Acusphere Company
Industry: Pharmaceutical company
DescriptionHeadquarters: Lexington, MA Founded: 1993 Subsidiaries: Acusphere ltd, Acusphere Securities Corp
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Acusphere Employees
Employee
Years
Job
Industry
Nicole D'Auteuil Nicole D'Auteuil's Acusphere Experience 2001 - 2006
Job SVP, Regulatory at Dyax Corp.
Industry Biotechnology
Experience
Dyax Corp. March 2014 - Present
Dyax Corp. August 2006 - Present
Acusphere 2001 - 2006
Genzyme 1995 - 2001
Skills
Biotechnology, Pharmaceutical Industry, Clinical Development, FDA, Lifesciences, Drug Development, Regulatory Affairs, Regulatory Submissions
Education
Colgate University
Dyax Corp. March 2014 - Present
Dyax Corp. August 2006 - Present
Acusphere 2001 - 2006
Genzyme 1995 - 2001
Skills
Biotechnology, Pharmaceutical Industry, Clinical Development, FDA, Lifesciences, Drug Development, Regulatory Affairs, Regulatory Submissions
Education
Colgate University
Steven Wieners Steven Wieners's Acusphere Experience June 2005 - April 2008
Job Senior Process Engineer at Dusa Pharmaceuticals
Industry Biotechnology
Experience
Dusa Pharmaceuticals May 2011 - Present
Anika Therapeutics April 2008 - May 2011
Acusphere June 2005 - April 2008
Duracell June 2004 - June 2005
Skills
Validation, Project Management, CAPA, Automation, Process Control, Sop, Commissioning, Technology Transfer, FDA, Process Engineering, Biotechnology, Process Simulation, Quality System, Manufacturing, GMP, Pharmaceutical Industry, V&V, SOP
Education
University of Massachusetts, Amherst 2000 — 2004
B.S., Chemical Engineering
Dusa Pharmaceuticals May 2011 - Present
Anika Therapeutics April 2008 - May 2011
Acusphere June 2005 - April 2008
Duracell June 2004 - June 2005
Skills
Validation, Project Management, CAPA, Automation, Process Control, Sop, Commissioning, Technology Transfer, FDA, Process Engineering, Biotechnology, Process Simulation, Quality System, Manufacturing, GMP, Pharmaceutical Industry, V&V, SOP
Education
University of Massachusetts, Amherst 2000 — 2004
B.S., Chemical Engineering
Lawrence Gyenes Lawrence Gyenes's Acusphere Experience October 2007 - April 2009
Job CFO at Elusys Therapeutics, Inc.
Industry Pharmaceuticals
Experience
Elusys Therapeutics, Inc. October 2013 - Present
Value Created & Realized LLC June 2013 - September 2013
Columbia Laboratories July 2009 - January 2013
Acusphere October 2007 - April 2009
Zila, Inc. March 2007 - July 2007
Savient Pharmaceuticals, Inc. August 2004 - October 2005
Reliant Pharmaceuticals, Inc. July 2001 - July 2004
DuPont Pharmaceuticals Company January 2001 - June 2001
Rand McNally & Co. February 1998 - September 2000
CompuServe Corporation April 1996 - January 1998
Skills
Investor Relations, Mergers, IPO, Joint Ventures, Fundraising, IT Management, Corporate Communications, Strategic Alliances, Management, Pharmaceutical Industry, Leadership, Mentoring, Mergers & Acquisitions, Strategy, Business Development, Due Diligence, Business Intelligence, Strategic Partnerships, Cross-functional Team..., Business Strategy, Marketing, Start-ups, Executive Management, Financial Modeling, Budgets, Strategic Planning, Financial Reporting, Managerial Finance, Sarbanes-Oxley Act, Accounting, Analysis, Forecasting, Business Planning, Auditing, Acquisition Integration, Competitive Analysis, Private Equity, Product Development, SEC filings, US GAAP, Internal Controls, Marketing Strategy, Sarbanes-Oxley, Valuation, Financial Analysis, Restructuring, Corporate Development
Education
The University of Chicago Booth School of Business 1981 — 1983
MBA, Executive Program
University of Illinois at Urbana-Champaign - College of Business 1968 — 1972
B.S., Accounting
Elusys Therapeutics, Inc. October 2013 - Present
Value Created & Realized LLC June 2013 - September 2013
Columbia Laboratories July 2009 - January 2013
Acusphere October 2007 - April 2009
Zila, Inc. March 2007 - July 2007
Savient Pharmaceuticals, Inc. August 2004 - October 2005
Reliant Pharmaceuticals, Inc. July 2001 - July 2004
DuPont Pharmaceuticals Company January 2001 - June 2001
Rand McNally & Co. February 1998 - September 2000
CompuServe Corporation April 1996 - January 1998
Skills
