Part 11, Biotechnology, CAPA, Change Control, FDA, GLP, SOP, Validation
Education
Quinnipiac University 1986 — 1991
B.S., Microbiology/Biotechnology
Jon Macey Jon Macey's Copley Pharmaceutical Experience May 1998 - January 2001
Job Experienced Analytical Development Chemist II
Industry Cosmetics
Experience
Seeking New Opportunity Analytical Development Chemist IIPrecision DermatologyDecember 2010 - April 2014
Collegium Pharmaceutical November 2007 - December 2010
Collegium Pharmaceutical February 2006 - November 2007
Teva Pharmaceuticals March 2001 - January 2006
Copley Pharmaceutical May 1998 - January 2001
Skills
HPLC, Analytical Chemistry, Wet Chemistry, Analytical Method..., UV/Vis, UV, GMP, Quality Control, Method Development, Titration, Laboratory, Validation, Dissolution, GLP, FDA, OSHA, ICH Guidelines, Viscosity, Cytotoxicity, Method Transfer, OOS, oot, USP, Pharmaceutical Industry, Microsoft Office, SOP
Education
Tufts University 1994 — 1997
Master of Science (MS), Chemistry
Colby College 1985 — 1989
Bachelor of Arts (B.A.), Chemistry
Lexington High School
Seeking New Opportunity Analytical Development Chemist IIPrecision DermatologyDecember 2010 - April 2014
Collegium Pharmaceutical November 2007 - December 2010
Collegium Pharmaceutical February 2006 - November 2007
Teva Pharmaceuticals March 2001 - January 2006
Copley Pharmaceutical May 1998 - January 2001
Skills
HPLC, Analytical Chemistry, Wet Chemistry, Analytical Method..., UV/Vis, UV, GMP, Quality Control, Method Development, Titration, Laboratory, Validation, Dissolution, GLP, FDA, OSHA, ICH Guidelines, Viscosity, Cytotoxicity, Method Transfer, OOS, oot, USP, Pharmaceutical Industry, Microsoft Office, SOP
Education
Tufts University 1994 — 1997
Master of Science (MS), Chemistry
Colby College 1985 — 1989
Bachelor of Arts (B.A.), Chemistry
Lexington High School
Lisa Vallier, PMP, CSM Lisa Vallier, PMP, CSM's Copley Pharmaceutical Experience January 1995 - November 1996
Job IT Director for DPH Soldier's homes, EIM/ESM and IER applications, Acting Director of EHS Data Warehouse, EOHHS
Industry Information Technology and Services
Experience
Executive Office of Health and Human Services August 2011 - September 2015
Executive office of Health and Human Services April 2010 - August 2011
MassHealth January 1997 - March 2010
Copley Pharmaceutical January 1995 - November 1996
Productivity Point International January 1992 - January 1995
Skills
Business Analysis, Software Project..., Requirements Analysis, Program Management, Agile Methodologies, Project Management, PMP, IT Strategy, Process Improvement, Microsoft Office, Leadership, SDLC, System Administration, Crystal Reports, Management, Software Development, Quality Assurance, Agile Project Management, Team Building, Training
Education
University of Massachusetts, Amherst 1987 — 1990
BA, Communications
Marblehead High School 1984 — 1987
Executive Office of Health and Human Services August 2011 - September 2015
Executive office of Health and Human Services April 2010 - August 2011
MassHealth January 1997 - March 2010
Copley Pharmaceutical January 1995 - November 1996
Productivity Point International January 1992 - January 1995
Skills
Business Analysis, Software Project..., Requirements Analysis, Program Management, Agile Methodologies, Project Management, PMP, IT Strategy, Process Improvement, Microsoft Office, Leadership, SDLC, System Administration, Crystal Reports, Management, Software Development, Quality Assurance, Agile Project Management, Team Building, Training
Education
University of Massachusetts, Amherst 1987 — 1990
BA, Communications
Marblehead High School 1984 — 1987
Michael Colacino Michael Colacino's Copley Pharmaceutical Experience 1994 - 2000
Job Director Drug Product at Aegerion Pharmaceuticals
Industry Pharmaceuticals
Experience
Aegerion Pharmaceuticals October 2012 - Present
Genzyme Corporation 2000 - September 2012
Copley Pharmaceutical 1994 - 2000
Procter & Gamble 1989 - 1993
Skills
Pharmaceuticals, Supply Chain Management, Clinical Supply, CMO Management, Project Management, Small Molecules, Drug Product, Technology Transfer, Supply, Pharmaceutical Industry, Change Control, Cleaning Validation, Drug Development, Drug Delivery, GMP, FDA, CMO management, CRO, Regulatory Affairs, Supply Chain, Formulation, Product Development, IND, Regulatory Submissions, GLP, 21 CFR Part 11, Quality Assurance, Validation, Clinical Trials, Manufacturing, Scale Up, Sop, Clinical Research, CAPA, Biotechnology, Process Simulation, GxP, CMC, SOP
Education
University of Maine 1986 — 1988
MS, Chemical Engineering
Rensselaer Polytechnic Institute 1982 — 1986
BS, Chemical Engineering
Aegerion Pharmaceuticals October 2012 - Present
Genzyme Corporation 2000 - September 2012
Copley Pharmaceutical 1994 - 2000
Procter & Gamble 1989 - 1993
Skills
Pharmaceuticals, Supply Chain Management, Clinical Supply, CMO Management, Project Management, Small Molecules, Drug Product, Technology Transfer, Supply, Pharmaceutical Industry, Change Control, Cleaning Validation, Drug Development, Drug Delivery, GMP, FDA, CMO management, CRO, Regulatory Affairs, Supply Chain, Formulation, Product Development, IND, Regulatory Submissions, GLP, 21 CFR Part 11, Quality Assurance, Validation, Clinical Trials, Manufacturing, Scale Up, Sop, Clinical Research, CAPA, Biotechnology, Process Simulation, GxP, CMC, SOP
Education
University of Maine 1986 — 1988
MS, Chemical Engineering
Rensselaer Polytechnic Institute 1982 — 1986
BS, Chemical Engineering
George Dainis George Dainis's Copley Pharmaceutical Experience December 1996 - March 1998
Job Principal, Industrial Facilities Design, Inc.
