OPK Biotech, LLC

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OPK Biotech, LLC Employees

Employee
Years
Job
Industry
Tyler Hubacz Tyler Hubacz Greater Boston Area Details
Tyler Hubacz's OPK Biotech, LLC Experience January 2009 - August 2011
Job Maintenance Technician III
Industry Pharmaceuticals
Experience
Alexion Pharmaceuticals, Inc.   April 2014 - Present
Alexion Pharmaceuticals  October 2011 - Present
OPK Biotech, LLC   January 2009 - August 2011
Great Point Energy   March 2008 - August 2008

Skills
cGMP practices, Delta V, HVAC, HVAC Controls, Utilities Management, Operating Systems, Corrective Maintenance, Preventive Maintenance, WFI Systems, Rodi water systems, Plant Steam, Clean Steam, Steam Boilers, Alarm Response, Metasys Building..., CMMS Infor Management..., Wastewater Treatment, Steam, Factory, Manufacturing, Pumps, Validation, Boilers

Education
Southern New Hampshire University
Continuing Education, English Language and Literature, General

St. Anselm's College
English Language and Literature, General

Joshua Ratta Joshua Ratta Greater Boston Area Details
Joshua Ratta's OPK Biotech, LLC Experience March 2010 - October 2011
Job Validation Specialist for Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group  November 2014 - Present
Amgen  2015 - 2015
Amgen  2015 - 2015
Lyophilization Services of New England  October 2011 - November 2014
OPK Biotech, LLC   March 2010 - October 2011

Skills
Biotechnology, Molecular Biology, PCR, Cell Culture, Microbiology, Biochemistry, Purification, DNA, ELISA, Western Blotting, HPLC, Genetics, GMP, SDS-PAGE, Chromatography, Immunology, Chemistry, SOP, Fermentation, Science, Protein Purification, cGMP, Diagnostics, Cell Biology

Education
Boston University   2014 — 2018
Bachelor's Degree, Clinical Laboratory Science/Medical Technology/Technologist

Middlesex Community College   2007 — 2012
Associate's degree, Biotechnology

Middlesex Community College   2007 — 2011
As, Biotechnology

Sean O'Quinn Sean O'Quinn Boston, Massachusetts Details
Sean O'Quinn's OPK Biotech, LLC Experience May 2012 - September 2012
Job Manufacturing Engineer I at GnuBIO, Inc
Industry Mechanical or Industrial Engineering
Experience
GnuBIO, Inc  October 2014 - Present
Genzyme  September 2013 - October 2014
OPK Biotech LLC  May 2012 - September 2012

Skills
Solidworks, Matlab, COMSOL, Labview, PowerPoint, Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, Research, Teamwork, Public Speaking, C++, Java, HTML, C, Photoshop, Social Media, English, PI Processbook, AutoCAD, SolidWorks

Education
Boston University   2009 — 2013
Bachelor of Science (BS), Mechanical Engineering

Tel Aviv University   2011 — 2011
N/A, Mechanical Engineering

Raymond Terrell Raymond Terrell Greater Boston Area Details
Raymond Terrell's OPK Biotech, LLC Experience June 2010 - June 2013
Job Senior Engineer at Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group  July 2013 - Present
OPK Biotech LLC  June 2010 - June 2013
Crosspoint Engineering  September 2008 - June 2010
Biopure  1994 - 1998

Skills
Validation, Engineering, Cross-functional Team..., Automation, Biotechnology, Risk Management, Control Systems Design, Cleaning Validation, Risk Assessment, GMP, FDA, CAPA, V&V, Quality System, Change Control, Computer System..., 21 CFR Part 11, Pharmaceutical Industry

Education
University of New Hampshire

Richard Rege Richard Rege Greater Boston Area Details
Richard Rege's OPK Biotech, LLC Experience January 2012 - April 2013
Job Sr. Capital Project Engineer at Shire Pharmaceuticals
Industry Pharmaceuticals
Experience
Shire Pharmaceuticals  December 2013 - Present
OPK Biotech, LLC   January 2012 - April 2013
Parsons  January 2001 - December 2011
CDI / Herzog Hart   May 1988 - January 2001
Koch Membrane Systems  May 1987 - May 1988
James River Corporation  May 1983 - May 1987

Skills
P&ID, Project Engineering, Validation, Process Engineering, GMP, Engineering, Plant Design, Chemical Engineering, Commissioning, Process Control, Piping

Education
University of Connecticut   1977 — 1982
BSME, Mechanical Engineering

Geoffrey von Holten Geoffrey von Holten Greater Philadelphia Area Details
Geoffrey von Holten's OPK Biotech, LLC Experience April 2011 - August 2011
Job Process Engineering Consultant at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation  October 2013 - Present
GvH Consulting, Inc.   February 2009 - Present
Shire HGT  August 2011 - October 2013
OPK Biotech, LLC   April 2011 - August 2011
MannKind Corporation  October 2010 - April 2011
Shire HGT  July 2009 - September 2010
MannKind Corporation  August 2004 - July 2009
Bosch  October 2003 - October 2006
Validation and Process Associates   July 2002 - August 2003

Skills
Commissioning, Process Validation, Cleaning Validation, Validation, Process Engineering, Process Improvement, Engineering, Chromatography, Sop, GAMP, GMP, CAPA, V&V, Change Control, Pharmaceutical Industry, Quality System, Biotechnology, 21 CFR Part 11, Continuous Improvement, Manufacturing, Computer System..., FDA, Testing, Software Documentation, Technology Transfer, Process Simulation, R&D, GxP, Biopharmaceuticals, ISO 13485, Quality Control, Process Optimization, Aseptic Processing, Medical Devices, Quality Auditing, Regulatory Affairs, Pharmaceutics, Filtration, Lifesciences, Quality Assurance