Investor Relations, Mergers, IPO, Joint Ventures, Fundraising, IT Management, Corporate Communications, Strategic Alliances, Management, Pharmaceutical Industry, Leadership, Mentoring, Mergers & Acquisitions, Strategy, Business Development, Due Diligence, Business Intelligence, Strategic Partnerships, Cross-functional Team..., Business Strategy, Marketing, Start-ups, Executive Management, Financial Modeling, Budgets, Strategic Planning, Financial Reporting, Managerial Finance, Sarbanes-Oxley Act, Accounting, Analysis, Forecasting, Business Planning, Auditing, Acquisition Integration, Competitive Analysis, Private Equity, Product Development, SEC filings, US GAAP, Internal Controls, Marketing Strategy, Sarbanes-Oxley, Valuation, Financial Analysis, Restructuring, Corporate Development
Education
The University of Chicago Booth School of Business 1981 — 1983
MBA, Executive Program
University of Illinois at Urbana-Champaign - College of Business 1968 — 1972
B.S., Accounting
Lena McLoughlin Lena McLoughlin's Acusphere Experience 2008 - 2009
Job Sr. Manager, Patient Marketing at Aegerion Pharmaceuticals
Industry Pharmaceuticals
Experience
Aegerion Pharmaceuticals December 2014 - Present
Dyax September 2012 - December 2014
Dyax December 2009 - August 2012
Dyax September 2008 - October 2009
SibEnzyme US, LLC October 2006 - August 2009
Acusphere 2008 - 2009
Skills
Digital Marketing, Direct to Consumer, Biopharmaceuticals, Social Media Marketing, SEM, Product Launch, Biotechnology, Pharmaceutical Industry, Strategy, Competitive Analysis, Commercialization, Product Development, Marketing, Lifesciences, FDA, Strategic Planning, Competitive Intelligence, Market Access, Global Marketing, CRM, Medical Affairs, SEO, Cross-functional..., Project Management, Immunology, Dermatology
Education
Boston University 1999 — 2003
Bachelor of Science (B.S.), Marketing/Marketing Management, General
Boston University - School of Management 1999 — 2003
Bachelor of Science, Business Administration
Aegerion Pharmaceuticals December 2014 - Present
Dyax September 2012 - December 2014
Dyax December 2009 - August 2012
Dyax September 2008 - October 2009
SibEnzyme US, LLC October 2006 - August 2009
Acusphere 2008 - 2009
Skills
Digital Marketing, Direct to Consumer, Biopharmaceuticals, Social Media Marketing, SEM, Product Launch, Biotechnology, Pharmaceutical Industry, Strategy, Competitive Analysis, Commercialization, Product Development, Marketing, Lifesciences, FDA, Strategic Planning, Competitive Intelligence, Market Access, Global Marketing, CRM, Medical Affairs, SEO, Cross-functional..., Project Management, Immunology, Dermatology
Education
Boston University 1999 — 2003
Bachelor of Science (B.S.), Marketing/Marketing Management, General
Boston University - School of Management 1999 — 2003
Bachelor of Science, Business Administration
Cecilia Juarez Cecilia Juarez's Acusphere Experience 2003 - 2005
Job Clinical Specialist In SVV Philips Healthcare
Industry Hospital & Health Care
Experience
St. Mary's Regional Medical Center MemberLAWC2008 - 2011
Acusphere 2003 - 2005
Philips Healthcare 1991 - 2005
Skills
Healthcare, Hospitals, Healthcare Management, Healthcare Information..., Medical Devices, Clinical Research, HIPAA, Customer Service, Microsoft Word, Medicine, Public Speaking, Program Development, PACS, Software Documentation, Cardiology
Education
Spokane Community College 1985 — 1987
Associate of Arts and Sciences (AAS), Cardiovascular Technology/Technologist
Colorado State University 1979 — 1983
Bachelor's degree, Anatomy Physiology
St. Mary's Regional Medical Center MemberLAWC2008 - 2011
Acusphere 2003 - 2005
Philips Healthcare 1991 - 2005
Skills
Healthcare, Hospitals, Healthcare Management, Healthcare Information..., Medical Devices, Clinical Research, HIPAA, Customer Service, Microsoft Word, Medicine, Public Speaking, Program Development, PACS, Software Documentation, Cardiology
Education
Spokane Community College 1985 — 1987
Associate of Arts and Sciences (AAS), Cardiovascular Technology/Technologist
Colorado State University 1979 — 1983
Bachelor's degree, Anatomy Physiology
Andrea Krikorian's Acusphere Experience 2003 - 2005
Job Manager, HR Services at GSI Group Inc.
