LTS - Lohmann Therapy Systems
Industry: Company
DescriptionFounded: 1984 Subsidiary: LTS Lohmann Therapy Systems Corporation
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LTS - Lohmann Therapy Systems Employees
Employee
Years
Job
Industry
Wieslaw Rakoczy Wieslaw Rakoczy's LTS - Lohmann Therapy Systems Experience September 1999 - June 2001
Job
Industry Pharmaceuticals
Experience
QualComp Consulting Services January 2014 - April 2014
QualComp Consulting Services June 2013 - October 2013
Merck May 2008 - December 2012
Organon September 2004 - May 2008
Organon February 2002 - September 2004
Organon June 2001 - February 2002
LTS - Lohmann Therapy Systems September 1999 - June 2001
Lamart Corporation February 1998 - September 1999
Web-Cote Ind.Inc., April 1992 - February 1998
Woodwork Enterprises January 1988 - October 1990
Skills
Sterile Manuf., LOC Manuf., Transdermal Manuf., Solid Dosage Manuf., Clean Rooms, Sanitization, BMS, Aseptic Intervention, Batch Record Review, SOP Review, Supervision, Quality Control, cGMP, QA Auditing, Process Improvement, Vendor Management, Trackwise, LIMS, SAP, QAS, BTS, Converting and Web..., Gamma Gauge Inline..., Metalwork Manufacturing, Machining, GMP, Reviews, Quality Assurance
Education
Montclair State University 2003 — 2005
Technical/Mechanical School, Sanok, Poland 1976 — 1981
Diploma
QualComp Consulting Services January 2014 - April 2014
QualComp Consulting Services June 2013 - October 2013
Merck May 2008 - December 2012
Organon September 2004 - May 2008
Organon February 2002 - September 2004
Organon June 2001 - February 2002
LTS - Lohmann Therapy Systems September 1999 - June 2001
Lamart Corporation February 1998 - September 1999
Web-Cote Ind.Inc., April 1992 - February 1998
Woodwork Enterprises January 1988 - October 1990
Skills
Sterile Manuf., LOC Manuf., Transdermal Manuf., Solid Dosage Manuf., Clean Rooms, Sanitization, BMS, Aseptic Intervention, Batch Record Review, SOP Review, Supervision, Quality Control, cGMP, QA Auditing, Process Improvement, Vendor Management, Trackwise, LIMS, SAP, QAS, BTS, Converting and Web..., Gamma Gauge Inline..., Metalwork Manufacturing, Machining, GMP, Reviews, Quality Assurance
Education
Montclair State University 2003 — 2005
Technical/Mechanical School, Sanok, Poland 1976 — 1981
Diploma
Saly Samuel Saly Samuel's LTS - Lohmann Therapy Systems Experience January 2013 - March 2015
Job Senior Technical Lead, Global Clinical Manufacturing at Celgene
Industry Pharmaceuticals
Experience
Celgene July 2015 - Present
LTS - Lohmann Therapy Systems January 2013 - March 2015
Merck June 2000 - December 2010
Alza Corporation October 1994 - June 2000
Teva Pharmaceuticals September 1992 - May 1994
Sun Refining and Marketing Company March 1990 - September 1990
Skills
GMP, Validation, FDA, Technology Transfer, V&V, Sop, Pharmaceutical Industry, R&D, Quality Assurance, Cross-functional Team..., Cleaning Validation, Process Simulation, Change Control, Lifesciences, Manufacturing, CAPA, SOP, Biopharmaceuticals, 21 CFR Part 11, GLP, Biotechnology, LIMS, Design of Experiments, Process Improvement, Process Optimization, Analytical Chemistry
Education
Rishikesh Yog Peeth, Rishikesh, India 2015 — 2015
Yoga Teacher Training/Yoga Therapy
Drexel University 1989 — 1992
B. S., Chemical Engineering
Celgene July 2015 - Present
LTS - Lohmann Therapy Systems January 2013 - March 2015
Merck June 2000 - December 2010
Alza Corporation October 1994 - June 2000
Teva Pharmaceuticals September 1992 - May 1994
Sun Refining and Marketing Company March 1990 - September 1990
Skills
GMP, Validation, FDA, Technology Transfer, V&V, Sop, Pharmaceutical Industry, R&D, Quality Assurance, Cross-functional Team..., Cleaning Validation, Process Simulation, Change Control, Lifesciences, Manufacturing, CAPA, SOP, Biopharmaceuticals, 21 CFR Part 11, GLP, Biotechnology, LIMS, Design of Experiments, Process Improvement, Process Optimization, Analytical Chemistry
Education
Rishikesh Yog Peeth, Rishikesh, India 2015 — 2015
Yoga Teacher Training/Yoga Therapy
Drexel University 1989 — 1992
B. S., Chemical Engineering
Tae (Paul) Chang Tae (Paul) Chang's LTS - Lohmann Therapy Systems Experience March 2000 - May 2001
Job Mechanical or Industrial Engineering Professional
Industry Mechanical or Industrial Engineering
Experience
E2M, Inc. August 2011 - May 2013
Pfizer March 2002 - October 2009
Pfizer May 2001 - March 2002
LTS - Lohmann Therapy Systems March 2000 - May 2001
Hayward Industries, Inc. October 1997 - March 2000
K.S. Huge Corp. May 1992 - October 1997
Skills
Production Managment, Production Support, Performance Management, Performance Improvement, Industrial Engineering, Process Engineering, Manufacturing..., Mechanical Engineering, Project Management, Process Improvement, Troubleshooting, Analytical Skills, Technical Training, Instrument Validation, CNC Programming, CNC manufacturing, SOP authoring
Education
New Jersey Institute of Technology 1994 — 1996
Bachelor's degree, Mechanical Engineering
E2M, Inc. August 2011 - May 2013
Pfizer March 2002 - October 2009
Pfizer May 2001 - March 2002
LTS - Lohmann Therapy Systems March 2000 - May 2001
Hayward Industries, Inc. October 1997 - March 2000
K.S. Huge Corp. May 1992 - October 1997
Skills
Production Managment, Production Support, Performance Management, Performance Improvement, Industrial Engineering, Process Engineering, Manufacturing..., Mechanical Engineering, Project Management, Process Improvement, Troubleshooting, Analytical Skills, Technical Training, Instrument Validation, CNC Programming, CNC manufacturing, SOP authoring
Education
New Jersey Institute of Technology 1994 — 1996
Bachelor's degree, Mechanical Engineering
Yosira Downs Yosira Downs's LTS - Lohmann Therapy Systems Experience January 2014 - Present
Job Planning Specialist at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems January 2014 - Present
LTS - Lohmann Therapy Systems April 2012 - Present
Medco Health Solutions May 2007 - March 2012
POP Displays May 2006 - May 2007
Skills
Lean Manufacturing, Process Improvement, Six Sigma, Quality Assurance, Cross-functional Team..., Root Cause Analysis, Process Engineering, Validation, Quality System, Quality Management, Operational Excellence, GMP, Continuous Improvement, Strategic Planning, CAPA, FDA, Management, Pharmaceutical Industry, Project Management, Vendor Management, Program Management