Education
Northeastern University   1997 — 2002
BS, Chemical Engineering

Nicole Arena-Burton Nicole Arena-Burton Cambridge, Massachusetts Details
Nicole Arena-Burton's OPK Biotech, LLC Experience October 2009 - March 2014
Job Finance Manager at Hemoglobin Oxygen Therapeutics LLC
Industry Pharmaceuticals
Experience
Hemoglobin Oxygen Therapeutics LLC   October 2014 - Present
OPK Biotech, LLC   October 2009 - March 2014
Biopure  July 1994 - October 2009

Skills
Sop, GMP, FDA, CAPA, Validation, Biotechnology, Technology Transfer, Pharmaceutical Industry, 21 CFR Part 11, Quality System, Computer System..., GxP, Clinical Development, Medical Devices, HPLC, Lifesciences, Biopharmaceuticals, V&V, Change Control, International Shipping, Supply Chain Management, Accounts Payable, GLP, GCP, SOP

Education
Bunker Hill Community College   1995 — 2000
Associate, Business Management

Jerry Kowalski Jerry Kowalski Greater Philadelphia Area Details
Jerry Kowalski's OPK Biotech, LLC Experience January 2011 - January 2013
Job Chairman CEO at Hemoglobin Oxygen Therapeutics
Industry Biotechnology
Experience
Hemoglobin Oxygen Therapeutics   August 2013 - Present
OPK Biotech, LLC   January 2011 - January 2013
International Industrial Bank   January 2006 - October 2010
Credit Suisse First Boston  2004 - 2006
Credit Suisse  January 2005 - December 2005
Rose Square Capital   June 2001 - December 2004
Bankers Trust Company  June 1985 - June 1999
Procter & Gamble  1982 - 1985

Skills
Investment Banking, Emerging Markets, Capital Markets, Corporate Finance, Equities, Derivatives, Fixed Income, Financial Structuring, Structured Finance, Investments, Mergers, Risk Management, Financial Modeling, Bonds, Trading, Financial Markets, Mergers & Acquisitions, Corporate Governance, Project Finance, Investment Management, Investor Relations, Financial Analysis, IPO, Options, Restructuring, Corporate Development, Due Diligence, Leveraged Finance, Funding

Education
University of Michigan   1977 — 1981
B.A

University of Michigan   1977 — 1981

de la salle   1973 — 1977

Gregory P. Dubé, Ph.D. Gregory P. Dubé, Ph.D. Greater Boston Area Details
Gregory P. Dubé, Ph.D.'s OPK Biotech, LLC Experience October 2009 - October 2013
Job Senior Director, Preclinical and Clinical Programs at Thermalin Diabetes, LLC
Industry Pharmaceuticals
Experience
Thermalin Diabetes, LLC  November 2013 - Present
OPK Biotech, LLC   October 2009 - October 2013
Clarimedix, Inc.   December 2009 - December 2010
N30 Pharmaceuticals  December 2008 - December 2009
Biopure Corporation  August 2006 - 2009
Nitromed, Inc.   December 2004 - April 2006
Eli Lilly and Company  June 1987 - December 2004
Vancouver Vascular Biology Research Centre   1996 - 2000

Skills
Drug Discovery, Clinical Development, Biotechnology, IND, Clinical Trials, Pharmacology, In Vitro, Lifesciences, In Vivo, R&D, Pharmaceutical Industry, Inflammation, Technology Transfer, Translational Medicine, FDA, Regulatory Affairs, Biomarkers, Clinical Study Design, Pharmaceutics, Toxicology, Clinical Research, CRO, Assay Development, Pharmacokinetics, Biochemistry, Medical Devices, Pharmacodynamics, HPLC, Cell Culture, ELISA, Regulatory Submissions, Diabetes, GLP, Animal Models, Biopharmaceuticals, Drug Development, Biologics, Immunology, Physiology, Metabolism, Validation, Life Sciences

Education
University of Cincinnati College of Medicine   1977 — 1984
Ph.D., Pharmacology & Cell Biophysics

Northeastern University   1972 — 1977
B.S., Biology

Chris Gaquin Chris Gaquin Greater Boston Area Details
Chris Gaquin's OPK Biotech, LLC Experience September 2010 - December 2013
Job Bio manufacturing professional
Industry Biotechnology
Experience
Acorda Therapeutics, Inc.   March 2015 - Present
Allergan  September 2014 - March 2015
OPK Biotech, LLC   September 2010 - December 2013
Boston University School of Medicine  February 2010 - September 2010
New England Aquarium  1985 - 1993
Travenol-Genentech   1981 - 1984

Skills
HPLC, cell culture, Cell Culture, Purification, Biotechnology, GMP, Sop, Aseptic Processing, Chromatography, Laboratory

Education
Boston University School of Medicine
Certificate Biomedical Laboratory Science

Sudeep Phatak Sudeep Phatak Alpharetta, Georgia Details
Sudeep Phatak's OPK Biotech, LLC Experience April 2010 - April 2013
Job Automation Engineer Siemens Energy
Industry Oil & Energy
Experience
Siemens Energy  April 2013 - Present
OPK Biotech, LLC   April 2010 - April 2013
Sikraft Infotech Pvt Ltd.   June 2005 - December 2007

Skills
INFI90, Siemens DCS,..., Commissioning, DCS, PLC, Automation, Engineering, Testing, Troubleshooting, Manufacturing, Validation, Software Documentation, GMP, Integration, Project Management, Sop, Process Engineering, Instrumentation, Quality Assurance, Calibration, CAPA, SOP