Industry Medical Devices
Experience
GSI Group Inc. September 2013 - Present
Sycamore Networks December 2006 - September 2013
Acusphere 2003 - 2005
Fidelity Investments 1993 - 2002
Skills
HRIS, Talent Acquisition, Employee Relations, Performance Management, Talent Management, Recruiting, Employee Engagement, Deferred Compensation, Human Resources, Employee Benefits, Onboarding, Applicant Tracking...
Education
Curry College 1989 — 1993
Bachelor's of Arts, Management/Communications
Bentley College
Meeting Management Certificate
GSI Group Inc. September 2013 - Present
Sycamore Networks December 2006 - September 2013
Acusphere 2003 - 2005
Fidelity Investments 1993 - 2002
Skills
HRIS, Talent Acquisition, Employee Relations, Performance Management, Talent Management, Recruiting, Employee Engagement, Deferred Compensation, Human Resources, Employee Benefits, Onboarding, Applicant Tracking...
Education
Curry College 1989 — 1993
Bachelor's of Arts, Management/Communications
Bentley College
Meeting Management Certificate
Geddie John Busanovich Geddie John Busanovich's Acusphere Experience 2001 - 2002
Job Project Manager Principal at Genzyme Corporation
Industry Biotechnology
Experience
Genzyme, A Sanofi Company July 2010 - Present
Pfizer 2008 - 2010
Wyeth Pharmaceuticals 2005 - 2008
Wyeth Pharmaceuticals 2002 - 2005
Acusphere 2001 - 2002
Millipore 1997 - 2001
National Medical Care - W.R. Grace & Co. 1992 - 1997
United States Army 1975 - 1981
Skills
Pharmaceutical Industry, Biotechnology, Cross-functional Team..., FDA, Technology Transfer, Medical Devices, GMP, V&V, Sop, Protein Chemistry, Manufacturing, Change Control, Vaccines, Validation, Lifesciences, Oncology, Strategy, Biopharmaceuticals, Management, Quality Control, Pharmaceutics, CAPA, 21 CFR Part 11, Regulatory Affairs, Quality System, LIMS, GxP, GLP, Computer System..., R&D, Drug Development, SOP, Laboratory
Education
Columbia University - Columbia Business School 1982 — 1983
MBA, Finance and Operations
Cardinal Dougherty High School
University of Pennsylvania
BA, Chemistry
Genzyme, A Sanofi Company July 2010 - Present
Pfizer 2008 - 2010
Wyeth Pharmaceuticals 2005 - 2008
Wyeth Pharmaceuticals 2002 - 2005
Acusphere 2001 - 2002
Millipore 1997 - 2001
National Medical Care - W.R. Grace & Co. 1992 - 1997
United States Army 1975 - 1981
Skills
Pharmaceutical Industry, Biotechnology, Cross-functional Team..., FDA, Technology Transfer, Medical Devices, GMP, V&V, Sop, Protein Chemistry, Manufacturing, Change Control, Vaccines, Validation, Lifesciences, Oncology, Strategy, Biopharmaceuticals, Management, Quality Control, Pharmaceutics, CAPA, 21 CFR Part 11, Regulatory Affairs, Quality System, LIMS, GxP, GLP, Computer System..., R&D, Drug Development, SOP, Laboratory
Education
Columbia University - Columbia Business School 1982 — 1983
MBA, Finance and Operations
Cardinal Dougherty High School
University of Pennsylvania
BA, Chemistry
Patrick Gallagher Patrick Gallagher's Acusphere Experience May 2007 - August 2008
Job Vice President, Business Development at Noven Pharmaceuticals
Industry Pharmaceuticals
Experience
Noven Pharmaceuticals February 2010 - Present
Acusphere May 2007 - August 2008
Mylan Laboratories, Inc. September 2002 - August 2005
Mylan 2002 - 2005
Bristol Myers Squibb March 1995 - July 2002
Johnson and Johnson January 1986 - March 1995
Skills
Technology Transfer, Biotechnology, Pharmaceutical Industry, Cross-functional Team..., Mergers & Acquisitions, R&D, FDA, Business Development, Sales, Strategic Planning, Biopharmaceuticals, Medical Devices, Market Research, Regulatory Affairs, Lifesciences, Business Strategy, Managed Care, Marketing Strategy, Commercialization, Licensing, Oncology, Pharmaceutics, Drug Development, Clinical Development, Sales Effectiveness, Clinical Trials, Competitive Intelligence, Product Launch, Life Sciences
Education
University of Pennsylvania - The Wharton School 2000 — 2002
MBA, Entreprenuership, Finance
La Salle University
B.S., Business Administration
Noven Pharmaceuticals February 2010 - Present
Acusphere May 2007 - August 2008
Mylan Laboratories, Inc. September 2002 - August 2005
Mylan 2002 - 2005
Bristol Myers Squibb March 1995 - July 2002
Johnson and Johnson January 1986 - March 1995
Skills
