BioBridges Company
Industry: Company
DescriptionFounded: 2005 Parent organization: The Adecco Group
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BioBridges Employees
BioBridges April 2015 - Present
AMRI (Albany Molecular Research Inc.) July 2014 - April 2015
Novartis Vaccines and Diagnostics September 2011 - 2013
BIND Therapeutics September 2008 - August 2011
Momenta Pharmaceuticals December 2007 - September 2008
Acceleron Pharma, Inc. October 2004 - December 2007
Shire Pharmaceuticals 2002 - 2004
Curis 2000 - 2002
Curis 1996 - 2000
Skills
GMP, Biotechnology, FDA, Pharmaceutical Industry, Validation, CAPA, Regulatory Affairs, GLP, Sop, Technology Transfer, Regulatory Submissions, Lifesciences, Quality System, Change Control, Clinical Trials, Quality Assurance, Process Simulation, GxP, Biopharmaceuticals, Cell Culture, LIMS, Regulatory Requirements, Clinical Development, Aseptic Processing, Cleaning Validation, Analytical Chemistry, V&V, Drug Development, Quality Auditing, IND, Trackwise, GCP, SOP, Life Sciences, Conscious Business
Education
Saint Michael's College 1992 — 1996
Bachelor of Science, Biology / Philosophy
Stealth BioTherapeutics August 2015 - Present
BioBridges April 2015 - Present
Vertex Pharmaceuticals April 2015 - August 2015
Tata Consultancy Services March 2009 - December 2014
Cipla June 2008 - March 2009
Skills
Management, Team Management, CRM, Clinical Trials, Leadership, Business Development, Regulatory Affairs, Vendor Management, Regulatory Submissions, Business Analysis, Project Management, Knowledge Transfer, Process Transitioning, New Business Development, BPO, Outsourcing, Six Sigma, Resource Management, Business Process..., Win-win, Transition Management, Quality Assurance, Communication Skills, People Management, Interpersonal Skill, MIS, Client Relationship..., ICH-GCP, Pharmaceutical Industry, FDA, Clinical Research
Education
Northeastern University
Master’s Degree, Regulatory Affairs
Institute Of Technology and Management (ITM), Mumbai 2009 — 2011
Master of Business Administration (M.B.A.), Operations Management
University of Pune 2004 — 2008
Bachelor of Pharmacy (B.Pharm.), Pharmacology, Pharmaceutics, Medicinal Chemistry
BioBridges September 2015 - Present
Boston University - Metropolitan College June 2015 - Present
BioBridges, LLC 2013 - Present
Vertex Pharmaceuticals 2012 - 2013
Dyax Corp. 2010 - 2012
Dyax Corp. 2009 - 2010
Dyax Corp. 2007 - 2009
Biogen 2001 - 2007
Biogen Idec 1996 - 2001
Skills
Clinical Trials, Clinical Development, Clinical Research, Cross-functional Team..., Medical Writing, Regulatory Submissions, Drug Development, Medical Education, Patient Advocacy, Corporate Social..., Strategic Planning, Issue Resolution..., Life Sciences, Leadership, FDA, Drug Discovery, GCP, Molecular Biology, Regulatory Affairs, Biotechnology, Change Control
Education
Simmons School of Management 2009 — 2012
MBA
Harvard University 1998 — 2000
EdM, Education
Boston University 1995 — 1996
MA, English
University of California, Los Angeles 1992 — 1994
BA, English
BioBridges March 2015 - Present
Consultant at Johnson and Johnson November 2014 - February 2015
BioBridges 2015 - 2015
CSL Behring January 2013 - November 2014
Endo Pharmaceuticals January 2010 - January 2013
Premier Research Group November 2007 - November 2009
AstraZeneca Pharmaceuticals August 2006 - November 2007
Glaxo Smith Kline January 2006 - September 2006
Glaxo SmithKline (GSK outsource group May 2006 - August 2006
Glaxo Smith Kline May 2005 - January 2006
Skills