Education
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2006
Bachelor of Science (B.S.), Industrial Engineering
LTS - Lohmann Therapy Systems January 2014 - Present
LTS - Lohmann Therapy Systems April 2012 - Present
Medco Health Solutions May 2007 - March 2012
POP Displays May 2006 - May 2007
Skills
Lean Manufacturing, Process Improvement, Six Sigma, Quality Assurance, Cross-functional Team..., Root Cause Analysis, Process Engineering, Validation, Quality System, Quality Management, Operational Excellence, GMP, Continuous Improvement, Strategic Planning, CAPA, FDA, Management, Pharmaceutical Industry, Project Management, Vendor Management, Program Management
Education
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2006
Bachelor of Science (B.S.), Industrial Engineering
Anne Vogt Anne Vogt's LTS - Lohmann Therapy Systems Experience 2008 - 2009
Job Accounts Director Custom Manufacturing, at Evonik Health Care
Industry Pharmaceuticals
Experience
Evonik Degussa Corporation, Health Care Business Line June 2013 - Present
Lonza Inc. USA 2011 - June 2013
Corning Incorporated 2009 - 2011
LTS - Lohmann Therapy Systems 2008 - 2009
Freelance 2006 - 2008
Lonza inc. June 2005 - September 2006
Evonik - North America 2003 - 2005
Evonik - North America 1999 - 2003
Evonik 1995 - 1999
Skills
Chemicals, R&D, Manufacturing, Pharmaceuticals, Technology Scouting, Healthcare Industry, Biotechnology Industry, Technology Transfer, Chemistry, Pharmaceutical Industry, Organic Chemistry, Biotechnology, Lifesciences, Chemical, Contract Manufacturing, New Business Development, Organic Synthesis, Cross-functional Team..., Chemical Engineering, Market Development, Formulation, Adhesives, Drug Development, Raw Materials, Product Development, Business Development, Commercialization, Process Optimization, Market Research, Spectroscopy, Leadership, Drug Discovery, Design of Experiments, Biopharmaceuticals, Mass Spectrometry, Polymers, Drug Delivery, Pharmaceutics, Medical Devices, Life Sciences
Education
Bergische Universität Wuppertal
PhD, Organic Chemistry, Summa cum Laude
IMD (International Institute for Management Development) - Business Programs
Degussa Emerging Leaders Program
University of Waterloo
Exchange Student in Ontario, Canada, Chemistry / Chemical Engineering
Universität Paderborn
Dipl.-Chem, Chemistry
Evonik Degussa Corporation, Health Care Business Line June 2013 - Present
Lonza Inc. USA 2011 - June 2013
Corning Incorporated 2009 - 2011
LTS - Lohmann Therapy Systems 2008 - 2009
Freelance 2006 - 2008
Lonza inc. June 2005 - September 2006
Evonik - North America 2003 - 2005
Evonik - North America 1999 - 2003
Evonik 1995 - 1999
Skills
Chemicals, R&D, Manufacturing, Pharmaceuticals, Technology Scouting, Healthcare Industry, Biotechnology Industry, Technology Transfer, Chemistry, Pharmaceutical Industry, Organic Chemistry, Biotechnology, Lifesciences, Chemical, Contract Manufacturing, New Business Development, Organic Synthesis, Cross-functional Team..., Chemical Engineering, Market Development, Formulation, Adhesives, Drug Development, Raw Materials, Product Development, Business Development, Commercialization, Process Optimization, Market Research, Spectroscopy, Leadership, Drug Discovery, Design of Experiments, Biopharmaceuticals, Mass Spectrometry, Polymers, Drug Delivery, Pharmaceutics, Medical Devices, Life Sciences
Education
Bergische Universität Wuppertal
PhD, Organic Chemistry, Summa cum Laude
IMD (International Institute for Management Development) - Business Programs
Degussa Emerging Leaders Program
University of Waterloo
Exchange Student in Ontario, Canada, Chemistry / Chemical Engineering
Universität Paderborn
Dipl.-Chem, Chemistry
Robert Molinaro, RAC Robert Molinaro, RAC's LTS - Lohmann Therapy Systems Experience May 2006 - April 2007
Job Regulatory Affairs Manager at Temptime Corporation
Industry Medical Devices
Experience
Temptime Corporation August 2015 - Present
Temptime Corporation February 2013 - July 2015
Novel Ingredient Services May 2011 - January 2013
Medco Health Solutions April 2007 - May 2011
LTS - Lohmann Therapy Systems May 2006 - April 2007
Roche Molecular Systems March 2002 - April 2006
Skills
cGMP, Quality Assurance, Medical Devices, Life Sciences, SOP, GMP, FDA, CAPA, Quality Systems, Quality Management, Process Improvement, Investigations, Biotechnology, Root Cause Analysis, Cross-functional Team..., Pharmaceuticals, In Vitro Diagnostics, Regulatory Affairs, Corporate Communications, Quality System, Prescription Drugs, Supplements, Pharmaceutical Industry, Sop, Lifesciences, IVD, Validation, 21 CFR Part 11, GxP, LIMS, Change Control, GLP, Regulatory Requirements, V&V, Pharmaceutics, Quality Control, Computer System..., Quality Auditing, ISO 13485
Education
RAPS Online University 2013 — 2014
Regulatory Affairs Certificate, Medical Devices
Montclair State University 2004 — 2008
MBA, Management
Montclair State University 1997 — 2002
BS, Biology
Belleville High School
Temptime Corporation August 2015 - Present
Temptime Corporation February 2013 - July 2015
Novel Ingredient Services May 2011 - January 2013
Medco Health Solutions April 2007 - May 2011
LTS - Lohmann Therapy Systems May 2006 - April 2007
Roche Molecular Systems March 2002 - April 2006
Skills
cGMP, Quality Assurance, Medical Devices, Life Sciences, SOP, GMP, FDA, CAPA, Quality Systems, Quality Management, Process Improvement, Investigations, Biotechnology, Root Cause Analysis, Cross-functional Team..., Pharmaceuticals, In Vitro Diagnostics, Regulatory Affairs, Corporate Communications, Quality System, Prescription Drugs, Supplements, Pharmaceutical Industry, Sop, Lifesciences, IVD, Validation, 21 CFR Part 11, GxP, LIMS, Change Control, GLP, Regulatory Requirements, V&V, Pharmaceutics, Quality Control, Computer System..., Quality Auditing, ISO 13485
Education
RAPS Online University 2013 — 2014
Regulatory Affairs Certificate, Medical Devices
Montclair State University 2004 — 2008
MBA, Management
Montclair State University 1997 — 2002
BS, Biology
Belleville High School
Mark Svenjak Mark Svenjak's LTS - Lohmann Therapy Systems Experience January 2014 - November 2014
Job _ at Port Authority of NY & NJ
