Syner-G Pharma CMC Consulting, LLC
Address: 2 Park Central Dr #110, Southborough, MA 01772 Phone: (508) 460-9700: : : Hours: : Category: : : Place name: Website: Website: http://www.synergpharma.com/ Category: Consultant Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?Add missing informationAdd business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Syner-G Pharma Consulting Posting publicly on the Web Write a review Reviews Be the first to review
Syner-G Pharma CMC Consulting, LLC List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Syner-G Pharma CMC Consulting, LLC. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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Syner-G Pharma CMC Consulting, LLC Employees
Zimmer April 2014 - Present
Syner-G Pharma CMC Consulting, LLC November 2012 - April 2014
Bulfinch temporary services - TIMI study group August 2012 - November 2012
Bristol-Myers Squibb, Princeton, New Jersey February 2010 - April 2010
Merck February 2009 - January 2010
B. Braun Medical June 2008 - December 2008
Pfizer May 2007 - June 2007
Skills
Team Leadership, Organizing, Detail Orientation, Documentation, Clinical Trial..., Clinical Data Management, Data Entry, CTMS, CMC Regulatory Affairs, IND, Software Documentation, Regulatory Affairs, CMC, Regulatory Submissions, GMP, Validation, GLP
Education
Northeastern University 2010 — 2012
Masters, Regulatory Affairs for Drugs, Biologics and Medical Devices
Dr. B. N. College 2004 — 2008
Bachelor in Pharmacy, Pharmacy
Syner-G Pharma CMC Consulting, LLC December 2013 - Present
AstraZeneca 2007 - 2012
Millennium Pharmaceuticals 2004 - 2006
Skills
Drug Discovery, Medicinal Chemistry, Organic Synthesis, Regulatory Affairs, Drug Design, Sop, Clinical Research, CMC Regulatory Affairs, Project Management, Analytical Chemistry, Quality Control, GMP, Compliance Audit
Education
Northeastern University 2011 — 2013
MS, Regulatory Affairs of Drugs, Biologics, and Medical Devices
The Ohio State University
Master's degree, Organic Chemistry
Ocular Therapeutix, Inc. April 2014 - Present
Syner-G Pharma CMC Consulting LLC April 2013 - April 2014
Novartis Consumer Health August 2012 - March 2013
Northeastern University 2010 - 2012
Aurobindo Pharma August 2009 - August 2010
Dr. Reddy's Laboratories June 2009 - June 2009
Trident Pharmaceuticals Ltd June 2008 - June 2008
Skills
IND, NDA, ANDA, MAA, Register, Informed Consent, Medical Devices, Biologics, Risk Management, CE marking, SPL, Food & Drug Law, MDR, Formulation, PMA, Regulatory Submissions, ICH-GCP, Product Development, CMC Regulatory Affairs, 510(k), Drug Listing, Publishing, eCTD, Regulatory Operations, Pharmacovigilance, FDA, Validation, Regulatory Affairs, Clinical Trials
Education
Northeastern University 2010 — 2012
Master's degree, Regulatory Affairs for Drugs, Biologics and Medical Devices
Jawaharlal Nehru Technological University 2006 — 2010
Bachelor's degree, Pharmacy
Syner-G Pharma CMC Consulting, LLC September 2011 - Present
U.S. Pharmacopeia September 2010 - Present
AVEO Oncology January 2012 - July 2012
Vertex Pharmaceuticals April 2008 - August 2011
AAPS 2007 - 2009
Cubist Pharmaceuticals 2005 - 2008
Wyeth Pharmaceuticals 2004 - 2005
Sepracor 1998 - 2004
Bristol-Myers Squibb 1991 - 1998
Skills
Regulatory Affairs, Pharmaceutics, CMC, Pharmaceutical Industry, Quality by Design, Drug Development, Regulatory Submissions, Technology Transfer, FDA, GMP, Biopharmaceuticals, Biotechnology, Regulations, Clinical Development, Product Development, CMC Regulatory Affairs, GLP, Validation, Quality Assurance, Drug Discovery, Sop, Commercialization, Clinical Trials, Change Control, Lifesciences, Drug Delivery, Analytical Chemistry, Clinical Research, IND, Medical Devices, CAPA, V&V, 21 CFR Part 11, Regulatory Requirements, HPLC, Computer System..., Management, Quality System, Compliance, Vaccines, Formulation, Pharmacology, GxP, Science based..., Applied Regulatory..., Genotox Impurities, SOP, Life Sciences
