RenaMed Biologics
Industry: Company
DescriptionFounded: 1994
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RenaMed Biologics Employees
O'Neill Consulting Group October 2013 - Present
Rubenesque May 2012 - Present
IBG Productions March 2010 - Present
Business Consultant 2006 - 2012
RenaMed Biologics August 2003 - October 2006
WYETH Pharmaceuticals August 1999 - July 2003
University of Rhode Island 1996 - 1999
Skills
Public Speaking, Leadership, Budgets, Event Planning, Microsoft Excel, Microsoft Word, Business Planning, Acting, Microsoft Publisher, QuickBooks, Art Direction, Multi-line Phone, Creative Writing, Workshop Facilitation, Stage Management, Editing, Communication Skills, Musical Theatre, Singing, Expense Management, PowerPoint, Outlook, Time Management, Management Contracts, Sewing, Fashion Design, Fashion Shows, Theatrical Production, Music Publishing, Expense Reports, Music Production, Management Consulting
Education
University of Rhode Island
Bachelor's Degree, Business Administration
S.K. High
Medtronic June 2015 - Present
Advent Global Solutions July 2014 - March 2015
AmWINS Group Benefits July 2012 - February 2014
Petro Home Services August 2010 - January 2012
Blue Cross & Blue Shield of Rhode Island November 2009 - August 2010
Bank of America June 2006 - September 2009
RenaMed Biologics November 2004 - June 2006
Skills
Internet, Microsoft Office, Data Entry, Information Technology, Operational Efficiency, Software Documentation, Customer Satisfaction, Customer Service, Sales, Telephone Skills, Call Centers, Computer Hardware, Follow Through, Database Administration, Organization, Teamwork, Microsoft Excel, Employee Benefits, Health Insurance, Insurance, Account Management, GMP, cGMP practices, Sanitation, Facilities Operations, Leadership, PowerPoint, SOP, Documentation, Social Networking, Web Design, Computer Graphics Design, HTML
Education
Community College of Rhode Island 2012 — 2015
Industrial Certificate, Biotechnology
William M. Davies, Jr. Career & Technical High School 1997 — 2001
Trade Certificate, Business & Computer Technology
Red Sky Partners 2009 - Present
Proteon Therapeutics 2008 - Present
Charles River School, Dover, MA 2005 - Present
EPIX Pharmaceuticals 2004 - 2009
RenaMed Biologics 2004 - 2007
Dyax 1998 - 2002
Genzyme 1991 - 1997
Education
Harvard Business School 1973 — 1975
MBA, Business Administration
Bradley University 1967 — 1971
BSEE, Electrical Engineering
uniQure 2014 - 2015
BioCompass, Inc. (formerly Audit QCS, LLC) 2007 - 2014
Transport Pharmaceuticals 2006 - 2007
RenaMed Biologics 2005 - 2006
Boston Scientific 2003 - 2005
Stryker 2001 - 2003
AstraZeneca 1997 - 2001
Skills
GMP, Validation, FDA, Sop, CAPA, V&V, Pharmaceutical Industry, Technology Transfer, Quality System, Quality Assurance, 21 CFR Part 11, Change Control, GLP, Biotechnology, Analytical Chemistry, Quality Auditing, Medical Devices, Biopharmaceuticals, SOP, Regulatory Submissions
Education
Massachusetts Institute of Technology - Sloan School of Management 2015 — 2017
Candidate for Executive MBA
Boston College
BS, Chemistry, Pre-Med
Precision Additives January 2014 - Present
Independence Oilfield Chemicals, LLC August 2013 - December 2013
C&J Energy Services, Inc. March 2011 - July 2013
Bionovo, Inc. March 2008 - September 2010
Amgen February 2006 - November 2007
RenaMed Biologics July 2005 - February 2006
Skills
GMP, Biotechnology, Biopharmaceuticals, Chemistry, Sop, Validation, V&V, R&D, Analytical Chemistry, Manufacturing, Microbiology, Cell Culture, Product Development, FDA, Lifesciences, Technology Transfer, Filtration, LIMS, Change Control, Chromatography, Life Sciences, Engineering, SOP