Technology Transfer, Biotechnology, Pharmaceutical Industry, Cross-functional Team..., Mergers & Acquisitions, R&D, FDA, Business Development, Sales, Strategic Planning, Biopharmaceuticals, Medical Devices, Market Research, Regulatory Affairs, Lifesciences, Business Strategy, Managed Care, Marketing Strategy, Commercialization, Licensing, Oncology, Pharmaceutics, Drug Development, Clinical Development, Sales Effectiveness, Clinical Trials, Competitive Intelligence, Product Launch, Life Sciences
Education
University of Pennsylvania - The Wharton School 2000 — 2002
MBA, Entreprenuership, Finance
La Salle University
B.S., Business Administration
Brian Kim's Acusphere Experience 1997 - 1999
Job Senior Vice President, Business Development and Marketing at ikaSystems
Industry Hospital & Health Care
Experience
ikaSystems October 2014 - Present
ikaSystems December 2012 - October 2014
ikaSystems November 2011 - December 2012
Medco Health Solutions September 2008 - November 2011
ezw8 inc. October 2007 - May 2008
NaviMedix January 2006 - May 2007
NaviMedix September 1999 - December 2005
Acusphere 1997 - 1999
Blue Cross Blue Shield of Massachusetts 1995 - 1997
Fletcher Spaght 1993 - 1995
Skills
SaaS, Healthcare, Strategic Partnerships, Healthcare Information..., Business Development, Product Management, Process Improvement, Program Management, Product Development, Executive Management, Leadership, Cross-functional Team..., Strategic Planning, Account Management, Start-ups, Mergers & Acquisitions, Team Building, Marketing Strategy, Project Management, Strategy, Enterprise Software, Business Analysis, Product Marketing, Business Intelligence
Education
Harvard University 1989 — 1993
BA
ikaSystems October 2014 - Present
ikaSystems December 2012 - October 2014
ikaSystems November 2011 - December 2012
Medco Health Solutions September 2008 - November 2011
ezw8 inc. October 2007 - May 2008
NaviMedix January 2006 - May 2007
NaviMedix September 1999 - December 2005
Acusphere 1997 - 1999
Blue Cross Blue Shield of Massachusetts 1995 - 1997
Fletcher Spaght 1993 - 1995
Skills
SaaS, Healthcare, Strategic Partnerships, Healthcare Information..., Business Development, Product Management, Process Improvement, Program Management, Product Development, Executive Management, Leadership, Cross-functional Team..., Strategic Planning, Account Management, Start-ups, Mergers & Acquisitions, Team Building, Marketing Strategy, Project Management, Strategy, Enterprise Software, Business Analysis, Product Marketing, Business Intelligence
Education
Harvard University 1989 — 1993
BA
Dustin Hewett Dustin Hewett's Acusphere Experience 2007 - 2009
Job Technical Document Writer Tech Transfer at Shire
Industry Biotechnology
Experience
Shire HGT April 2010 - Present
Hyaluron Contract Manufacturing October 2009 - March 2010
acusphere 2007 - 2009
Skills
GMP, Sop, LIMS, Aseptic Technique, Technical Writing, Aseptic Processing, Manufacturing, Clean Rooms, Deviations, Document Review, Document Management, Buffer, Trackwise, Technical Documentation, SAP, Validation, SOP, FDA, Pharmaceutical Industry, CAPA, Biotechnology, Change Control, TrackWise
Education
Mount Washington College 2002 — 2003
General
Shire HGT April 2010 - Present
Hyaluron Contract Manufacturing October 2009 - March 2010
acusphere 2007 - 2009
Skills
GMP, Sop, LIMS, Aseptic Technique, Technical Writing, Aseptic Processing, Manufacturing, Clean Rooms, Deviations, Document Review, Document Management, Buffer, Trackwise, Technical Documentation, SAP, Validation, SOP, FDA, Pharmaceutical Industry, CAPA, Biotechnology, Change Control, TrackWise
Education
Mount Washington College 2002 — 2003
General
Howard Bernstein's Acusphere Experience November 1994 - November 2008
Job
Industry Biotechnology
Experience
SQZ Biotechnologies July 2015 - Present
Seventh Sense Biosystems November 2008 - June 2015
Acusphere November 1994 - November 2008
Alkermes 1992 - 1994
Skills
Medical Devices, Biotechnology, Life Sciences, R&D, Clinical Trials, Diagnostics, Pharmaceuticals, Technology Transfer, Start-ups, Biomedical Engineering, FDA, Nanotechnology, Pharmaceutical..., Early Stage Companies, Patent Portfolio..., Drug Delivery, Technology Development, Technology Evaluation, Strategic Planning, Product Development, Alliance Management, Organizational..., Operations Management, Formulation Chemistry, Biologics, Biopharmaceuticals, Drug Development, Drug Discovery, Lifesciences, Patents, Pharmaceutical Industry, Sop, Strategic Alliances, Validation, Clinical Development
Education
Harvard Medical School 1985 — 1989
M.D.
