AMEC BioPharmaceuticals

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AMEC BioPharmaceuticals Employees

Employee
Years
Job
Industry
Tracy Thor Tracy Thor Baltimore, Maryland Area Details
Tracy Thor's AMEC BioPharmaceuticals Experience March 2004 - March 2007
Job Director QA at Chesapeake PERL
Industry Biotechnology
Experience
Chesapeake PERL  February 2006 - September 2013
AMEC BioPharmaceuticals   March 2004 - March 2007
Phoenix Imperative   May 2000 - March 2007
Advanced Biotechnologies Inc. (ABI)   September 1999 - May 2000
Bio Science Contract Production Corp.   July 1998 - September 1999
ONCOR Inc.  December 1991 - July 1998
Amvax Inc.   July 1989 - December 1991

Skills
CAPA, GMP, Quality System, Biotechnology, Lifesciences, Sop, V&V, Validation, Change Control, Quality Assurance, FDA, Protein Chemistry, Vaccines, GLP, 21 CFR Part 11, GxP, Microbiology, Biopharmaceuticals, Software Documentation, Technology Transfer, LIMS, Aseptic Processing, Life Sciences

Education
Howard Community College
Laboratory Science Program

Audrey Prosser Audrey Prosser Tucson, Arizona Area Details
Audrey Prosser's AMEC BioPharmaceuticals Experience February 2006 - August 2008
Job at Ventana Medical Systems
Industry Medical Devices
Experience
Ventana Medical Systems (a subsidary of Roche)   March 2011 - Present
Byron Medical division of Mentor Corporation (a owned subsididary of Johnson & Johnson)   August 2008 - April 2011
Xeridiem (formerly MRI Medical)   2011 - 2011
AMEC Biopharmaceuticals   February 2006 - August 2008
Guidant  2004 - 2006
Allergan  1998 - 2004
Certified Facilities   1996 - 1998
Validation Systems, Inc.   1994 - 1996
Molecular Biosystems  1993 - 1994
Skyland Scientific   1992 - 1993

Skills
ISO 13485, Quality System, Cross-functional Team..., Quality Assurance, Validation, Change Control, Medical Devices, FDA, CAPA, Quality Auditing, Auditing, ISO, GMP, Quality Control, Sop, Leadership, V&V, Biotechnology, Continuous Improvement, Six Sigma, Lean Manufacturing, Manufacturing, Regulatory Requirements, SOP, Pharmaceutical Industry, 21 CFR Part 11, Technology Transfer, Regulatory Affairs, Life Sciences, GLP

Education
California State University-Dominguez Hills   1995 — 1997
MS, Quality Assurance

Harvey Mudd College   1985 — 1990
B.S, Applied Chemistry / General Engineering

Matthew K. Fox Matthew K. Fox Greater Boston Area Details
Matthew K. Fox's AMEC BioPharmaceuticals Experience January 2006 - June 2007
Job Managing Director Business Development & Strategy at Insight Numerics, LLC
Industry Biotechnology
Experience
Insight Numerics, LLC   July 2014 - Present
Xymeo   April 2012 - September 2014
Biogen Idec  August 2012 - July 2014
Biogen Idec  April 2011 - July 2014
Biogen Idec  June 2007 - April 2011
Amec BioPharmaceuticals   January 2006 - June 2007
IBM Corp.  January 2001 - August 2001

Skills
Cross-functional Team..., Process Engineering, GMP, Management, Strategy, Entrepreneurship, Process Improvement, FDA, 21 CFR Part 11, Project Management, Biotechnology, Strategic Planning, Manufacturing, Technology Transfer, Biopharmaceuticals, Start-ups, Quality System, Process Simulation, Lifesciences, Engineering, Data Analysis, Quality Assurance, Business Strategy, Microsoft Excel, Computer System..., Six Sigma, Business Analysis, Problem Solving, Operations Management, Team Leadership, CAPA, V&V, Change Control, R&D, GAMP, GxP, cGMP, Excel, Change Management, Risk Management, Social Entrepreneurship, F&G, Oil & Gas Industry, Life Sciences

Education
Boston University Graduate School of Management   2010 — 2012
MBA, Strategy Management, and Operations & Technology Management

Clarkson University   2004 — 2006
ME, Civil / Environmental Engineering

Clarkson University   1999 — 2003
BS, Chemical Engineering

Burak Begen, Ph.D., MBA Burak Begen, Ph.D., MBA Greater Boston Area Details
Burak Begen, Ph.D., MBA's AMEC BioPharmaceuticals Experience July 2007 - December 2008
Job Associate Director of Quality Control at Genzyme
Industry Pharmaceuticals
Experience
Genzyme  November 2014 - Present
Genzyme  January 2014 - October 2014
Ben Venue Laboratories, Inc.   July 2013 - January 2014
Ben Venue Laboratories, Inc  November 2010 - June 2013
Ben Venue Laboratories, Inc.   April 2009 - October 2010
AMEC BioPharmaceuticals   July 2007 - December 2008
Biogen Idec  July 2007 - March 2008
Novartis Pharmaceuticals  December 2001 - June 2002
Novartis Pharmaceuticals  June 1999 - November 2001