Industry Transportation/Trucking/Railroad
Experience
Port Authority of NY & NJ November 2014 - Present
LTS - Lohmann Therapy Systems January 2014 - November 2014
Merck September 2001 - October 2013
CM Furnaces August 2000 - September 2001
Vac-U-Max June 1996 - July 2000
Skills
PLC Allen Bradley, RSLogix, PLC Programming, HMI Programming, RSView, Control Logix, HMI design, Process Automation, Vision inspection..., Servo Control: ELAU,..., Robotics: KUKA, Fenuc,..., Siemens PLC's and HMI's, OEE Parsec TrakSYS, Validation, Cognex, Automation Direct, Omron, Keyence, CTC Interact, Argus / Leatus, Barcode, Fanuc Robots, Siemens S7-200, ACAD, FDA GMP, Sensors, GMP, FDA, Pharmaceutical Industry, Cross-functional Team..., Sop, 21 CFR Part 11, Process Improvement, Allen Bradley, Automation, Continuous Improvement, GAMP, Manufacturing, CAPA, SOP, Control Logic, Change Control
Education
Bergen Community College
Electrical, Electronic and Communications Engineering Technology/Technician
Port Authority of NY & NJ November 2014 - Present
LTS - Lohmann Therapy Systems January 2014 - November 2014
Merck September 2001 - October 2013
CM Furnaces August 2000 - September 2001
Vac-U-Max June 1996 - July 2000
Skills
PLC Allen Bradley, RSLogix, PLC Programming, HMI Programming, RSView, Control Logix, HMI design, Process Automation, Vision inspection..., Servo Control: ELAU,..., Robotics: KUKA, Fenuc,..., Siemens PLC's and HMI's, OEE Parsec TrakSYS, Validation, Cognex, Automation Direct, Omron, Keyence, CTC Interact, Argus / Leatus, Barcode, Fanuc Robots, Siemens S7-200, ACAD, FDA GMP, Sensors, GMP, FDA, Pharmaceutical Industry, Cross-functional Team..., Sop, 21 CFR Part 11, Process Improvement, Allen Bradley, Automation, Continuous Improvement, GAMP, Manufacturing, CAPA, SOP, Control Logic, Change Control
Education
Bergen Community College
Electrical, Electronic and Communications Engineering Technology/Technician
Daniel Bianco's LTS - Lohmann Therapy Systems Experience August 1999 - Present
Job Machine Operator at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems August 1999 - Present
Ciba Geigy Summit NJ October 1985 - November 1998
Skills
Validation, FDA, Quality System, GMP, Sop, Pharmaceutical Industry, Lean Manufacturing, CAPA, LIMS, Change Control, Quality Control, V&V, Aseptic Processing, Biotechnology, Calibration, Manufacturing
Education
Union County Vocational Technical School 1982 — 1984
Diploma, Radio & TV
Scotch Plains Fanwwod High School 1980 — 1982
High School Diploma
LTS - Lohmann Therapy Systems August 1999 - Present
Ciba Geigy Summit NJ October 1985 - November 1998
Skills
Validation, FDA, Quality System, GMP, Sop, Pharmaceutical Industry, Lean Manufacturing, CAPA, LIMS, Change Control, Quality Control, V&V, Aseptic Processing, Biotechnology, Calibration, Manufacturing
Education
Union County Vocational Technical School 1982 — 1984
Diploma, Radio & TV
Scotch Plains Fanwwod High School 1980 — 1982
High School Diploma
Jennifer McDermott Jennifer McDermott's LTS - Lohmann Therapy Systems Experience January 2011 - September 2011
Job Vice President & General Manager at G&W Laboratories
Industry Pharmaceuticals
Experience
G&W Laboratories July 2014 - Present
G&W Laboratories June 2014 - Present
Halo Pharmaceutical, Inc. March 2014 - June 2014
Halo Pharmaceutical, Inc. August 2013 - March 2014
Halo Pharmaceutical, Inc. December 2012 - August 2013
Halo Pharmaceutical, Inc. April 2012 - December 2012
Halo Pharmaceuticals October 2011 - April 2012
LTS - Lohmann Therapy Systems January 2011 - September 2011
Pfizer Pharmaceuticals 2007 - 2010
Pfizer 2006 - 2007
Skills
Cross-functional Team..., Six Sigma, Continuous Improvement, Manufacturing, Leadership, Management, Operational Excellence, 5S, SDLC, Quality Control, Team Building, Human Resources
Education
Iona College 2001 — 2004
MBA, Management
Rutgers University 1996 — 2001
BA, Chemistry
CPHS 1992 — 1996
G&W Laboratories July 2014 - Present
G&W Laboratories June 2014 - Present
Halo Pharmaceutical, Inc. March 2014 - June 2014
Halo Pharmaceutical, Inc. August 2013 - March 2014
Halo Pharmaceutical, Inc. December 2012 - August 2013
Halo Pharmaceutical, Inc. April 2012 - December 2012
Halo Pharmaceuticals October 2011 - April 2012
LTS - Lohmann Therapy Systems January 2011 - September 2011
Pfizer Pharmaceuticals 2007 - 2010
Pfizer 2006 - 2007
Skills
Cross-functional Team..., Six Sigma, Continuous Improvement, Manufacturing, Leadership, Management, Operational Excellence, 5S, SDLC, Quality Control, Team Building, Human Resources
Education
Iona College 2001 — 2004
MBA, Management
Rutgers University 1996 — 2001
BA, Chemistry
CPHS 1992 — 1996
Kalyn Holt Kalyn Holt's LTS - Lohmann Therapy Systems Experience February 2000 - Present
Job In Process Control Operator/ Inspector at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems February 2000 - Present
Department of Youth and Family Services September 2011 - December 2011
LibertyHealth Jersey City Medical Center September 2010 - November 2010
Community Solutions June 2010 - November 2010
Skills
Social Services, Helping Clients, Pharmaceutical Industry, Sop, Compassion, FDA, GMP, Validation, Regulatory Affairs, Sociology, Quality System, Case Managment
Education
New Jersey City University 2008 — 2012
Bachelor of Arts (BA), Sociology
LTS - Lohmann Therapy Systems February 2000 - Present
Department of Youth and Family Services September 2011 - December 2011
LibertyHealth Jersey City Medical Center September 2010 - November 2010
Community Solutions June 2010 - November 2010
Skills
Social Services, Helping Clients, Pharmaceutical Industry, Sop, Compassion, FDA, GMP, Validation, Regulatory Affairs, Sociology, Quality System, Case Managment
Education
New Jersey City University 2008 — 2012
Bachelor of Arts (BA), Sociology
Tom Schell Tom Schell's LTS - Lohmann Therapy Systems Experience November 2010 - October 2012
Job Manufacturing Manager | Process Engineer | Quality Manager
Industry Medical Devices
Experience
Amneal Pharmaceuticals May 2014 - Present
Raw Deal Inc. September 2013 - May 2014
LTS - Lohmann Therapy Systems November 2010 - October 2012
International Specialty Products January 2006 - February 2010
ISP 2006 - February 2010
ISP 2001 - 2005
ISP 1994 - 2000
ISP 1992 - 1993