Education
Boston University - School of Management 2003 — 2004
Executive MBA, Business Administration and Management, General
Brown University 1988 — 1991
Post-Doctoral Training, Organic / Bio-organic Chemistry
Oregon State University 1983 — 1988
Ph.D., Organic Chemistry
Madras University 1977 — 1982
BSC, MSc, Chemistry
Cambridge IT Compliance LLC. March 2013 - Present
Syner-G Pharma CMC Consulting LLC September 2012 - Present
Histogenics November 2012 - March 2013
Ziopharm Oncology November 2012 - January 2013
Vertex Pharmaceuticals October 2011 - September 2012
Vertex Pharmaceuticals September 2008 - October 2011
My Piece Of Chennai January 2010 - July 2010
Bunker Hill Community College August 2008 - April 2010
Cignus Solutions LLC 2005 - January 2009
Wyeth 2006 - 2008
Skills
Entrepreneurship, Change Management, Strategic Planning, Consent Decree, Quality Assurance, Quality System, Laboratory Automation, Regulatory Guidelines, FDA, FDA GMP, 21 CFR Part 11, 21 CFR, Computer System..., Infrastructure, network qualification, ITIL, GAMP, System Design, System Testing, Business Requirements, Trackwise, Documentum, Argus Safety, ARISg, SAP, Oracle Applications, Biotechnology, GxP, GMP, Validation, Lifesciences, Change Control, Drug Development, CAPA, LIMS, Regulatory Requirements, Quality Auditing, Medical Devices, Quality Control, Technology Transfer, Sop, Pharmaceutical Industry, SOP, TrackWise, Life Sciences
Education
Babson College - Franklin W. Olin Graduate School of Business 2010 — 2012
Fast Track MBA
Texas A&M University-Corpus Christi 2002 — 2004
Masters of Science, Environmental Science
University of Madras 1996 — 2000
Bachelors in Engineering Degree, Electronics and Communication
St Bede's Anglo Indian Higher Secondary School 1983 — 1993
Higher Secondary
BioMarin Pharmaceutical Inc. February 2015 - Present
BioMarin Pharmaceutical Inc. May 2014 - February 2015
Syner-G Pharma CMC Consulting, LLC February 2013 - May 2014
Packard Consulting November 2012 - February 2013
Cubist Pharmaceuticals October 2012 - February 2013
Cubist Pharmaceuticals January 2012 - October 2012
Amgen July 2011 - October 2011
INFOCOMMONS, Northeastern University September 2010 - July 2011
Ranbaxy Laboratories Ltd. , Dewas, India June 2009 - July 2009
CHL- Apollo Hospital, Indore July 2008 - July 2008
Skills
Regulatory Affairs, Online Communications, SOP, GMP, IND, Clinical Trials, Regulatory Requirements, Excel, Microsoft Office, Document Management, CRO, Auditing, eCTD, Sop
Education
Northeastern University 2010 — 2012
Masters, Regulatory Affairs
Rajiv Gandhi Prodyogiki Vishwavidyalaya 2006 — 2010
Bachelor's, Pharmacy
Choithram School 1999 — 2005
RiconPharma LLC May 2014 - Present
Syner-G Pharma CMC Consulting, LLC March 2014 - May 2014
MCPHS University August 2013 - May 2014
MCPHS University January 2013 - May 2014
Skills
ANDAs, DMF, Annual Reports, eCTD, Regulatory Operations, Regulatory Submissions, Adobe Acrobat, ISI Toolbox, Regulatory Affairs, Regulatory Filings, Quality Assurance, Change Control, Medical Devices, Microsoft Word, Microsoft Excel, ANDA, cGMP practices, FDA, 21 CFR, Pharmaceutical Industry, Regulatory Requirements
Education
Massachusetts College of Pharmacy and Health Sciences 2013 — 2014
Master's Degree, Regulatory Affairs and Health Care Policy, 4.0/4.0
Andhra University 2008 — 2012
Bachelor's degree, Pharmacy, 3.53/4.0
Syner-G Pharma CMC Consulting, LLC August 2015 - Present
Biogen Idec May 2012 - February 2014
Biogen Idec January 2009 - May 2012
Biogen Idec January 2004 - January 2009
Skills
Biotechnology, 21 CFR Part 11, Technology Transfer, GxP, Validation, Computer System..., Change Control, LIMS, FDA, GMP, Pharmaceutical Industry, Formulation, Purification, Cell Culture, Biopharmaceuticals, Life Sciences, Drug Development