M.I.T. 1982 — 1985
Ph.D, Chemical Engineering
M.I.T. 1981 — 1982
SM, Chemical Engineering
SQZ Biotechnologies July 2015 - Present
Seventh Sense Biosystems November 2008 - June 2015
Acusphere November 1994 - November 2008
Alkermes 1992 - 1994
Skills
Medical Devices, Biotechnology, Life Sciences, R&D, Clinical Trials, Diagnostics, Pharmaceuticals, Technology Transfer, Start-ups, Biomedical Engineering, FDA, Nanotechnology, Pharmaceutical..., Early Stage Companies, Patent Portfolio..., Drug Delivery, Technology Development, Technology Evaluation, Strategic Planning, Product Development, Alliance Management, Organizational..., Operations Management, Formulation Chemistry, Biologics, Biopharmaceuticals, Drug Development, Drug Discovery, Lifesciences, Patents, Pharmaceutical Industry, Sop, Strategic Alliances, Validation, Clinical Development
Education
Harvard Medical School 1985 — 1989
M.D.
M.I.T. 1982 — 1985
Ph.D, Chemical Engineering
M.I.T. 1981 — 1982
SM, Chemical Engineering
Brandon Leveille's Acusphere Experience August 1997 - April 2002
Job Sr. Manager, Pharmaceutical Development at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec April 2002 - Present
Acusphere August 1997 - April 2002
Skills
Biotechnology, GMP, Pharmaceutical Industry
Education
University of Notre Dame 1993 — 1997
Biogen Idec April 2002 - Present
Acusphere August 1997 - April 2002
Skills
Biotechnology, GMP, Pharmaceutical Industry
Education
University of Notre Dame 1993 — 1997
Robert Foresteire's Acusphere Experience Manufacturing TechnicianAlkermes2000 - 2002
Job Sr Tech at Acusphere
Industry Biotechnology
Experience
Acusphere Manufacturing TechnicianAlkermes2000 - 2002
Education
Middlesex Community College 1999 — 2002
Associates in Science, Biotechnology
Acusphere Manufacturing TechnicianAlkermes2000 - 2002
Education
Middlesex Community College 1999 — 2002
Associates in Science, Biotechnology
Julie Straub's Acusphere Experience 1995 - April 2009
Job Pharmaceutical Consultant
Industry Pharmaceuticals
Experience
DEI Consulting April 2009 - Present
Acusphere 1995 - April 2009
Alkermes 1989 - 1995
Harvard University 1987 - 1989
Skills
Pharmaceutical Industry, Biotechnology, Drug Delivery, Drug Discovery, Analytical Chemistry, IND, Drug Development, R&D, Regulatory Affairs, Oncology, Regulatory Submissions, Organic Chemistry, Organic Synthesis, Pharmaceutics, Project Management, Grant Writing, Technical Writing, Program Management, CTD, Pharmaceutical process..., Project Planning, Chemistry, Biopharmaceuticals, GMP, FDA, Clinical Development, Lifesciences, Clinical Trials, Protein Chemistry, GLP, HPLC, 21 CFR Part 11, Validation, Formulation, Sop, Chromatography, CRO, Change Control, Life Sciences
Education
Massachusetts Institute of Technology 1983 — 1984
Ph.D., Chemistry
Caltech 1979 — 1983
B.S. / M.S., Chemistry
DEI Consulting April 2009 - Present
Acusphere 1995 - April 2009
Alkermes 1989 - 1995
Harvard University 1987 - 1989
Skills
Pharmaceutical Industry, Biotechnology, Drug Delivery, Drug Discovery, Analytical Chemistry, IND, Drug Development, R&D, Regulatory Affairs, Oncology, Regulatory Submissions, Organic Chemistry, Organic Synthesis, Pharmaceutics, Project Management, Grant Writing, Technical Writing, Program Management, CTD, Pharmaceutical process..., Project Planning, Chemistry, Biopharmaceuticals, GMP, FDA, Clinical Development, Lifesciences, Clinical Trials, Protein Chemistry, GLP, HPLC, 21 CFR Part 11, Validation, Formulation, Sop, Chromatography, CRO, Change Control, Life Sciences
Education
Massachusetts Institute of Technology 1983 — 1984
Ph.D., Chemistry
Caltech 1979 — 1983
B.S. / M.S., Chemistry