ISP December 1983 - December 1991
ISP May 1982 - November 1983
Skills
Quality Assurance, GMP, Management, FDA, Validation, Manufacturing, Supply Chain Management, Quality System, Medical Devices, ERP, GLP, LIMS, Sop, Chemistry, Change Control, Regulatory Affairs, R&D, CAPA, Quality Management, V&V, Technology Transfer, Process Improvement, Cross-functional Team..., Iso 9000, Six Sigma, Process Engineering, Root Cause Analysis, Process Simulation, Testing, SAP, Lean Manufacturing, Continuous Improvement, Product Development, Quality Auditing, Quality Control, Formulation
Education
Lehigh University 1980 — 1981
MBA
Lehigh University 1972 — 1976
B.S., Chemical Engineering
Amneal Pharmaceuticals May 2014 - Present
Raw Deal Inc. September 2013 - May 2014
LTS - Lohmann Therapy Systems November 2010 - October 2012
International Specialty Products January 2006 - February 2010
ISP 2006 - February 2010
ISP 2001 - 2005
ISP 1994 - 2000
ISP 1992 - 1993
ISP December 1983 - December 1991
ISP May 1982 - November 1983
Skills
Quality Assurance, GMP, Management, FDA, Validation, Manufacturing, Supply Chain Management, Quality System, Medical Devices, ERP, GLP, LIMS, Sop, Chemistry, Change Control, Regulatory Affairs, R&D, CAPA, Quality Management, V&V, Technology Transfer, Process Improvement, Cross-functional Team..., Iso 9000, Six Sigma, Process Engineering, Root Cause Analysis, Process Simulation, Testing, SAP, Lean Manufacturing, Continuous Improvement, Product Development, Quality Auditing, Quality Control, Formulation
Education
Lehigh University 1980 — 1981
MBA
Lehigh University 1972 — 1976
B.S., Chemical Engineering
Dinah Lee Dinah Lee's LTS - Lohmann Therapy Systems Experience May 2007 - February 2008
Job Senior Scientist at Ferring Pharmaceuticals
Industry Pharmaceuticals
Experience
Ferring Pharmaceuticals March 2015 - Present
Merck February 2008 - March 2015
Schering-Plough Research Institute February 2008 - July 2012
LTS - Lohmann Therapy Systems May 2007 - February 2008
QTI April 2005 - April 2007
Skills
Dissolution
Education
Fairleigh Dickinson University-Florham Campus 2006 — 2009
MS Chemistry, Pharmaceutical Chemistry
Rutgers University-New Brunswick 2000 — 2005
BA Biology, BA Psychology, Biology, Psychology
Seton Hall University
Student in PhD Program, Chemistry - Concentration TBD
Ferring Pharmaceuticals March 2015 - Present
Merck February 2008 - March 2015
Schering-Plough Research Institute February 2008 - July 2012
LTS - Lohmann Therapy Systems May 2007 - February 2008
QTI April 2005 - April 2007
Skills
Dissolution
Education
Fairleigh Dickinson University-Florham Campus 2006 — 2009
MS Chemistry, Pharmaceutical Chemistry
Rutgers University-New Brunswick 2000 — 2005
BA Biology, BA Psychology, Biology, Psychology
Seton Hall University
Student in PhD Program, Chemistry - Concentration TBD
Greg Tsodikov Greg Tsodikov's LTS - Lohmann Therapy Systems Experience 2013 - 2014
Job Manager, Analytical Development at Aprecia Pharmaceuticals
Industry Pharmaceuticals
Experience
Aprecia Pharmaceuticals July 2014 - Present
LTS - Lohmann Therapy Systems 2013 - 2014
LTS - Lohmann Therapy Systems 2013 - 2014
Merial January 2008 - January 2013
BRISTOL-MYERS SQUIBB - Pharmaceutical Research Institute 1996 - 2008
Bristol-Myers Squibb 1996 - 2008
Skills
Pharmaceutical Industry, GMP, HPLC, Validation, GLP, Sop, FDA, Technology Transfer, Analytical Chemistry, LC-MS, Laboratory, GxP, Chromatography, Quality Control, Formulation, UV/Vis, LIMS, Dissolution, SOP
Education
Seton Hall University 1995 — 2000
Master of Science (MS), Chemistry
Seton Hall University 1990 — 1994
Bachelor of Science (B.S.), Chemistry
Aprecia Pharmaceuticals July 2014 - Present
LTS - Lohmann Therapy Systems 2013 - 2014
LTS - Lohmann Therapy Systems 2013 - 2014
Merial January 2008 - January 2013
BRISTOL-MYERS SQUIBB - Pharmaceutical Research Institute 1996 - 2008
Bristol-Myers Squibb 1996 - 2008
Skills
Pharmaceutical Industry, GMP, HPLC, Validation, GLP, Sop, FDA, Technology Transfer, Analytical Chemistry, LC-MS, Laboratory, GxP, Chromatography, Quality Control, Formulation, UV/Vis, LIMS, Dissolution, SOP
Education
Seton Hall University 1995 — 2000
Master of Science (MS), Chemistry
Seton Hall University 1990 — 1994
Bachelor of Science (B.S.), Chemistry
Lucja Orzechowski Lucja Orzechowski's LTS - Lohmann Therapy Systems Experience August 2014 - Present
Job Quality Assurance Auditor, QA at Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems August 2014 - Present
Skills
Medicinal Chemistry, Drug Discovery, Organic Synthesis, LCMS, NMR, Strategic Planning, Pharmacology, Drug Metabolism, HPLC, Technical Writing, DNA Chemistry, Technology Transfer, Organic Chemistry, Heterocyclic Chemistry, Analytical Chemistry, Drug Development, ADME, Biotechnology, Metabolism, LC-MS, Synthetic Organic..., Drug Design, Lead Change, Purification
Education
Montclair State University
M.S., Organic Chemistry
Technical University of Lodz
B.S., Biotechnology and Food Science
LTS - Lohmann Therapy Systems August 2014 - Present
Skills
Medicinal Chemistry, Drug Discovery, Organic Synthesis, LCMS, NMR, Strategic Planning, Pharmacology, Drug Metabolism, HPLC, Technical Writing, DNA Chemistry, Technology Transfer, Organic Chemistry, Heterocyclic Chemistry, Analytical Chemistry, Drug Development, ADME, Biotechnology, Metabolism, LC-MS, Synthetic Organic..., Drug Design, Lead Change, Purification
Education
Montclair State University
M.S., Organic Chemistry
Technical University of Lodz
B.S., Biotechnology and Food Science
Lauren Bobrow CQA Lauren Bobrow CQA's LTS - Lohmann Therapy Systems Experience June 2014 - Present
Job QA Compliance Specialist at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems June 2014 - Present
Pfizer 2011 - June 2014
LTS - Lohmann Therapy Systems 2014 - 2014
Pfizer 2009 - 2010
Wyeth 2008 - 2009
Vyteris September 2003 - January 2008
Schering-Plough Pharmaceuticals 1996 - 2003
Schering- Plough Corporation 1996 - 2003
Skills
Chemistry, GMP, Sop, FDA, Technology Transfer, Validation, 21 CFR Part 11, CAPA, Pharmaceutical Industry, Change Control, Analytical Chemistry, LIMS, Biotechnology, Trackwise, Quality Assurance, Laboratory, Quality Control, Gas Chromatography, Aseptic Processing, HPLC, Quality System
Education
Seton Hall University 1998 — 2002
