Able Laboratories Inc
Industry: Pharmaceutical company
DescriptionFounded: 1988 People also search for: Abbott Laboratories, Synvista Therapeutics, Inc, Allergan Finance
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Able Laboratories Inc Employees
Catalent Pharma Solutions August 2011 - Present
Catalent Pharma Solutions August 2008 - August 2011
Cardinal Health November 2005 - August 2008
Able Laboratories Inc 2001 - 2005
Skills
Project Management, CRO, Cross-functional Team..., GMP, Pharmaceutical Industry, Validation, FDA, Regulatory Affairs, SOP, Change Control, 21 CFR Part 11, Quality Assurance, Clinical Trials, CAPA, Technology Transfer, Quality System, Contract Manufacturing, Microsoft Project
Education
University of Massachusetts, Amherst 1997 — 2001
Bachelor of Arts (B.A.), Political Science and Government
palm Beach Pharm Corp. March 2015 - Present
Perscriptions Plus June 2014 - February 2015
DS Laboratories Inc August 2013 - April 2014
Palm Beach Gardens Medical Center April 2013 - August 2013
Actavis, Inc. August 2007 - February 2013
North Broward Hospital District July 2004 - April 2010
Able Laboratories Inc. 2002 - 2004
Roche Diagnostics January 2002 - March 2002
LabCorp February 2001 - December 2001
ConvaTec August 1998 - March 2000
Skills
Topical Medication..., Consumer Product..., Cosmetic Product..., Consumer Product Calims..., FDA GMP, Sop, ANDAs, IV, TPN, Validation, FDA, Pharmaceutical Industry, cGLP, Labels, eCTD, Adobe Acrobat, Clinical Development, GMP, V&V, Clinical Trials, Medical Devices, ANDA, Regulatory Submissions, Chemistry, Regulatory Requirements, GLP, CAPA, 21 CFR Part 11, Change Control, Biopharmaceuticals, CRO, Drug Development, GCP, Technology Transfer, Oncology, Aseptic Processing, Lifesciences, Dissolution, NDA, Generic Programming, LIMS, Computer System..., Drug Delivery, Quality System, Protocol, Pharmaceutics, IND, ISO 13485, Trackwise, Cleaning Validation
Education
Medvance Institute-Fort Lauderdale 2004 — 2005
Diploma, Pharmacy Teachnician
Franklin Pierce College 1976 — 1980
Bachelor's degree, Biology, General
Catalent Pharma Solutions November 2012 - Present
Hemispherx BioPharma Inc. March 2010 - November 2012
Lannett Company January 2007 - January 2010
STRIDES, INC July 2005 - October 2006
ABLE LABORATORIES, Inc September 2002 - June 2005
ORTHO-CLINICAL DIAGNOSTICS, INC January 1985 - November 2001
Skills
Microsoft Access, cGMP Training, FDA Regulations, GMP, FDA, Computer System..., Access, Quality System, CAPA, 21 CFR Part 11, Validation, Sop, Quality Assurance, Manufacturing, Medical Devices, Change Control, GLP, Process Improvement, SOP, Pharmaceutics, Pharmaceutical Industry, V&V
Education
Thomas Edison State College
Attenting, Quality Assurance Management
Piscataway High School
Teva Pharmaceuticals August 2014 - Present
Caraco Pharmaceutical Laboratories April 2010 - July 2014
Caraco Pharmaceutical Laboratories November 2004 - March 2010
Able Laboratories Inc 2003 - 2004
Able Laboratories Inc 2003 - 2004
Aventis Pharma 1999 - 2003
Sun Pharmaceutical Industries, Inc. September 1996 - December 1999
Blue Cross Laboratories Ltd October 1992 - August 1996
Skills
Validation, Analytical Chemistry, ANDA, Quality Control, Method Development, Sop, GMP, HPLC, GLP, Technology Transfer, Cleaning Validation, Regulatory Affairs, Pharmaceutical Industry, FDA, Dissolution, Chemistry, Chromatography, UV, CAPA
Education
WIPO Academy 2013 — 2013
General course on intellectual property
University of Pune 1990 — 1992
MS, Chemistry
Cambrex June 2015 - Present
Actavis September 2005 - June 2015
Able Laboratories Inc October 2000 - August 2005
Sun Pharmaceuticals July 1997 - October 2000