Jaclyn Ortiz's Acusphere Experience 1999 - 2000
Job Senior Executive Assistant
Industry Management Consulting
Experience
The Boston Consulting Group May 2008 - Present
The Boston Consulting Group - Boston Office July 2012 - July 2013
The Boston Consulting Group - Boston Office November 2007 - May 2008
The Boston Consulting Group - NYC Office April 2005 - December 2006
Citizens Union November 2001 - April 2005
Deutsche Banc Alex. Brown 2000 - 2001
Acusphere 1999 - 2000
Skills
Management Consulting, Organizational Design, Strategy, Business Strategy, Project Management, Strategic Planning, Microsoft Excel, Event Planning, Research, Management, Change Management, Corporate Development, PowerPoint, Program Management, Nonprofits, Leadership, Start-ups, Mergers & Acquisitions, Social Media, Microsoft Office, Non-profits
Education
Connecticut College 1995 — 1999
BA, Cultural Anthropology
The Boston Consulting Group May 2008 - Present
The Boston Consulting Group - Boston Office July 2012 - July 2013
The Boston Consulting Group - Boston Office November 2007 - May 2008
The Boston Consulting Group - NYC Office April 2005 - December 2006
Citizens Union November 2001 - April 2005
Deutsche Banc Alex. Brown 2000 - 2001
Acusphere 1999 - 2000
Skills
Management Consulting, Organizational Design, Strategy, Business Strategy, Project Management, Strategic Planning, Microsoft Excel, Event Planning, Research, Management, Change Management, Corporate Development, PowerPoint, Program Management, Nonprofits, Leadership, Start-ups, Mergers & Acquisitions, Social Media, Microsoft Office, Non-profits
Education
Connecticut College 1995 — 1999
BA, Cultural Anthropology
Gordon Ashton's Acusphere Experience February 2005 - February 2008
Job Operations Director at Anika Therapeutics
Industry Pharmaceuticals
Experience
Anika February 2008 - Present
Acusphere February 2005 - February 2008
Repligen Corporation 2002 - 2005
Skills
GMP, FDA, Quality Assurance, Aseptic Processing, Fermentation, Purification, Aseptic Technique, R&D, Sop, Biopharmaceuticals, Biotechnology, Manufacturing, Change Control, Validation, Pharmaceutical Industry, V&V, Technology Transfer, CAPA, Clinical Trials, 21 CFR Part 11, Quality System, ISO 13485, Quality Control, GLP, Regulatory Affairs, Regulatory Submissions, Lifesciences, Process Simulation, Trackwise, Lyophilization, Quality Auditing, SOP, Life Sciences
Education
Northeastern University 1990 — 1994
Anika February 2008 - Present
Acusphere February 2005 - February 2008
Repligen Corporation 2002 - 2005
Skills
GMP, FDA, Quality Assurance, Aseptic Processing, Fermentation, Purification, Aseptic Technique, R&D, Sop, Biopharmaceuticals, Biotechnology, Manufacturing, Change Control, Validation, Pharmaceutical Industry, V&V, Technology Transfer, CAPA, Clinical Trials, 21 CFR Part 11, Quality System, ISO 13485, Quality Control, GLP, Regulatory Affairs, Regulatory Submissions, Lifesciences, Process Simulation, Trackwise, Lyophilization, Quality Auditing, SOP, Life Sciences
Education
Northeastern University 1990 — 1994
Donna Sokolski's Acusphere Experience 2000 - 2007
Job Quality Assurance Consultant at Complya Consulting Group
Industry Biotechnology
Experience
Complya Consulting Group December 2013 - Present
AMAG Pharmaceuticals, Inc. July 2011 - October 2012
AMAG Pharmaceuticals March 2009 - August 2011
Hyaluron, Inc. 2007 - 2008
Acusphere 2000 - 2007
Vertex Pharmaceuticals 1997 - 1999
Biogen, Inc. 1991 - 1993
Skills