Skills
Change Control, CAPA, Validation, GMP, Program Management, Sop, Quality Assurance, FDA, Aseptic Processing, 21 CFR Part 11, Pharmaceutical Industry, Quality Systems..., Six Sigma Tools and..., Annual Product Reviews..., Data Management, Biotechnology, Six Sigma, Lean Manufacturing, Cross-functional Team..., Manufacturing, Regulatory Requirements, Process Simulation, Trackwise, V&V, Computer System..., Quality System, GxP, Regulatory Affairs, Pharmaceutics, GLP, LIMS, Quality Auditing, Deviations, Quality Control, Site Inspections, Team Leadership, Laboratory, Technical Leadership, Problem Solving, Problem Management, USP, SOP, TrackWise

Education
The University of Akron   2002 — 2007
Doctor of Philosophy (PhD), Polymer Science

Kent State University   2011 — 2011
Certificate, Project Management

Villanova University   2010 — 2010
Master Certificate, Lean Six Sigma

Marmara University   1999 — 2002
MBA, Concentration in Marketing

Boğaziçi University   1994 — 1998
BS, Chemical Engineering

Kadikoy Anadolu High School   1987 — 1994
High School, Science

Jennifer Lauria Clark, CPIP Jennifer Lauria Clark, CPIP Charleston, South Carolina Area Details
Jennifer Lauria Clark, CPIP's AMEC BioPharmaceuticals Experience 2005 - 2007
Job Director of Technical Services and KAM Program at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc  January 2013 - Present
ISPE  2003 - Present
Biotech Company  2012 - 2012
Biotech Company  June 2011 - December 2011
Yonkers Industries, Inc  February 2007 - November 2011
OSD Facility   2007 - January 2009
Client  2007 - 2008
AMEC BioPharmaceuticals   2005 - 2007
Key Club and Circle K International   1996 - 2005

Skills
General Utility..., FDA, Validation, GMP, V&V, Sop, Biotechnology, Change Control, Pharmaceutical Industry, Process Simulation, Quality Assurance, Quality System, CAPA, Process Engineering, Commissioning, GLP, Technical Writing, Software Documentation, Microbiology, LIMS, Aseptic Processing, Cross-functional Team..., Manufacturing, Project Management, Lifesciences, Cleaning Validation, Computer System..., 21 CFR Part 11, Testing, GAMP, GxP, SOP, Life Sciences, Technology Transfer

Education
North Carolina State University   2000 — 2005
BS, Industrial Engineering

Wake Forest-Rolesville High School   1996 — 2000

Brooks Fardy Brooks Fardy Garner, North Carolina Details
Brooks Fardy's AMEC BioPharmaceuticals Experience 2004 - 2005
Job Regional Business Development Manager at Mangan Inc.
Industry Pharmaceuticals
Experience
Mangan Inc.  June 2011 - Present
Vantage Consulting Group  October 2009 - 2011
BE&K BioPharm   2007 - 2008
PharmEng   July 2005 - January 2007
Wyeth Biotech  2004 - 2006
AMEC BioPharmaceuticals   2004 - 2005
Merck  2000 - 2005
Merck  2003 - 2004
Merck  2003 - 2004
Merck  2002 - 2004

Skills
Validation, Computer System..., Quality Control, 21 CFR Part 11, CAPA, GMP, Biotechnology, Leadership, Sop, GAMP, V&V, Quality Assurance, FDA, Pharmaceutical Industry, Business Development, GxP, Change Control, Process Engineering, Quality System, SOP

Education
Nash Community College   1995 — 1998
Ass. Science, Information Systems

East Carolina University
B.S., Industrial Technology

Todd Kichefski Todd Kichefski Providence, Rhode Island Area Details
Todd Kichefski's AMEC BioPharmaceuticals Experience 2001 - 2005
Job QA Specialist IV at Alexion Pharmaceuticals, Inc.
Industry Biotechnology
Experience
Alexion Pharmaceuticals, Inc.   May 2015 - Present
Amgen  May 2006 - Present
Cardinal Health, SPS  2005 - 2006
AMEC BioPharmaceuticals   2001 - 2005
Day & Zimmermann  1999 - 2001
AAIPharma  February 1997 - October 1999