Education
University of Rhode Island 2000 — 2004
B.S., Biology Major, Chemistry Minor
University of Rhode Island 2000 — 2004
Bachelor of Science (B.S.), Biology, General
Allchem Industries September 2005 - Present
RenaMed Biologics August 2004 - August 2005
Virginia Industries 2002 - 2004
Kewill Software 1999 - 2001
Virginia Industries 1997 - 1999
Skills
ERP, Great Plains, Solomon, EDI, Great Plains Software, Supply Chain Management, Logistics, Manufacturing, MRP, Inventory Management, Customer Relations, JD Edwards, Supply Chain, Process Engineering, Microsoft Dynamics, Business Intelligence, Lean Manufacturing, Purchasing, PeopleSoft, Production Planning, Microsoft Office, Continuous Improvement, Procurement, Warehousing, Strategic Planning, Business Analysis, BPCS, Materials Management, Business Process, Financials, Siebel, Warehouse Management
Education
Quinnipiac University 1993 — 1996
Bachelors, Computer Science
Waterbury State Technical College 1990 — 1992
Associates, Information Systems
Insulet Corporation June 2013 - Present
Tandem Diabetes Care July 2010 - June 2013
Covidien March 2007 - May 2010
RenaMed Biologics November 2005 - November 2006
Kinetic Concepts Inc July 2003 - November 2005
Siemens Medical Solutions May 2001 - December 2001
Skills
Biomedical Engineering, Design of Experiments, Medical Devices, Validation, Labview, R&D, Matlab, Clinical Development, Product Development, Data Acquisition, Cross-functional Team..., FDA, CAPA, Lifesciences, Biomaterials, Quality System, GMP, V&V, Technology Transfer, Medical Device R&D, Design Control, Manufacturing, Testing, ISO 13485, Biotechnology, Commercialization, Engineering, Process Simulation, Design for Manufacturing, FMEA, Product Launch, Injection Molding, ISO 14971, Minitab, Process Engineering, Manufacturing..., Six Sigma
Education
Clarence High School
Manipal Academy of Higher Education
B.E
Texas A&M University
Masters
Avalanche Biotechnologies, Inc. January 2015 - Present
Self-Employed August 2013 - December 2014
Ceregene, Inc October 2007 - August 2013
RenaMed Biologics October 2001 - April 2007
University of Michigan Health System 1993 - September 2001
Skills
Biotechnology, GMP, FDA, Validation, Lifesciences, Technology Transfer, Quality System, Quality Assurance, Quality Control, Facility Start-up, Gene Therapy, Cell Therapy, Staff Development, Vendor Management, Regulatory Requirements, Microbiology, Medical Devices, Molecular Biology, ELISA, PCR
Education
University of Michigan 1988 — 1992
B.S., Chemical Engineering
Envivo Pharmaceuticals 2008 - 2014
GTC Biotherapeutics 2007 - 2007
RenaMed Biologics 2006 - 2007
Bioscience Associates, LTD. 2004 - 2006
Biopure 1988 - 2004
Baxter International Inc. 1987 - 1987
Rush University Medical Center 1985 - 1987
Rush University Medical Center 1983 - 1985
Education
Antioch College
Bachelor of Science (B.S.), Mathematics and Chemistry
The University of Connecticut Health Center
Doctor of Philosophy (Ph.D.), Biomedical Sciences, Immunology
Baxter Healthcare August 2015 - Present
Gambro July 2013 - Present
CytoPherx, Inc February 2009 - July 2013
PLC Medical Systems May 2007 - February 2009
RenaMed Biologics July 2003 - May 2007
Vitagen September 2002 - July 2003
Massachusetts Genaral Hospital September 1996 - July 2003
Skills
Medical Devices, Biotechnology, Regulatory Affairs, Clinical Research, Healthcare, Clinical Support, CRO, Clinical Development, Clinical Trials, Lifesciences, Pharmaceutical Industry, FDA, Hospitals, Regulatory Submissions, Biomedical Engineering, Cardiology, Life Sciences, ISO 13485, Oncology