Pharmaceuticals, 21 CFR Part 11, cGMP, FDA, GMP, Biotechnology, Quality Systems, Clinical Trials, Compliance, Quality Assurance, SOP, Clinical, Documentation, Software Documentation, Quality Control, Sop, V&V, Quality System, Change Control, Regulatory Affairs, Technology Transfer, CAPA, Drug Development, Clinical Development, Pharmaceutical Industry, Training
Education
Northeastern University
Complya Consulting Group December 2013 - Present
AMAG Pharmaceuticals, Inc. July 2011 - October 2012
AMAG Pharmaceuticals March 2009 - August 2011
Hyaluron, Inc. 2007 - 2008
Acusphere 2000 - 2007
Vertex Pharmaceuticals 1997 - 1999
Biogen, Inc. 1991 - 1993
Skills
Pharmaceuticals, 21 CFR Part 11, cGMP, FDA, GMP, Biotechnology, Quality Systems, Clinical Trials, Compliance, Quality Assurance, SOP, Clinical, Documentation, Software Documentation, Quality Control, Sop, V&V, Quality System, Change Control, Regulatory Affairs, Technology Transfer, CAPA, Drug Development, Clinical Development, Pharmaceutical Industry, Training
Education
Northeastern University
Julie Matthew's Acusphere Experience June 2004 - May 2007
Job at
Industry Biotechnology
Experience
Amgen June 2015 - Present
Amgen January 2013 - Present
Amgen January 2011 - December 2012
Amgen, Inc. July 2009 - December 2010
Amgen February 2008 - August 2008
Acusphere June 2004 - May 2007
Skills
Quality Assurance, Manufacturing, Aseptic Processing, GMP, Biotechnology, Biopharmaceuticals, Quality by Design, Lifesciences, Lyophilization, Process Engineering, Trackwise, Purification, Operational Excellence, Commercialization, Technology Transfer, Sop, Process Improvement, CAPA, Change Control, Cross-functional Team..., Pharmaceutical Industry, FDA, Quality System, Lean Manufacturing
Education
Massachusetts Institute of Technology 2007 — 2009
MS, Chemical Engineering
Massachusetts Institute of Technology - Sloan School of Management 2007 — 2009
MBA, Operations Management and Supervision
University of Massachusetts, Amherst 2000 — 2004
BS, Chemical Engineering
Amgen June 2015 - Present
Amgen January 2013 - Present
Amgen January 2011 - December 2012
Amgen, Inc. July 2009 - December 2010
Amgen February 2008 - August 2008
Acusphere June 2004 - May 2007
Skills
Quality Assurance, Manufacturing, Aseptic Processing, GMP, Biotechnology, Biopharmaceuticals, Quality by Design, Lifesciences, Lyophilization, Process Engineering, Trackwise, Purification, Operational Excellence, Commercialization, Technology Transfer, Sop, Process Improvement, CAPA, Change Control, Cross-functional Team..., Pharmaceutical Industry, FDA, Quality System, Lean Manufacturing
Education
Massachusetts Institute of Technology 2007 — 2009
MS, Chemical Engineering
Massachusetts Institute of Technology - Sloan School of Management 2007 — 2009
MBA, Operations Management and Supervision
University of Massachusetts, Amherst 2000 — 2004
BS, Chemical Engineering
Deb Forrest's Acusphere Experience 2008 - December 2009
Job Owner / Designer at Bimbimbee LLC
Industry Biotechnology
Experience
Bimbimbee LLC 2012 - Present
AMRI November 2009 - November 2012
Acusphere 2008 - December 2009
Wyeth BioPharma 2003 - 2008
Hadco 1986 - 2002
Hadco 1986 - 2002
Printed Circuit Corp 1981 - 1986
Skills
CAPA, GMP, Quality System, Quality Assurance, FDA, Aseptic Processing, Training, SPC, QA Engineering, SOP development, Calibration, Environmental Monitoring, Team Facilitation, Batchrecord review, Trackwise, Quality Control, Quality Auditing, 21 CFR Part 11, Change Control, Sop, Biotechnology, GLP, Pharmaceutical Industry, Validation, V&V, LIMS
Education
NHCTC 2002 — 2003
AS, Biotechnology
Salem State University 1976 — 1980
BA, Psychology
Bimbimbee LLC 2012 - Present
AMRI November 2009 - November 2012
Acusphere 2008 - December 2009
Wyeth BioPharma 2003 - 2008
Hadco 1986 - 2002