Education
Rutgers University 1982 — 1986
Bachelor's degree, Chemistry
Rutgers University-New Brunswick
Regulatory and Quality Solutions LLC (R&Q) July 2015 - Present
R&Q February 2014 - July 2015
Philips Healthcare July 2013 - February 2014
Syner-G Pharma CMC Consulting, LLC January 2013 - April 2013
Arteriocyte June 2012 - December 2012
SERVOMAX INDIA LIMITED April 2010 - May 2012
Skills
Regulatory Affairs, Quality Assurance, Quality Control, Regulatory Submissions, CE marking, FDA, Medical Devices, GMP, CAPA, Quality System, 21 CFR Part 11, Clinical Research, Biotechnology, Regulatory Requirements, IND, SOP
Education
Northeastern University 2011 — 2013
Master's degree, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs, 3.7
Jawaharlal Nehru Technological University 2007 — 2011
Bachelor's degree, Pharmacy
Medical Discovery Partners LLC June 2015 - Present
Syner-G Pharma CMC Consulting, LLC May 2014 - Present
Syner-G Pharma CMC Consulting, LLC November 2013 - April 2014
Harvard Medical School July 2007 - October 2013
Boston Children's Hospital July 2007 - October 2013
Beth Israel Deaconess Medical Center February 2001 - June 2007
NII - National Institute of Immunology July 1999 - January 2001
Education
University of Madras 1995 — 1999
Doctor of Philosophy (Ph.D.)
University of Madras 1994 — 1995
Master's degree
Syner-G Pharma CMC Consulting, LLC September 2014 - Present
Bausch + Lomb January 2010 - Present
Skills
GMP, Validation, Pharmaceutical Industry, FDA, R&D, Medical Devices, Regulatory Affairs, Technology Transfer, CAPA, Aseptic Processing, Biotechnology, Regulatory Submissions, GCP, Clinical Trials, Pharmaceutics, Quality System
Education
University of Michigan
Masters
University of Michigan
Bachelors
Syner-G Pharma CMC Consulting, LLC September 2015 - Present
Vertex Pharmaceuticals March 2013 - August 2015
Vertex Pharmaceuticals April 2012 - March 2013
Infinity Pharmaceuticals June 2011 - April 2012
AMAG Pharmaceuticals August 2010 - June 2011
AMAG Pharmaceuticals January 2009 - August 2010
Vertex Pharmaceuticals February 2008 - January 2009
Vertex Pharmaceuticals July 2005 - February 2008
Skills
HPLC, Analytical Chemistry, Pharmaceutical Industry, Validation, Chromatography, Technology Transfer, Chemistry, Gas Chromatography, Quality Assurance, Microbiology, Quality Control, Method Development, Clinical Development, Biotechnology, CAPA, GMP, Drug Discovery, Regulatory Affairs, Analytical Method..., Drug Development, GxP, 21 CFR Part 11, Laboratory, CMC, Change Control, IND, Regulatory Submissions, FDA, UV/Vis, CRO, LC-MS, Sop, Bioanalysis, Assay Development, SOP
Education
Babson College 2011 — 2015
Master of Business Administration (M.B.A.), Business Analytics and Healthcare
Union College 2001 — 2005
Bachelor of Science, Biochemistry
Syner-G Pharma CMC Consulting, LLC December 2014 - Present
Puma Biotechnology November 2011 - Present
Johnson & Johnson May 2007 - March 2012
Abraxis BioScience 2005 - 2007
Amgen 2004 - 2005
Abbott Laboratories 2002 - 2004
Fresenius Kabi February 1998 - April 2002
MPA (Meical Prouct Agency) April 1997 - February 1998
Skills
IND, eCTD, CMC, Regulatory Submissions, Regulatory Requirements, Regulatory Affairs, FDA, Regulations, Pharmaceutical Industry, Drug Development
Education
Uppsala universitet 1992 — 1996
Ms. in Pharmacy, Pharmacy
Temple University
Ironwood Pharmaceuticals April 2015 - Present
Syner-G Pharma CMC Consulting, LLC December 2013 - April 2015
Amarin Corporation February 2010 - November 2013
GTx, Inc. March 2007 - February 2010
Alkermes January 1997 - February 2007
Seragen August 1993 - January 1997
Education
Harvard University 1999 — 2003
Master's degree, Biology, General
Boston University
Bachelor's degree, Biology, General