Skills
Validation, Cleaning Validation, Project Management, Process Validation (PPQ), Quality Assurance, Regulatory Compliance, CAPA, Change Control, Biopharmaceuticals, 21 CFR Part 11, FDA, SOP, Technology Transfer

Education
University of North Carolina at Wilmington

Miles Chamblee Miles Chamblee Raleigh-Durham, North Carolina Area Details
Miles Chamblee's AMEC BioPharmaceuticals Experience 2003 - 2005
Job National Sales Manager at ITT Engineered Valves
Industry Biotechnology
Experience
ITT Engineered Valves  September 2013 - Present
ITT Engineered Valves  January 2010 - September 2013
ITT Pure Flo   March 2007 - December 2009
PharmEng   2005 - 2007
AMEC BioPharmaceuticals   2003 - 2005

Skills
Technology Transfer, Sales, Process Engineering, Sales Operations, FDA, Process Optimization, Change Control, GMP, Manufacturing, Validation, V&V, Quality System, Biotechnology, Management, CAPA

Education
North Carolina State University   1998 — 2002
BS, Chemical Engineering

Frank Botelho Frank Botelho Raleigh-Durham, North Carolina Area Details
Frank Botelho's AMEC BioPharmaceuticals Experience 2003 - 2007
Job Vice President at ZB Validation Solutions LLC
Industry Pharmaceuticals
Experience
ZB Validation Solutions LLC   February 2008 - Present
Z&B Validation Solutions LLC   January 2007 - Present
amec inc.  2003 - 2008
AMEC BioPharmaceuticals   2003 - 2007

Skills
Quality Management, Quality Control, GMP, Change Control, Quality Assurance, Sop, Validation, V&V, Pharmaceutical Industry, Commissioning, Biotechnology, 21 CFR Part 11, FDA, Quality System, Technology Transfer, Process Simulation, Project Management, Lifesciences, Automation, Start-ups, Process Engineering, Piping, CAPA, Software Documentation, Construction, Document Management, Change Management, Regulatory Affairs, SOP

Education
Regis University   1975 — 1977

Norma Griffin Norma Griffin New Market, Maryland Details
Norma Griffin's AMEC BioPharmaceuticals Experience 2003 - 2008
Job Regulatory Project Manager for CDER/OHOP/DOP2
Industry Government Administration
Experience
FDA/CDER/Office of Hematology and Oncology Products/Division of Oncology Products 2   October 2008 - Present
Meridian BioGroup, LLC  March 2008 - October 2008
AMEC BioPharmaceuticals   2003 - 2008
AMEC  2000 - 2008
Phoenix Imperative   March 2000 - March 2003
CapricornPharma   February 1999 - March 2000
North American Vaccine  November 1997 - February 1999
Cephalon  1992 - 1996
Pharmacia-ENI Diagnostics   1983 - 1992

Skills
Compliance, Biotechnology, Validation, cGMP, Quality Systems, Pharmaceuticals, Quality Assurance, Documentation, GMP, FDA, Regulatory Affairs, Auditing, Medical Devices, Cleaning Validation, SOP, Document Management

Education
Mary Washington College   1978 — 1982
Bachelor of Science, Biology

Medical College of Virginia, Virginia Commenwealth University   1980 — 1981
Medical Technology

John D. Beam John D. Beam Raleigh-Durham, North Carolina Area Details
John D. Beam's AMEC BioPharmaceuticals Experience March 2001 - December 2007
Job Consultant Engineer at Oxford International
Industry Pharmaceuticals
Experience
Oxford International  February 2013 - Present
PharmaMatrix, Inc   January 2008 - March 2013
AMEC BioPharmaceuticals   March 2001 - December 2007
ValiCor Associates, Inc.   July 1997 - March 2001
Kemper Masterson, Inc.   May 1991 - July 1997
Morrison Knudsen Corporation  January 1989 - May 1991
Fluor Daniel  April 1987 - November 1988
CooperVision-Cilco, Inc.   August 1984 - April 1987
ASTRA Pharmaceutical Products, Inc.,   May 1981 - August 1984
Parke-Davis,  February 1978 - May 1981

Skills
Quality System, GMP, Validation, Laboratory, Quality Assurance, CAPA, Sop, Commissioning, V&V, GAMP, Pharmaceutics, Computer System..., Testing, FDA, Pharmaceutical Industry, Medical Devices, Manufacturing, HVAC, Management, Process Engineering, Change Control, Biotechnology, Biopharmaceuticals, Project Planning, Calibration, Software Documentation, 21 CFR Part 11, Instrumentation, Budgets, Technology Transfer, Electronics, Start-ups, Sterilization, Quality Control

Education
Northeastern University   1975 — 1977
BSIT, Electronics

Northeastern University   1967 — 1975
ASEE, Electronics