Industry Architecture & Planning
Experience
Industrial Facilities Design, Inc. (IFDI) June 2000 - Present
Process Facilities Inc. (PFI) March 1998 - June 2000
Copley Pharmaceutical December 1996 - March 1998
Process Facilities Inc. (PFI) July 1993 - December 1996
Badger Engineers June 1991 - July 1993
Texas Instruments (TI) September 1980 - June 1991
Skills
Process Engineering, Manufacturing, Program Management, Project Management, GMP, Start-ups, Project Engineering, Validation, Management, Construction Management, Construction, Business Development, FDA, Chemical Engineering, Technology Transfer, Process Control, Engineering
Education
Worcester Polytechnic Institute 1981 — 1991
MS, Computer Science
Massachusetts Institute of Technology (MIT) 1979 — 1980
SM, Chemical Engineering
Worcester Polytechnic Institute 1975 — 1979
BS, Chemical Engineering
Industrial Facilities Design, Inc. (IFDI) June 2000 - Present
Process Facilities Inc. (PFI) March 1998 - June 2000
Copley Pharmaceutical December 1996 - March 1998
Process Facilities Inc. (PFI) July 1993 - December 1996
Badger Engineers June 1991 - July 1993
Texas Instruments (TI) September 1980 - June 1991
Skills
Process Engineering, Manufacturing, Program Management, Project Management, GMP, Start-ups, Project Engineering, Validation, Management, Construction Management, Construction, Business Development, FDA, Chemical Engineering, Technology Transfer, Process Control, Engineering
Education
Worcester Polytechnic Institute 1981 — 1991
MS, Computer Science
Massachusetts Institute of Technology (MIT) 1979 — 1980
SM, Chemical Engineering
Worcester Polytechnic Institute 1975 — 1979
BS, Chemical Engineering
Paul Larose Paul Larose's Copley Pharmaceutical Experience January 1990 - June 1991
Job Bioprocess Specialist at BristolMyers Squibb
Industry Biotechnology
Experience
Albany Molecular Research February 2006 - January 2011
Anika Therapeutics October 1995 - February 2006
Anika Therapeutics June 1991 - October 1995
Copley Pharmaceutical January 1990 - June 1991
Fisons Corporation 1977 - 1989
Skills
Aseptic Processing, Sterilization, Lyophilization, Environmental Monitoring, Contamination Control, Clean Rooms, Biotechnology, GMP, Trackwise, Purification, Filtration, Downstream Processing, CAPA, FDA, 21 CFR Part 11, Sop, Validation, Pharmaceutical Industry, Change Control, Quality Auditing, Formulation, Manufacturing, Quality Control, Technology Transfer, Biopharmaceuticals, ISO, GLP, V&V, Cleaning Validation, Microbiology, LIMS, Continuous Improvement, GxP, Computer System..., Quality Management, Quality System, FDA GMP, ISO 13485, Chromatography, Regulatory Affairs, Manufacturing Operations, Contract Manufacturing, SOP, TrackWise
Education
University of Massachusetts Lowell
Business Management
Albany Molecular Research February 2006 - January 2011
Anika Therapeutics October 1995 - February 2006
Anika Therapeutics June 1991 - October 1995
Copley Pharmaceutical January 1990 - June 1991
Fisons Corporation 1977 - 1989
Skills
Aseptic Processing, Sterilization, Lyophilization, Environmental Monitoring, Contamination Control, Clean Rooms, Biotechnology, GMP, Trackwise, Purification, Filtration, Downstream Processing, CAPA, FDA, 21 CFR Part 11, Sop, Validation, Pharmaceutical Industry, Change Control, Quality Auditing, Formulation, Manufacturing, Quality Control, Technology Transfer, Biopharmaceuticals, ISO, GLP, V&V, Cleaning Validation, Microbiology, LIMS, Continuous Improvement, GxP, Computer System..., Quality Management, Quality System, FDA GMP, ISO 13485, Chromatography, Regulatory Affairs, Manufacturing Operations, Contract Manufacturing, SOP, TrackWise
Education
University of Massachusetts Lowell
Business Management
Erick Galvez's Copley Pharmaceutical Experience July 1992 - January 2000
Job Sr Manufacturing Associate at Genzyme sanofi
Industry Biotechnology
Experience
Genzyme sanofi March 2004 - Present
Wyeth September 2001 - January 2003
Copley pharmaceutical July 1992 - January 2000
Skills
Biotechnology, CAPA, FDA, GMP, Sop, Biopharmaceuticals, 21 CFR Part 11, Change Control, Validation, Aseptic Processing, Technology Transfer, V, GxP, Quality System, Trackwise, SOP, TrackWise
Education
Bridgewater State University 2002 — 2004
Bachelor's degree, Economics
Massasoit Community College 2000 — 2002
Associate of Science (AS), Business Administration, Management and Operations
Genzyme sanofi March 2004 - Present
Wyeth September 2001 - January 2003
Copley pharmaceutical July 1992 - January 2000
Skills
Biotechnology, CAPA, FDA, GMP, Sop, Biopharmaceuticals, 21 CFR Part 11, Change Control, Validation, Aseptic Processing, Technology Transfer, V, GxP, Quality System, Trackwise, SOP, TrackWise
Education
Bridgewater State University 2002 — 2004
Bachelor's degree, Economics
Massasoit Community College 2000 — 2002
Associate of Science (AS), Business Administration, Management and Operations
Vincent Andolina's Copley Pharmaceutical Experience April 1999 - July 2000
Job VP Regulatory Affairs (Generics)
Industry Pharmaceuticals
Experience
AuroMedics Pharma LLC July 2011 - Present
Sun Pharmaceutical Industries Inc September 2010 - July 2011
GeneraMedix Inc. June 2005 - September 2010
Teva Pharmaceuticals USA August 2000 - June 2005
Copley Pharmaceutical April 1999 - July 2000
Alpharma December 1988 - January 1999
Halsey Drug Co. October 1977 - November 1988
Le Jacq Publishing September 1984 - August 1985
Skills