Caraco Pharmaceutical Laboratories February 1998 - November 1998
Novartis April 1996 - July 1997
FDC Limited June 1994 - March 1996
Cipla September 1989 - June 1994
Skills
FDA, GMP, CAPA, Validation, SOP, Regulatory Affairs, Cleaning Validation, Project Management, Analytical Chemistry, Quality System, HPLC, Advertising, Drug Discovery, Regulatory Requirements, Formulation, Method Transfer, Microsoft Office, Empower, Pharmaceutical Industry, Dissolution, Supervisory Skills, Analytical Methods..., Analytical Method..., Operations Management, Technology Transfer, GLP, 21 CFR Part 11, R&D, Change Control, ANDA, Regulatory Submissions, Quality Assurance, Chromatography, Chemistry, Documentation, Management, Method Development, UV/Vis, Laboratory, Gas Chromatography, Protocol, Cross-functional Team..., Leadership, TrackWise, Product Launch, Product Development, Assay Development, Microbiology, CMC Regulatory Affairs, Training
Education
University of Mumbai 1985 — 1988
Bachelor's Degree
Ramnarain Ruia College
Post Graduate Diploma
Prin. L.N. Wellingkar Institute Of Mgt. Develop
Diploma
Boehringer Ingelheim November 2014 - Present
Boehringer Ingelheim March 2007 - October 2014
GSK September 1998 - February 2007
Able Laboratories Inc. January 1997 - August 1998
Purepac Pharmaceuticals December 1991 - December 1996
Skills
Quality by Design, Design of Experiments, Validation, Six Sigma, FDA, Pharmaceutical Industry, Change Control, Sop, Project Management, Quality System, Regulatory Submissions, Global Technology..., PAT, CMC documents, 21 CFR Part 11, CAPA, Formulation, SOP
Education
University of Tennessee-Knoxville 1990 — 1992
MS
Gujarat University 1984 — 1988
BS
RAPS
Regulatory Affairs Certificate
Xavier University
Xavier University
Encompass Elements 2014 - Present
Infodrivensolutions.LLC 2014 - Present
SDI 2014 - 2014
Gallus BioPharmaceuticals 2011 - 2014
Tris Pharma 2010 - 2011
Tris Pharma 2006 - 2010
KVD Pharma Inc., 2005 - 2005
Able Laboratories Inc 2004 - 2005
Ernst & Young 2004 - 2004
Skills
Server Architecture, XP, Disaster Recovery, SAN, VMware, Servers, Empower, shima, perki, Network Security, Sonicwall, 21 CFR Part 11, FDA GMP, GLP, IQ, PQS, Mac OS, Management, Group Policy, IT Strategy, IT Operations, QuickBooks, Microsoft Exchange, Active Directory, SOP development, Historian, SCADA, FMEA, Storage, Enterprise Architecture, Information Technology, Technical Support, Change Control, Validation, VMware ESX, Networking, Infrastructure, Business Intelligence, Process Improvement, Information Security, FDA, Storage Area Networks, Computer System..., IT Management, Vendor Management, Integration
Education
La Salle University 2013 — 2015
Master of Science (MS), Information Technology Leadership, 3.9 GPA
Enzon Pharmaceuticals June 2009 - Present
Enzon Pharmaceuticals 2002 - 2008
Johnson & Johnson Consumer Products April 2000 - April 2002
Able Laboratories July 1998 - April 2000
Able Laboratories Inc. April 1998 - August 1998
Wyeth-Ayerst Research August 1996 - February 1998
Education
Cornell University 1991 — 1995
Bachelors, Chemistry
Severn Trent Environmental Services April 2010 - Present
NYCOMED US (Altana Pharma) 2002 - 2008
Shire US Inc May 2000 - December 2001
ABLE Laboratories Inc. 1997 - November 1999
Chromak Research Inc January 1995 - January 1997
Skills
Validation, GMP, Sop, HPLC, Analytical Chemistry, Quality System, Quality Control, FDA, CAPA, Regulatory Affairs, Laboratory, Testing, Quality Auditing, Analysis, Program Management, Gas Chromatography, Training, Wet Chemistry, Calibration, Team Building
Education
State University 'Lviv Polytechnics' 1980 — 1985
MS, Chemical Engineering, Organic Chemistry