MS, Chemistry
Montclair State University 1990 — 1996
B.S., Chemistry
LTS - Lohmann Therapy Systems June 2014 - Present
Pfizer 2011 - June 2014
LTS - Lohmann Therapy Systems 2014 - 2014
Pfizer 2009 - 2010
Wyeth 2008 - 2009
Vyteris September 2003 - January 2008
Schering-Plough Pharmaceuticals 1996 - 2003
Schering- Plough Corporation 1996 - 2003
Skills
Chemistry, GMP, Sop, FDA, Technology Transfer, Validation, 21 CFR Part 11, CAPA, Pharmaceutical Industry, Change Control, Analytical Chemistry, LIMS, Biotechnology, Trackwise, Quality Assurance, Laboratory, Quality Control, Gas Chromatography, Aseptic Processing, HPLC, Quality System
Education
Seton Hall University 1998 — 2002
MS, Chemistry
Montclair State University 1990 — 1996
B.S., Chemistry
Isabel Pinho's LTS - Lohmann Therapy Systems Experience June 2007 - Present
Job Human Resources/ Benefits at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems June 2007 - Present
Skills
Pharmaceutical Industry, Human Resources, Personnel Management, Process Improvement, Management, Payroll, Microsoft Office
Education
St. Peter's College
Bachelor's degree, Business Administration and Management, General
LTS - Lohmann Therapy Systems June 2007 - Present
Skills
Pharmaceutical Industry, Human Resources, Personnel Management, Process Improvement, Management, Payroll, Microsoft Office
Education
St. Peter's College
Bachelor's degree, Business Administration and Management, General
William Lepse's LTS - Lohmann Therapy Systems Experience January 2011 - Present
Job Mechanical Engineer at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems January 2011 - Present
Alfa Wassermann March 2006 - December 2010
Hosokawa Micron 1999 - 2006
Emcore 1996 - 1998
Skills
CAPA, V&V, Validation, FDA, GMP, Technology Transfer, Quality System, Sop, Medical Devices, R&D, Root Cause Analysis, Manufacturing, Design Control, Lean Manufacturing, Cross-functional Team..., Product Development, Process Engineering, SOP
Education
Rutgers, The State University of New Jersey-New Brunswick 1991 — 1996
Bachelor of Science (BS), Chemical Engineering
LTS - Lohmann Therapy Systems January 2011 - Present
Alfa Wassermann March 2006 - December 2010
Hosokawa Micron 1999 - 2006
Emcore 1996 - 1998
Skills
CAPA, V&V, Validation, FDA, GMP, Technology Transfer, Quality System, Sop, Medical Devices, R&D, Root Cause Analysis, Manufacturing, Design Control, Lean Manufacturing, Cross-functional Team..., Product Development, Process Engineering, SOP
Education
Rutgers, The State University of New Jersey-New Brunswick 1991 — 1996
Bachelor of Science (BS), Chemical Engineering
Brandi Kornegay's LTS - Lohmann Therapy Systems Experience February 2014 - February 2015
Job Chemist
Industry Pharmaceuticals
Experience
Water Jel technologies February 2015 - Present
LTS - Lohmann Therapy Systems February 2014 - February 2015
SGS January 2012 - July 2013
Chantilly Biopharma LLC July 2011 - December 2011
Biovail Technologies May 2005 - January 2011
Baxter BioScience September 2001 - February 2005
Education
Lincoln University 1996 — 2000
B.S., Chemistry
Water Jel technologies February 2015 - Present
LTS - Lohmann Therapy Systems February 2014 - February 2015
SGS January 2012 - July 2013
Chantilly Biopharma LLC July 2011 - December 2011
Biovail Technologies May 2005 - January 2011
Baxter BioScience September 2001 - February 2005
Education
Lincoln University 1996 — 2000
B.S., Chemistry
Gregg Mauriello's LTS - Lohmann Therapy Systems Experience July 2015 - Present
Job Validation Manager at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems July 2015 - Present
QPharma, Inc. July 2001 - July 2015
Ranbaxy 2006 - 2007
Sanofi Pasteur 2006 - 2006
Skills
Computer System..., 21 CFR Part 11
Education
University of Rhode Island 1989 — 1993
BS, Resource Management
LTS - Lohmann Therapy Systems July 2015 - Present
QPharma, Inc. July 2001 - July 2015
Ranbaxy 2006 - 2007
Sanofi Pasteur 2006 - 2006
Skills
Computer System..., 21 CFR Part 11
Education
University of Rhode Island 1989 — 1993
BS, Resource Management
Steve Amelio's LTS - Lohmann Therapy Systems Experience October 2001 - Present
Job Electrical Engineer at LTS Corp.
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems October 2001 - Present
Durr Systems, Inc. June 1990 - October 2001
Skills
Engineering, Instrumentation, Root Cause Analysis, Manufacturing, SCADA, PLC, Process Control, R&D, Validation, Six Sigma, Quality System, GMP, Project Management, Troubleshooting, Process Improvement, Process Automation, Electrical Engineering, Electricians, CAPA, Allen Bradley, Control Systems Design, Calibration, PLC Programming
Education
NJIT 1985 — 1987
Electrical and Electronics Engineering Technology
County College of Morris
Associate of Arts and Sciences (A.A.S.), Electrical and Electronics Engineering
LTS - Lohmann Therapy Systems October 2001 - Present
Durr Systems, Inc. June 1990 - October 2001
Skills
Engineering, Instrumentation, Root Cause Analysis, Manufacturing, SCADA, PLC, Process Control, R&D, Validation, Six Sigma, Quality System, GMP, Project Management, Troubleshooting, Process Improvement, Process Automation, Electrical Engineering, Electricians, CAPA, Allen Bradley, Control Systems Design, Calibration, PLC Programming
Education
NJIT 1985 — 1987
Electrical and Electronics Engineering Technology
County College of Morris
Associate of Arts and Sciences (A.A.S.), Electrical and Electronics Engineering
Fadia Alkhalil, PhD MBA's LTS - Lohmann Therapy Systems Experience October 1998 - January 2000
Job VP Global Busines Development & Strategy
Industry Pharmaceuticals
Experience
SGS Life Science Services May 2008 - Present
TUI January 2006 - December 2013
Phenomenex 2000 - 2007
LTS - Lohmann Therapy Systems October 1998 - January 2000
Pfizer 1995 - 1998
Skills
Pharmaceutical Industry, HPLC, Strategy, Validation, Analytical Chemistry, LC-MS, Lifesciences, Biotechnology, Product Development, Biopharmaceuticals, GMP, Business Development, Chromatography, Drug Discovery, FDA, Leadership, Management, Project Management, Quality Assurance, Technology Transfer, Supply Chain Management, R, Outsourcing, Pharmaceutics, Forecasting, International Sales, Mergers, Continuous Improvement, Team Management, Account Management, Cross-functional Team..., Laboratory, Team Building, Global Business..., Marketing, Market Analysis, Life Sciences, CRO, New Business Development, CAPA, Chemistry, R&D, Regulatory Affairs