Regulatory Affairs, Generics, Regulatory Submissions, US Agent, SPL, Topical Medication, CMC, Generic Programming, Nasal, Ophthalmology, Clinical Development, ANDA, FDA, GMP, eCTD, Pharmacovigilance, Pharmaceutical Industry, Pharmaceutics, NDA, Regulatory Requirements, IND, GxP, CAPA, Change Control, Sop, V&V, Validation, ANDAs, Technology Transfer, Drug Development, Clinical Trials, 21 CFR Part 11, GLP, Generic Drugs, Formulation, Drug Delivery, Biopharmaceuticals, GCP, Regulatory Filings, CMC Regulatory Affairs, CRO, Dissolution, SOP
Education
University at Buffalo 1975 — 1977
BS Health Sci., Major - Biochemical Pharmacology
Saint John's University 1973 — 1975
(transferred out), Pharmacy
AuroMedics Pharma LLC July 2011 - Present
Sun Pharmaceutical Industries Inc September 2010 - July 2011
GeneraMedix Inc. June 2005 - September 2010
Teva Pharmaceuticals USA August 2000 - June 2005
Copley Pharmaceutical April 1999 - July 2000
Alpharma December 1988 - January 1999
Halsey Drug Co. October 1977 - November 1988
Le Jacq Publishing September 1984 - August 1985
Skills
Regulatory Affairs, Generics, Regulatory Submissions, US Agent, SPL, Topical Medication, CMC, Generic Programming, Nasal, Ophthalmology, Clinical Development, ANDA, FDA, GMP, eCTD, Pharmacovigilance, Pharmaceutical Industry, Pharmaceutics, NDA, Regulatory Requirements, IND, GxP, CAPA, Change Control, Sop, V&V, Validation, ANDAs, Technology Transfer, Drug Development, Clinical Trials, 21 CFR Part 11, GLP, Generic Drugs, Formulation, Drug Delivery, Biopharmaceuticals, GCP, Regulatory Filings, CMC Regulatory Affairs, CRO, Dissolution, SOP
Education
University at Buffalo 1975 — 1977
BS Health Sci., Major - Biochemical Pharmacology
Saint John's University 1973 — 1975
(transferred out), Pharmacy
Joseph Cassella's Copley Pharmaceutical Experience January 1994 - November 1999
Job Associate Director, ProPharma Group. Business Development, process/computer validations, project management, staffing
Industry Biotechnology
Experience
ProPharma Group March 2015 - Present
LabAnswer July 2014 - January 2015
iTrend November 2012 - November 2014
QPharma, Inc. November 2013 - February 2014
Prime Technologies June 2013 - October 2013
Regeneron Pharmaceuticals August 2011 - May 2013
Mannkind Corporation June 2006 - April 2011
Breachway Solutions 2004 - 2006
Purdue Pharma 1999 - 2004
Copley Pharmaceutical January 1994 - November 1999
Skills
Validation, 21 CFR Part 11, Pharmaceutical Industry, Computer System..., FDA, Change Control, Sop, GMP, Quality Assurance, GxP, LIMS, Process Improvement, Cross-functional Team..., GLP, CAPA, Business Analysis, MS Project, V&V, Project Management, R&D, Clinical Trials, Quality System, Biopharmaceuticals, Biotechnology, CRO, Software Documentation, Start-ups, Quality Control, Drug Discovery, Regulatory Submissions, Drug Development, Pharmaceutics, Technology Transfer, Lifesciences, Regulatory Affairs, EDC, CTMS, Clinical Development, GCP, Process Simulation, Regulatory Requirements, Data Management, Medical Devices, Clinical Data Management, Pharmacovigilance, Oncology, SOP
Education
Syracuse University
Bachelor's degree
Villanova University 2010 — 2010
Certificate, Six Sigma Certified
ProPharma Group March 2015 - Present
LabAnswer July 2014 - January 2015
iTrend November 2012 - November 2014
QPharma, Inc. November 2013 - February 2014
Prime Technologies June 2013 - October 2013
Regeneron Pharmaceuticals August 2011 - May 2013
Mannkind Corporation June 2006 - April 2011
Breachway Solutions 2004 - 2006
Purdue Pharma 1999 - 2004
Copley Pharmaceutical January 1994 - November 1999
Skills
Validation, 21 CFR Part 11, Pharmaceutical Industry, Computer System..., FDA, Change Control, Sop, GMP, Quality Assurance, GxP, LIMS, Process Improvement, Cross-functional Team..., GLP, CAPA, Business Analysis, MS Project, V&V, Project Management, R&D, Clinical Trials, Quality System, Biopharmaceuticals, Biotechnology, CRO, Software Documentation, Start-ups, Quality Control, Drug Discovery, Regulatory Submissions, Drug Development, Pharmaceutics, Technology Transfer, Lifesciences, Regulatory Affairs, EDC, CTMS, Clinical Development, GCP, Process Simulation, Regulatory Requirements, Data Management, Medical Devices, Clinical Data Management, Pharmacovigilance, Oncology, SOP
Education
Syracuse University
Bachelor's degree
Villanova University 2010 — 2010
Certificate, Six Sigma Certified
Cedric A. D'Hue's Copley Pharmaceutical Experience 1999 - 2000
Job Patent Attorney, Member at D'Hue Law LLC
Industry Law Practice
Experience
D'Hue Law, LLC July 2009 - Present
D'Hue Realty LLC 2010 - 2015
D'Hue Realty LLC 2010 - 2015
Bingham Greenebaum Doll LLP December 2011 - December 2012
Baker & Daniels September 2005 - July 2009
Office of the Indiana Attorney General 2004 - 2004
Indianapolis Office of Corporation Counsel 2003 - 2003
copley pharmaceutical 1999 - 2000
teva usa 1999 - 2000
Skills
Patent Prosecution, Chemistry, Life Sciences, Patentability, Intellectual Property, Patents, Patent preparation, Technology Transfer, Patent Drafting, Patent Strategy, Patent Portfolio..., Client Counseling, Invention, Prosecution, Intellectual Property..., Patent Analysis, Medical Devices, Biotechnology, Pharmaceuticals, Lifesciences, Trademarks, Pharmaceutical Industry, Leadership, Legal Research, Analytical Chemistry, Cancer Research, Copyright Law, Registered Patent..., Patent Applications, Trade Secrets, Legal Opinions, Trademark Infringement
Education
Purdue University 2012 — 2017
Doctor of Philosophy (Ph.D.), Analytical Chemistry