Education
State University of New York at Binghamton   2008 — 2010
Master of Science (MS), Industrial Engineering

Mumbai University   2000 — 2004
Bachelor of Science (BS), Instrumentation Technology/Technician

Dustin Waldron Dustin Waldron Greater Boston Area Details
Dustin Waldron's OPK Biotech, LLC Experience November 2009 - January 2014
Job Chief Boiler Engineer/Maintenance Lead at OPK Biotech, LLC
Industry Pharmaceuticals
Experience
Brayton Point Power Plant   April 2014 - Present
OPK Biotech, LLC   November 2009 - January 2014
Great Point Energy   August 2008 - October 2009
Biopure  May 2005 - April 2008

Skills
Commissioning, FDA, Microsoft Excel, Sop, GMP, Validation, CAPA, Change Control, Computer System..., 21 CFR Part 11, GAMP, V&V, LIMS, Technology Transfer, Pharmaceutical Industry, Quality System, GxP, Aseptic Processing, Boilers, Cleaning Validation, Quality Assurance

Education
Peterson School

UMass Dartmouth

Vanly Thipphavong Vanly Thipphavong Greater Boston Area Details
Vanly Thipphavong's OPK Biotech, LLC Experience January 2010 - February 2013
Job Quality Compliance Officer at Avedro, Inc.
Industry Pharmaceuticals
Experience
TESARO, Inc.   December 2014 - Present
Avedro, Inc.   February 2013 - September 2014
OPK Biotech, LLC   January 2010 - February 2013
Synta Pharmaceuticals  February 2008 - April 2009
Altus Pharmaceuticals  November 2004 - October 2007
Ansen   March 2004 - November 2004
Serologicals  November 2003 - March 2004
ArQule  June 2001 - December 2002
Saturn Electronics & Engineering  March 2000 - June 2001
Eltech Systems Corporation  June 1997 - March 2000

Skills
CAPA, FDA, GMP, Validation, Pharmaceutical Industry, GxP, 21 CFR Part 11, Change Control, GLP, Sop, Biotechnology, Computer System..., Cleaning Validation, Quality System, Quality Assurance, Quality Auditing, Quality Control, Document Management, cGMP manufacturing, Deviations, Medical Devices, Biopharmaceuticals

Education
University of Massachusetts Lowell   1998 — 2002

Cristina Khun Cristina Khun Greater Boston Area Details
Cristina Khun's OPK Biotech, LLC Experience June 2010 - March 2013
Job QC Micro Analyst II at uniQure
Industry Biotechnology
Experience
uniQure  July 2014 - Present
Amgen  October 2013 - June 2014
Genzyme  March 2013 - October 2013
OPK Biotech, LLC   June 2010 - March 2013

Skills
GMP, LIMS, SOP, Validation, HPLC, Microbiology, Quality Control, Aseptic Technique, Aseptic Processing, ELISA, GLP, Chromatography, FDA, Environmental Monitoring, Endotoxin, Autoclave, Analytical Chemistry, FDA GMP, Bioburden, TOC, cGMP practices, Wet Chemistry, Growth Promotion, Biological Indicators, Micro IDs, Compressed Air, Compressed Gas

Education
Suffolk University   2006 — 2010
Bachelor of Science (B.S.), Biology, General

Andrew Rapsomanikis Andrew Rapsomanikis Greater Boston Area Details
Andrew Rapsomanikis's OPK Biotech, LLC Experience June 2011 - September 2011
Job Intern at Massachusetts Department of Public Safety
Industry Aviation & Aerospace
Experience
Massachusetts Department of Public Safety  June 2015 - Present
RPI ALAC   January 2014 - Present
Toshiba Business Solutions  June 2013 - August 2013
OPK Biotech, LLC   June 2011 - September 2011
OPK Biotech, LLC   June 2011 - August 2011

Skills
Quality Assurance, Engineering, Aerospace, Matlab, SolidWorks, C++, Microsoft Office, Microsoft Excel, Java, C, NX Unigraphics

Education
Rensselaer Polytechnic Institute   2012 — 2015
Bachelor of Science (BS), Dual Major Aeronautical Engineering Mechanical Engineering

Rensselaer Polytechnic Institute   2012 — 2015
Bachelor of Science (B.S.), Mechanical Aeronautical Engineering

Delasie Dela-Seshie Delasie Dela-Seshie Greater Boston Area Details
Delasie Dela-Seshie's OPK Biotech, LLC Experience October 2011 - January 2012
Job Senior Manufacturing Associate at Histogenics Corporation
Industry Pharmaceuticals
Experience
Histogenics Corporation  July 2013 - Present
Genzyme Biosurgery  January 2012 - July 2013
OPK Biotech, LLC   October 2011 - January 2012
OPK Biotech, LLC   February 2010 - October 2011
Sur La Table  January 2007 - February 2010
Sur La Table  October 2006 - December 2006

Skills
Biotechnology, HPLC, Protein Purification, Troubleshooting, Customer Service, Sales, Sop, Purification, Gel Electrophoresis, GMP, Chromatography, GLP, Validation, ELISA, CAPA, Aseptic Technique, SOP

Education
Boston University School of Medicine   2006 — 2007
Biomedical Laboratory Science, Biotechnology

Yanick Andrade Yanick Andrade Boston, Massachusetts Details
Yanick Andrade's OPK Biotech, LLC Experience December 2010 - March 2013
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Acorda Therapeutics, Inc.   February 2015 - Present
OPK Biotech, LLC   December 2010 - March 2013
Amgen  2010 - 2013

Skills
GMP, Sop, Testing, Pharmaceutical Industry, CAPA, Aseptic Processing, GxP, GLP, Validation, FDA, Cleaning Validation, SOP, Computer System...