Education
Salem State College 1992 — 1996
BSN, RN
Alexion Pharmaceuticals February 2007 - Present
RenaMed Biologics October 2004 - November 2006
CVS Pharmacy November 2002 - October 2004
Skills
Biotechnology, Quality System, Pharmaceutical Industry, ELISA, Cell Culture, Sop, GMP, Biopharmaceuticals, Cell, Aseptic Processing, Validation, FDA, LIMS, Technology Transfer, GLP, V&V, Fermentation, CAPA, Aseptic Technique, Change Control, Vaccines
Education
Community College of Rhode Island 2003 — 2005
University of Rhode Island
Provia Laboratories: Store-A-Tooth 2010 - Present
Alumni Association - Cornell College of Agriculture & Life Sciences June 2009 - Present
Air Systems Technologies, Inc. April 2007 - Present
RenaMed Biologics 2006 - 2007
ViaCell, Inc. 2005 - 2007
Acceleron Pharma, Inc. 2004 - 2006
Osiris Therapeutics February 2004 - March 2004
James S. Sigler Biotech Consulting 2003 - 2004
Curis, Inc 2000 - 2002
Reprogenesis 1998 - 2000
Skills
Technology Transfer, FDA, Lifesciences, Biotechnology, Manufacturing, Drug Discovery, Clinical Trials, Life Sciences, Clinical Development, Oncology, Mergers & Acquisitions, Regulatory Affairs, R&D
Education
Harvard Business School 1988 — 1990
MBA
Cornell University 1977 — 1981
B.S., Biology/General Studies
Independent Biotechnology Consultant March 2014 - Present
Biogen-idec March 2012 - February 2014
Stromedix Inc. June 2007 - March 2012
RenaMed Biologics December 2005 - April 2007
Amgen 1998 - 2004
Emory University School of Medicine July 1987 - March 1998
Harvard Medical School July 1986 - June 1987
Skills
Executive Management, Product Development, Clinical Development, Regulatory Affairs, Nephrology, Internal Medicine, Biotechnology, Drug Development, Clinical Trials, Biopharmaceuticals, Clinical Research, Translational Medicine, FDA, Regulatory Submissions, Biologics, Molecular Biology, GCP, Cross-functional Team..., Protein Chemistry, CRO, Vaccines, Pharmacovigilance, Therapeutic Areas, Pharmacology, Technology Transfer, Protocol, Pharmaceutical Sales, Medical Writing, Biostatistics, IND, Assay Development, Rheumatology, Cancer, Market Access, Health Economics, Cardiology, Endocrinology, Neuroscience, Sop, Dermatology, Clinical Study Design
Education
Harvard Medical School 1983 — 1987
Nephrology
University of Washington School of Medicine 1975 — 1979
MD, Medicine
Seattle University 1971 — 1975
BS, Psychology
Alexion Pharmaceuticals April 2007 - Present
RenaMed Biologics 2004 - 2007
RenaMed Biologics/Nephros Therapeutics 2004 - 2007
Nephros Therapeutics 2004 - 2007
Skills
GMP, Technology Transfer, Process Engineering, Biotechnology, Aseptic Technique, Biopharmaceuticals, Validation, FDA, Sop, Fermentation, CAPA, V&V, Purification, Change Control, Aseptic Processing
Education
University of California, Davis 1990 — 1993
Postdoctoral Fellow
East China University of Science and Technology 1978 — 1989
Doctor of Philosophy (PhD), Chemical and Biomolecular Engineering
Partners HealthCare June 2013 - Present
Department of Biomedical Informatics, Stanford University School of Medicine October 2011 - October 2012
Starbuck Designs September 2000 - August 2008
The Wheeler School October 2001 - September 2007
RenaMed Biologics September 2005 - November 2006
Skills
Emergency Medicine, Clinical Decision Making, Decision Analysis, Tutoring, Brewing, Science, Cell Culture, Research, ELISA, Taiko
Education
Stanford University School of Medicine 2008 — 2013
Doctor of Medicine (M.D.)