Indiana University Robert H. McKinney School of Law 2002 — 2005
JD, Law
Valparaiso University 2002 — 2002
ICLEO 2002 Fellow
Purdue University 2000 — 2002
MS, Chemistry
Tufts University 1995 — 1999
Bachelor of Science, Chemistry
Pace Academy 1991 — 1995
High School Diploma
D'Hue Law, LLC July 2009 - Present
D'Hue Realty LLC 2010 - 2015
D'Hue Realty LLC 2010 - 2015
Bingham Greenebaum Doll LLP December 2011 - December 2012
Baker & Daniels September 2005 - July 2009
Office of the Indiana Attorney General 2004 - 2004
Indianapolis Office of Corporation Counsel 2003 - 2003
copley pharmaceutical 1999 - 2000
teva usa 1999 - 2000
Skills
Patent Prosecution, Chemistry, Life Sciences, Patentability, Intellectual Property, Patents, Patent preparation, Technology Transfer, Patent Drafting, Patent Strategy, Patent Portfolio..., Client Counseling, Invention, Prosecution, Intellectual Property..., Patent Analysis, Medical Devices, Biotechnology, Pharmaceuticals, Lifesciences, Trademarks, Pharmaceutical Industry, Leadership, Legal Research, Analytical Chemistry, Cancer Research, Copyright Law, Registered Patent..., Patent Applications, Trade Secrets, Legal Opinions, Trademark Infringement
Education
Purdue University 2012 — 2017
Doctor of Philosophy (Ph.D.), Analytical Chemistry
Indiana University Robert H. McKinney School of Law 2002 — 2005
JD, Law
Valparaiso University 2002 — 2002
ICLEO 2002 Fellow
Purdue University 2000 — 2002
MS, Chemistry
Tufts University 1995 — 1999
Bachelor of Science, Chemistry
Pace Academy 1991 — 1995
High School Diploma
Maria Micalizzi Conklin's Copley Pharmaceutical Experience August 1996 - August 2000
Job Senior Analytical Development Scientist
Industry Biotechnology
Experience
Karyopharm Therapeutics Inc November 2014 - Present
Momenta Pharmaceuticals August 2014 - November 2014
Ironwood Pharmaceuticals July 2009 - January 2014
Ironwood Pharmaceuticals October 2007 - July 2009
ImmunoGen March 2007 - October 2007
Praecis Pharmaceuticals September 2005 - March 2007
Johnson Matthey Pharma Services February 2002 - August 2005
Charles River Labs September 2000 - January 2002
Copley Pharmaceutical August 1996 - August 2000
Skills
Analytical Chemistry, GMP, Validation, Organic Chemistry, Pharmaceutical Industry, IND, Sop, Chromatography, Biotechnology, cGMP, Pharmaceuticals, HPLC, Product Development, Protein Chemistry, Organic Synthesis, FDA, Quality Control, NMR, SOP, Life Sciences, LC-MS
Education
Northeastern University 1997 — 2001
Master of Science, Chemistry
Boston University 1991 — 1995
Bachelor's, Chemistry
Karyopharm Therapeutics Inc November 2014 - Present
Momenta Pharmaceuticals August 2014 - November 2014
Ironwood Pharmaceuticals July 2009 - January 2014
Ironwood Pharmaceuticals October 2007 - July 2009
ImmunoGen March 2007 - October 2007
Praecis Pharmaceuticals September 2005 - March 2007
Johnson Matthey Pharma Services February 2002 - August 2005
Charles River Labs September 2000 - January 2002
Copley Pharmaceutical August 1996 - August 2000
Skills
Analytical Chemistry, GMP, Validation, Organic Chemistry, Pharmaceutical Industry, IND, Sop, Chromatography, Biotechnology, cGMP, Pharmaceuticals, HPLC, Product Development, Protein Chemistry, Organic Synthesis, FDA, Quality Control, NMR, SOP, Life Sciences, LC-MS
Education
Northeastern University 1997 — 2001
Master of Science, Chemistry
Boston University 1991 — 1995
Bachelor's, Chemistry
Kim Raposo's Copley Pharmaceutical Experience June 1992 - April 2000
Job Quality Engineer 2 at Siemens Healthcare
Industry Pharmaceuticals
Experience
Siemens Healthcare April 2014 - Present
Siemens Healthcare April 2014 - Present
University of Phoenix March 2007 - Present
Tedor Pharma January 2014 - April 2014
BFS Pharma December 2011 - April 2013
BFS Pharma August 2011 - April 2013
Brockton High School September 2007 - December 2011
Epic Therapeutics, Inc. February 2001 - January 2007
Dow Biopharmaceutical April 2000 - February 2001
Copley Pharmaceutical June 1992 - April 2000
Skills
GMP, Laboratory, GLP, HPLC, Team Leadership, Quality Control, Team Management, 21 CFR Part 11, HACCP, ICH guidelines, USP, Pharmaceutical Industry, Raw Material Testing, Wet Chemistry Techniques, Quality System..., Manage Clean Room..., Job Scheduling, Statistical Data...
Education
University of Phoenix 2012 — 2014
Master of Business Administration (MBA), 3.93
Northeastern University 2000 — 2005
MS, Chemistry
Bridgewater State College 1984 — 1989
BS, Mathematics
Siemens Healthcare April 2014 - Present
Siemens Healthcare April 2014 - Present
University of Phoenix March 2007 - Present
Tedor Pharma January 2014 - April 2014
BFS Pharma December 2011 - April 2013
BFS Pharma August 2011 - April 2013
Brockton High School September 2007 - December 2011
Epic Therapeutics, Inc. February 2001 - January 2007
Dow Biopharmaceutical April 2000 - February 2001
Copley Pharmaceutical June 1992 - April 2000
Skills
GMP, Laboratory, GLP, HPLC, Team Leadership, Quality Control, Team Management, 21 CFR Part 11, HACCP, ICH guidelines, USP, Pharmaceutical Industry, Raw Material Testing, Wet Chemistry Techniques, Quality System..., Manage Clean Room..., Job Scheduling, Statistical Data...
Education
University of Phoenix 2012 — 2014
Master of Business Administration (MBA), 3.93
Northeastern University 2000 — 2005
MS, Chemistry
Bridgewater State College 1984 — 1989
BS, Mathematics
Cheryl Koertje's Copley Pharmaceutical Experience 1987 - 1998
Job Senior Director of Quality at PreCision Dermatology Inc.