Education
UMass Boston   2011 — 2015
Bachelor's degree, Biology/Biological Sciences, General

Tahinara Rassi Tahinara Rassi Braintree, Massachusetts Details
Tahinara Rassi's OPK Biotech, LLC Experience September 2010 - Present
Job QC Microbiology Analyst at OPK Biotech, LLC
Industry Pharmaceuticals
Experience
OPK Biotech, LLC   September 2010 - Present

Skills
FDA, Sop, GLP, GMP, Biotechnology, Chromatography, Microbiology, HPLC, Validation, CAPA, V&V, Technology Transfer, Aseptic Processing, Pharmaceutical Industry, Cleaning Validation, GxP, LIMS, IND, Quality System, Change Control, 21 CFR Part 11

Education
UMass Boston   2006 — 2010
Bachelor of Science (B.S.), Biology

Laurie Doucette-Belanksy Laurie Doucette-Belanksy Leominster, Massachusetts Details
Laurie Doucette-Belanksy's OPK Biotech, LLC Experience January 2012 - December 2013
Job QA Document Coordinator
Industry Biotechnology
Experience
Johnson Matthey Pharma Services  November 2014 - Present
OPK Biotech, LLC   January 2012 - December 2013
Bristol-Myers Squibb, Devens MA/Aerotek   May 2011 - January 2012
HealthAlliance Hospital  April 2003 - May 2011
Quebecor World Eusey Press, Inc. - Leominster, MA   October 1998 - August 2002

Skills
Validation, Microsoft Excel, Customer Service, Pharmaceutical Industry, Teamwork, Hospitals, GDP, HIPAA, Microsoft Word, Proofreading, Notary Public, Close Attention to..., Organization, cGMP practices, Master Control, GxP, 21 CFR Part 11, Cleaning Validation, Trackwise, LIMS, Aseptic Processing, CAPA, Microsoft Office

Education
Mount Wachusett Community College   2009 — 2011
Associates

Fitchburg State University

Brad Miscowski Brad Miscowski Greater Boston Area Details
Brad Miscowski's OPK Biotech, LLC Experience November 2011 - December 2013
Job Engineer II
Industry Pharmaceuticals
Experience
Azzur Group  March 2014 - Present
OPK Biotech, LLC   November 2011 - December 2013
Lantheus Medical Imaging  January 2010 - November 2011

Skills
AutoCAD, PIDs, PFD, cGMP practices, Process Engineering, Chemical Engineering, Radiation Safety, Validation, GMP, CAPA, FDA, 21 CFR Part 11, Sop, Change Control, Teamwork, Biopharmaceuticals, Purification, Chromatography, HPLC, Aseptic Processing, Cleaning Validation, Process Simulation, Biotechnology, V&V, Technology Transfer, GxP

Education
University of New Hampshire   2005 — 2009
B.S., Chemical Engineering

Boston Architectural College
AutoCAD I-2D

John White III John White III Greater Boston Area Details
John White III's OPK Biotech, LLC Experience July 2010 - December 2013
Job Manufacturing Tech II at OPK Biotech, LLC
Industry Pharmaceuticals
Experience
OPK Biotech, LLC   July 2010 - December 2013
Tyco Fire & Security  1995 - 2008

Skills
GMP, Validation, Manufacturing, Biotechnology, Purification, Sop

Education
Mount Wachusett Community College   2010 — 2010
Biotechnology, Liberal Arts

Mary Chum Mary Chum Lynn, Massachusetts Details
Mary Chum's OPK Biotech, LLC Experience May 2010 - Present
Job Quality Control Analyst at OPK Biotech, LLC
Industry Pharmaceuticals
Experience
OPK Biotech, LLC   May 2010 - Present
Rite Aid Pharmacy  February 2005 - February 2012
NMT Medical  June 1999 - August 1999

Skills
Clinical Trials, HPLC, Sop, GLP, Pharmaceutical Industry, GMP, FDA, Biotechnology, Chromatography, Validation, Analytical Chemistry, Purification

Education
Salem State College
Bachelor of Applied Science (B.A.Sc.), Medical Technology (Minor Chemistry)

Peter Chrysanthopoulos Peter Chrysanthopoulos Boston, Massachusetts Details
Peter Chrysanthopoulos's OPK Biotech, LLC Experience March 2011 - March 2013
Job Manufacturing Associate at Genzyme
Industry Biotechnology
Experience
Genzyme  April 2013 - Present
OPK Biotech, LLC   March 2011 - March 2013
Tri Wire Engineering Solutions, Inc.   2005 - 2010
Pfizer (Wyeth)   1998 - 2004

Skills
GMP, Validation, Biotechnology, FDA, Sop, Aseptic Technique, HPLC, Chromatography, Protein Purification, Pharmaceutical Industry, Biopharmaceuticals, Aseptic Processing, Filtration, LIMS, Software Documentation, Manufacturing, SOP

Education
Bunker Hill Community College   2012 — 2015
Associate of Science (A.S.), Biomedical/Medical Engineering

Jay Congdon, CEM, CBCPM, CMVP, CEA Jay Congdon, CEM, CBCPM, CMVP, CEA New London/Norwich, Connecticut Area Details
Jay Congdon, CEM, CBCPM, CMVP, CEA's OPK Biotech, LLC Experience 2010 - 2010
Job Engineering Consultant, Energy Engineering Services, Regulated Industry Commissioning/Validation/QA Services
Industry Mechanical or Industrial Engineering
Experience
Biogen Idec  October 2010 - Present
BioMed Realty Trust  October 2010 - Present
Commissioning Agents, Inc  July 2003 - Present
Shire HGT  November 2008 - March 2010
Genzyme  2010 - 2010
OPK Biotech, LLC   2010 - 2010
Commissioning Agents, Inc  2003 - 2009
Pfizer  February 2008 - November 2008
Progenics Pharmaceuticals  2006 - 2008
Amgen  2003 - 2007