Brown University 2001 — 2005
Sc.B., Biomedical Engineering
Moravian Academy 1996 — 2000
High School Diploma, Science, Math, Spanish, Photography, Cross Country, and Juggling
Shire Pharmaceuticals April 2015 - Present
Shire February 2007 - Present
Shire HGT 2007 - Present
RenaMed Biologics 2005 - 2006
Skills
Aseptic Processing, GMP, Trackwise, Biotechnology, Sop, Biopharmaceuticals, CAPA, Validation, Technology Transfer, Change Control, Aseptic Technique, FDA, 21 CFR Part 11, LIMS, Filtration, Deviations, Quality System, Cell Culture, Cleaning Validation, GLP, SOP
Education
University of Massachusetts Dartmouth 2000 — 2002
University of Massachusetts Dartmouth
Bachelor's degree
Amgen April 2015 - Present
Amgen March 2014 - April 2015
Amgen October 2008 - February 2014
MassBiologics February 2007 - August 2008
RenaMed Biologics 2006 - 2006
Therion Biologics 2003 - 2006
Biopure 2000 - 2003
Skills
GMP, Biotechnology, CAPA, Filtration, Manufacturing, Process Simulation, FDA, Sop, Biopharmaceuticals, Technology Transfer, Validation, Purification
Education
Suffolk University
Complya Consulting Group May 2012 - Present
Ipsen May 2011 - May 2012
Genzyme January 2007 - May 2011
RenaMed Biologics 2005 - 2006
Amgen 2002 - 2005
Skills
Quality Assurance, GMP, CAPA, Change Control, FDA, 21 CFR Part 11, Validation, Sop, Biotechnology, Biopharmaceuticals, LIMS, GxP, Pharmaceutical Industry, Trackwise
Education
University of Rhode Island 1997 — 2002
Bachelor of Science (B.S.), Microbiology
Stromedix Inc June 2006 - Present
RenaMed Biologics December 2006 - April 2007
Education
Harvard Medical School 1983 — 1987
Nephrology
Mayo School of Health Sciences 1979 — 1982
Internal Medicine
University of Washington 1975 — 1979
MD, Medicine
Chiasma June 2015 - Present
Aegerion Pharmaceuticals, Inc. 2011 - 2015
Proteon Therapeutics, Inc. July 2007 - May 2011
RenaMed Biologics 2005 - 2007
Dynogen Pharmaceuticals, Inc. 2002 - 2005
WorldStreet Corporation 1998 - 2002
Diacrin 1991 - 1998
Repligen Corporation 1987 - 1991
Education
Boston College 1980 — 1984
BS
Holyoke High School
Genzyme November 2011 - Present
Genzyme July 2007 - November 2011
RenaMed Biologics March 2005 - July 2006
Genzyme December 2004 - March 2005
BiogenIdec - Cambridge Center March 2004 - December 2004
Monsanto June 2001 - October 2003
Commissioning Agents, Inc June 2000 - July 2001
Skills
CIP, Regulatory Submissions, Technology Transfer, Lifesciences, Computer System..., Environmental..., Kaizen, Lean Transformation, Purification, Quality Assurance, Quality System, Quality Control, FDA, GMP, CAPA, Change Control, Biotechnology
Education
Augusta State University
Tri-County Technical High School
Dana Farber Cancer Institute BSN programEmmanuel College2007 - 2009
RenaMed Biologics 2004 - 2006
Fresenius Medical Care January 1999 - July 2004
Fresenius Medical Care 2000 - 2004
Kendall Healthcare 1999 - 1999
Skills
ACLS, BLS, Healthcare, Inpatient, Nursing, Patient Safety
Education
Emmanuel College 2007 — 2009
BSN, Nursing
Covidien January 2014 - Present
Xcellerex October 2008 - January 2014
Lonza January 2007 - September 2008
RenaMed Biologics October 2004 - December 2006
Dowpharma November 2003 - September 2004
Pfizer Pharmaceuticals May 2002 - September 2003
Electronic Environments Corporation October 1999 - March 2002
Spalding Sports Worldwide, Inc March 1989 - September 1999
Schering-Plough Research Institute April 1996 - March 1998
Bechtel July 1995 - March 1996
Skills
Management, Troubleshooting, Human Resources, Sop, Software Documentation, HVAC, Facilities Management, Construction, Engineering, Leadership, Budgets, Recruiting, Data Center
Education
University of Massachusetts Dartmouth 1986 — 1989
BSME, Design