Industry Pharmaceuticals
Experience
PreCision Dermatology Inc. November 2010 - Present
Collegium Pharmaceutical, Inc. November 2004 - November 2010
Copley Pharmaceutical 1987 - 1998
Education
University of Massachusetts, Amherst 1983 — 1987
B.S., chemistry
Northeastern University
M.S., Chemistry
PreCision Dermatology Inc. November 2010 - Present
Collegium Pharmaceutical, Inc. November 2004 - November 2010
Copley Pharmaceutical 1987 - 1998
Education
University of Massachusetts, Amherst 1983 — 1987
B.S., chemistry
Northeastern University
M.S., Chemistry
Langyu Wu's Copley Pharmaceutical Experience 1998 - 1998
Job Senior Scientist at Amphitide
Industry Pharmaceuticals
Experience
Amphitide October 2014 - Present
Waters Corp July 2009 - February 2014
Waters, Worldwide Quality and Service March 2008 - March 2009
Boston Scientific August 1998 - January 2008
Copley Pharmaceutical 1998 - 1998
Cambridge Neuroscience 1997 - 1998
Advanced Magnetics 1991 - 1996
Skills
HPLC, R&D, LC-MS, GLP, Validation, Chromatography, Drug Discovery, Biotechnology, FDA, Biochemistry, Protein Chemistry, Technology Transfer, GC-MS, GMP, Chemistry
Education
Ohio University
M.S., Analytical Chemistry
Peking University
B.S., Analytical Chemistry
Amphitide October 2014 - Present
Waters Corp July 2009 - February 2014
Waters, Worldwide Quality and Service March 2008 - March 2009
Boston Scientific August 1998 - January 2008
Copley Pharmaceutical 1998 - 1998
Cambridge Neuroscience 1997 - 1998
Advanced Magnetics 1991 - 1996
Skills
HPLC, R&D, LC-MS, GLP, Validation, Chromatography, Drug Discovery, Biotechnology, FDA, Biochemistry, Protein Chemistry, Technology Transfer, GC-MS, GMP, Chemistry
Education
Ohio University
M.S., Analytical Chemistry
Peking University
B.S., Analytical Chemistry
Les Swartz's Copley Pharmaceutical Experience 1994 - 1999
Job Director of Trade Relations at CutisPharma, Inc.
Industry Pharmaceuticals
Experience
CutisPharma, Inc. September 2013 - Present
Onset Dermatologics November 2007 - September 2013
CutisPharma, Inc. June 2001 - November 2007
Copley Pharmaceutical 1994 - 1999
Skills
Dermatology, Pharmaceutical Sales, Managed Care, Pharmaceutical Industry, Sales Operations, Product Launch, Selling, Sales Management, Sales, Sales Force Development, Product Development, Forecasting, Healthcare, Cardiology, Account Management, Neurology, Selling Skills, Marketing, Urology
Education
Emerson College 1982 — 1986
B.S., Communications
CutisPharma, Inc. September 2013 - Present
Onset Dermatologics November 2007 - September 2013
CutisPharma, Inc. June 2001 - November 2007
Copley Pharmaceutical 1994 - 1999
Skills
Dermatology, Pharmaceutical Sales, Managed Care, Pharmaceutical Industry, Sales Operations, Product Launch, Selling, Sales Management, Sales, Sales Force Development, Product Development, Forecasting, Healthcare, Cardiology, Account Management, Neurology, Selling Skills, Marketing, Urology
Education
Emerson College 1982 — 1986
B.S., Communications
Nick Tamasco's Copley Pharmaceutical Experience 1993 - 1997
Job Quality Assurance Executive
Industry Pharmaceuticals
Experience
Forum Pharmaceuticals September 2014 - Present
Eisai Andover, 2005 - December 2013
Idenix Pharmaceuticals, Inc. 2004 - 2005
Coley Pharmaceutical Group 2003 - 2004
Lyne Laboratories 1997 - 2003
Copley Pharmaceutical 1993 - 1997
Colgate Oral Pharmaceuticals 1987 - 1991
Skills
Quality Assurance, GMP, Sop, FDA, GLP, Validation, Pharmaceutical Industry, Change Control, Biotechnology, Clinical Development, Technology Transfer, 21 CFR Part 11, CAPA, Regulatory Affairs, Computer System..., Drug Development, Regulatory Submissions, GxP, Biopharmaceuticals, CRO, IND, GCP, V&V, Clinical Trials, Regulatory Requirements, CMC, Quality System
Education
Massachusetts College of Pharmacy and Health Sciences 1966 — 1971
Forum Pharmaceuticals September 2014 - Present
Eisai Andover, 2005 - December 2013
Idenix Pharmaceuticals, Inc. 2004 - 2005
Coley Pharmaceutical Group 2003 - 2004
Lyne Laboratories 1997 - 2003
Copley Pharmaceutical 1993 - 1997
Colgate Oral Pharmaceuticals 1987 - 1991
Skills
Quality Assurance, GMP, Sop, FDA, GLP, Validation, Pharmaceutical Industry, Change Control, Biotechnology, Clinical Development, Technology Transfer, 21 CFR Part 11, CAPA, Regulatory Affairs, Computer System..., Drug Development, Regulatory Submissions, GxP, Biopharmaceuticals, CRO, IND, GCP, V&V, Clinical Trials, Regulatory Requirements, CMC, Quality System
Education
Massachusetts College of Pharmacy and Health Sciences 1966 — 1971
Carol Pagucci's Copley Pharmaceutical Experience 1991 - 1999
Job Senior Scientist
Industry Pharmaceuticals
Experience
Tedor Pharma February 2004 - Present
Shuster Laboratories December 1999 - December 2003
Copley Pharmaceutical 1991 - 1999
Skills
Methods Development, Dissolution, Research and Development, Sop, Pharmaceutical Research, Analytical Techniques, Equipment Qualification, Pharmaceutical Industry, GMP, Technology Transfer, Analytical Chemistry, HPLC, Cleaning Validation, Drug Development, Formulation, Method Development, NMR, R&D, GLP, FDA, 21 CFR Part 11, UV/Vis, Validation, SOP
Education
Quincy College 1993 — 1998
AS, Science
Tedor Pharma February 2004 - Present
Shuster Laboratories December 1999 - December 2003
Copley Pharmaceutical 1991 - 1999
Skills