Skills
Validation, Commissioning, Engineering, SOP, Biotechnology, Technical Writing, Quality Assurance, Troubleshooting, Documentation, Process Engineering, Change Management, Problem Solving, Process Improvement, Continuous Improvement, GMP, Testing, Quality Systems, Technical Training, HVAC, cGMP, Project Planning, Scheduling, Measurement and..., Energy Engineering, Sop, Nuclear, Certified Building..., Certified Energy Manager, Energy Audits, Engineering Change..., Change Control, Training, Quality System, Preventive Maintenance, Computer System..., Project Management, Facilities Management, GAMP, Process Simulation, GxP, FDA, 21 CFR Part 11, Root Cause Analysis, Energy, CAPA, R&D, Steam, Automation, Pharmaceutical Industry, Maintenance Management

Education
University of the State of New York   1989 — 1990
BS

North Central College   1978 — 1981
Worked towards BS, Mathematics, Psychology, Computers, Business, Sociology, English, History, Acting, Radio

Naperville North High School   1976 — 1978

Bayshore High School   1974 — 1976

Bruce Leibensperger Bruce Leibensperger Greater Philadelphia Area Details
Bruce Leibensperger's OPK Biotech, LLC Experience January 2010 - April 2014
Job Plant Director at Hemoglobin Oxygen Therapeutics LLC.
Industry Pharmaceuticals
Experience
Hemoglobin Oxygen Therapeutics LLC.   May 2014 - Present
OPK Biotech, LLC   January 2010 - April 2014
Globus Medical  November 2008 - January 2010
Biopure  September 2001 - November 2008
Biopure  September 1998 - September 2001

Skills
GMP, FDA, CAPA, Project Management, Medical Devices, Biotechnology, Pharmaceutical Industry, Quality Assurance, Quality System, Manufacturing, PowerPoint, Microsoft Excel, Sop, Budget, Budgets, Validation, ISO 9001, ISO 13485, ISO 22442-2:2007, Product Launch, GLP, Iso 9000, Lifesciences, V&V, Regulatory Affairs, Change Control, Technology Transfer, Biopharmaceuticals

Education
Susquehanna University   1991 — 1995
BS, Biology

Heather McCormick Heather McCormick Greater Boston Area Details
Heather McCormick's OPK Biotech, LLC Experience August 2010 - September 2011
Job Sr Manager Quality Systems
Industry Biotechnology
Experience
Vertex Pharmaceuticals  June 2015 - Present
Genzyme  August 2012 - May 2015
Dyax  September 2011 - August 2012
OPK Biotech, LLC   August 2010 - September 2011
Shire Pharmaceuticals  October 2009 - April 2010
Shire Pharmaceuticals  April 2009 - October 2009
Shire Pharmaceuticals  September 2006 - April 2009
Harvard Clinical Research Institute  July 2003 - September 2006

Skills
GMP, Quality System, CAPA, FDA, Sop, Change Control, Quality Assurance, Software Documentation, Quality Control, Validation, GCP, 21 CFR Part 11, Document Management, Quality Management, Performance Management, Quality System..., GAMP, Technology Transfer, Manufacturing, MRB, Quality Systems, Documentation, ERP, Annual Product Review, Staff Training, Personnel Supervision, Complaint Handling, Complaint Management, Internal Audit, ICH Guidelines, Consent Decree, SOP, Biotechnology, Pharmaceutical Industry, Biopharmaceuticals, Medical Devices, Personnel Management

Education
Southern New Hampshire University   2014 — 2016
Bachelor's Degree

Christopher Newport University   1993 — 1997

Molly McCormick Molly McCormick Greater Boston Area Details
Molly McCormick's OPK Biotech, LLC Experience May 2012 - August 2012
Job Registrar's Clerical Office Assistant at University of Massachusetts Amherst
Industry Research
Experience
University of Massachusetts Amherst  September 2014 - Present
Aramark  April 2011 - May 2014
OPK Biotech LLC  May 2012 - August 2012

Skills
Organization, Hardwork, Laboratory Skills, Customer Service, Microsoft Excel, Microsoft Word, Microsoft Office, PowerPoint, ServSafe, Telephone Skills

Education
University of Massachusetts, Amherst   2012 — 2016
Bachelor of Science (B.S.), Biology, General

Boston Latin School   2006 — 2012
High School Diploma

Mark Hochstetler Mark Hochstetler San Francisco Bay Area Details
Mark Hochstetler's OPK Biotech, LLC Experience January 2010 - September 2010
Job
Industry Hospital & Health Care
Experience
Decision Resources Group  June 2014 - May 2015
Lumleian, LLC  July 2011 - February 2013
OPK Biotech, LLC   January 2010 - September 2010
Leerink Swann Strategic Advisors   September 2007 - December 2009
Leerink Swann  September 2004 - June 2007

Skills
Biotechnology, Lifesciences, Pharmaceutical Industry, Commercialization, Oncology, Medical Devices, Technology Transfer, Clinical Development, Biopharmaceuticals, Clinical Trials, Cross-functional Team..., Licensing, Healthcare, Product Launch, FDA, Infectious Diseases, Venture Capital, Life Sciences

Education
Duke University - The Fuqua School of Business   2002 — 2004
MBA, Health Sector Management