Clinical Data Management, EDC, CRO, Clinical Trials, CTMS, Data Management, FDA, Oncology, Clinical Development, Oracle Clinical, Pharmaceutical Industry, Therapeutic Areas, Clinical Research, GCP, CDISC, CRF design, Sop, 21 CFR Part 11, ICH-GCP, Regulatory Affairs, Drug Development, Cross-functional Team..., Biotechnology, Protocol, Validation, Inform, Infectious Diseases, Clinical Study Design, Clinical Monitoring, Regulatory Submissions, Pharmacovigilance, Life Sciences, Lifesciences, Quality Assurance, Medical Writing, Computer System..., Biopharmaceuticals, IND, GxP, Project Management, SOP
Education
Project Management Institute 2014 — 2014
Project Management Professional, Project Management
CCDM: Society For Clinical data Management 2009 — 2009
CCDM, Clinical data management certification
Campbell University 1999 — 2002
Clinical Research
Coe College 1989 — 1993
BA, Biology and Material Science
Coe College 1989 — 1992
BA, Biology
Visva-Bharati 1985 — 1989
Mathematics and
Wake Forest University
BioBridges June 2015 - Present
BioBridges January 2015 - June 2015
BioBridges August 2013 - December 2014
PPD July 2012 - August 2013
Execupharm April 2008 - June 2012
Wyeth March 2005 - April 2008
Merck 1999 - 2005
Skills
GCP, CTMS, Clinical Trials, Clinical Development, Therapeutic Areas, Pharmaceutical Industry, CRO, ICH-GCP, Infectious Diseases, Medical Affairs, EDC, Clinical Research, Sop, Regulatory Submissions, Clinical Data Management, Protocol, Clinical Monitoring, Vaccines, Medical Writing, Project Delivery, Trial Management, SOP
Education
Liberty University 1994 — 1997
B.S., Communications
BioBridges June 2013 - Present
EnVivo Pharmaceuticals August 2012 - February 2013
Alkermes, Inc. February 2011 - August 2012
Genentech July 2007 - February 2011
Organogenesis February 2006 - July 2007
MDCI January 2003 - January 2006
Bone Care International April 2001 - December 2002
Skills
Clinical Trials, Oncology, Clinical Monitoring, Clinical Development, GCP, EDC, CTMS, Pharmaceutical Industry, Medical Devices, Cross-functional Team..., Clinical Trial..., Timeline Development, Budget Estimating, Budget Forecasts, Budget Reconciliation, Vendor Management, Protocol Development, Study Reports, SOP, Biotechnology Industry, CNS disorders, Protocol, Drug Development, CRO, Sop, Clinical Operations, Dermatology, IND, ICH-GCP, Clinical Research
Education
University of Rochester 1990 — 1994
B.S., Molecular Genetics
BioBridges June 2015 - Present
Cubist Pharmaceuticals June 2013 - May 2015
Cubist Pharmaceuticals December 2012 - June 2013
Stryker Biotech July 2010 - March 2011
Stryker Biotech March 2010 - July 2010
Lantheus Medical Imaging February 2009 - February 2010
BioVex, Inc. June 2008 - January 2009
ArQule November 2007 - June 2008
Outcome 2007 - 2007
Quintiles 1998 - 2000
Education
Tufts University 1989 — 1993
Bachelor’s Degree, Psychology
Boston Latin School 1983 — 1989
Boston Engineering January 2015 - Present
ETIAM July 2013 - December 2014
ETIAM March 2013 - June 2013
BioBridges September 2012 - February 2013
AwareManager/Database International Group October 2011 - July 2012
Matrix Medical Technologies October 2010 - October 2011
Continuing Education Group October 2009 - July 2010
Genisys Medical Management Services February 2008 - September 2009
Mizuho America May 2005 - January 2008
Integra April 2002 - April 2005
Skills
Product Development, Medical Devices, Clinical Development, Biotechnology, Clinical Trials, Regulatory Affairs, Capital Equipment, Cardiology, Clinical Research, Product Launch, Hospitals, Market Development, Healthcare, Oncology, Cross-functional Team..., FDA, Business Development, Pharmaceutical Industry
Education
Skidmore College 1985 — 1988
BA, Business Administration