Methods Development, Dissolution, Research and Development, Sop, Pharmaceutical Research, Analytical Techniques, Equipment Qualification, Pharmaceutical Industry, GMP, Technology Transfer, Analytical Chemistry, HPLC, Cleaning Validation, Drug Development, Formulation, Method Development, NMR, R&D, GLP, FDA, 21 CFR Part 11, UV/Vis, Validation, SOP
Education
Quincy College 1993 — 1998
AS, Science
Anthony Carpanzano's Copley Pharmaceutical Experience June 1992 - September 1994
Job Director, Research and Development at JRS Pharma
Industry Pharmaceuticals
Experience
JRS Pharma, LP September 2011 - Present
Penwest Pharmaceuticals July 2004 - March 2011
Purdue Pharma L.P. 1999 - 2004
Schein Pharmaceutical September 1994 - October 1999
Schein Phramaceutical 1994 - 1999
Copley Pharmaceutical June 1992 - September 1994
Procter & Gamble (Richardson-Vicks) 1979 - 1992
Richardson-Vicks 1979 - 1992
Skills
Leadership, Drug Discovery, Chromatography, Product Development, Sop, Pharmaceutics, Pharmaceutical Industry, GLP, GMP, FDA, HPLC, Validation, Management, Formulation, Chemistry, Analytical Chemistry, R&D, IND, CAPA, Change Control, Drug Development, Quality Assurance, Technology Transfer, CRO, Regulatory Affairs, Drug Delivery, Biotechnology, Lifesciences, V&V, Regulatory Submissions, LIMS
Education
LIU Brooklyn 1973 — 1977
B.S., Pharmacy
LIU Brooklyn 1972 — 1976
University of Hartford 1971 — 1973
AAS, Chemistry, Liberal Arts
JRS Pharma, LP September 2011 - Present
Penwest Pharmaceuticals July 2004 - March 2011
Purdue Pharma L.P. 1999 - 2004
Schein Pharmaceutical September 1994 - October 1999
Schein Phramaceutical 1994 - 1999
Copley Pharmaceutical June 1992 - September 1994
Procter & Gamble (Richardson-Vicks) 1979 - 1992
Richardson-Vicks 1979 - 1992
Skills
Leadership, Drug Discovery, Chromatography, Product Development, Sop, Pharmaceutics, Pharmaceutical Industry, GLP, GMP, FDA, HPLC, Validation, Management, Formulation, Chemistry, Analytical Chemistry, R&D, IND, CAPA, Change Control, Drug Development, Quality Assurance, Technology Transfer, CRO, Regulatory Affairs, Drug Delivery, Biotechnology, Lifesciences, V&V, Regulatory Submissions, LIMS
Education
LIU Brooklyn 1973 — 1977
B.S., Pharmacy
LIU Brooklyn 1972 — 1976
University of Hartford 1971 — 1973
AAS, Chemistry, Liberal Arts
Erica Connolly's Copley Pharmaceutical Experience 1993 - 1995
Job Manager, Drug Supply Chain
Industry Biotechnology
Experience
Alkermes, Inc. June 2013 - Present
Ziopharm Oncology August 2011 - June 2013
Infinity Pharmaceuticals, Inc. April 2008 - August 2011
Alkermes 2006 - 2008
Alkermes 2001 - 2006
Braintree Laboratories 1995 - 1998
Copley Pharmaceutical 1993 - 1995
Education
Northeastern University 1988 — 1993
B.S, Chemistry
Alkermes, Inc. June 2013 - Present
Ziopharm Oncology August 2011 - June 2013
Infinity Pharmaceuticals, Inc. April 2008 - August 2011
Alkermes 2006 - 2008
Alkermes 2001 - 2006
Braintree Laboratories 1995 - 1998
Copley Pharmaceutical 1993 - 1995
Education
Northeastern University 1988 — 1993
B.S, Chemistry
Karin Catalano's Copley Pharmaceutical Experience 1994 - 1997
Job Instrumentation Specialist II at Bentely Univeristy
Industry Higher Education
Experience
Bentely Univeristy July 2012 - Present
Bentley College September 2007 - June 2012
Alkermes December 1997 - September 2007
Copley Pharmaceutical 1994 - 1997
Skills
Biotechnology, Pharmaceutical Industry, HPLC, Cross-functional Team..., Analytical Chemistry, GMP
Education
University of Massachusetts at Lowell 1990 — 1994
Bachelor of Science (BS), Chemistry
Bentely Univeristy July 2012 - Present
Bentley College September 2007 - June 2012
Alkermes December 1997 - September 2007
Copley Pharmaceutical 1994 - 1997
Skills
Biotechnology, Pharmaceutical Industry, HPLC, Cross-functional Team..., Analytical Chemistry, GMP
Education
University of Massachusetts at Lowell 1990 — 1994
Bachelor of Science (BS), Chemistry
Jason Pepin's Copley Pharmaceutical Experience 1998 - 2000
Job Sr. Quality Engineer at Smith & Nephew Endoscopy
Industry Medical Devices
Experience
Smith & Nephew Endoscopy March 2006 - Present
Teleflex Medical 2005 - 2006
Genzyme Biosurgery 2001 - 2005
Wyeth Pharmaceuticals 2000 - 2001
Copley Pharmaceutical 1998 - 2000
Copley Pharmaceutical 1996 - 1998
Copley Pharmaceutical 1995 - 1996
Copley Pharmaceutical 1993 - 1995
Skills
Root Cause Analysis, Design of Experiments, Design Control, FDA, Design for Manufacturing, Quality System, Manufacturing..., ISO 14971, Quality Assurance, ISO 13485, CAPA, SPC, Medical Devices, V&V, FMEA
Education
University of Massachusetts Dartmouth 1990 — 1993
BSME, Mechanical Engineering
Smith & Nephew Endoscopy March 2006 - Present
Teleflex Medical 2005 - 2006
Genzyme Biosurgery 2001 - 2005
Wyeth Pharmaceuticals 2000 - 2001
Copley Pharmaceutical 1998 - 2000
Copley Pharmaceutical 1996 - 1998
Copley Pharmaceutical 1995 - 1996
Copley Pharmaceutical 1993 - 1995
Skills
Root Cause Analysis, Design of Experiments, Design Control, FDA, Design for Manufacturing, Quality System, Manufacturing..., ISO 14971, Quality Assurance, ISO 13485, CAPA, SPC, Medical Devices, V&V, FMEA
Education
University of Massachusetts Dartmouth 1990 — 1993
BSME, Mechanical Engineering
Russell French's Copley Pharmaceutical Experience 1993 - 2000
Job Human Resources Professional