Hadco 1986 - 2002
Printed Circuit Corp 1981 - 1986
Skills
CAPA, GMP, Quality System, Quality Assurance, FDA, Aseptic Processing, Training, SPC, QA Engineering, SOP development, Calibration, Environmental Monitoring, Team Facilitation, Batchrecord review, Trackwise, Quality Control, Quality Auditing, 21 CFR Part 11, Change Control, Sop, Biotechnology, GLP, Pharmaceutical Industry, Validation, V&V, LIMS
Education
NHCTC 2002 — 2003
AS, Biotechnology
Salem State University 1976 — 1980
BA, Psychology
Jane Spurrell's Acusphere Experience 2006 - 2007
Job QA Engineer
Industry Medical Devices
Experience
Sunrise Labs, Inc. September 2014 - Present
Emerson Ecologics June 2010 - June 2014
PAREXEL / Perceptive Informatics, Inc. March 2009 - July 2010
Eleme Medical 2007 - 2008
Acusphere 2006 - 2007
Elbit Systems of America, KMC division 2005 - 2006
Twin Mountain Spring Water 2004 - 2005
Elbit Systems of America 2004 - 2005
Saint Anselm College 1999 - 2003
Epoxy Technology 1995 - 1997
Skills
Quality System, GMP, Quality Assurance, CAPA, Quality Control, ISO 13485, 21 CFR Part 11, Six Sigma, Sop, SPC, Manufacturing, Iso 9000, Design of Experiments, People Skills, Technical Writing, Testing, Supplier Quality, Quality Auditing
Education
Rivier College 1989 — 1991
MEd, Secondary Education
Rivier College 1978 — 1982
BS, Chemistry
Southern New Hampshire University
MS, Operations and Project Management
Sunrise Labs, Inc. September 2014 - Present
Emerson Ecologics June 2010 - June 2014
PAREXEL / Perceptive Informatics, Inc. March 2009 - July 2010
Eleme Medical 2007 - 2008
Acusphere 2006 - 2007
Elbit Systems of America, KMC division 2005 - 2006
Twin Mountain Spring Water 2004 - 2005
Elbit Systems of America 2004 - 2005
Saint Anselm College 1999 - 2003
Epoxy Technology 1995 - 1997
Skills
Quality System, GMP, Quality Assurance, CAPA, Quality Control, ISO 13485, 21 CFR Part 11, Six Sigma, Sop, SPC, Manufacturing, Iso 9000, Design of Experiments, People Skills, Technical Writing, Testing, Supplier Quality, Quality Auditing
Education
Rivier College 1989 — 1991
MEd, Secondary Education
Rivier College 1978 — 1982
BS, Chemistry
Southern New Hampshire University
MS, Operations and Project Management
Diane Palermo's Acusphere Experience 2005 - 2008
Job Quality Assurance Consultant
Industry Medical Devices
Experience
Leica Biosystems 2014 - 2015
IntelligentMDx 2012 - 2014
BG Medicine 2008 - 2012
Acusphere 2005 - 2008
Skills
FDA, Quality Assurance, Internal Audit, GMP, Biotechnology, CAPA, Quality System, Auditing, Quality Auditing, ISO 13485, Continuous Improvement, Change Control, Software Documentation, Document Management, V&V, Management, R&D, 21 CFR Part 11, Medical Devices, GLP, LIMS, Quality Control, CE marking, Clinical Trials, GxP, Immunoassays, Laboratory, Lifesciences, Sop, Validation, Design Control, Life Sciences, SOP
Education
UMass Dartmouth
Bachelor of Science (B.S.), Biology, General
Leica Biosystems 2014 - 2015
IntelligentMDx 2012 - 2014
BG Medicine 2008 - 2012
Acusphere 2005 - 2008
Skills
FDA, Quality Assurance, Internal Audit, GMP, Biotechnology, CAPA, Quality System, Auditing, Quality Auditing, ISO 13485, Continuous Improvement, Change Control, Software Documentation, Document Management, V&V, Management, R&D, 21 CFR Part 11, Medical Devices, GLP, LIMS, Quality Control, CE marking, Clinical Trials, GxP, Immunoassays, Laboratory, Lifesciences, Sop, Validation, Design Control, Life Sciences, SOP
Education
UMass Dartmouth
Bachelor of Science (B.S.), Biology, General
Merck
Johnson & Johnson
GlaxoSmithKline
Bristol Myers Squibb
Eli Lilly and Company
Novartis
Abbott Laboratories
AstraZeneca