Education
Université des Sciences et Technologies de Lille (Lille I) 1984 — 1989
Masters, Pharmaceutical Chemistry/Polymer Chemistry
Touro College 2002 — 2007
PhD, Business
University of Phoenix 1997 — 2000
MBA, Technology Management
SGS Life Science Services May 2008 - Present
TUI January 2006 - December 2013
Phenomenex 2000 - 2007
LTS - Lohmann Therapy Systems October 1998 - January 2000
Pfizer 1995 - 1998
Skills
Pharmaceutical Industry, HPLC, Strategy, Validation, Analytical Chemistry, LC-MS, Lifesciences, Biotechnology, Product Development, Biopharmaceuticals, GMP, Business Development, Chromatography, Drug Discovery, FDA, Leadership, Management, Project Management, Quality Assurance, Technology Transfer, Supply Chain Management, R, Outsourcing, Pharmaceutics, Forecasting, International Sales, Mergers, Continuous Improvement, Team Management, Account Management, Cross-functional Team..., Laboratory, Team Building, Global Business..., Marketing, Market Analysis, Life Sciences, CRO, New Business Development, CAPA, Chemistry, R&D, Regulatory Affairs
Education
Université des Sciences et Technologies de Lille (Lille I) 1984 — 1989
Masters, Pharmaceutical Chemistry/Polymer Chemistry
Touro College 2002 — 2007
PhD, Business
University of Phoenix 1997 — 2000
MBA, Technology Management
marilyn odee's LTS - Lohmann Therapy Systems Experience May 2000 - Present
Job documentation at LTS
Industry Health, Wellness and Fitness
Darlene Freeland's LTS - Lohmann Therapy Systems Experience October 2013 - May 2014
Job Operator Packaging at Impax Laboratories
Industry Pharmaceuticals
Experience
Impax Laboratories July 2014 - Present
LTS - Lohmann Therapy Systems October 2013 - May 2014
Merck Pharmaceuticals January 2012 - December 2012
Real House Inc September 2011 - April 2012
ASCONUMATICS January 1999 - July 2009
COMMUNICATIONS October 1987 - January 1999
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, NJHMIS, ERP, Project Planning, Software Documentation, Customer Service, Manufacturing, Continuous Improvement, Cross-functional Team..., Six Sigma, Management, MRP, Supply Chain Management, Lean Manufacturing, Product Development, Process Improvement
Education
Essex County College 2009 — 2012
Associates Degree, Human and Social Services, 3.9
Barringer High
High School Diploma, Business
Impax Laboratories July 2014 - Present
LTS - Lohmann Therapy Systems October 2013 - May 2014
Merck Pharmaceuticals January 2012 - December 2012
Real House Inc September 2011 - April 2012
ASCONUMATICS January 1999 - July 2009
COMMUNICATIONS October 1987 - January 1999
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, NJHMIS, ERP, Project Planning, Software Documentation, Customer Service, Manufacturing, Continuous Improvement, Cross-functional Team..., Six Sigma, Management, MRP, Supply Chain Management, Lean Manufacturing, Product Development, Process Improvement
Education
Essex County College 2009 — 2012
Associates Degree, Human and Social Services, 3.9
Barringer High
High School Diploma, Business
Vera Badmaev's LTS - Lohmann Therapy Systems Experience May 2000 - March 2006
Job Senior VMI Analyst at J&J
Industry Pharmaceuticals
Experience
J&J July 2006 - Present
LTS - Lohmann Therapy Systems May 2000 - March 2006
Oracle January 1997 - January 2000
Electrolux Major Appliances May 1989 - January 1997
Skills
VMI, Demand Planning, Demand Forecasting
Education
University of Bridgeport
Mathematics
J&J July 2006 - Present
LTS - Lohmann Therapy Systems May 2000 - March 2006
Oracle January 1997 - January 2000
Electrolux Major Appliances May 1989 - January 1997
Skills
VMI, Demand Planning, Demand Forecasting
Education
University of Bridgeport
Mathematics
Jerry Udud's LTS - Lohmann Therapy Systems Experience 2001 - 2007
Job SVP Compliance Testing
Industry Financial Services
Experience
Citigroup May 2010 - Present
NYSE Euronext January 2007 - May 2010
LTS - Lohmann Therapy Systems 2001 - 2007
Skills
Securities, Capital Markets, Equities, AML, Derivatives, Hedge Funds, Fixed Income, Risk Management, Banking, Financial Risk, Trading Systems, Financial Services, Financial Markets, Trading, Options, Investment Banking, Asset Management, Bloomberg, Internal Audit, USA PATRIOT Act, Operational Risk, Financial Regulation, Risk Assessment, KYC, OFAC, Fraud, Bank Secrecy Act
Education
Fairleigh Dickinson University 2004 — 2008
Master of Business Administration (MBA), Business/Commerce, General
Lviv Ivan Franko National University 1993 — 1998
Master's degree, Law
Citigroup May 2010 - Present
NYSE Euronext January 2007 - May 2010
LTS - Lohmann Therapy Systems 2001 - 2007
Skills
Securities, Capital Markets, Equities, AML, Derivatives, Hedge Funds, Fixed Income, Risk Management, Banking, Financial Risk, Trading Systems, Financial Services, Financial Markets, Trading, Options, Investment Banking, Asset Management, Bloomberg, Internal Audit, USA PATRIOT Act, Operational Risk, Financial Regulation, Risk Assessment, KYC, OFAC, Fraud, Bank Secrecy Act
Education
Fairleigh Dickinson University 2004 — 2008
Master of Business Administration (MBA), Business/Commerce, General
Lviv Ivan Franko National University 1993 — 1998
Master's degree, Law
Robert Buccino's LTS - Lohmann Therapy Systems Experience July 2013 - Present
Job Technology Transfer Manager at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems July 2013 - Present
Sanofi Pasteur December 2008 - July 2013
Unigene Laboratories, Inc. March 1999 - December 2008
Merck November 1996 - March 1999
Skills
Pharmaceutical Industry, Validation, 21 CFR Part 11, Computer System..., Change Control, GMP, Vaccines, Sop, GxP, Clinical Trials, FDA, EDC, GCP, Biotechnology, LIMS, Technology Transfer, GAMP, Project Management, HPLC, Biopharmaceuticals, Process Simulation, Chromatography, V&V, Fermentation, Design of Experiments, CAPA, GLP, Quality System, SOP
Education
University of Scranton 2011 — 2016
Master of Business Administration (MBA), Master of Business Administration
Rutgers University 1991 — 1996
BS, Chemical Engineering
LTS - Lohmann Therapy Systems July 2013 - Present
Sanofi Pasteur December 2008 - July 2013