Industry Human Resources
Experience
Bristol Seafood LLC April 2014 - December 2014
Cozy Harbor Seafood November 2009 - March 2014
Martin's Point Health Care September 2008 - October 2009
IDEXX Laboratories 2002 - 2008
TEVA Pharmaceuticals 2000 - 2001
Copley Pharmaceutical 1993 - 2000
Skills
Employee Benefits, Payroll, Benefits, Compensation, Executive Compensation, Employee Relations, Performance Management, Deferred Compensation, Training, Process Improvement, Onboarding, ADP Payroll, Mergers & Acquisitions, Human Resources, Program Management, Employment Law, Benefits Administration, Executive Pay, Personnel Management, Vendor Management, HR Policies, Management, Compensation & Benefit, Recruiting, Succession Planning, Policy, Coaching, Organizational..., Leadership, Talent Acquisition, HRIS, Workforce Planning, HR Consulting, Employee Training, Organizational Design, Interviews, Talent Management, Sourcing, New Hire Orientations, Strategic Human..., Temporary Placement, Employee Engagement, Job Analysis, Compensation & Benefits
Education
Board Connect
Board Connect
University of Massachusetts Boston
BS, Accounting and Finance
Bristol Seafood LLC April 2014 - December 2014
Cozy Harbor Seafood November 2009 - March 2014
Martin's Point Health Care September 2008 - October 2009
IDEXX Laboratories 2002 - 2008
TEVA Pharmaceuticals 2000 - 2001
Copley Pharmaceutical 1993 - 2000
Skills
Employee Benefits, Payroll, Benefits, Compensation, Executive Compensation, Employee Relations, Performance Management, Deferred Compensation, Training, Process Improvement, Onboarding, ADP Payroll, Mergers & Acquisitions, Human Resources, Program Management, Employment Law, Benefits Administration, Executive Pay, Personnel Management, Vendor Management, HR Policies, Management, Compensation & Benefit, Recruiting, Succession Planning, Policy, Coaching, Organizational..., Leadership, Talent Acquisition, HRIS, Workforce Planning, HR Consulting, Employee Training, Organizational Design, Interviews, Talent Management, Sourcing, New Hire Orientations, Strategic Human..., Temporary Placement, Employee Engagement, Job Analysis, Compensation & Benefits
Education
Board Connect
Board Connect
University of Massachusetts Boston
BS, Accounting and Finance
Jennifer Kligman's Copley Pharmaceutical Experience September 1992 - September 1997
Job key holder at Cornerstone Brands
Industry Retail
Experience
Cornerstone Brands February 2008 - Present
Copley Pharmaceutical September 1992 - September 1997
Education
University of Massachusetts, Amherst 1989 — 1992
BS, psychology
Cornerstone Brands February 2008 - Present
Copley Pharmaceutical September 1992 - September 1997
Education
University of Massachusetts, Amherst 1989 — 1992
BS, psychology
Steve Keohane's Copley Pharmaceutical Experience January 1998 - January 2000
Job Senior Facility Manager at CB Richard Ellis
Industry Facilities Services
Experience
CBRE– care of Siemens Healthcare April 2012 - Present
CBRE– care of State Street Corp October 2007 - March 2012
CBRE– care of State Street Corp and Bayer Health Care May 2000 - October 2007
Copley Pharmaceutical January 1998 - January 2000
Education
Massasoit Community College
AS, Electronic Technology and Business Management
Stonehill College
BS Business Management
CBRE– care of Siemens Healthcare April 2012 - Present
CBRE– care of State Street Corp October 2007 - March 2012
CBRE– care of State Street Corp and Bayer Health Care May 2000 - October 2007
Copley Pharmaceutical January 1998 - January 2000
Education
Massasoit Community College
AS, Electronic Technology and Business Management
Stonehill College
BS Business Management
Kangwen Lin's Copley Pharmaceutical Experience 1996 - 2000
Job Director, Technical Services at Impax Labs
Industry Pharmaceuticals
Experience
Impax Labs 2006 - Present
Chiron 2002 - 2006
Longwood Pharmaceuticals Inc 2000 - 2002
Copley Pharmaceutical 1996 - 2000
Proctor and Gamble Pharmaceuticals 1994 - 1996
Skills
GMP, Validation, cGMP, Technology Transfer, Process Validation, FDA, SOP, Pharmaceuticals, Formulation Development, R&D, Product Development, Process Improvement, Process Development, Process Optimization, Cross-functional Team..., Problem Solving, Manufacturing, Regulatory Submissions, Pharmaceutical Industry, Root Cause Analysis, Pharmaceutics, Sop, V&V, Aseptic Processing, Quality System, 21 CFR Part 11, Cleaning Validation, GLP, Biopharmaceuticals, GxP, LIMS, Regulatory Affairs, Change Control, Computer System..., HPLC, Biotechnology, Analytical Chemistry, Regulatory Requirements, Chromatography, LC-MS, Formulation, Trackwise, UV/Vis, Process Simulation
Education
Purdue University 1988 — 1993
Ph.D., Industrial and Physical Pharmacy
National Taiwan University
Purdue University
Impax Labs 2006 - Present
Chiron 2002 - 2006
Longwood Pharmaceuticals Inc 2000 - 2002
Copley Pharmaceutical 1996 - 2000
Proctor and Gamble Pharmaceuticals 1994 - 1996
Skills
GMP, Validation, cGMP, Technology Transfer, Process Validation, FDA, SOP, Pharmaceuticals, Formulation Development, R&D, Product Development, Process Improvement, Process Development, Process Optimization, Cross-functional Team..., Problem Solving, Manufacturing, Regulatory Submissions, Pharmaceutical Industry, Root Cause Analysis, Pharmaceutics, Sop, V&V, Aseptic Processing, Quality System, 21 CFR Part 11, Cleaning Validation, GLP, Biopharmaceuticals, GxP, LIMS, Regulatory Affairs, Change Control, Computer System..., HPLC, Biotechnology, Analytical Chemistry, Regulatory Requirements, Chromatography, LC-MS, Formulation, Trackwise, UV/Vis, Process Simulation