Stanford University   1989 — 1993
BA, Political Science

Javed Baqai Javed Baqai Greater Boston Area Details
Javed Baqai's OPK Biotech, LLC Experience May 2013 - Present
Job Senior Manager of Process Development at OPK Biotech LLC
Industry Pharmaceuticals
Experience
OPK Biotech LLC  May 2013 - Present
Coastal BioPharm, LLC   November 2008 - Present
Biopure Corporation  January 1985 - June 2008

Education
University of Leeds
BSc. Hons, Biochemistry and Genetics (Joint Honours)

Kartikeya Pant Kartikeya Pant Greater Boston Area Details
Kartikeya Pant's OPK Biotech, LLC Experience October 2010 - December 2013
Job Sr Analyst at Wellington Management
Industry Research
Experience
Wellington Management  September 2014 - Present
University of Massachusetts Boston  January 2014 - Present
OPK Biotech, LLC   October 2010 - December 2013
Wolfe Laboratories, Inc.   November 2008 - October 2010
MIT  October 2005 - October 2008

Skills
LC-MS, HPLC, UV/Vis, Drug Discovery, NMR, R&D, Chromatography, Analytical Chemistry, Mass Spectrometry, Chemistry, Data Analysis, GLP, Protein Chemistry, PCR, Purification, Data Mining, real-time PCR, PCR primer design, GMP, Data Modeling, R, Python, Java, SQL, AWS, Hadoop, MapReduce, Apache Pig, Hive

Education
Cornell University   1999 — 2005
Ph.D, Chemistry

Indian Institute of Technology, Bombay   1994 — 1999

Carlos A. Benitez Carlos A. Benitez Greater Boston Area Details
Carlos A. Benitez's OPK Biotech, LLC Experience June 2010 - July 2013
Job Principal Research Associate Gene Therapy Development at Genzyme Sanofi
Industry Biotechnology
Experience
Genzyme Sanofi  July 2013 - Present
OPK Biotech, LLC   June 2010 - July 2013
Shire Human Genetic Therapies  December 2007 - June 2010
Allied Healthcare Products, Inc.   October 2006 - November 2007
MIT Summer Research Program (MSRP)   June 2005 - August 2005
NSF Research Experience for Undergraduates (Colorado State, University)   June 2004 - August 2004

Skills
Technology Transfer, Chromatography, Biotechnology, Downstream Processing, Ultrafiltration, Manufacturing, Commercialization, GMP, ELISA, HPLC, Purification, Biopharmaceuticals, Protein Purification, SOP, Cell Culture, Process Simulation, GLP, Life Sciences

Education
Tufts University   2015 — 2017
Master of Science in Engineering Management, Engineering/Management

Tufts University
Graduate Certificate, Biotechnology Engineering

University of Massachusetts, Amherst
Bachelor of Science, Chemical Engineering

Hakim Rashid Hakim Rashid Greater Philadelphia Area Details
Hakim Rashid's OPK Biotech, LLC Experience May 2011 - March 2013
Job Validation Specialist at AVS
Industry Biotechnology
Experience
AVS  March 2013 - Present
OPK Biotech, LLC   May 2011 - March 2013
Orthovita  September 2009 - June 2010
Wuxi AppTec Inc  April 2007 - January 2009

Skills
Medical Devices, Validation, Mentoring, Upstream Processing, Downstream Processing, Purification, Biopharmaceuticals, Technology Transfer, GLP, Pharmaceutical Industry, Biotechnology, Lifesciences, Cell Culture, HPLC, FDA, V&V, CAPA, GMP, Chromatography, Sop, 21 CFR Part 11, Aseptic Technique, Trackwise, LIMS

Education
Immaculata University   2009 — 2012
Organizational Leadership

Morehouse College   1984 — 1988
Biology/Pre-Med

William Richard Light William Richard Light Greater Boston Area Details
William Richard Light's OPK Biotech, LLC Experience November 2009 - Present
Job VP R&D at OPK Biotech, LLC
Industry Biotechnology
Experience
OPK Biotech, LLC   November 2009 - Present
Biopure  March 2007 - October 2009
Biopure Corporation  November 2002 - March 2006
Biopure  1991 - November 2002

Skills
Drug Discovery, FDA, Process Simulation, Biotechnology, R&D, Lifesciences, Validation, GMP, Clinical Development, Pharmaceutical Industry, Infectious Diseases, Clinical Trials

Education
Rice University   1981 — 1987
Ph.D., Biochemistry

Katie Holbrook Katie Holbrook Greater Boston Area Details
Katie Holbrook's OPK Biotech, LLC Experience July 2010 - March 2011
Job Owner & General Manager at Brand New Ballgame
Industry Sports
Experience
Brand New Ballgame   July 2015 - Present
Extra Innings Inc  February 2013 - July 2015
Skyhawks Sports Academy  March 2011 - February 2013
OPK Biotech, LLC   July 2010 - March 2011
Kaplan  August 2009 - July 2010

Skills
Leadership, Coaching, Customer Service, Event Planning, Softball Instruction, Baseball Instruction, Employee Training, Program Evaluation, Program Management, Recreation Planning, Program Coordination, Marketing, Time Management, Microsoft Excel, PowerPoint, Social Media, Microsoft Word, Public Speaking, Sales, Microsoft Office, Budgets, Strategic Planning, Outlook, Financial Analysis, Finance

Education
Bridgewater State College   2005 — 2009
BS, Accounting

Salvatore DiRusso Salvatore DiRusso Greater Chicago Area Details
Salvatore DiRusso's OPK Biotech, LLC Experience January 2010 - February 2014
Job Lead Facilities Supervisor, Metrology at CSL Behring
Industry Pharmaceuticals
Experience
CSL Behring  March 2015 - Present
CSL Behring  March 2014 - Present
OPK Biotech, LLC   January 2010 - February 2014
AMAG Pharmaceuticals  May 2009 - January 2010
Crosspoint Engineering  December 2008 - May 2009
Biopure  September 2006 - December 2008
Boston Scientific  September 2005 - September 2006
Crosspoint Engineering  2004 - 2005
Abbott  2004 - 2005
Shire Pharmaceuticals  1999 - 2004