Unigene Laboratories, Inc. March 1999 - December 2008
Merck November 1996 - March 1999
Skills
Pharmaceutical Industry, Validation, 21 CFR Part 11, Computer System..., Change Control, GMP, Vaccines, Sop, GxP, Clinical Trials, FDA, EDC, GCP, Biotechnology, LIMS, Technology Transfer, GAMP, Project Management, HPLC, Biopharmaceuticals, Process Simulation, Chromatography, V&V, Fermentation, Design of Experiments, CAPA, GLP, Quality System, SOP
Education
University of Scranton 2011 — 2016
Master of Business Administration (MBA), Master of Business Administration
Rutgers University 1991 — 1996
BS, Chemical Engineering
Thuy Nguyen's LTS - Lohmann Therapy Systems Experience April 2014 - Present
Job QC Group Leader at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems April 2014 - Present
GlaxoSmithKline May 2010 - April 2014
GlaxoSmithKline December 2007 - May 2010
GlaxoSmithKline April 2006 - December 2007
Hoffman La Roche January 2003 - April 2006
Hoffman La Roche May 2002 - January 2003
Skills
GMP, Change Control, CAPA, Sop, Pharmaceutical Industry, GLP, GxP, FDA, Biotechnology, HPLC, Technology Transfer, Quality Management, •MS Office Word, Excel..., •myLearning system, a..., •Laboratory..., •Expertise in cGMPs,..., Drug Development, V&V, Gas Chromatography, Laboratory, Protein Chemistry, LIMS, Validation, UV, Microbiology, Clinical Development, Cross-functional Team..., 21 CFR Part 11, Quality Control, Computer System..., Regulatory Requirements, UV/Vis, Formulation, Dissolution, IND, Aseptic Processing, Drug Discovery, Chemistry, cGMP practices, Deviation Management
Education
Rutgers University 1998 — 2002
Bachelor's degree, Biochemistry
LTS - Lohmann Therapy Systems April 2014 - Present
GlaxoSmithKline May 2010 - April 2014
GlaxoSmithKline December 2007 - May 2010
GlaxoSmithKline April 2006 - December 2007
Hoffman La Roche January 2003 - April 2006
Hoffman La Roche May 2002 - January 2003
Skills
GMP, Change Control, CAPA, Sop, Pharmaceutical Industry, GLP, GxP, FDA, Biotechnology, HPLC, Technology Transfer, Quality Management, •MS Office Word, Excel..., •myLearning system, a..., •Laboratory..., •Expertise in cGMPs,..., Drug Development, V&V, Gas Chromatography, Laboratory, Protein Chemistry, LIMS, Validation, UV, Microbiology, Clinical Development, Cross-functional Team..., 21 CFR Part 11, Quality Control, Computer System..., Regulatory Requirements, UV/Vis, Formulation, Dissolution, IND, Aseptic Processing, Drug Discovery, Chemistry, cGMP practices, Deviation Management
Education
Rutgers University 1998 — 2002
Bachelor's degree, Biochemistry
Karen Toscano's LTS - Lohmann Therapy Systems Experience July 2014 - Present
Job Analytical Scientist Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems July 2014 - Present
Shire Pharmaceuticals (formerly NPS Pharmaceutials) December 2013 - July 2014
SGS Life Science Services August 2012 - June 2013
Novartis Pharmaceutical Corporation 1994 - 2012
Skills
FDA, Quality Assurance, Method Development, USP, V&V, Drug Development, GLP, GMP, HPLC, Drug Discovery, LC-MS, UV/Vis, Technology Transfer, Assay Development, Cell Culture, Pharmaceutics
Education
Delaware Valley University
B.S., Animal Sciences
Maria Regina High School
Uniondale, New York
LTS - Lohmann Therapy Systems July 2014 - Present
Shire Pharmaceuticals (formerly NPS Pharmaceutials) December 2013 - July 2014
SGS Life Science Services August 2012 - June 2013
Novartis Pharmaceutical Corporation 1994 - 2012
Skills
FDA, Quality Assurance, Method Development, USP, V&V, Drug Development, GLP, GMP, HPLC, Drug Discovery, LC-MS, UV/Vis, Technology Transfer, Assay Development, Cell Culture, Pharmaceutics
Education
Delaware Valley University
B.S., Animal Sciences
Maria Regina High School
Uniondale, New York
Stephen Wargacki's LTS - Lohmann Therapy Systems Experience April 2013 - April 2015
Job Manager, Research and Development
Industry Pharmaceuticals
Experience
MonoSol Rx, LLC April 2015 - Present
LTS - Lohmann Therapy Systems April 2013 - April 2015
LTS - Lohmann Therapy Systems January 2011 - April 2013
LTS - Lohmann Therapy Systems January 2009 - December 2010
Design West Technologies, Inc. 2007 - 2008
Air Force Research Laboratory 2005 - 2007
University of Tennessee 2000 - 2005
Skills
Chemistry, Differential Scanning..., Polymers, Polymer Science, Fomulation, Design of Experiments, Process Improvement, Quality by Design, Microscopy, Thin Film Coating, GLP, ANDA, Formulation, Drug Delivery, GMP, Rheology, Polymer Chemistry, Pharmaceutical Industry, HPLC, Validation, Organic Chemistry, Chromatography, R&D, Laboratory, Technology Transfer, Gas Chromatography
Education
University of Tennessee-Knoxville 2000 — 2005
PhD., Chemistry
Cumberland College 1996 — 1999
B.S., Chemistry, Physics
MonoSol Rx, LLC April 2015 - Present
LTS - Lohmann Therapy Systems April 2013 - April 2015
LTS - Lohmann Therapy Systems January 2011 - April 2013
LTS - Lohmann Therapy Systems January 2009 - December 2010
Design West Technologies, Inc. 2007 - 2008
Air Force Research Laboratory 2005 - 2007
University of Tennessee 2000 - 2005
Skills
Chemistry, Differential Scanning..., Polymers, Polymer Science, Fomulation, Design of Experiments, Process Improvement, Quality by Design, Microscopy, Thin Film Coating, GLP, ANDA, Formulation, Drug Delivery, GMP, Rheology, Polymer Chemistry, Pharmaceutical Industry, HPLC, Validation, Organic Chemistry, Chromatography, R&D, Laboratory, Technology Transfer, Gas Chromatography
Education
University of Tennessee-Knoxville 2000 — 2005
PhD., Chemistry
Cumberland College 1996 — 1999
B.S., Chemistry, Physics
Sutapa Baksi, MS,CQA's LTS - Lohmann Therapy Systems Experience September 2013 - Present
Job Quality Assurance Auditor at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems September 2013 - Present
Skills
Compliance, Technical Writing, Technical Documentation, GMP, GLP, Quality Assurance, Quality Control, Drug Discovery, Drug Development, Drug Testing, CMC, Biotechnology, Rsearch and Development, FDA GMP, Regulatory Documentation, Trackwise, GxPharma, EDMS, Biochemistry, Immunology, Immunoassays, Validation, Kaizen, CAPA, Lean Six Sigma, Auditing, Batch Record Review, LIMS, Protein Chemistry, Technology Transfer, FDA
Education
New York Medical College
M.S
Saint Thomas Aquinas College
B.S.