Education
Purdue University 1988 — 1993
Ph.D., Industrial and Physical Pharmacy
National Taiwan University
Purdue University
Donna Devens's Copley Pharmaceutical Experience January 1988 - October 1991
Job Quality Engineer, Principal at Genzyme, a Sanofi company
Industry Biotechnology
Experience
Genzyme, a Sanofi company June 2015 - Present
Genzyme March 2011 - June 2015
BOSTON SCIENTIFIC CORPORATION January 2010 - March 2011
Boston Scientific September 2008 - January 2010
Perrigo November 2004 - August 2008
Perrigo January 2001 - November 2004
Wyeth March 2000 - December 2000
Alpha-Beta Technology October 1991 - January 1999
Copley Pharmaceutical January 1988 - October 1991
Skills
Quality Assurance, FDA, CAPA, Validation, Cross-functional Team..., Six Sigma, GMP, Troubleshooting, HPLC, Biopharmaceuticals, Quality Control, R&D, Process Engineering, V&V, Regulatory Affairs, 21 CFR Part 11
Education
Northeastern University 1988 — 1991
BS, Biochemistry
Rochester Institute of Technology 1984 — 1987
Chemistry
Killingly High School 1981 — 1984
college prep
NORTHEASTERN UNIVERSITY
BACHELOR, SCIENCE BIOLOGICAL CHEMICAL TECHNOLOGY
Rochester Institute of Technology
Chemistry
Genzyme, a Sanofi company June 2015 - Present
Genzyme March 2011 - June 2015
BOSTON SCIENTIFIC CORPORATION January 2010 - March 2011
Boston Scientific September 2008 - January 2010
Perrigo November 2004 - August 2008
Perrigo January 2001 - November 2004
Wyeth March 2000 - December 2000
Alpha-Beta Technology October 1991 - January 1999
Copley Pharmaceutical January 1988 - October 1991
Skills
Quality Assurance, FDA, CAPA, Validation, Cross-functional Team..., Six Sigma, GMP, Troubleshooting, HPLC, Biopharmaceuticals, Quality Control, R&D, Process Engineering, V&V, Regulatory Affairs, 21 CFR Part 11
Education
Northeastern University 1988 — 1991
BS, Biochemistry
Rochester Institute of Technology 1984 — 1987
Chemistry
Killingly High School 1981 — 1984
college prep
NORTHEASTERN UNIVERSITY
BACHELOR, SCIENCE BIOLOGICAL CHEMICAL TECHNOLOGY
Rochester Institute of Technology
Chemistry
Gerson Archila P.'s Copley Pharmaceutical Experience 1993 - 2000
Job Pharmaceutical/Biopharmaceutical cGMP Manufacturing Expertise.
Industry Pharmaceuticals
Experience
AMRI - GLOBAL December 2013 - Present
Lonza Inc December 2010 - September 2013
Tedor Pharma Inc July 2009 - September 2010
Tedor Pharma Inc. May 2007 - June 2009
Tedor Pharma Inc. 2002 - 2007
Armstrong Pharmaceuticals Inc. 2001 - 2002
Pharmasol Corporation 2000 - 2001
Copley Pharmaceutical 1993 - 2000
Copley Pharmaceutical 1989 - 1993
Skills
cGMP, FDA, Technology Transfer, Quality Management, R&D, Validation, Coatings, Compression, DEA, GMP, Process Validation, Quality Systems, Contract Manufacturing, Lean Manufacturing, Process Development, Pharmaceuticals, Quality Auditing, Regulatory Affairs, Change Control, Pharmaceutical Industry, GLP, 21 CFR Part 11, Process Improvement, Product Development, Cleaning Validation, Quality System, Manufacturing, Regulatory Submissions, Pharmaceutics, CAPA, Formulation, Quality Control, Sop, Drug Delivery, cGMP practices, Purification, Six Sigma, Aseptic Processing, Biopharmaceuticals, Biotechnology, FDA GMP, Trackwise, Computer System..., GxP, Lifesciences, Chromatography, Analytical Chemistry, LIMS, Quality Assurance, cGMP manufacturing
Education
Universidad de San Carlos de Guatemala 1981 — 1985
Engineering Industrial
Dr, Imrich Fischmann 1976 — 1981
BS, BS in Industries and Bachelor degree in Refrigeration and Air Conditioning.
Casa Central 1972 — 1975
High School
AMRI - GLOBAL December 2013 - Present
Lonza Inc December 2010 - September 2013
Tedor Pharma Inc July 2009 - September 2010
Tedor Pharma Inc. May 2007 - June 2009
Tedor Pharma Inc. 2002 - 2007
Armstrong Pharmaceuticals Inc. 2001 - 2002
Pharmasol Corporation 2000 - 2001
Copley Pharmaceutical 1993 - 2000
Copley Pharmaceutical 1989 - 1993
Skills
cGMP, FDA, Technology Transfer, Quality Management, R&D, Validation, Coatings, Compression, DEA, GMP, Process Validation, Quality Systems, Contract Manufacturing, Lean Manufacturing, Process Development, Pharmaceuticals, Quality Auditing, Regulatory Affairs, Change Control, Pharmaceutical Industry, GLP, 21 CFR Part 11, Process Improvement, Product Development, Cleaning Validation, Quality System, Manufacturing, Regulatory Submissions, Pharmaceutics, CAPA, Formulation, Quality Control, Sop, Drug Delivery, cGMP practices, Purification, Six Sigma, Aseptic Processing, Biopharmaceuticals, Biotechnology, FDA GMP, Trackwise, Computer System..., GxP, Lifesciences, Chromatography, Analytical Chemistry, LIMS, Quality Assurance, cGMP manufacturing
Education
Universidad de San Carlos de Guatemala 1981 — 1985
Engineering Industrial
Dr, Imrich Fischmann 1976 — 1981
BS, BS in Industries and Bachelor degree in Refrigeration and Air Conditioning.
Casa Central 1972 — 1975
High School
Merck
Johnson & Johnson
GlaxoSmithKline
Bristol Myers Squibb
Eli Lilly and Company
Novartis
Abbott Laboratories
AstraZeneca