Skills
GMP, Change Control, Metrology, Validation, Biotechnology, FDA, Calibration, Sop, Manufacturing, Pharmaceutical Industry, Clinical Trials, Troubleshooting, Aseptic Processing, Quality System, Clinical Development, CAPA, Facilities Management, V&V, GxP, 21 CFR Part 11, GLP, Computer System..., Biopharmaceuticals, Electronics, GAMP, Testing, Technology Transfer, Medical Devices, SOP

Education
Community College of the Air Force   1990 — 1995
Bachelor of Science eq. in Electronics Engineering Technology, Metrology and Electronics Engineering

Thomas Page Ph.D Thomas Page Ph.D College Station, Texas Details
Thomas Page Ph.D's OPK Biotech, LLC Experience 2010 - May 2013
Job aVP Engineering at Kalon Biotherapeutics, LLC
Industry Biotechnology
Experience
Kalon Biotherapeutics, LLC  May 2013 - Present
OPK Biotech, LLC   2010 - May 2013
Sangart  2005 - 2009

Skills
Plant Design, GMP, Pharmaceutical process..., Viral Clearance, TSE Clearance, Process Optimization, Manufacturing, Validation, Risked based Validation, EMA, Outsourcing Management, Disposables, Automation, Facilities Engineering, Technology Transfer, Inventiveness, Integration, FDA, Biotechnology, V&V, Biopharmaceuticals, Aseptic Processing, CAPA, Purification, Sop, Change Control, GxP, 21 CFR Part 11, Vaccines, GAMP, Computer System..., Chromatography, Process Engineering, LIMS, GLP, Process Simulation, Quality System, SOP

Education
Rice University   1991 — 1996
Doctor of Philosophy (PhD), Chemical Engineering, Bioengineering

Texas A&M University   1986 — 1991
Bachelor of Science (BS), Biochemistry, Honors

Texas A&M University
Bachelor of Science (BS), Chemical Engineering, Honors

Cynthia Babb Cynthia Babb Greater Boston Area Details
Cynthia Babb's OPK Biotech, LLC Experience October 2009 - Present
Job Human Rources at OPK Biotech LLC
Industry Biotechnology
Experience
OPK Biotech LLC  October 2009 - Present
OPK Biotech LLC  October 2009 - Present
OPK Biotech LLC  1990 - 2009
Biopure Corporation  January 1995 - July 2004

Skills
Biotechnology, Lifesciences, FDA, GMP, Sop, Validation, Clinical Trials, Oncology, Clinical Development, CAPA, Human Resources, 21 CFR Part 11, Pharmaceutical Industry, Biopharmaceuticals, Change Control

Education
Northeastern University
BS, Marketing

Joshua Kagiwada Joshua Kagiwada Middleboro, Massachusetts Details
Joshua Kagiwada's OPK Biotech, LLC Experience August 2010 - January 2011
Job :)
Industry Electrical/Electronic Manufacturing
Experience
Tech-Etch Inc.  September 2015 - Present
Schneider Electric  August 2011 - Present
OPK Biotech LLC  August 2010 - January 2011
Crosspoint Engineering  December 2009 - August 2010
US Navy  August 2008 - November 2009
US Navy  September 2007 - November 2009
Horlick   November 2006 - September 2007
AutoZone  July 2006 - November 2006
Specialized HVAC   July 2004 - November 2006
Subway  October 2004 - July 2006

Skills
Soldering, Engineering, Research, wiring, Excel, Word, PowerPoint, Technical Drawing, Engineering Drawings, Troubleshooting, Manufacturing, Microsoft Excel, Wiring, Microsoft Word, Software Documentation, Electronics, Test Equipment, Electricians, Calibration

Education
Northeastern University   2013 — 2014
Bachelor of Engineering (BEng), Electrical Engineering Technology

Northeastern University   2010 — 2013
Associate's degree in Engineering, Electrical Engineering Technology

University of Phoenix   2009 — 2012
Associates Degree of Science, Information Technology, B

Electronics Technician "A" School, US Navy   2007 — 2008
N/A, Electronics / Electrical

Brian Cottee Brian Cottee United States Details
Brian Cottee's OPK Biotech, LLC Experience October 2010 - October 2013
Job Operations and purchasing manager at Simtech USA
Industry Biotechnology
Experience
Simtech USA   February 2015 - Present
Michel's Bakery  October 2013 - February 2015
OPK Biotech, LLC   October 2010 - October 2013
Centocor Research and Development   August 2008 - October 2010
Centocor Research & Development, Inc   June 2006 - August 2008
Centocor Research & Development, Inc   April 2005 - June 2006
Centocor Research & Development, Inc   January 2004 - April 2005
Johnson and Johnson PRD  January 2001 - January 2004

Skills
GMP, Cell Culture, Biopharmaceuticals, Sop, Monoclonal Antibodies, Technology Transfer, GLP, Validation, Biotechnology, Fermentation, Aseptic Processing, Purification, Cell, Trackwise, LIMS, Filtration, Pharmaceutical Industry, FDA, R&D, Life Sciences, CAPA

Education
Delaware Valley College
Working towards a Bachelors of Science, Biology

Montgomery County Community College
A.S, Biological Sciences

North Montco Technical Career Center

Jerry Asuncion Jerry Asuncion Greater Boston Area Details
Jerry Asuncion's OPK Biotech, LLC Experience December 2010 - March 2013
Job QC Analyst at OPK Biotech, LLC
Industry Biotechnology
Experience
OPK Biotech, LLC   December 2010 - March 2013
University of San Francisco  January 2010 - June 2010
Mainfreight USA  June 2008 - August 2008

Skills
Biotechnology, Research, GMP, Sop, GLP, Validation, CAPA, 21 CFR Part 11, GxP, HPLC, Chromatography, Analytical Chemistry

Education
University of San Francisco   2006 — 2010
B.S., Chemistry with Biochemistry emphasis

Erik Held Erik Held Cambridge, Massachusetts Details
Erik Held's OPK Biotech, LLC Experience September 2010 - December 2010
Job Senior Manufacturing Engineer at BIND Therapeutics
Industry Pharmaceuticals
Experience
BIND Therapeutics  July 2015 - Present
BIND Therapeutics  May 2014 - Present
Acusphere, Inc.   January 2011 - May 2014
OPK Biotech, LLC   September 2010 - December 2010

Skills
Sop, Process Simulation, Manufacturing

Education
The University of North Dakota
Bachelor's Degree, Chemical Engineering

Patrick Barrows Patrick Barrows Greater Boston Area Details
Patrick Barrows's OPK Biotech, LLC Experience March 2012 - June 2013
Job GENZYME , Contractor
Industry Biotechnology
Experience
GENZYME Talentburst Contractor   June 2013 - Present
OPK Biotech, LLC   March 2012 - June 2013
Pfizer  June 2008 - July 2011
Wyeth  June 2002 - June 2008

Skills
Cell Culture, Protein Purification, Buffer Preparation, Delta V, iFix, SAP, Microsoft Office, TFF, HPLC, GLP, Manufacturing

Education
Middlesex Community College
Liberal Sciences

Scott Hotyckey Scott Hotyckey Framingham, Massachusetts Details
Scott Hotyckey's OPK Biotech, LLC Experience October 2009 - Present
Job Senior Equipment Berg
Industry Pharmaceuticals
Experience
OPK Biotech, LLC   October 2009 - Present
Biopure  2006 - 2009
Biopure  2006 - 2009
Biopure  2006 - 2009
Biopure  August 2007 - September 2008
Computer Palace   January 1988 - December 2006

Skills
Microsoft certified..., Microsoft Certified..., Web server host and..., Manufacture of Computer..., Sales and marketing..., Importing Computer..., Manufacturing of Custom..., Maintenance Work at OPK, Manufacture of..., Professional Auto..., Build and frame Houses, HPLC, Chromatography, Manufacturing, Automation, CompTIA A+ Certification, Microsoft Exchange, Purification, Testing, Sop, Laboratory, Technology Transfer, Validation

Education
Centeral New England   1981 — 1985
BS Computer Science and Engineering

Massachusetts Bay Community College   1981 — 1983
Associate's degree, Law Enforcement

Justin Pleva Justin Pleva Greater Boston Area Details
Justin Pleva's OPK Biotech, LLC Experience February 2010 - May 2013
Job QC Lab Analyst II at Cubist Pharmaceuticals
Industry Pharmaceuticals
Experience
Cubist Pharmaceuticals  May 2013 - Present
OPK Biotech, LLC   February 2010 - May 2013

Skills
GMP, Sop, Validation, HPLC, Chromatography, Pharmaceutical Industry, Biotechnology, Analytical Chemistry, Quality System, ELISA

Education
University of New Hampshire   2005 — 2008
Bachelor of Science (BS), Chemistry

University of Maine at Farmington   2003 — 2005

Timothy Thao Timothy Thao Warwick, Rhode Island Details
Timothy Thao's OPK Biotech, LLC Experience March 2012 - Present
Job Bio Technician at OPK Biotech, LLC
Industry Pharmaceuticals
Experience
OPK Biotech, LLC   March 2012 - Present
OPK Biotech   2012 - 2013
Metro Honda  February 2008 - November 2010

Education
New England Institute of Technology   2006 — 2008
Associate's degree

Pilgrim High School

Scott Hotyckey Scott Hotyckey Framingham, Massachusetts Details
Scott Hotyckey's OPK Biotech, LLC Experience January 2009 - July 2013
Job Senior Automation Mech. at Thermo Fisher Scientific (Life Technologies)
Industry Biotechnology
Experience
Thermo Fisher Scientific (Life Technologies)   January 2014 - Present
Genzyme  September 2013 - January 2014
OPK Biotech LLC  January 2009 - July 2013

Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Teaching, Photoshop, Public Speaking, HTML, Strategic Planning, Budgets, Process Automation, Emerson DeltaV, Clean Rooms

Education
Nichols College
Bachelor's degree, Computer Science and Engineering

Mass Bay community College
Associate's degree, Law

Sopheap (Sophia) Reach Sopheap (Sophia) Reach Woburn, Massachusetts Details
Sopheap (Sophia) Reach's OPK Biotech, LLC Experience January 2013 - November 2013
Job QC Analyst III at Amgen
Industry Biotechnology
Experience
Amgen  November 2013 - Present
OPK Biotech LLC  January 2013 - November 2013
OPK Biotech LLC  March 2009 - January 2013

Skills
Quality Control, GMP, Sop, CAPA, GLP, 21 CFR Part 11, FDA, Change Control, HPLC, Aseptic Processing, Chromatography, Quality System, Endotoxin, TOC, Analytical Chemistry, ELISA, FTIR, Agarose Gel..., UV/Vis

Education
State University of New York College at Old Westbury   1987 — 1992
Bachelor of Science (BS)

New Utrecht High School   1983 — 1987