LTS - Lohmann Therapy Systems September 2013 - Present
Skills
Compliance, Technical Writing, Technical Documentation, GMP, GLP, Quality Assurance, Quality Control, Drug Discovery, Drug Development, Drug Testing, CMC, Biotechnology, Rsearch and Development, FDA GMP, Regulatory Documentation, Trackwise, GxPharma, EDMS, Biochemistry, Immunology, Immunoassays, Validation, Kaizen, CAPA, Lean Six Sigma, Auditing, Batch Record Review, LIMS, Protein Chemistry, Technology Transfer, FDA
Education
New York Medical College
M.S
Saint Thomas Aquinas College
B.S.
ray maioran's LTS - Lohmann Therapy Systems Experience January 2009 - Present
Job Associate Scientist at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems January 2009 - Present
Johnson & Johnson January 2006 - December 2007
Pfizer January 2000 - January 2006
Skills
FDA, Pharmaceutical Industry, GMP, Validation, Sop, GLP, V&V, LIMS, Technology Transfer, Change Control, Formulation, HPLC, Biotechnology, SOP
Education
County College of Morris 1981 — 1982
Keystone College 1979 — 1981
ABS, Business Administration and Management, General
LTS - Lohmann Therapy Systems January 2009 - Present
Johnson & Johnson January 2006 - December 2007
Pfizer January 2000 - January 2006
Skills
FDA, Pharmaceutical Industry, GMP, Validation, Sop, GLP, V&V, LIMS, Technology Transfer, Change Control, Formulation, HPLC, Biotechnology, SOP
Education
County College of Morris 1981 — 1982
Keystone College 1979 — 1981
ABS, Business Administration and Management, General
Nishat Shakil's LTS - Lohmann Therapy Systems Experience June 2002 - Present
Job Senior Chemist at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems June 2002 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Dissolution, GLP, Chromatography
Education
Montclair State University 1994 — 1998
Bachelor of Science (BS), Biology, General
LTS - Lohmann Therapy Systems June 2002 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Dissolution, GLP, Chromatography
Education
Montclair State University 1994 — 1998
Bachelor of Science (BS), Biology, General
Nona Khaselev's LTS - Lohmann Therapy Systems Experience May 2013 - Present
Job Head of AR&D at LTS Lohmann Therapy Systems
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems May 2013 - Present
Merial August 2007 - May 2013
Bristol-Myers Squibb, New Brunswick, NJ February 2000 - August 2007
Skills
GLP, GMP, Pharmaceutical Industry, Technology Transfer, Validation, FDA, Sop, HPLC, Formulation, 21 CFR Part 11, Drug Development, Analytical Chemistry, CAPA, Quality Assurance, Chromatography, Regulatory Affairs, Pharmaceutics, Regulatory Submissions, Biotechnology, Regulatory Requirements, CMC, Change Control, IND
Education
Technion - Israel Institute of Technology 1991 — 1996
DSc/PhD, Organic Chemistry/Mass Spectrometry
LTS - Lohmann Therapy Systems May 2013 - Present
Merial August 2007 - May 2013
Bristol-Myers Squibb, New Brunswick, NJ February 2000 - August 2007
Skills
GLP, GMP, Pharmaceutical Industry, Technology Transfer, Validation, FDA, Sop, HPLC, Formulation, 21 CFR Part 11, Drug Development, Analytical Chemistry, CAPA, Quality Assurance, Chromatography, Regulatory Affairs, Pharmaceutics, Regulatory Submissions, Biotechnology, Regulatory Requirements, CMC, Change Control, IND
Education
Technion - Israel Institute of Technology 1991 — 1996
DSc/PhD, Organic Chemistry/Mass Spectrometry
Lucy Lukaszek's LTS - Lohmann Therapy Systems Experience March 2003 - March 2004
Job QC Manager at Temptime Corporation
Industry Pharmaceuticals
Experience
Temptime Corporation February 2013 - Present
Catalent Pharma Solutions November 2011 - Present
Logotech January 2009 - November 2011
Pfizer April 2004 - October 2008
LTS - Lohmann Therapy Systems March 2003 - March 2004
Union Camp/International Paper 1995 - 2002
Skills
SOP, GMP, Pharmaceutical Industry, CAPA, Validation, Change Control, FDA, 21 CFR Part 11, Quality System, Quality Control, Stability Testing, Calibration, OSHA, ISO 9001, ISO 14001, Training
Education
Montclair State University 1994 — 1998
BA
Temptime Corporation February 2013 - Present
Catalent Pharma Solutions November 2011 - Present
Logotech January 2009 - November 2011
Pfizer April 2004 - October 2008
LTS - Lohmann Therapy Systems March 2003 - March 2004
Union Camp/International Paper 1995 - 2002
Skills
SOP, GMP, Pharmaceutical Industry, CAPA, Validation, Change Control, FDA, 21 CFR Part 11, Quality System, Quality Control, Stability Testing, Calibration, OSHA, ISO 9001, ISO 14001, Training
Education
Montclair State University 1994 — 1998
BA
Richard Ragula's LTS - Lohmann Therapy Systems Experience August 2004 - April 2014
Job Consultant at RJR
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems August 2004 - April 2014
Osteotech 1996 - 2004
BioMatrix 1989 - 1995
Skills
CAPA, Validation, FDA, GMP, Sop, Quality System, V&V, Change Control, Pharmaceutical Industry, Regulatory Affairs, Technology Transfer, GxP
Education
New Jersey Institute of Technology
MS
Rutgers, The State University of New Jersey - Rutgers Business School
MBA
University of Illinois at Chicago
Bachelor of Science (BS)
LTS - Lohmann Therapy Systems August 2004 - April 2014
Osteotech 1996 - 2004
BioMatrix 1989 - 1995
Skills
CAPA, Validation, FDA, GMP, Sop, Quality System, V&V, Change Control, Pharmaceutical Industry, Regulatory Affairs, Technology Transfer, GxP
Education
New Jersey Institute of Technology
MS
Rutgers, The State University of New Jersey - Rutgers Business School
MBA
University of Illinois at Chicago
Bachelor of Science (BS)
Jane Kraska's LTS - Lohmann Therapy Systems Experience June 2000 - November 2014
Job Pursuing new opportunities in Southwest Florida
Industry Pharmaceuticals
Experience
LTS - Lohmann Therapy Systems June 2000 - November 2014
EKATO CORPORATION 1998 - 2000
Krupp Werner & Pfleiderer 1991 - 1998
Skills
Management, Inventory Management, Project Management, Budgets, Production Planning, Data Analysis, Quality System, GMP, Pharmaceutical Industry, Quality Assurance, SOP, Validation
Education
Bloomfield College
Certificate of Materials Management
William Paterson University of New Jersey
Bachelor of Applied Science (B.A.Sc.), Business Administratiion
LTS - Lohmann Therapy Systems June 2000 - November 2014
EKATO CORPORATION 1998 - 2000
Krupp Werner & Pfleiderer 1991 - 1998
Skills
Management, Inventory Management, Project Management, Budgets, Production Planning, Data Analysis, Quality System, GMP, Pharmaceutical Industry, Quality Assurance, SOP, Validation
Education
Bloomfield College
Certificate of Materials Management
William Paterson University of New Jersey
Bachelor of Applied Science (B.A.Sc.), Business Administratiion
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY