MonoSol Rx, LLC
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MonoSol Rx, LLC Employees
Employee
Years
Job
Industry
Joseph Dirr Joseph Dirr's MonoSol Rx, LLC Experience January 2014 - Present
Job Owner, Sapheit Fitness
Industry Health, Wellness and Fitness
Experience
Sapheit Fitness October 2014 - Present
Monosol Rx, LLC January 2014 - Present
Elmhurst Park District September 2012 - Present
Celgene June 2006 - July 2012
US Navy 2003 - 2006
Skills
Troubleshooting, Preventive Maintenance, Validation, Process Engineering, Process Improvement, Pneumatics, AutoCAD, Six Sigma, GMP, Electricians, Metal Fabrication, 21 CFR Part 11, Aseptic Processing, Pharmaceutical Industry, CAPA, Personal Training, Weight Loss, Nutritional Counseling, TRX Suspension Training, Boot Camp, Group Exercise..., Weight Training, Fabrication, Electrical, Hydraulics, Technical Training, Triathlon, Marathon, FDA, Leadership, Change Control, Sop, Military, Regulatory Affairs, Root Cause Analysis, Fitness Training, Cycling, Coaching, Technical Writing, 5S, Quality System, Training, Calibration
Education
Elmhurst College 2012 — 2013
Bachelor of Science (B.S.), Kinesiology and Exercise Science
Northern Illinois University 2010 — 2011
Industrial Technology/Technician
Penn Foster College 2007 — 2009
Associate of Science (A.S.), Mechanical Engineering/Mechanical Technology/Technician
Miami University 2000 — 2002
Psychology/Physics
Sapheit Fitness October 2014 - Present
Monosol Rx, LLC January 2014 - Present
Elmhurst Park District September 2012 - Present
Celgene June 2006 - July 2012
US Navy 2003 - 2006
Skills
Troubleshooting, Preventive Maintenance, Validation, Process Engineering, Process Improvement, Pneumatics, AutoCAD, Six Sigma, GMP, Electricians, Metal Fabrication, 21 CFR Part 11, Aseptic Processing, Pharmaceutical Industry, CAPA, Personal Training, Weight Loss, Nutritional Counseling, TRX Suspension Training, Boot Camp, Group Exercise..., Weight Training, Fabrication, Electrical, Hydraulics, Technical Training, Triathlon, Marathon, FDA, Leadership, Change Control, Sop, Military, Regulatory Affairs, Root Cause Analysis, Fitness Training, Cycling, Coaching, Technical Writing, 5S, Quality System, Training, Calibration
Education
Elmhurst College 2012 — 2013
Bachelor of Science (B.S.), Kinesiology and Exercise Science
Northern Illinois University 2010 — 2011
Industrial Technology/Technician
Penn Foster College 2007 — 2009
Associate of Science (A.S.), Mechanical Engineering/Mechanical Technology/Technician
Miami University 2000 — 2002
Psychology/Physics
Joe Kluemper's MonoSol Rx, LLC Experience June 2012 - Present
Job Project Engineer at Monosol Rx, LLC
Industry Pharmaceuticals
Experience
Monosol Rx, LLC June 2012 - Present
Skills
Pharmacueticals, Chemical Engineering, cGMP practices, Process Qualification, Equipment Qualification, Project Management, CAPA, Validation, Computer System..., GMP, Change Control, 21 CFR Part 11, Cleaning Validation, Pharmaceutical Industry
Education
Purdue University 2008 — 2012
Bachelor of Science (BS), Chemical Engineering
Monosol Rx, LLC June 2012 - Present
Skills
Pharmacueticals, Chemical Engineering, cGMP practices, Process Qualification, Equipment Qualification, Project Management, CAPA, Validation, Computer System..., GMP, Change Control, 21 CFR Part 11, Cleaning Validation, Pharmaceutical Industry
Education
Purdue University 2008 — 2012
Bachelor of Science (BS), Chemical Engineering
Jenny Gallo Jenny Gallo's MonoSol Rx, LLC Experience September 2013 - May 2015
Job Manager, DEA Compliance
Industry Pharmaceuticals
Experience
Teva Pharmaceuticals May 2015 - Present
Monosol Rx, LLC September 2013 - May 2015
Monosol Rx, LLC October 2010 - August 2013
Great Lakes Labs July 2009 - July 2010
Florida International University August 2007 - June 2009
Florida International University August 2007 - May 2009
Pfizer Pharmaceuticals May 2007 - August 2007
Michigan State University August 2004 - May 2007
Pfizer Pharmaceuticals May 2006 - August 2006
Skills
HPLC, Chemistry, GC-MS, FTIR, Dissolution, TLC, UV/Vis, Laboratory, HR-ICP-MS, XRF, TD-GC-MS, Headspace GC, Empower, 21 CFR Part 1300 to End, Controlled Substances..., ARCOS Reporting, YERS Reporting, Controlled Substance..., DEA Compliance, Controlled Substance..., DEA 222 Form Management, ICP-MS, ASE, USP/NF Raw Material..., MAE, Karl Fisher, Chemstation, Microsoft Office, Scanning Electron..., X-ray Diffraction..., Solid Phase Extraction, GMP, Analytical Chemistry, Gas Chromatography, Mass Spectrometry, Chromatography, Quality Control, GLP, Titration, Toxicology, Validation
Education
Florida International University 2007 — 2009
M.S., Forensic Science
Michigan State University 2003 — 2007
B.S., Chemistry
Teva Pharmaceuticals May 2015 - Present
Monosol Rx, LLC September 2013 - May 2015
Monosol Rx, LLC October 2010 - August 2013
Great Lakes Labs July 2009 - July 2010
Florida International University August 2007 - June 2009
Florida International University August 2007 - May 2009
Pfizer Pharmaceuticals May 2007 - August 2007
Michigan State University August 2004 - May 2007
Pfizer Pharmaceuticals May 2006 - August 2006
Skills
HPLC, Chemistry, GC-MS, FTIR, Dissolution, TLC, UV/Vis, Laboratory, HR-ICP-MS, XRF, TD-GC-MS, Headspace GC, Empower, 21 CFR Part 1300 to End, Controlled Substances..., ARCOS Reporting, YERS Reporting, Controlled Substance..., DEA Compliance, Controlled Substance..., DEA 222 Form Management, ICP-MS, ASE, USP/NF Raw Material..., MAE, Karl Fisher, Chemstation, Microsoft Office, Scanning Electron..., X-ray Diffraction..., Solid Phase Extraction, GMP, Analytical Chemistry, Gas Chromatography, Mass Spectrometry, Chromatography, Quality Control, GLP, Titration, Toxicology, Validation
Education
Florida International University 2007 — 2009
M.S., Forensic Science
Michigan State University 2003 — 2007
B.S., Chemistry
Rachel Sykes-Dudek Rachel Sykes-Dudek's MonoSol Rx, LLC Experience August 2013 - November 2014
Job Product Quality Assurance Supervisor at Monosol Rx, LLC
Industry Pharmaceuticals
Experience
Sony DADC November 2014 - Present
Monosol Rx, LLC August 2013 - November 2014
CSL Behring April 2013 - August 2013
CSL Behring January 2012 - March 2013
CSL Behring November 2008 - December 2011
STARadio April 2004 - June 2008
Skills
Specifications, Pharmaceutical Industry, Quality Assurance, Sop, cGMP manufacturing, GMP, Training, Procedures Documentation, Production Support, SAP, Quality Procedures, Plateau, Minitab, Aseptic Technique, Clean Rooms, FDA, Compliance, 21 CFR Part 211, Microsoft Excel, Microsoft Word, Microsoft Office, PowerPoint, Trackwise, Expense Reports, Capital & Expense..., Commercial Copy, DCMS, Process Improvement, SOP
Education
Eureka College 1999 — 2003
Bachelor of Arts (B.A.), Communication, General
Sony DADC November 2014 - Present
Monosol Rx, LLC August 2013 - November 2014
CSL Behring April 2013 - August 2013
CSL Behring January 2012 - March 2013
CSL Behring November 2008 - December 2011
STARadio April 2004 - June 2008
Skills
Specifications, Pharmaceutical Industry, Quality Assurance, Sop, cGMP manufacturing, GMP, Training, Procedures Documentation, Production Support, SAP, Quality Procedures, Plateau, Minitab, Aseptic Technique, Clean Rooms, FDA, Compliance, 21 CFR Part 211, Microsoft Excel, Microsoft Word, Microsoft Office, PowerPoint, Trackwise, Expense Reports, Capital & Expense..., Commercial Copy, DCMS, Process Improvement, SOP
Education
Eureka College 1999 — 2003
Bachelor of Arts (B.A.), Communication, General
Samone Hu's MonoSol Rx, LLC Experience August 2011 - March 2012
Job Clinical Support Specialist Shift Lead at Accretive Health
Industry Hospital & Health Care
Experience
Accretive Health August 2013 - Present
Accretive Health March 2012 - August 2013
Monosol Rx, LLC August 2011 - March 2012
University of Illinois Testing Center March 2010 - May 2011
#1 Chop Suey, Inc May 2008 - August 2009
Skills
EMR, Epic Systems, Healthcare, Meditech, Microsoft Word, Cerner, Healthcare Information..., Microsoft Excel, HIPAA, Customer Service, Outlook, Data Analysis, Clinical Research, Healthcare Management, PowerPoint, Healthcare Consulting, EHR
Education
University of Illinois at Urbana-Champaign 2006 — 2011
BACHELOR OF SCIENCE, Chemistry: Environmental Chemistry Concentration
Accretive Health August 2013 - Present
Accretive Health March 2012 - August 2013
Monosol Rx, LLC August 2011 - March 2012
University of Illinois Testing Center March 2010 - May 2011
#1 Chop Suey, Inc May 2008 - August 2009
Skills
EMR, Epic Systems, Healthcare, Meditech, Microsoft Word, Cerner, Healthcare Information..., Microsoft Excel, HIPAA, Customer Service, Outlook, Data Analysis, Clinical Research, Healthcare Management, PowerPoint, Healthcare Consulting, EHR
Education
University of Illinois at Urbana-Champaign 2006 — 2011
BACHELOR OF SCIENCE, Chemistry: Environmental Chemistry Concentration
Mandy Lucious's MonoSol Rx, LLC Experience March 2012 - March 2015
Job Project Analyst, Order Management at ArcelorMittal USA
Industry Pharmaceuticals
Experience
ArcelorMittal USA April 2015 - Present
Monosol Rx, LLC March 2012 - March 2015
Medical Billing Office February 2011 - March 2012
Edgewater Systems July 2010 - February 2011
Edgewater Systems August 2006 - May 2008
Skills
Administrative..., Accounts Receivable, Management, Invoicing, Accounts Payable, Pharmaceutical Industry, GMP, Sop, Customer Service, Data Entry, Interviews, Analysis, Time Management, Finance, Negotiation, Medical Billing, Business Travel, Expense Management, Project Management, User Requirements, Purchase Orders, Events Coordination, Administrative..., Microsoft Office, SOP, Training
Education
Keller Graduate School of Management of DeVry University 2013 — 2015
Master of Business Administration (M.B.A.), Accounting and Business/Management
Purdue University Calumet 2005 — 2010
Bachelor of Science (B.S.), Organizational Leadership and Supervision
ArcelorMittal USA April 2015 - Present
Monosol Rx, LLC March 2012 - March 2015
Medical Billing Office February 2011 - March 2012
Edgewater Systems July 2010 - February 2011
Edgewater Systems August 2006 - May 2008
Skills
Administrative..., Accounts Receivable, Management, Invoicing, Accounts Payable, Pharmaceutical Industry, GMP, Sop, Customer Service, Data Entry, Interviews, Analysis, Time Management, Finance, Negotiation, Medical Billing, Business Travel, Expense Management, Project Management, User Requirements, Purchase Orders, Events Coordination, Administrative..., Microsoft Office, SOP, Training
Education
Keller Graduate School of Management of DeVry University 2013 — 2015
Master of Business Administration (M.B.A.), Accounting and Business/Management
Purdue University Calumet 2005 — 2010
Bachelor of Science (B.S.), Organizational Leadership and Supervision
Kristina (Poland) Gonzalez's MonoSol Rx, LLC Experience July 2014 - Present
Job Validation Engineer MonoSol Rx
Industry Biotechnology
Experience
MonoSol Rx, LLC July 2014 - Present
Therapeutic Proteins International, LLC May 2013 - June 2014
Microworks, Inc December 2010 - May 2013
Skills
Microbiology, Aseptic Technique, Sop, Validation, Environmental Monitoring, GLP, Laboratory, Pharmaceutical Industry, SOP, Change Control
Education
Indiana University Bloomington 2007 — 2010
Bachelor's degree, Microbiology
MonoSol Rx, LLC July 2014 - Present
Therapeutic Proteins International, LLC May 2013 - June 2014
Microworks, Inc December 2010 - May 2013
Skills
Microbiology, Aseptic Technique, Sop, Validation, Environmental Monitoring, GLP, Laboratory, Pharmaceutical Industry, SOP, Change Control
Education
Indiana University Bloomington 2007 — 2010
Bachelor's degree, Microbiology
Evan Cutler Evan Cutler's MonoSol Rx, LLC Experience September 2014 - July 2015
Job Managing Director at Cutler Solutions, LLC
Industry Pharmaceuticals
Experience
Cutler Solutions, LLC January 2012 - Present
Meridan Consulting, LLC June 2011 - Present
MonoSol Rx, LLC September 2014 - July 2015
MonoSol Rx November 2012 - February 2014
Johnson & Johnson - Noramco, Inc. March 2007 - November 2012
VTS Consultants, Inc. February 1998 - November 2012
The Validation Group February 1997 - February 1998
FDA July 1990 - February 1996
Skills
Quality Assurance, Validation, FDA, Change Control, CAPA, GMP, Pharmaceutical Industry, 21 CFR Part 11, Quality System, V&V, Regulatory Affairs, Computer System..., Medical Devices, Regulatory Submissions, GAMP, Biopharmaceuticals, Quality Auditing, Regulatory Requirements, ISO, Pharmaceutics, Biotechnology, ISO 13485, GLP, Quality Control, SOP, Auditing, Risk Assessment, Quality Management, Software Documentation, Management, Packaging, Design Control, Documentation, Qualification Testing, Lifesciences, Quality Systems, cGMP, Pharmaceuticals, Compliance, Investigations, Process Validation
Education
Rutgers, The State University of New Jersey-New Brunswick 1986 — 1990
Bachelor, Biology
Cherry Hill High School East 1982 — 1986
Diploma
Cutler Solutions, LLC January 2012 - Present
Meridan Consulting, LLC June 2011 - Present
MonoSol Rx, LLC September 2014 - July 2015
MonoSol Rx November 2012 - February 2014
Johnson & Johnson - Noramco, Inc. March 2007 - November 2012
VTS Consultants, Inc. February 1998 - November 2012
The Validation Group February 1997 - February 1998
FDA July 1990 - February 1996
Skills
Quality Assurance, Validation, FDA, Change Control, CAPA, GMP, Pharmaceutical Industry, 21 CFR Part 11, Quality System, V&V, Regulatory Affairs, Computer System..., Medical Devices, Regulatory Submissions, GAMP, Biopharmaceuticals, Quality Auditing, Regulatory Requirements, ISO, Pharmaceutics, Biotechnology, ISO 13485, GLP, Quality Control, SOP, Auditing, Risk Assessment, Quality Management, Software Documentation, Management, Packaging, Design Control, Documentation, Qualification Testing, Lifesciences, Quality Systems, cGMP, Pharmaceuticals, Compliance, Investigations, Process Validation
Education
Rutgers, The State University of New Jersey-New Brunswick 1986 — 1990
Bachelor, Biology
Cherry Hill High School East 1982 — 1986
Diploma
Curtis Burks's MonoSol Rx, LLC Experience June 2005 - December 2010
Job Quality Assurance Professional
Industry Medical Devices
Experience
Cell Marque a Sigma Aldrich Company June 2014 - Present
Volcano Corporation June 2012 - June 2014
Arbour Group LLC April 2011 - June 2012
Monosol Rx, LLC June 2005 - December 2010
CSL Behring June 2000 - June 2004
Skills
Computer System..., 21 CFR Part 11, Validation, SDLC, Equipment Qualification, Manufacturing Process..., Quality Systems..., Reqgulatory Compliance, Manufacturing, Quality System, Sop, Quality Assurance, V&V, FDA, CAPA, GMP, Cross-functional Team..., Medical Devices
Education
Northwestern University 2008 — 2012
Pending, Quality Assurance and Regulatory Science for Pharmaceutical Drugs, Medical Devices, Biologics, 3.8
Governors State University 2000 — 2004
Bachelors, Health Care Administration, 3.75
St. Francis De Sales/Our Lady Gate of Heaven
Cell Marque a Sigma Aldrich Company June 2014 - Present
Volcano Corporation June 2012 - June 2014
Arbour Group LLC April 2011 - June 2012
Monosol Rx, LLC June 2005 - December 2010
CSL Behring June 2000 - June 2004
Skills
Computer System..., 21 CFR Part 11, Validation, SDLC, Equipment Qualification, Manufacturing Process..., Quality Systems..., Reqgulatory Compliance, Manufacturing, Quality System, Sop, Quality Assurance, V&V, FDA, CAPA, GMP, Cross-functional Team..., Medical Devices
Education
Northwestern University 2008 — 2012
Pending, Quality Assurance and Regulatory Science for Pharmaceutical Drugs, Medical Devices, Biologics, 3.8
Governors State University 2000 — 2004
Bachelors, Health Care Administration, 3.75
St. Francis De Sales/Our Lady Gate of Heaven
Nathan David Nathan David's MonoSol Rx, LLC Experience September 2010 - June 2012
Job QA Engineer Swiss American Products
Industry Pharmaceuticals
Experience
Swiss-American Products, Inc. June 2015 - Present
NantPharma April 2013 - March 2015
Now Foods August 2012 - April 2013
Monosol Rx, LLC September 2010 - June 2012
CSL Behring August 2009 - September 2010
Pollution Control Industries August 2007 - August 2009
University Of Illinois Dining Services January 2004 - May 2007
Skills
FDA, Data Analysis, Troubleshooting, Microsoft Office, Excel, SOP Writing, PowerPoint, CAPA, Change Control, Pharmaceutical Industry, Quality System, Quality Auditing, Sop, Training, Batch Records, GMP, Validation, cGMP practices, GxP, Microsoft Excel, Manufacturing, Quality Assurance, Master Control, 21 CFR Part 11, Process Improvement, Cleaning Validation, SOP, Deviations, APIs, Analytical Method..., SOP Development
Education
University Of Illinois - Urbana/Champaign Campus 2003 — 2007
B.S, Molecular & Cellular Biology / Chemistry
University of Illinois at Urbana-Champaign 2003 — 2007
BS, Molecular & Cellular Biology
Swiss-American Products, Inc. June 2015 - Present
NantPharma April 2013 - March 2015
Now Foods August 2012 - April 2013
Monosol Rx, LLC September 2010 - June 2012
CSL Behring August 2009 - September 2010
Pollution Control Industries August 2007 - August 2009
University Of Illinois Dining Services January 2004 - May 2007
Skills
FDA, Data Analysis, Troubleshooting, Microsoft Office, Excel, SOP Writing, PowerPoint, CAPA, Change Control, Pharmaceutical Industry, Quality System, Quality Auditing, Sop, Training, Batch Records, GMP, Validation, cGMP practices, GxP, Microsoft Excel, Manufacturing, Quality Assurance, Master Control, 21 CFR Part 11, Process Improvement, Cleaning Validation, SOP, Deviations, APIs, Analytical Method..., SOP Development
Education
University Of Illinois - Urbana/Champaign Campus 2003 — 2007
B.S, Molecular & Cellular Biology / Chemistry
University of Illinois at Urbana-Champaign 2003 — 2007
BS, Molecular & Cellular Biology
Gary Stein Gary Stein's MonoSol Rx, LLC Experience September 2013 - Present
Job Project Engineer at Monosol Rx, LLC
Industry Pharmaceuticals
Experience
Monosol Rx, LLC September 2013 - Present
Monosol Rx, LLC May 2013 - September 2013
NantPharma LLC December 2012 - April 2013
Think America LLC July 2012 - December 2012
Celgene April 2011 - June 2012
Celgene October 2010 - September 2011
Abraxis BioScience January 2009 - October 2010
APP Pharmaceuticals December 2007 - November 2008
APP Pharmaceuticals October 2006 - January 2008
APP Pharmaceuticals August 2005 - October 2006
Skills
Electronics, FDA, Metrology, HVAC, Power Generation, Project Engineering, Nanotechnology, Nuclear, Reactor, AutoCAD, Packaging, Lyophilization, UV, Administration, Technical Writing, Spectrophotometry, Nuclear Engineering, Microsoft Office, Nuclear Energy, CAD, GMP, Aseptic Processing, cGMP, CAPA, 21 CFR Part 11, Invention, Military, Electrical Maintenance, Electrical Controls, Validation, Quality System, GLP, V&V, Trackwise, Calibration, Change Control, Sop, Quality Assurance, Pharmaceutical Industry, Computer System..., Technology Transfer, Pharmaceutics, Biopharmaceuticals, LIMS, Cleaning Validation, Regulatory Requirements, Sterilization, Quality Control, GxP, Quality Auditing
Education
Robert Morris College 2004 — 2006
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General, 4.0
Robert Morris College 2003 — 2004
Associate's degree, Business Administration and Management, General, 4.0
Monosol Rx, LLC September 2013 - Present
Monosol Rx, LLC May 2013 - September 2013
NantPharma LLC December 2012 - April 2013
Think America LLC July 2012 - December 2012
Celgene April 2011 - June 2012
Celgene October 2010 - September 2011
Abraxis BioScience January 2009 - October 2010
APP Pharmaceuticals December 2007 - November 2008
APP Pharmaceuticals October 2006 - January 2008
APP Pharmaceuticals August 2005 - October 2006
Skills
Electronics, FDA, Metrology, HVAC, Power Generation, Project Engineering, Nanotechnology, Nuclear, Reactor, AutoCAD, Packaging, Lyophilization, UV, Administration, Technical Writing, Spectrophotometry, Nuclear Engineering, Microsoft Office, Nuclear Energy, CAD, GMP, Aseptic Processing, cGMP, CAPA, 21 CFR Part 11, Invention, Military, Electrical Maintenance, Electrical Controls, Validation, Quality System, GLP, V&V, Trackwise, Calibration, Change Control, Sop, Quality Assurance, Pharmaceutical Industry, Computer System..., Technology Transfer, Pharmaceutics, Biopharmaceuticals, LIMS, Cleaning Validation, Regulatory Requirements, Sterilization, Quality Control, GxP, Quality Auditing
Education
Robert Morris College 2004 — 2006
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General, 4.0
Robert Morris College 2003 — 2004
Associate's degree, Business Administration and Management, General, 4.0
Margaret Moran's MonoSol Rx, LLC Experience December 2013 - Present
Job Quality Manager at Monosol Rx, LLC
Industry Pharmaceuticals
Experience
Monosol Rx, LLC December 2013 - Present
Monosol Rx, LLC April 2013 - December 2013
EMD Millipore August 2011 - March 2013
CSL Behring December 2008 - August 2011
CSL Behring June 2007 - December 2008
CSL Behring March 2007 - June 2007
Pollution Control Industries March 2006 - March 2007
Skills
Validation, cGMP, Auditing, Pharmaceuticals, Process Validation, Cleaning Validation, Change Control, Manufacturing, FDA, Quality Assurance, Biotechnology, Biopharmaceuticals, Monoclonal Antibodies, GMP, Quality Systems, 21 CFR Part 11, Technology Transfer, ISO, Microbiology, Computer System..., Regulatory Affairs, V&V, GAMP, HPLC, Quality Control, ISO 13485, Aseptic Processing, Quality Auditing, Vaccines, CAPA, GxP, Chromatography, Quality System, Regulatory Requirements, Pharmaceutical Industry, Lifesciences, Sop, GLP, LIMS, cGMP manufacturing, FDA GMP, Sterilization, Trackwise, cGMP practices
Education
Purdue University 2012 — 2015
Master of Science in Industrial and Physical Pharmacy, Regulatory and Quality Compliance
University of Illinois at Chicago 2002 — 2005
B.S., Biological Sciences
University College Dublin 2004 — 2004
Study Abroad, Biological Sciences / Arts
Prairie State College 2001 — 2002
A.A., Biological Sciences / Arts
Monosol Rx, LLC December 2013 - Present
Monosol Rx, LLC April 2013 - December 2013
EMD Millipore August 2011 - March 2013
CSL Behring December 2008 - August 2011
CSL Behring June 2007 - December 2008
CSL Behring March 2007 - June 2007
Pollution Control Industries March 2006 - March 2007
Skills
Validation, cGMP, Auditing, Pharmaceuticals, Process Validation, Cleaning Validation, Change Control, Manufacturing, FDA, Quality Assurance, Biotechnology, Biopharmaceuticals, Monoclonal Antibodies, GMP, Quality Systems, 21 CFR Part 11, Technology Transfer, ISO, Microbiology, Computer System..., Regulatory Affairs, V&V, GAMP, HPLC, Quality Control, ISO 13485, Aseptic Processing, Quality Auditing, Vaccines, CAPA, GxP, Chromatography, Quality System, Regulatory Requirements, Pharmaceutical Industry, Lifesciences, Sop, GLP, LIMS, cGMP manufacturing, FDA GMP, Sterilization, Trackwise, cGMP practices
Education
Purdue University 2012 — 2015
Master of Science in Industrial and Physical Pharmacy, Regulatory and Quality Compliance
University of Illinois at Chicago 2002 — 2005
B.S., Biological Sciences
University College Dublin 2004 — 2004
Study Abroad, Biological Sciences / Arts
Prairie State College 2001 — 2002
A.A., Biological Sciences / Arts
Chris LaCorata Chris LaCorata's MonoSol Rx, LLC Experience March 2011 - September 2012
Job Chief Operations Executive consumer & Industrial manufacturing
Industry Executive Office
Experience
Innocor, Inc. July 2014 - Present
PaperWorks Industries, Inc. December 2013 - July 2014
Monosol Rx, LLC March 2011 - September 2012
Obrist Americas June 2007 - September 2009
ClearSource Inc. February 2004 - May 2007
Consolidated Container 2001 - 2003
WisPak Pepsi-Cola 1998 - 2001
Nestles Waters North America 1994 - 1998
Coca-Cola of New York 1986 - 1995
Skills
Continuous Improvement, Mergers, Supply Chain, Start-ups, Process Improvement, Restructuring, Turn Around Management, Lean Manufacturing, Cross-functional Team..., Manufacturing, Six Sigma, Product Development, Logistics, Operational Excellence, Executive Management, Interim Executive, Business Valuation, Team Building, Strategy / Deployment, Forecasting, Supply Chain Management, Management, Mergers & Acquisitions, Kaizen, Organizational..., EBITDA Advancement, EBITDA Growth, Building Supply Chain..., Customer Relations, Customer Service, Program Management, Sales, Warehousing, Business Development, CRM, Training, Procurement, Sourcing, P&L, Operational Consulting, Strategy, Talent Management, Leadership, Change Management, Business Process..., Leadership Development
Education
Marian University
MS, Organizational Leadership & Quality
University of Connecticut
BS, Business
Rutgers University
Executive Certification- Pharmaceutical Management, Pharmaceuticals
Harvard Business School
Executive Certification, Turnaround Management
ASQ
Six Sigma Black Belt
Innocor, Inc. July 2014 - Present
PaperWorks Industries, Inc. December 2013 - July 2014
Monosol Rx, LLC March 2011 - September 2012
Obrist Americas June 2007 - September 2009
ClearSource Inc. February 2004 - May 2007
Consolidated Container 2001 - 2003
WisPak Pepsi-Cola 1998 - 2001
Nestles Waters North America 1994 - 1998
Coca-Cola of New York 1986 - 1995
Skills
Continuous Improvement, Mergers, Supply Chain, Start-ups, Process Improvement, Restructuring, Turn Around Management, Lean Manufacturing, Cross-functional Team..., Manufacturing, Six Sigma, Product Development, Logistics, Operational Excellence, Executive Management, Interim Executive, Business Valuation, Team Building, Strategy / Deployment, Forecasting, Supply Chain Management, Management, Mergers & Acquisitions, Kaizen, Organizational..., EBITDA Advancement, EBITDA Growth, Building Supply Chain..., Customer Relations, Customer Service, Program Management, Sales, Warehousing, Business Development, CRM, Training, Procurement, Sourcing, P&L, Operational Consulting, Strategy, Talent Management, Leadership, Change Management, Business Process..., Leadership Development
Education
Marian University
MS, Organizational Leadership & Quality
University of Connecticut
BS, Business
Rutgers University
Executive Certification- Pharmaceutical Management, Pharmaceuticals
Harvard Business School
Executive Certification, Turnaround Management
ASQ
Six Sigma Black Belt
Jennifer Hayes's MonoSol Rx, LLC Experience August 2013 - Present
Job Human Resources Coordinator at MonoSol, LLC
Industry Human Resources
Experience
Monosol Rx, LLC August 2013 - Present
Waters and Sims Employment Services May 2013 - August 2013
New York Sports Club June 2010 - July 2013
Waters and Sims Employment Services February 2013 - May 2013
Skills
Microsoft Office, Microsoft Word, PowerPoint, Microsoft Excel, Social Media, Social Networking, Customer Service
Education
Monmouth University 2009 — 2013
Bachelor of Arts (B.A.), Psychology
Rutgers University-New Brunswick
Human Resource Management
Monosol Rx, LLC August 2013 - Present
Waters and Sims Employment Services May 2013 - August 2013
New York Sports Club June 2010 - July 2013
Waters and Sims Employment Services February 2013 - May 2013
Skills
Microsoft Office, Microsoft Word, PowerPoint, Microsoft Excel, Social Media, Social Networking, Customer Service
Education
Monmouth University 2009 — 2013
Bachelor of Arts (B.A.), Psychology
Rutgers University-New Brunswick
Human Resource Management
Jennifer Tannous's MonoSol Rx, LLC Experience December 2013 - Present
Job Process Engineer at Monosol Rx, LLC
Industry Pharmaceuticals
Experience
Monosol Rx, LLC December 2013 - Present
Boehringer Ingelheim December 2011 - December 2013
Alliance Scientific Solutions August 2011 - December 2011
Best Buy August 2005 - August 2011
Skills
GMP, Process Validation, Technology Transfer, Project Management, Lean Six Sigma, 5S, Conversational Arabic, Microsoft Office, Validation, Sop, Pharmaceutical Industry, Process Engineering, GLP, Quality Assurance, Formulation, Cross-functional Team..., FDA, CAPA, Process Simulation, Manufacturing
Education
Miami University 2007 — 2011
Bachelors, Chemical Engineering
Monosol Rx, LLC December 2013 - Present
Boehringer Ingelheim December 2011 - December 2013
Alliance Scientific Solutions August 2011 - December 2011
Best Buy August 2005 - August 2011
Skills
GMP, Process Validation, Technology Transfer, Project Management, Lean Six Sigma, 5S, Conversational Arabic, Microsoft Office, Validation, Sop, Pharmaceutical Industry, Process Engineering, GLP, Quality Assurance, Formulation, Cross-functional Team..., FDA, CAPA, Process Simulation, Manufacturing
Education
Miami University 2007 — 2011
Bachelors, Chemical Engineering
Allison Parlapiano Allison Parlapiano's MonoSol Rx, LLC Experience April 2012 - May 2014
Job Associate Scientist at Ethicon, Inc.
Industry Pharmaceuticals
Experience
Ethicon, Inc. May 2014 - Present
MonoSol Rx, LLC April 2012 - May 2014
Merck November 1998 - October 2011
UMDNJ June 1996 - June 1998
Animerge Emergency Veterinary Hospital June 1994 - May 1996
Skills
Surgery, Pharmacokinetics, Team Building, Team Leadership, Teamwork, In Vivo, Pharmacodynamics, Animal Models, Stress Resistant, Self Starter, Well Organised, Resilient, Highly Adaptable, Training/Mentoring, Cross-functional Team..., Biotechnology, Science, Pharmaceuticals, R&D, Diabetes, Drug Discovery, Problem Solving, Research, Pharmacology, Mentoring, Coaching, Pharmaceutical Industry, Cell Culture, GLP, Lifesciences, Drug Development, Biomarkers, ELISA, Assay Development, Immunology, Clinical Development, Vaccines, Toxicology, Drug Metabolism, Infectious Diseases, Sop, Adaptation, SOP, Life Sciences
Education
Cook College, Rutgers University 1992 — 1998
BS, Animal Science
Kean University 1990 — 1991
Ethicon, Inc. May 2014 - Present
MonoSol Rx, LLC April 2012 - May 2014
Merck November 1998 - October 2011
UMDNJ June 1996 - June 1998
Animerge Emergency Veterinary Hospital June 1994 - May 1996
Skills
Surgery, Pharmacokinetics, Team Building, Team Leadership, Teamwork, In Vivo, Pharmacodynamics, Animal Models, Stress Resistant, Self Starter, Well Organised, Resilient, Highly Adaptable, Training/Mentoring, Cross-functional Team..., Biotechnology, Science, Pharmaceuticals, R&D, Diabetes, Drug Discovery, Problem Solving, Research, Pharmacology, Mentoring, Coaching, Pharmaceutical Industry, Cell Culture, GLP, Lifesciences, Drug Development, Biomarkers, ELISA, Assay Development, Immunology, Clinical Development, Vaccines, Toxicology, Drug Metabolism, Infectious Diseases, Sop, Adaptation, SOP, Life Sciences
Education
Cook College, Rutgers University 1992 — 1998
BS, Animal Science
Kean University 1990 — 1991
Alex Szopinski Alex Szopinski's MonoSol Rx, LLC Experience December 2005 - May 2008
Job Systems Engineer at InnerWorkings
Industry Information Technology and Services
Experience
InnerWorkings January 2014 - Present
Cision March 2013 - January 2014
Cision September 2011 - March 2013
Feeding America July 2010 - September 2011
MonoSol, LLC May 2008 - September 2011
MonoSol Rx, LLC December 2005 - May 2008
Skills
Technical Support, Troubleshooting, Operating Systems, System Administration, Hardware, Windows, Software Documentation, Active Directory, Windows Server, VMware, Windows 7, Microsoft Office, Microsoft Exchange, Windows XP, Microsoft SQL Server, DHCP, Server Administration, Security, Windows Vista, SharePoint, Windows XP Pro, Servers, SCCM, Group Policy, Access, SQL, DNS, Citrix, VMware ESX, Powershell, vSphere, Virtualization, VMware Infrastructure, SAN, Microsoft Technologies, Backup Exec, WSUS, IIS, Citrix XenApp, CommVault, CentOS, Linux, MySQL Cluster, Cisco UCS, Linux System...
Education
Ivy Tech Community College 2009 — 2010
AAS, Computer Information Systems
InnerWorkings January 2014 - Present
Cision March 2013 - January 2014
Cision September 2011 - March 2013
Feeding America July 2010 - September 2011
MonoSol, LLC May 2008 - September 2011
MonoSol Rx, LLC December 2005 - May 2008
Skills
Technical Support, Troubleshooting, Operating Systems, System Administration, Hardware, Windows, Software Documentation, Active Directory, Windows Server, VMware, Windows 7, Microsoft Office, Microsoft Exchange, Windows XP, Microsoft SQL Server, DHCP, Server Administration, Security, Windows Vista, SharePoint, Windows XP Pro, Servers, SCCM, Group Policy, Access, SQL, DNS, Citrix, VMware ESX, Powershell, vSphere, Virtualization, VMware Infrastructure, SAN, Microsoft Technologies, Backup Exec, WSUS, IIS, Citrix XenApp, CommVault, CentOS, Linux, MySQL Cluster, Cisco UCS, Linux System...
Education
Ivy Tech Community College 2009 — 2010
AAS, Computer Information Systems
Gint Butenas Gint Butenas's MonoSol Rx, LLC Experience March 2006 - April 2009
Job IT Professional seeking opportunities in: Big Data, IT Project Management, Business Analysis, Infrastructure
Industry Information Technology and Services
Experience
DePaul University January 2014 - Present
Self employed April 2009 - Present
Monosol Rx, LLC March 2006 - April 2009
Haig & Associates, LTD September 1999 - March 2006
Lighthouse Consulting December 1998 - September 1999
Metamor Technologies, LTD April 1996 - December 1998
Bansley & Kiener, LLP April 1993 - April 1996
Skills
Project Management, IT Management, Big Data, Hadoop, MongoDB, Cloud Computing, Microsoft Server..., Enterprise Architecture, Microsoft Exchange, Firewalls, Management, Networking, SQL, IT Service Management, Start-ups, Information Security, Certified Novell...
Education
DePaul University 2013 — 2013
Institute of Professional Development Certificate, Big Data using Hadoop Program
DePaul University 2013 — 2013
Institute of Professional Development Certificate, Big Data and NoSQL Program
DePaul University 2009 — 2010
Master of Science, IT Project Management
University of Illinois at Chicago
Bachelor Science Degree, Finance and Economics
DePaul University January 2014 - Present
Self employed April 2009 - Present
Monosol Rx, LLC March 2006 - April 2009
Haig & Associates, LTD September 1999 - March 2006
Lighthouse Consulting December 1998 - September 1999
Metamor Technologies, LTD April 1996 - December 1998
Bansley & Kiener, LLP April 1993 - April 1996
Skills
Project Management, IT Management, Big Data, Hadoop, MongoDB, Cloud Computing, Microsoft Server..., Enterprise Architecture, Microsoft Exchange, Firewalls, Management, Networking, SQL, IT Service Management, Start-ups, Information Security, Certified Novell...
Education
DePaul University 2013 — 2013
Institute of Professional Development Certificate, Big Data using Hadoop Program
DePaul University 2013 — 2013
Institute of Professional Development Certificate, Big Data and NoSQL Program
DePaul University 2009 — 2010
Master of Science, IT Project Management
University of Illinois at Chicago
Bachelor Science Degree, Finance and Economics
Mario Mas-Nieves Mario Mas-Nieves's MonoSol Rx, LLC Experience 2006 - 2007
Job Manufacturing Quality Manager at Elanco
Industry Pharmaceuticals
Experience
Elanco 2012 - Present
ProPharma Group March 2012 - August 2012
United States Steel Company 2008 - 2012
MonoSol Rx LLC 2006 - 2007
Takeda Abbott Pharmaceuticals 2002 - 2006
Takeda Abbott Pharmaceuticals 1999 - 2002
Abbott Healthcare 1995 - 1999
Abbott Health Products 1993 - 1995
Pfizer Pharmaceuticals Inc. 1990 - 1993
Pfizer Pharmaceuticals 1988 - 1990
Skills
FDA GMP, DEA, Pharmaceutical Industry, Pharmaceutics, Steel Plant, Change Control, CAPA, Quality Assurance, Quality Management, Quality System, Quality Control, Supplier Quality, Product Transfer, Technology Transfer, Controlled Substances, Validation, Computer System..., Cleaning Validation, HPLC, Gas Chromatography, TrackWise, PVWorks, Manufacturing, Lean Manufacturing, Contract Manufacturing, Contract Research..., ex-US Inspections, GxP, Supply Chain Management, FT-IR, Mass Spectrometry, SEM, Wet Chemistry, USP, Polymorph Screening, API manufacturing
Education
University of Puerto Rico-Rio Piedras 1982 — 1987
Bachelor's Degree, Chemistry, Cum Laude
Elanco 2012 - Present
ProPharma Group March 2012 - August 2012
United States Steel Company 2008 - 2012
MonoSol Rx LLC 2006 - 2007
Takeda Abbott Pharmaceuticals 2002 - 2006
Takeda Abbott Pharmaceuticals 1999 - 2002
Abbott Healthcare 1995 - 1999
Abbott Health Products 1993 - 1995
Pfizer Pharmaceuticals Inc. 1990 - 1993
Pfizer Pharmaceuticals 1988 - 1990
Skills
FDA GMP, DEA, Pharmaceutical Industry, Pharmaceutics, Steel Plant, Change Control, CAPA, Quality Assurance, Quality Management, Quality System, Quality Control, Supplier Quality, Product Transfer, Technology Transfer, Controlled Substances, Validation, Computer System..., Cleaning Validation, HPLC, Gas Chromatography, TrackWise, PVWorks, Manufacturing, Lean Manufacturing, Contract Manufacturing, Contract Research..., ex-US Inspections, GxP, Supply Chain Management, FT-IR, Mass Spectrometry, SEM, Wet Chemistry, USP, Polymorph Screening, API manufacturing
Education
University of Puerto Rico-Rio Piedras 1982 — 1987
Bachelor's Degree, Chemistry, Cum Laude
Patricia Woods Patricia Woods's MonoSol Rx, LLC Experience September 2012 - January 2013
Job Experienced Laboratory Technician! A Perspective of Patricia Woods
Industry Research
Experience
CSU CHICAGO 2014 - 2015
Monosol Rx, LLC September 2012 - January 2013
Dow Chemcial May 2011 - September 2011
Innophos April 2010 - February 2011
Chicago State University August 2009 - December 2009
Argonne National Laboratory May 2009 - July 2009
Chicago State University August 2008 - May 2009
Chicago State University June 2004 - August 2004
Chicago State University June 2002 - August 2002
Skills
Wet Chemistry, PCR, Quality Assurance, Gel Electrophoresis, Biochemistry, Testing, SDS-PAGE, Western Blotting, Cell Culture, Microscopy, Microbiology, Cell, UV/Vis, Laboratory, RT-PCR, Bacterial Transformation, Aseptic Technique, Chemistry, LIMS, Spectrophotometry, DNA, Titration, Analytical Chemistry
Education
Percy Lavon Julian 1998 — 2002
Diploma, Career Academic
Chicago State University
Bachelor of Science, Biology
CSU CHICAGO 2014 - 2015
Monosol Rx, LLC September 2012 - January 2013
Dow Chemcial May 2011 - September 2011
Innophos April 2010 - February 2011
Chicago State University August 2009 - December 2009
Argonne National Laboratory May 2009 - July 2009
Chicago State University August 2008 - May 2009
Chicago State University June 2004 - August 2004
Chicago State University June 2002 - August 2002
Skills
Wet Chemistry, PCR, Quality Assurance, Gel Electrophoresis, Biochemistry, Testing, SDS-PAGE, Western Blotting, Cell Culture, Microscopy, Microbiology, Cell, UV/Vis, Laboratory, RT-PCR, Bacterial Transformation, Aseptic Technique, Chemistry, LIMS, Spectrophotometry, DNA, Titration, Analytical Chemistry
Education
Percy Lavon Julian 1998 — 2002
Diploma, Career Academic
Chicago State University
Bachelor of Science, Biology
Ramona McCudden Ramona McCudden's MonoSol Rx, LLC Experience December 2013 - Present
Job Sr. Recruiter at Monosol Rx, LLC
Industry Information Technology and Services
Experience
Monosol Rx, LLC December 2013 - Present
Global Gate Greet March 2013 - Present
MGD Services September 2009 - December 2013
Merck April 1997 - April 2009
Colin Services December 1996 - April 1997
Steve Forbes For President Campaign April 1996 - December 1996
Skills
Visio, Business Analysis, Software Documentation, SEO, Outlook, Social Media Marketing, Social Media, PowerPoint, Microsoft Excel, SharePoint, CRM, Cross-functional Team...
Education
Raritan Valley Community College 1990 — 1990
Monosol Rx, LLC December 2013 - Present
Global Gate Greet March 2013 - Present
MGD Services September 2009 - December 2013
Merck April 1997 - April 2009
Colin Services December 1996 - April 1997
Steve Forbes For President Campaign April 1996 - December 1996
Skills
Visio, Business Analysis, Software Documentation, SEO, Outlook, Social Media Marketing, Social Media, PowerPoint, Microsoft Excel, SharePoint, CRM, Cross-functional Team...
Education
Raritan Valley Community College 1990 — 1990
Ashley Lister Ashley Lister's MonoSol Rx, LLC Experience March 2012 - October 2013
Job Director, Preformulation and Analytical Development at Ferring Pharmaceuticals
Industry Pharmaceuticals
Experience
Ferring Pharmaceuticals October 2013 - Present
Monosol Rx, LLC March 2012 - October 2013
Gilead Sciences January 2012 - February 2012
Pharmasset, Inc. March 2010 - January 2012
Amicus Therapeutics October 2005 - October 2009
Purdue Pharma January 1998 - October 2005
Skills
Regulatory Strategy, Early-phase drug..., CMC, Technical Operations, Manufacturing Support, Pharmaceutical..., Analytical Chemistry, Methods Development, Validation, Regulatory Submissions, Drug Development, Pharmaceutical Industry, Drug Discovery, FDA, Technology Transfer, Chemistry, LC-MS, UV/Vis, Lifesciences, Manufacturing, Biopharmaceuticals, Pharmaceutics, CRO, Quality by Design, GMP, HPLC, Strategy, Clinical Research, Product Development, Formulation, CAPA, Biotechnology, Sop, GCP, GLP, R&D, GxP, Chromatography, Regulatory Affairs, LIMS, 21 CFR Part 11, Clinical Development, Dissolution, IND, Clinical Trials, V&V, Analytical Methods..., Pharmacokinetics, Oncology, Drug Delivery
Education
Florida State University 1994 — 1997
Ph.D., Analytical Chemistry
University of Cincinnati 1993 — 1994
Analytical Chemistry
Furman University 1989 — 1993
BS, Chemistry
Ferring Pharmaceuticals October 2013 - Present
Monosol Rx, LLC March 2012 - October 2013
Gilead Sciences January 2012 - February 2012
Pharmasset, Inc. March 2010 - January 2012
Amicus Therapeutics October 2005 - October 2009
Purdue Pharma January 1998 - October 2005
Skills
Regulatory Strategy, Early-phase drug..., CMC, Technical Operations, Manufacturing Support, Pharmaceutical..., Analytical Chemistry, Methods Development, Validation, Regulatory Submissions, Drug Development, Pharmaceutical Industry, Drug Discovery, FDA, Technology Transfer, Chemistry, LC-MS, UV/Vis, Lifesciences, Manufacturing, Biopharmaceuticals, Pharmaceutics, CRO, Quality by Design, GMP, HPLC, Strategy, Clinical Research, Product Development, Formulation, CAPA, Biotechnology, Sop, GCP, GLP, R&D, GxP, Chromatography, Regulatory Affairs, LIMS, 21 CFR Part 11, Clinical Development, Dissolution, IND, Clinical Trials, V&V, Analytical Methods..., Pharmacokinetics, Oncology, Drug Delivery
Education
Florida State University 1994 — 1997
Ph.D., Analytical Chemistry
University of Cincinnati 1993 — 1994
Analytical Chemistry
Furman University 1989 — 1993
BS, Chemistry
SAL (Bhoie) LOPEZ's MonoSol Rx, LLC Experience August 2012 - Present
Job Sr. Analytical Scientist (Chemist)
Industry Pharmaceuticals
Experience
Mono Sol Rx, LLC August 2012 - Present
Mono Sol Rx, LLC August 2012 - Present
MonoSol Rx, LLC August 2012 - Present
Energizer Personal Care April 2011 - December 2011
Teva Pharmaceutical Industries Ltd. January 2010 - December 2010
Barr Laboratories July 2005 - December 2009
Schering Plough June 2003 - July 2005
Solgar Vitamin & Herb March 2002 - March 2003
Chr. Hansen A/S October 2000 - March 2002
Stepan Company December 1997 - June 1999
Skills
HPLC, Dissolution, Validation, Wet Chemistry, TLC, UV, UV-Vis, IR, Analytical Chemistry, LIMS, GLP, Chromatography, cGMP, USP, SOP, GMP, Process Validation, QC, FDA, Spectrophotometry, Pharmaceuticals, Technology Transfer, Biotechnology, Chemistry, R&D, 21 CFR Part 11, Spectroscopy, CAPA, Technical report writing, Technical Reports, UV/Vis, Sop, Gas Chromatography, Technical Writing, V&V, Pharmaceutical Industry, Quality Control, Stability Testing, Empower, Analytical Method..., Analytical Methods..., Formulation, LC-MS, Laboratory, Cleaning Validation, Change Control, Pharmaceutics
Education
University of St Tomas 1974 — 1978
M Sc. in Analytical Chemistry, physical Chemistry
University of Santo Tomas 1967 — 1973
BS in Chemical engineering, Chemical Engineering
Mono Sol Rx, LLC August 2012 - Present
Mono Sol Rx, LLC August 2012 - Present
MonoSol Rx, LLC August 2012 - Present
Energizer Personal Care April 2011 - December 2011
Teva Pharmaceutical Industries Ltd. January 2010 - December 2010
Barr Laboratories July 2005 - December 2009
Schering Plough June 2003 - July 2005
Solgar Vitamin & Herb March 2002 - March 2003
Chr. Hansen A/S October 2000 - March 2002
Stepan Company December 1997 - June 1999
Skills
HPLC, Dissolution, Validation, Wet Chemistry, TLC, UV, UV-Vis, IR, Analytical Chemistry, LIMS, GLP, Chromatography, cGMP, USP, SOP, GMP, Process Validation, QC, FDA, Spectrophotometry, Pharmaceuticals, Technology Transfer, Biotechnology, Chemistry, R&D, 21 CFR Part 11, Spectroscopy, CAPA, Technical report writing, Technical Reports, UV/Vis, Sop, Gas Chromatography, Technical Writing, V&V, Pharmaceutical Industry, Quality Control, Stability Testing, Empower, Analytical Method..., Analytical Methods..., Formulation, LC-MS, Laboratory, Cleaning Validation, Change Control, Pharmaceutics
Education
University of St Tomas 1974 — 1978
M Sc. in Analytical Chemistry, physical Chemistry
University of Santo Tomas 1967 — 1973
BS in Chemical engineering, Chemical Engineering
Jasmin DeVance's MonoSol Rx, LLC Experience June 2012 - March 2013
Job Quality Assurance Professional
Industry Chemicals
Experience
Optimum Nutrition March 2013 - October 2014
Monosol Rx, LLC June 2012 - March 2013
US Smokeless Tobacco Company September 2011 - April 2012
Gold Eagle Company September 2007 - June 2011
Antech Diagnostics November 2006 - May 2007
Chicago State University August 2004 - May 2006
Sherwin Williams Steudal Laboratory June 2002 - August 2004
Skills
GMP, HPLC, Sop, GLP, Analytical Chemistry, Change Control, Quality Control, Quality Assurance, Leadership, Management, Microsoft Office, Manufacturing, Laboratory, Continuous Improvement, SOP, Six Sigma, FDA, Pharmaceutical Industry, Validation
Education
Chicago State University
of Bachelor Degree Requirements, Biochemistry
Optimum Nutrition March 2013 - October 2014
Monosol Rx, LLC June 2012 - March 2013
US Smokeless Tobacco Company September 2011 - April 2012
Gold Eagle Company September 2007 - June 2011
Antech Diagnostics November 2006 - May 2007
Chicago State University August 2004 - May 2006
Sherwin Williams Steudal Laboratory June 2002 - August 2004
Skills
GMP, HPLC, Sop, GLP, Analytical Chemistry, Change Control, Quality Control, Quality Assurance, Leadership, Management, Microsoft Office, Manufacturing, Laboratory, Continuous Improvement, SOP, Six Sigma, FDA, Pharmaceutical Industry, Validation
Education
Chicago State University
of Bachelor Degree Requirements, Biochemistry
Amy Gorcowski's MonoSol Rx, LLC Experience May 2015 - Present
Job Director of Supply Chain at MonoSol Rx, LLC
Industry Pharmaceuticals
Experience
MonoSol Rx, LLC May 2015 - Present
Monosol Rx, LLC 2012 - Present
Monosol Rx, LLC 2008 - 2012
Monosol Rx, LLC 2004 - 2008
Skills
GMP, Sop, Pharmaceutical Industry, Pharmaceutics, Supply Chain, Strategic Planning, Strategy, Contract Management, Relationship Management, Business Alliances, Manufacturing, Purchasing, Vendor Management, Project Management, Project Planning, Business Development, R&D Planning, Collaborative R&D, Product Development, Cross-functional Team..., Leadership, Operations Management, FDA, Quality System, Management, Biotechnology, CAPA
Education
Purdue University Calumet 2001 — 2003
BS Chemistry
Purdue University Calumet 1999 — 2003
BS, Chemistry
MonoSol Rx, LLC May 2015 - Present
Monosol Rx, LLC 2012 - Present
Monosol Rx, LLC 2008 - 2012
Monosol Rx, LLC 2004 - 2008
Skills
GMP, Sop, Pharmaceutical Industry, Pharmaceutics, Supply Chain, Strategic Planning, Strategy, Contract Management, Relationship Management, Business Alliances, Manufacturing, Purchasing, Vendor Management, Project Management, Project Planning, Business Development, R&D Planning, Collaborative R&D, Product Development, Cross-functional Team..., Leadership, Operations Management, FDA, Quality System, Management, Biotechnology, CAPA
Education
Purdue University Calumet 2001 — 2003
BS Chemistry
Purdue University Calumet 1999 — 2003
BS, Chemistry
Cassie (Cassie Schaufele) Jung's MonoSol Rx, LLC Experience October 2013 - Present
Job Director, Product Development Management at MonoSol Rx, LLC
Industry Pharmaceuticals
Experience
MonoSol Rx, LLC October 2013 - Present
MonoSol Rx, LLC October 2011 - October 2013
MonoSol Rx, LLC July 2011 - October 2011
MonoSol Rx, LLC November 2009 - July 2011
MonoSol Rx, LLC May 2008 - November 2009
MonoSol Rx, LLC April 2007 - May 2008
MonoSol Rx, LLC September 2006 - April 2007
MonoSol Rx, LLC January 2004 - September 2006
Skills
Microsoft Office, Management, Microsoft Excel, Microsoft Word, Research, PowerPoint
Education
Purdue University 1997 — 2001
Bachelor of Science (B.S.), Management
MonoSol Rx, LLC October 2013 - Present
MonoSol Rx, LLC October 2011 - October 2013
MonoSol Rx, LLC July 2011 - October 2011
MonoSol Rx, LLC November 2009 - July 2011
MonoSol Rx, LLC May 2008 - November 2009
MonoSol Rx, LLC April 2007 - May 2008
MonoSol Rx, LLC September 2006 - April 2007
MonoSol Rx, LLC January 2004 - September 2006
Skills
Microsoft Office, Management, Microsoft Excel, Microsoft Word, Research, PowerPoint
Education
Purdue University 1997 — 2001
Bachelor of Science (B.S.), Management
Joshua Mitchem Joshua Mitchem's MonoSol Rx, LLC Experience October 2013 - March 2014
Job Production Supervisor at Perdue Farms
Industry Research
Experience
Perdue Farms September 2014 - Present
Monosol Rx, LLC October 2013 - March 2014
Alkermes plc. April 2011 - September 2013
Piedmont College, Dept. of Natural Science August 2008 - December 2010
Skills
Dissolution Testing, HPLC, Gas Chromatography, Chemstation Software, Waters: Empower..., Viscosity, Chromatography, FDA, Dissolution, Laboratory, Sop, Chemistry
Education
Piedmont College 2006 — 2010
Bachelor of Science (BS), Biology/Biological Sciences, General
Shiloh High School 2002 — 2006
Perdue Farms September 2014 - Present
Monosol Rx, LLC October 2013 - March 2014
Alkermes plc. April 2011 - September 2013
Piedmont College, Dept. of Natural Science August 2008 - December 2010
Skills
Dissolution Testing, HPLC, Gas Chromatography, Chemstation Software, Waters: Empower..., Viscosity, Chromatography, FDA, Dissolution, Laboratory, Sop, Chemistry
Education
Piedmont College 2006 — 2010
Bachelor of Science (BS), Biology/Biological Sciences, General
Shiloh High School 2002 — 2006
Sanford Plachter Sanford Plachter's MonoSol Rx, LLC Experience June 2013 - Present
Job Sr. Marketing Manager at Monosol Rx, LLC
Industry Marketing and Advertising
Experience
MonoSol Rx, LLC June 2013 - Present
Centron October 2012 - May 2013
GREY Healthcare Group July 2005 - September 2012
Lyons Lavey Nickel Swift January 2000 - June 2005
MDC Advertising January 1996 - January 2000
Ogilvy Healthworld January 1993 - December 1995
Baltimore Magazine 1988 - 1990
Skills
Creative Strategy, Digital Strategy, Interactive Marketing, Oncology, Advertising, Interactive Advertising, Healthcare, Strategy, Integrated Marketing, Diabetes, Creative Direction, Pharmaceutical Industry, Medical Education, Account Management, Direct Mail, Managed Care, Direct Marketing, Digital Media, Marketing, Digital Marketing, Hospital Sales, Brand Development, Allergy, Brand Management, Marketing Strategy, Product Launch, Marketing Communications, Management, Social Media, Market Research, Email Marketing
Education
The Johns Hopkins University - Carey Business School 1987 — 1990
Master of Business Administration (M.B.A.), Marketing
University of Maryland College Park 1983 — 1987
Bachelor of Science (B.S.), Marketing
Roslyn H.S. 1978 — 1982
H.S. Diplomas, H.S.
MonoSol Rx, LLC June 2013 - Present
Centron October 2012 - May 2013
GREY Healthcare Group July 2005 - September 2012
Lyons Lavey Nickel Swift January 2000 - June 2005
MDC Advertising January 1996 - January 2000
Ogilvy Healthworld January 1993 - December 1995
Baltimore Magazine 1988 - 1990
Skills
Creative Strategy, Digital Strategy, Interactive Marketing, Oncology, Advertising, Interactive Advertising, Healthcare, Strategy, Integrated Marketing, Diabetes, Creative Direction, Pharmaceutical Industry, Medical Education, Account Management, Direct Mail, Managed Care, Direct Marketing, Digital Media, Marketing, Digital Marketing, Hospital Sales, Brand Development, Allergy, Brand Management, Marketing Strategy, Product Launch, Marketing Communications, Management, Social Media, Market Research, Email Marketing
Education
The Johns Hopkins University - Carey Business School 1987 — 1990
Master of Business Administration (M.B.A.), Marketing
University of Maryland College Park 1983 — 1987
Bachelor of Science (B.S.), Marketing
Roslyn H.S. 1978 — 1982
H.S. Diplomas, H.S.
Stephanie Varjan Stephanie Varjan's MonoSol Rx, LLC Experience August 2013 - Present
Job Formulation Scientist at Monosol Rx, LLC
Industry Medical Devices
Experience
Monosol Rx, LLC August 2013 - Present
Hackensack University Medical Center February 2012 - August 2013
Hackensack University Medical Center June 2011 - September 2011
Stevens Institute of Technology January 2009 - May 2009
Skills
Research, Data Analysis, Medical Devices, Biomedical Engineering, Visio, Microsoft Office, Cell Culture, Microsoft Excel, Labview, PowerPoint, Process Improvement, Project Management
Education
Stevens Institute of Technology 2007 — 2011
BE, Biomedical Engineer
Stevens Institute of Technology 2007 — 2011
ME, Engineering Management
Stevens Institute of Technology 2007 — 2011
Graduate Certificate, Pharmaceutical Manufacturing Practices
Monosol Rx, LLC August 2013 - Present
Hackensack University Medical Center February 2012 - August 2013
Hackensack University Medical Center June 2011 - September 2011
Stevens Institute of Technology January 2009 - May 2009
Skills
Research, Data Analysis, Medical Devices, Biomedical Engineering, Visio, Microsoft Office, Cell Culture, Microsoft Excel, Labview, PowerPoint, Process Improvement, Project Management
Education
Stevens Institute of Technology 2007 — 2011
BE, Biomedical Engineer
Stevens Institute of Technology 2007 — 2011
ME, Engineering Management
Stevens Institute of Technology 2007 — 2011
Graduate Certificate, Pharmaceutical Manufacturing Practices
Andrew Wasowicz's MonoSol Rx, LLC Experience July 2013 - March 2014
Job Research Associate I at Pacira Pharmaceuticals, Inc.
Industry Chemicals
Experience
Pacira Pharmaceuticals, Inc. April 2014 - Present
Monosol Rx, LLC July 2013 - March 2014
TestAmerica April 2011 - July 2013
Outback Steakhouse January 2008 - October 2012
Purdue University Calumet September 2009 - June 2011
Illianana Speedway 2004-2006 March 2006 - April 2007
Skills
HPLC, Wet Chemistry, UV/Vis, Analytical Chemistry, Chromatography, Gas Chromatography, Ion Chromatography, Titration, Chemistry, FTIR, NMR, Organic Chemistry, NMR spectroscopy, Discrete Analyzers, Column Chromatography, Ecommerce, TOX, TCLP, Karl Fischer, Solution Preparation, Documentation, Standard Operating..., Microsoft Office, FDA/DEA regulations, cGMP practices, cGMP manufacturing, Mass Spectrometry, GMP
Education
Purdue University Calumet 2006 — 2010
BS, Chemistry
Lake Central High SchoolSt. John 2002 — 2006
Academic Honors
Pacira Pharmaceuticals, Inc. April 2014 - Present
Monosol Rx, LLC July 2013 - March 2014
TestAmerica April 2011 - July 2013
Outback Steakhouse January 2008 - October 2012
Purdue University Calumet September 2009 - June 2011
Illianana Speedway 2004-2006 March 2006 - April 2007
Skills
HPLC, Wet Chemistry, UV/Vis, Analytical Chemistry, Chromatography, Gas Chromatography, Ion Chromatography, Titration, Chemistry, FTIR, NMR, Organic Chemistry, NMR spectroscopy, Discrete Analyzers, Column Chromatography, Ecommerce, TOX, TCLP, Karl Fischer, Solution Preparation, Documentation, Standard Operating..., Microsoft Office, FDA/DEA regulations, cGMP practices, cGMP manufacturing, Mass Spectrometry, GMP
Education
Purdue University Calumet 2006 — 2010
BS, Chemistry
Lake Central High SchoolSt. John 2002 — 2006
Academic Honors
Jemma Williams, M.B.A's MonoSol Rx, LLC Experience 2012 - 2013
Job President & CEO of J Consulting Services, Inc.
Industry Pharmaceuticals
Experience
J Consulting Services, Inc. June 2010 - Present
CorePharma LLC 2013 - 2013
Monosol Rx, LLC 2012 - 2013
LexaMed, Ltd October 2007 - June 2010
Nostrum Laboratories May 2006 - September 2007
Nostrum Laboratories, Inc., formerly known May 2006 - September 2007
Pharmaceutical Associates February 2005 - May 2006
Pharmaceutical Associates, Inc February 2005 - May 2006
Alpharma October 2002 - February 2005
Alpharma 2002 - 2005
Skills
Validation, Training, CAPA, FDA, Sop, Manufacturing, Change Control, GMP, Quality Assurance, HPLC, Quality System, Software Documentation, UV/Vis, V&V, Medical Devices, LIMS, Regulatory Submissions, Quality Control, GLP, Laboratory, Microbiology, 21 CFR Part 11, Pharmaceutics, Root Cause Analysis, Auditing
Education
University of Phoenix 2006 — 2007
MBA, business
Coppin State University 1983 — 1987
BS, Chemistry
J Consulting Services, Inc. June 2010 - Present
CorePharma LLC 2013 - 2013
Monosol Rx, LLC 2012 - 2013
LexaMed, Ltd October 2007 - June 2010
Nostrum Laboratories May 2006 - September 2007
Nostrum Laboratories, Inc., formerly known May 2006 - September 2007
Pharmaceutical Associates February 2005 - May 2006
Pharmaceutical Associates, Inc February 2005 - May 2006
Alpharma October 2002 - February 2005
Alpharma 2002 - 2005
Skills
Validation, Training, CAPA, FDA, Sop, Manufacturing, Change Control, GMP, Quality Assurance, HPLC, Quality System, Software Documentation, UV/Vis, V&V, Medical Devices, LIMS, Regulatory Submissions, Quality Control, GLP, Laboratory, Microbiology, 21 CFR Part 11, Pharmaceutics, Root Cause Analysis, Auditing
Education
University of Phoenix 2006 — 2007
MBA, business
Coppin State University 1983 — 1987
BS, Chemistry
Gabrielle Cubberley's MonoSol Rx, LLC Experience May 2013 - Present
Job Manager, Quality Control at Monosol Rx, LLC
Industry Biotechnology
Experience
Monosol Rx, LLC May 2013 - Present
Active Biomaterials June 2011 - April 2013
HumanZyme, Inc June 2007 - June 2011
HumanZyme, Inc June 2007 - March 2010
Regeneron 2006 - 2007
Skills
Quality Assurance, Protein Chemistry, ELISA, Lifesciences, Antibodies, Quality System, Protein Purification, GLP, Technology Transfer, Biotechnology, Validation, HPLC, Change Control, CAPA, FDA, V&V, Sop, Quality Control, Laboratory, LIMS, GMP, Chemistry, Biopharmaceuticals, GxP, Chromatography, Analytical Chemistry, SOP, Cross-functional Team..., Leadership Development, Life Sciences
Education
Columbia University College of Physicians and Surgeons 2004 — 2007
MA, M Phil, Biochemistry and Molecular Biophysics
Northwestern University 1995 — 1999
Bachelor of Arts (B.A.)
McNicholas High School
Monosol Rx, LLC May 2013 - Present
Active Biomaterials June 2011 - April 2013
HumanZyme, Inc June 2007 - June 2011
HumanZyme, Inc June 2007 - March 2010
Regeneron 2006 - 2007
Skills
Quality Assurance, Protein Chemistry, ELISA, Lifesciences, Antibodies, Quality System, Protein Purification, GLP, Technology Transfer, Biotechnology, Validation, HPLC, Change Control, CAPA, FDA, V&V, Sop, Quality Control, Laboratory, LIMS, GMP, Chemistry, Biopharmaceuticals, GxP, Chromatography, Analytical Chemistry, SOP, Cross-functional Team..., Leadership Development, Life Sciences
Education
Columbia University College of Physicians and Surgeons 2004 — 2007
MA, M Phil, Biochemistry and Molecular Biophysics
Northwestern University 1995 — 1999
Bachelor of Arts (B.A.)
McNicholas High School
Autumn Anderson Autumn Anderson's MonoSol Rx, LLC Experience December 2006 - October 2012
Job Market Complaint Investigator at Wockhardt USA
Industry Pharmaceuticals
Experience
Wockhardt USA November 2012 - Present
Monosol Rx, LLC December 2006 - October 2012
Monosol Rx, LLC May 2006 - December 2006
Morton Grove Pharmaceuticals July 2004 - May 2006
Skills
Pharmaceutical Market..., GDP, GMP, CAPA, Internal Audit, Data review, DEA compliance, understanding USP/EP..., representing QC for FDA..., change control system, OOS/OOT investigations, Deviations management, analyst training, regulatory stability..., support lab safety, QC test scheduling and...
Education
Knox College 1994 — 1998
BA, Chemistry
Wockhardt USA November 2012 - Present
Monosol Rx, LLC December 2006 - October 2012
Monosol Rx, LLC May 2006 - December 2006
Morton Grove Pharmaceuticals July 2004 - May 2006
Skills
Pharmaceutical Market..., GDP, GMP, CAPA, Internal Audit, Data review, DEA compliance, understanding USP/EP..., representing QC for FDA..., change control system, OOS/OOT investigations, Deviations management, analyst training, regulatory stability..., support lab safety, QC test scheduling and...
Education
Knox College 1994 — 1998
BA, Chemistry
Francis Beideman Francis Beideman's MonoSol Rx, LLC Experience February 2014 - Present
Job Director of Analytical Research and Development at Monosol Rx, LLC
Industry Pharmaceuticals
Experience
Monosol Rx, LLC February 2014 - Present
Independent Consultant 2013 - January 2014
Students2Science March 2013 - September 2013
SGS Life Science Services March 2011 - November 2012
Pfizer January 2006 - December 2010
Wyeth January 1995 - January 2006
Lederle Laboratories January 1994 - January 1995
Lederle Laboratories January 1990 - January 1993
Shulton Research, American Cyanamid Company January 1977 - January 1990
Skills
HPLC, Validation, FDA, Analytical Chemistry, Pharmaceutical Industry, GMP, Quality Control, 21 CFR Part 11, LIMS, Technology Transfer, Cleaning Validation, Sop, CAPA, Gas Chromatography, GLP, Quality System, Change Control, Quality Assurance, R&D, Dissolution, Vaccines, Biotechnology, Regulatory Affairs, LC-MS, Computer System..., Analytical Method..., Chemistry, Laboratory, Chromatography, GxP, V&V, Regulatory Submissions, Drug Development, Regulatory Requirements, Pharmaceutics, CRO, Method Development, Spectroscopy, Lifesciences, UV/Vis, UV
Education
The University of Georgia 1972 — 1978
PhD, Analytical Chemistry
Franklin & Marshall College 1968 — 1972
AB, Chemistry
Monosol Rx, LLC February 2014 - Present
Independent Consultant 2013 - January 2014
Students2Science March 2013 - September 2013
SGS Life Science Services March 2011 - November 2012
Pfizer January 2006 - December 2010
Wyeth January 1995 - January 2006
Lederle Laboratories January 1994 - January 1995
Lederle Laboratories January 1990 - January 1993
Shulton Research, American Cyanamid Company January 1977 - January 1990
Skills
HPLC, Validation, FDA, Analytical Chemistry, Pharmaceutical Industry, GMP, Quality Control, 21 CFR Part 11, LIMS, Technology Transfer, Cleaning Validation, Sop, CAPA, Gas Chromatography, GLP, Quality System, Change Control, Quality Assurance, R&D, Dissolution, Vaccines, Biotechnology, Regulatory Affairs, LC-MS, Computer System..., Analytical Method..., Chemistry, Laboratory, Chromatography, GxP, V&V, Regulatory Submissions, Drug Development, Regulatory Requirements, Pharmaceutics, CRO, Method Development, Spectroscopy, Lifesciences, UV/Vis, UV
Education
The University of Georgia 1972 — 1978
PhD, Analytical Chemistry
Franklin & Marshall College 1968 — 1972
AB, Chemistry
Krystle Owens Krystle Owens's MonoSol Rx, LLC Experience October 2011 - February 2013
Job Laboratory Technician at Zoetis
Industry Pharmaceuticals
Experience
Owens Bookkeeping & Tax Service 1998 - Present
Zoetis February 2013 - January 2015
Monosol Rx, LLC October 2011 - February 2013
Fresenius Kabi USA October 2010 - August 2011
H2O Plus August 2010 - September 2010
Abbott December 2006 - February 2010
Skills
GLP, HPLC, GMP, Pharmaceutical Industry, Biotechnology, Sop, Microbiology, Drug Discovery, Validation, Chromatography, Analytical Chemistry, ELISA, Cell Culture, FTIR, Aseptic Technique, Laboratory, Life Sciences, Wet Chemistry, Chemistry, Cell, R, Quality Assurance, CAPA, FDA, UV/Vis, Regulatory Affairs, Gas Chromatography, Leadership, Quality Control, Microsoft Excel, Research, Quality System, Microsoft Word, Raw Materials
Education
Southern Illinois University, Carbondale 2001 — 2006
Bachelor of Arts (B.A.), Chemistry
City Colleges of Chicago-Olive-Harvey College 1998 — 2004
Associate of Arts (A.A.), Biology, General
Owens Bookkeeping & Tax Service 1998 - Present
Zoetis February 2013 - January 2015
Monosol Rx, LLC October 2011 - February 2013
Fresenius Kabi USA October 2010 - August 2011
H2O Plus August 2010 - September 2010
Abbott December 2006 - February 2010
Skills
GLP, HPLC, GMP, Pharmaceutical Industry, Biotechnology, Sop, Microbiology, Drug Discovery, Validation, Chromatography, Analytical Chemistry, ELISA, Cell Culture, FTIR, Aseptic Technique, Laboratory, Life Sciences, Wet Chemistry, Chemistry, Cell, R, Quality Assurance, CAPA, FDA, UV/Vis, Regulatory Affairs, Gas Chromatography, Leadership, Quality Control, Microsoft Excel, Research, Quality System, Microsoft Word, Raw Materials
Education
Southern Illinois University, Carbondale 2001 — 2006
Bachelor of Arts (B.A.), Chemistry
City Colleges of Chicago-Olive-Harvey College 1998 — 2004
Associate of Arts (A.A.), Biology, General
Cynthia Eitel's MonoSol Rx, LLC Experience October 2006 - April 2008
Job Scientist at Advantar
Industry Biotechnology
Experience
Advantar Labs October 2011 - Present
Traversa Therapeutics May 2010 - March 2012
Catalent April 2008 - May 2010
Monosol Rx, LLC October 2006 - April 2008
Skills
GLP, HPLC, LC-MS, UV/Vis, Assay Development, GMP, Formulation, Sop, Laboratory, Protein Chemistry, Analytical Chemistry, SOP
Education
Indiana University Bloomington 2002 — 2006
B.S., Chemistry, Minor in Mathematics
Advantar Labs October 2011 - Present
Traversa Therapeutics May 2010 - March 2012
Catalent April 2008 - May 2010
Monosol Rx, LLC October 2006 - April 2008
Skills
GLP, HPLC, LC-MS, UV/Vis, Assay Development, GMP, Formulation, Sop, Laboratory, Protein Chemistry, Analytical Chemistry, SOP
Education
Indiana University Bloomington 2002 — 2006
B.S., Chemistry, Minor in Mathematics
Richard Sine Richard Sine's MonoSol Rx, LLC Experience April 2014 - Present
Job Calibration Technician at MonoSol Rx, LLC
Industry Pharmaceuticals
Experience
MonoSol Rx, LLC April 2014 - Present
Cal Lab Co., Inc. July 1999 - April 2014
Sears Home Services January 1988 - July 1999
Skills
Calibration, Continuous Improvement, GMP, Electronics, Metrology, Field Service, Instrumentation, Manufacturing, Medical Devices, Quality Assurance, Root Cause Analysis, Test Equipment, Testing, Troubleshooting, Automation
Education
DeVry University
MonoSol Rx, LLC April 2014 - Present
Cal Lab Co., Inc. July 1999 - April 2014
Sears Home Services January 1988 - July 1999
Skills
Calibration, Continuous Improvement, GMP, Electronics, Metrology, Field Service, Instrumentation, Manufacturing, Medical Devices, Quality Assurance, Root Cause Analysis, Test Equipment, Testing, Troubleshooting, Automation
Education
DeVry University
Donna R. Vickery M.D., A.B.F.M.'s MonoSol Rx, LLC Experience January 2015 - Present
Job Director Clinical Affairs at MonoSol Rx, LLC
Industry Pharmaceuticals
Experience
MonoSol Rx, LLC January 2015 - Present
Forest Research Institute May 2010 - March 2014
Forest Research Institute April 2009 - May 2010
Schering-Plough February 2007 - August 2008
Becton Dickinson April 2006 - October 2006
Summit Oaks Hospital May 2002 - May 2006
EMO Medical Care June 1989 - January 2001
United States Army Reserve December 1979 - September 1991
Muhlenberg Regional Medical Center July 1978 - July 1980
Skills
Clinical Research, Clinical Trials, Infectious Diseases, Medical Affairs, Cardiology, Internal Medicine, Pulmonology, Neurology, FDA, Clinical Development, Protocol, Biotechnology, Pharmaceutical Industry, IND, Medicine, Therapeutic Areas, Drug Discovery, Pediatrics, Psychiatry
Education
University of Medicine and Dentistry of New Jersey -New Jersey Medical School 1983 — 1987
Doctor of Medicine (MD), Medicine
J.F.K. Medical Center Family Practice Residency Program 1987 — 1990
M.D., Internal medicine, Pediatrics, Surgery, Ob/Gyn, Psychiatry, and selected subspecialties
Rutgers University 2011 — 2014
Master of Business & Science, Drug Discovery & Development
University of Delaware 2006 — 2006
Certificate Program (Distance learning), Clinical Research Monitoring and Coordination
Rutgers, The State University of New Jersey-Newark 1980 — 1983
BA, Physiology
Union County College 1975 — 1978
ASc., Nursing
MonoSol Rx, LLC January 2015 - Present
Forest Research Institute May 2010 - March 2014
Forest Research Institute April 2009 - May 2010
Schering-Plough February 2007 - August 2008
Becton Dickinson April 2006 - October 2006
Summit Oaks Hospital May 2002 - May 2006
EMO Medical Care June 1989 - January 2001
United States Army Reserve December 1979 - September 1991
Muhlenberg Regional Medical Center July 1978 - July 1980
Skills
Clinical Research, Clinical Trials, Infectious Diseases, Medical Affairs, Cardiology, Internal Medicine, Pulmonology, Neurology, FDA, Clinical Development, Protocol, Biotechnology, Pharmaceutical Industry, IND, Medicine, Therapeutic Areas, Drug Discovery, Pediatrics, Psychiatry
Education
University of Medicine and Dentistry of New Jersey -New Jersey Medical School 1983 — 1987
Doctor of Medicine (MD), Medicine
J.F.K. Medical Center Family Practice Residency Program 1987 — 1990
M.D., Internal medicine, Pediatrics, Surgery, Ob/Gyn, Psychiatry, and selected subspecialties
Rutgers University 2011 — 2014
Master of Business & Science, Drug Discovery & Development
University of Delaware 2006 — 2006
Certificate Program (Distance learning), Clinical Research Monitoring and Coordination
Rutgers, The State University of New Jersey-Newark 1980 — 1983
BA, Physiology
Union County College 1975 — 1978
ASc., Nursing
Jon Sadowitz's MonoSol Rx, LLC Experience 2012 - 2013
Job Validation Engineer /Compliance Consultant
Industry Pharmaceuticals
Experience
Icalis-US Inc June 2010 - Present
Icalis-US Inc January 2004 - Present
Monosol Rx, LLC 2012 - 2013
Sandoz 2010 - 2012
NSM Enterprises 2006 - July 2010
Global Health Connection Inc 2007 - March 2008
Mettler-Toledo November 2001 - December 2003
Barr Laboratories 1997 - 2002
Schein Pharmaceutical (Watson Labs) 1993 - 1996
Skills
Validation, FDA, CAPA, Sop, Quality Assurance, V&V, Chromatography, Cleaning Validation, HPLC, R&D, Quality Auditing, GMP, 21 CFR Part 11, Lifesciences, Aseptic Processing, Medical Devices
Education
State University of New York at Binghamton 1984 — 1988
BA, Chemistry
Icalis-US Inc June 2010 - Present
Icalis-US Inc January 2004 - Present
Monosol Rx, LLC 2012 - 2013
Sandoz 2010 - 2012
NSM Enterprises 2006 - July 2010
Global Health Connection Inc 2007 - March 2008
Mettler-Toledo November 2001 - December 2003
Barr Laboratories 1997 - 2002
Schein Pharmaceutical (Watson Labs) 1993 - 1996
Skills
Validation, FDA, CAPA, Sop, Quality Assurance, V&V, Chromatography, Cleaning Validation, HPLC, R&D, Quality Auditing, GMP, 21 CFR Part 11, Lifesciences, Aseptic Processing, Medical Devices
Education
State University of New York at Binghamton 1984 — 1988
BA, Chemistry
Tushar Misra's MonoSol Rx, LLC Experience July 2004 - August 2006
Job VP, Pharmaceutical Operations at Millennium Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals International Co. October 2014 - Present
Millennium Pharmaceuticals, The Takeda Oncology Company July 2012 - October 2012
Sunovion Pharmaceuticals, Inc. (formerly Sepracor, Inc.) August 2006 - August 2012
MonoSol Rx LLC July 2004 - August 2006
Biovail Technologies, LTD. (formerly Fuisz Technologies, LTD.) 1995 - 2004
American Cyanamid 1992 - 1995
Exxon Production Research Co 1989 - 1992
Skills
Pharmaceutical Industry, Chemistry, FDA, V&V, GMP, Sop, Validation, HPLC, Technology Transfer, Clinical Development, Regulatory Affairs, Biotechnology, GLP, 21 CFR Part 11, CAPA, Product Development, Process Simulation, Drug Discovery, Drug Development, Formulation, R&D, Regulatory Submissions, Biopharmaceuticals, Clinical Trials, CRO, Commercialization, IND, Oncology, Vaccines, Pharmaceutics, Lifesciences, Change Control, Analytical Chemistry, Medicinal Chemistry, GCP, Organic Chemistry, Regulatory Requirements, Immunology, Drug Delivery, CTMS, Infectious Diseases, Pharmacology, Pharmacovigilance, Toxicology, Life Sciences
Education
University of Rhode Island 1983 — 1989
Ph. D., Chemical Engineering
National Institute of Technology Rourkela 1976 — 1981
B.Sc. (HONS), Chemical Engineering
Takeda Pharmaceuticals International Co. October 2014 - Present
Millennium Pharmaceuticals, The Takeda Oncology Company July 2012 - October 2012
Sunovion Pharmaceuticals, Inc. (formerly Sepracor, Inc.) August 2006 - August 2012
MonoSol Rx LLC July 2004 - August 2006
Biovail Technologies, LTD. (formerly Fuisz Technologies, LTD.) 1995 - 2004
American Cyanamid 1992 - 1995
Exxon Production Research Co 1989 - 1992
Skills
Pharmaceutical Industry, Chemistry, FDA, V&V, GMP, Sop, Validation, HPLC, Technology Transfer, Clinical Development, Regulatory Affairs, Biotechnology, GLP, 21 CFR Part 11, CAPA, Product Development, Process Simulation, Drug Discovery, Drug Development, Formulation, R&D, Regulatory Submissions, Biopharmaceuticals, Clinical Trials, CRO, Commercialization, IND, Oncology, Vaccines, Pharmaceutics, Lifesciences, Change Control, Analytical Chemistry, Medicinal Chemistry, GCP, Organic Chemistry, Regulatory Requirements, Immunology, Drug Delivery, CTMS, Infectious Diseases, Pharmacology, Pharmacovigilance, Toxicology, Life Sciences
Education
University of Rhode Island 1983 — 1989
Ph. D., Chemical Engineering
National Institute of Technology Rourkela 1976 — 1981
B.Sc. (HONS), Chemical Engineering
Maria Caceres's MonoSol Rx, LLC Experience 2014 - Present
Job Sr. Scientist PK at Merck & Co.
Industry Pharmaceuticals
Experience
MonoSol Rx, LLC 2014 - Present
Merck 2009 - 2013
Merck / Schering Plough 2005 - 2009
Merck (formerly Schering-Plough) 2000 - 2005
Purdue Pharma L.P. 2000 - 2000
Novartis 1995 - 2000
Skills
Pharmaceutical Industry, Clinical Trials, Drug Discovery, Drug Metabolism, Clinical Development, DMPK, Drug Development, Biotechnology, Regulatory Submissions, Pharmacokinetics, Oncology, CRO, Sop, GLP, ADME, Pharmaceutics, Bioanalysis, GMP, GCPs, SOP
Education
The Johns Hopkins University
Certificate in Clinical Development, Design and Interpretation of Clinical Trials, A-95
Montclair State University
Medicinal Chemistry
Shafer and Fisher modeling course at San Francisco
Shafer and Fisher modeling course at San Francisco
University of Puerto Rico-Rio Piedras
Bachelor's Degree, Analytical Chemistry
modeling course
MonoSol Rx, LLC 2014 - Present
Merck 2009 - 2013
Merck / Schering Plough 2005 - 2009
Merck (formerly Schering-Plough) 2000 - 2005
Purdue Pharma L.P. 2000 - 2000
Novartis 1995 - 2000
Skills
Pharmaceutical Industry, Clinical Trials, Drug Discovery, Drug Metabolism, Clinical Development, DMPK, Drug Development, Biotechnology, Regulatory Submissions, Pharmacokinetics, Oncology, CRO, Sop, GLP, ADME, Pharmaceutics, Bioanalysis, GMP, GCPs, SOP
Education
The Johns Hopkins University
Certificate in Clinical Development, Design and Interpretation of Clinical Trials, A-95
Montclair State University
Medicinal Chemistry
Shafer and Fisher modeling course at San Francisco
Shafer and Fisher modeling course at San Francisco
University of Puerto Rico-Rio Piedras
Bachelor's Degree, Analytical Chemistry
modeling course
Harlan Dawson's MonoSol Rx, LLC Experience January 2007 - February 2008
Job Kelly Services on assignment at Dow Agro
Industry Chemicals
Experience
Kelly Services March 2014 - Present
Philadelphia Water Department March 2008 - Present
Monosol Rx LLC January 2007 - February 2008
Skills
Engineering, Process Engineering, Project Engineering, Environmental..., Six Sigma, Confined Space, Fall Protection, FDA, Analysis, Environmental Awareness, Leadership, Process Simulation, Public Speaking, Quality System
Education
Florida State University 1996 — 2004
Bachelors, Chemical and Biomedical Engineering
Florida Agricultural and Mechanical University 1996 — 2003
Bachelor's degree, Chemical Engineering
Kelly Services March 2014 - Present
Philadelphia Water Department March 2008 - Present
Monosol Rx LLC January 2007 - February 2008
Skills
Engineering, Process Engineering, Project Engineering, Environmental..., Six Sigma, Confined Space, Fall Protection, FDA, Analysis, Environmental Awareness, Leadership, Process Simulation, Public Speaking, Quality System
Education
Florida State University 1996 — 2004
Bachelors, Chemical and Biomedical Engineering
Florida Agricultural and Mechanical University 1996 — 2003
Bachelor's degree, Chemical Engineering
Daniel Barber's MonoSol Rx, LLC Experience April 2014 - Present
Job Vice President, Value Creation at MonoSol Rx, LLC
Industry Pharmaceuticals
Experience
MonoSol Rx, LLC April 2014 - Present
Monosol Rx, LLC 2011 - 2014
Monosol Rx 2009 - 2011
Monosol Rx, LLC 2007 - 2009
Quest Diagnostics 2004 - 2007
Xerox Corporation 2000 - 2004
Education
Seton Hall University 2000 — 2003
MBA
State University of New York College at Geneseo 1994 — 1998
MonoSol Rx, LLC April 2014 - Present
Monosol Rx, LLC 2011 - 2014
Monosol Rx 2009 - 2011
Monosol Rx, LLC 2007 - 2009
Quest Diagnostics 2004 - 2007
Xerox Corporation 2000 - 2004
Education
Seton Hall University 2000 — 2003
MBA
State University of New York College at Geneseo 1994 — 1998
Greg J. Slominski's MonoSol Rx, LLC Experience July 2008 - May 2012
Job Director, Manufacturing Science & Technology Novartis
Industry Pharmaceuticals
Experience
Novartis Consumer Health September 2012 - Present
MonosolRx July 2008 - May 2012
Monosol Rx, LLC July 2008 - May 2012
Novartis Consumer Health January 2002 - May 2008
Skills
21 CFR Part 11, V&V, Sop, Validation, Regulatory Affairs, Cleaning Validation, Quality System, Analytical Chemistry, Trackwise, Pharmaceutics, Root Cause Analysis, Drug Delivery, Deviations, Continuous Improvement, IND
Education
Briar Cliff University 1987 — 1991
Bachelor of Science (BS), Chemistry
Novartis Consumer Health September 2012 - Present
MonosolRx July 2008 - May 2012
Monosol Rx, LLC July 2008 - May 2012
Novartis Consumer Health January 2002 - May 2008
Skills
21 CFR Part 11, V&V, Sop, Validation, Regulatory Affairs, Cleaning Validation, Quality System, Analytical Chemistry, Trackwise, Pharmaceutics, Root Cause Analysis, Drug Delivery, Deviations, Continuous Improvement, IND
Education
Briar Cliff University 1987 — 1991
Bachelor of Science (BS), Chemistry
Jacob Hays's MonoSol Rx, LLC Experience May 2012 - Present
Job Senior Manager, Compensation and Benefits at Monosol Rx, LLC
Industry Human Resources
Experience
Monosol Rx, LLC May 2012 - Present
Oce Business Services November 2011 - April 2012
JJH Consulting January 2011 - November 2011
Hewlett-Packard November 2008 - January 2011
Hewlett-Packard Financial Services August 2000 - November 2008
CIT 1992 - 2000
Willis Corroon Group 1990 - 1992
Continental Insurance 1986 - 1990
Chemical Bank 1980 - 1986
Skills
Executive Compensation, Talent Acquisition, Organizational..., Talent Management, Strategy, Personnel Management, Executive Pay, Human Resources, Deferred Compensation, Mergers & Acquisitions
Education
Dickinson College
BA, Political Science
Monmouth University
MBA, Management
New York Law School
JD, Law
Monosol Rx, LLC May 2012 - Present
Oce Business Services November 2011 - April 2012
JJH Consulting January 2011 - November 2011
Hewlett-Packard November 2008 - January 2011
Hewlett-Packard Financial Services August 2000 - November 2008
CIT 1992 - 2000
Willis Corroon Group 1990 - 1992
Continental Insurance 1986 - 1990
Chemical Bank 1980 - 1986
Skills
Executive Compensation, Talent Acquisition, Organizational..., Talent Management, Strategy, Personnel Management, Executive Pay, Human Resources, Deferred Compensation, Mergers & Acquisitions
Education
Dickinson College
BA, Political Science
Monmouth University
MBA, Management
New York Law School
JD, Law
Gonzalo Garreton's MonoSol Rx, LLC Experience February 2011 - July 2011
Job FMS Instrumentation & Calibration Service Specialist at Johnson Controls
Industry Pharmaceuticals
Experience
Johnson Controls July 2011 - Present
Monosol Rx, LLC February 2011 - July 2011
Advanced Technology Services July 2010 - February 2011
Abraxis BioScience February 2010 - May 2010
Covance January 2009 - April 2009
Corium International September 2008 - December 2008
Pfizer May 2003 - May 2008
Apotex Inc. December 2002 - May 2003
PharmEng Technology November 2002 - December 2002
SRP Control Systems Ltd. March 2001 - September 2002
Skills
Calibration, Metrology, Analytical Chemistry, Quality Assurance, Spanish-speaking, Measurement Uncertainty, Measurement System..., HPLC, Chemical Engineering, Laboratory Equipment, Instrumentation, GMP, Sop, Change Control, FDA, Laboratory, Manufacturing, Medical Devices, Six Sigma, Pharmaceutical Industry, Quality System, CAPA, Root Cause Analysis, ISO, SOP
Education
Ryerson University 1985 — 1990
Bachelor of Engineering (B.Eng.), Chemical Engineering
Johnson Controls July 2011 - Present
Monosol Rx, LLC February 2011 - July 2011
Advanced Technology Services July 2010 - February 2011
Abraxis BioScience February 2010 - May 2010
Covance January 2009 - April 2009
Corium International September 2008 - December 2008
Pfizer May 2003 - May 2008
Apotex Inc. December 2002 - May 2003
PharmEng Technology November 2002 - December 2002
SRP Control Systems Ltd. March 2001 - September 2002
Skills
Calibration, Metrology, Analytical Chemistry, Quality Assurance, Spanish-speaking, Measurement Uncertainty, Measurement System..., HPLC, Chemical Engineering, Laboratory Equipment, Instrumentation, GMP, Sop, Change Control, FDA, Laboratory, Manufacturing, Medical Devices, Six Sigma, Pharmaceutical Industry, Quality System, CAPA, Root Cause Analysis, ISO, SOP
Education
Ryerson University 1985 — 1990
Bachelor of Engineering (B.Eng.), Chemical Engineering
Simon Scholte's MonoSol Rx, LLC Experience May 2015 - Present
Job Director of Technical Operations at MonoSol Rx, LLC
Industry Pharmaceuticals
Experience
MonoSol Rx, LLC May 2015 - Present
MonoSol Rx, LLC January 2013 - May 2015
Monosol Rx, LLC August 2012 - January 2013
CVCT, Inc. July 2012 - August 2012
Celgene October 2010 - June 2012
Abraxis BioScience January 2010 - June 2012
Abraxis BioScience 2007 - 2009
APP Pharmaceuticals 2003 - 2007
United States Navy September 1997 - September 2003
US Navy 1997 - 2003
Skills
Documentum, Trackwise, SAP, Oracle, Microsoft SQL Server, RS Linx, Maximo, MS Project, iFix, Intellution, PLC Allen Bradley, cGMP manufacturing, Capital Budgeting, Plant Maintenance, Biotechnology, Six Sigma, 5S, Lean Manufacturing, 21 CFR Part 11, Aseptic Processing, CAPA, Calibration, Change Control, FDA, GMP, GLP, Manufacturing, Quality Control, Quality System, RSLinx, Sop, V&V, Validation, Computer System..., Quality Assurance
Education
Excelsior College 2003 — 2007
Bachelors of Engineering, Nuclear
MonoSol Rx, LLC May 2015 - Present
MonoSol Rx, LLC January 2013 - May 2015
Monosol Rx, LLC August 2012 - January 2013
CVCT, Inc. July 2012 - August 2012
Celgene October 2010 - June 2012
Abraxis BioScience January 2010 - June 2012
Abraxis BioScience 2007 - 2009
APP Pharmaceuticals 2003 - 2007
United States Navy September 1997 - September 2003
US Navy 1997 - 2003
Skills
Documentum, Trackwise, SAP, Oracle, Microsoft SQL Server, RS Linx, Maximo, MS Project, iFix, Intellution, PLC Allen Bradley, cGMP manufacturing, Capital Budgeting, Plant Maintenance, Biotechnology, Six Sigma, 5S, Lean Manufacturing, 21 CFR Part 11, Aseptic Processing, CAPA, Calibration, Change Control, FDA, GMP, GLP, Manufacturing, Quality Control, Quality System, RSLinx, Sop, V&V, Validation, Computer System..., Quality Assurance
Education
Excelsior College 2003 — 2007
Bachelors of Engineering, Nuclear
joseph fuisz's MonoSol Rx, LLC Experience 2004 - 2007
Job fuisz pharma
Industry Pharmaceuticals
Experience
Vapor Tobacco Manufacturing LLC January 2013 - Present
fuisz pharma January 2010 - Present
fuisz tobacco January 2008 - December 2009
Monosol Rx, LLC 2004 - 2007
Sullivan & Cromwell LLP 1996 - 1999
Skills
Pharmaceutical Industry, Technology Transfer, Clinical Development, Biotechnology, Lifesciences, FDA, Regulatory Affairs, GMP, Pharmaceutics, Medical Devices, Oncology, Clinical Trials, R&D, Product Launch, Validation, Sop, Life Sciences
Education
Columbia University School of Law 1993 — 1996
Doctor of Law (JD)
Yale University 1989 — 1992
Bachelor's degree, Economics
Vapor Tobacco Manufacturing LLC January 2013 - Present
fuisz pharma January 2010 - Present
fuisz tobacco January 2008 - December 2009
Monosol Rx, LLC 2004 - 2007
Sullivan & Cromwell LLP 1996 - 1999
Skills
Pharmaceutical Industry, Technology Transfer, Clinical Development, Biotechnology, Lifesciences, FDA, Regulatory Affairs, GMP, Pharmaceutics, Medical Devices, Oncology, Clinical Trials, R&D, Product Launch, Validation, Sop, Life Sciences
Education
Columbia University School of Law 1993 — 1996
Doctor of Law (JD)
Yale University 1989 — 1992
Bachelor's degree, Economics
Dominique Campbell's MonoSol Rx, LLC Experience 2012 - 2012
Job Quality Specialist
Industry Pharmaceuticals
Experience
Monosol Rx, LLC 2012 - 2012
Eli Lilly 2002 - 2005
Skills
GMP, Pharmaceutical Industry, Validation, Sop, GLP, FDA, CAPA, GxP
Education
Jackson State University 1994 — 1996
B.S., Chemistry
Iowa State University
Monosol Rx, LLC 2012 - 2012
Eli Lilly 2002 - 2005
Skills
GMP, Pharmaceutical Industry, Validation, Sop, GLP, FDA, CAPA, GxP
Education
Jackson State University 1994 — 1996
B.S., Chemistry
Iowa State University
Briana Franz's MonoSol Rx, LLC Experience June 2005 - August 2006
Job Director of Laboratory Operations at Cyprotex US, LLC
Industry Research
Experience
Cyprotex US, LLC January 2014 - Present
CeeTox September 2012 - January 2014
CeeTox February 2011 - December 2013
CeeTox January 2010 - September 2012
Purdue University August 2008 - December 2009
Purdue University August 2007 - August 2008
Saint Joseph's College August 2006 - May 2007
Monosol Rx, LLC June 2005 - August 2006
Skills
Molecular Biology, Tissue Culture, Assay Development, Biotechnology, GLP, Cell Biology, In Vitro, Primary Cell Isolation, Expression Cloning, Biosensors/Bioassays, Bioprocessing, Cancer, GMP, Mammalian Cell Culture, Bacterial Cell Culture, Select Agents, Operations Management, Continuous Process..., Employee Management, Strategic Planning, Cell, SOP development, Molecular Microbiology, Laboratory Management, 21 CFR, Animal Handling, HACCP, HAZWOPER, Microbiology, Microscopy, Validation, CRO, Transfection, Molecular Cloning, Gel Electrophoresis, Experimental Design, in Vitro Toxicology, Laboratory, Animal Work
Education
Purdue University 2007 — 2010
Molecular Microbiology
St. Joseph's College (IN) 2003 — 2007
B.S., Biology, Summa cum laude
Cyprotex US, LLC January 2014 - Present
CeeTox September 2012 - January 2014
CeeTox February 2011 - December 2013
CeeTox January 2010 - September 2012
Purdue University August 2008 - December 2009
Purdue University August 2007 - August 2008
Saint Joseph's College August 2006 - May 2007
Monosol Rx, LLC June 2005 - August 2006
Skills
Molecular Biology, Tissue Culture, Assay Development, Biotechnology, GLP, Cell Biology, In Vitro, Primary Cell Isolation, Expression Cloning, Biosensors/Bioassays, Bioprocessing, Cancer, GMP, Mammalian Cell Culture, Bacterial Cell Culture, Select Agents, Operations Management, Continuous Process..., Employee Management, Strategic Planning, Cell, SOP development, Molecular Microbiology, Laboratory Management, 21 CFR, Animal Handling, HACCP, HAZWOPER, Microbiology, Microscopy, Validation, CRO, Transfection, Molecular Cloning, Gel Electrophoresis, Experimental Design, in Vitro Toxicology, Laboratory, Animal Work
Education
Purdue University 2007 — 2010
Molecular Microbiology
St. Joseph's College (IN) 2003 — 2007
B.S., Biology, Summa cum laude
Mike Hermanek's MonoSol Rx, LLC Experience July 2015 - Present
Job Quality Assurance Director at MonoSol Rx, LLC
Industry Pharmaceuticals
Experience
MonoSol Rx, LLC July 2015 - Present
Cambridge Major Laboratories, Inc. August 2014 - July 2015
Cambridge Major Laboratories, Inc. March 2014 - August 2014
Therapeutic Proteins International, LLC March 2013 - January 2014
Novartis Consumer Health August 2012 - March 2013
Emergent BioSolutions September 2010 - September 2012
Emergent BioSolutions July 2005 - September 2010
Denstply Pharmaceutical July 2002 - June 2005
American Pharmaceutical Partners November 2001 - July 2002
American Pharmaceutical Partners August 2000 - November 2001
Skills
Change Control, GMP, Sop, FDA, Validation, Quality System, Regulatory Affairs, Pharmaceutical Industry, Quality Auditing, Clinical Trials, Quality Control, CAPA, R&D, 21 CFR Part 11, V&V, Technology Transfer, Chemistry, Aseptic Processing, Pharmaceutics, LIMS, GLP, Quality Assurance, Cleaning Validation, Vaccines, Computer System..., Biopharmaceuticals, Protein Chemistry, Biotechnology, IND, GxP, Regulatory Submissions, SOP
Education
Purdue University Calumet 2003 — 2005
M.B.A., Executive Management Program
Northeastern Illinois University 1999 — 2002
M.S, Chemistry with a concentration in Separation Science
Benedictine University 1993 — 1997
B.S., Chemistry with a Forensic Science Concentration, Minor in Sociology
MonoSol Rx, LLC July 2015 - Present
Cambridge Major Laboratories, Inc. August 2014 - July 2015
Cambridge Major Laboratories, Inc. March 2014 - August 2014
Therapeutic Proteins International, LLC March 2013 - January 2014
Novartis Consumer Health August 2012 - March 2013
Emergent BioSolutions September 2010 - September 2012
Emergent BioSolutions July 2005 - September 2010
Denstply Pharmaceutical July 2002 - June 2005
American Pharmaceutical Partners November 2001 - July 2002
American Pharmaceutical Partners August 2000 - November 2001
Skills
Change Control, GMP, Sop, FDA, Validation, Quality System, Regulatory Affairs, Pharmaceutical Industry, Quality Auditing, Clinical Trials, Quality Control, CAPA, R&D, 21 CFR Part 11, V&V, Technology Transfer, Chemistry, Aseptic Processing, Pharmaceutics, LIMS, GLP, Quality Assurance, Cleaning Validation, Vaccines, Computer System..., Biopharmaceuticals, Protein Chemistry, Biotechnology, IND, GxP, Regulatory Submissions, SOP
Education
Purdue University Calumet 2003 — 2005
M.B.A., Executive Management Program
Northeastern Illinois University 1999 — 2002
M.S, Chemistry with a concentration in Separation Science
Benedictine University 1993 — 1997
B.S., Chemistry with a Forensic Science Concentration, Minor in Sociology
Eric Nickerson's MonoSol Rx, LLC Experience January 2014 - Present
Job VP, Quality and Compliance at MonoSol Rx, LLC
Industry Pharmaceuticals
Experience
Monosol Rx, LLC January 2014 - Present
Savient Pharmaceuticals 2006 - January 2014
Savient Pharmaceuticals, Inc. 2004 - 2005
Johnson & Johnson 2001 - 2004
Johnson & Johnson 1999 - 2001
Johnson & Johnson 1998 - 1999
Cordis 1995 - 1998
Skills
FDA, Validation, GMP, Pharmaceutical Industry, Technology Transfer, CAPA, Regulatory Affairs, Medical Devices, Change Control, Sop, Quality System, 21 CFR Part 11, Lifesciences, Biopharmaceuticals, Quality Assurance, Pharmaceutics, SOP, Life Sciences
Education
Lehigh University 1992 — 1995
Master of Business Administration (MBA), Business Administration and Management, General
Lehigh University 1985 — 1989
BS, Mechanical Engineering
Monosol Rx, LLC January 2014 - Present
Savient Pharmaceuticals 2006 - January 2014
Savient Pharmaceuticals, Inc. 2004 - 2005
Johnson & Johnson 2001 - 2004
Johnson & Johnson 1999 - 2001
Johnson & Johnson 1998 - 1999
Cordis 1995 - 1998
Skills
FDA, Validation, GMP, Pharmaceutical Industry, Technology Transfer, CAPA, Regulatory Affairs, Medical Devices, Change Control, Sop, Quality System, 21 CFR Part 11, Lifesciences, Biopharmaceuticals, Quality Assurance, Pharmaceutics, SOP, Life Sciences
Education
Lehigh University 1992 — 1995
Master of Business Administration (MBA), Business Administration and Management, General
Lehigh University 1985 — 1989
BS, Mechanical Engineering
Lillian Kakidas's MonoSol Rx, LLC Experience October 2010 - September 2011
Job Senior Quality Consultant
Industry Pharmaceuticals
Experience
Independent Consultant September 2011 - Present
Monosol Rx, LLC October 2010 - September 2011
Medefil Inc 2008 - 2010
Brogan Pharmceuticals 2006 - 2008
Abbott Diagnostics 2000 - 2006
Abbott Laboratories 1996 - 2000
Solvay Pharmaceuticals 1993 - 1996
Solvay Pharmaceuticals 1988 - 1993
Skills
cGMP, Validation, FDA, GMP, SOP, CAPA, Process Validation, ISO 13485, Quality Systems, Biotechnology, Quality Assurance, GxP, ISO, Medical Devices, Quality Auditing, Change Control, Microbiology, Documentation, Pharmaceuticals, Compliance, Cleaning Validation, Validations, Root Cause Analysis, Life Sciences, QC, Sop, V&V, Technology Transfer, Pharmaceutical Industry, Quality System, Lifesciences, Quality Control, 21 CFR Part 11, Aseptic Processing, 21 CFR, Software Documentation, GLP, Computer System..., Regulatory Affairs, Equipment Qualification, ISO 14971, Regulatory Submissions, LIMS, Trackwise, Biopharmaceuticals, GAMP, cGMP practices, Design Control, Quality Management, Analytical Chemistry
Education
Illinois Institute of Technology
MS, Microbiology
Purdue University
BS, Microbiology
Independent Consultant September 2011 - Present
Monosol Rx, LLC October 2010 - September 2011
Medefil Inc 2008 - 2010
Brogan Pharmceuticals 2006 - 2008
Abbott Diagnostics 2000 - 2006
Abbott Laboratories 1996 - 2000
Solvay Pharmaceuticals 1993 - 1996
Solvay Pharmaceuticals 1988 - 1993
Skills
cGMP, Validation, FDA, GMP, SOP, CAPA, Process Validation, ISO 13485, Quality Systems, Biotechnology, Quality Assurance, GxP, ISO, Medical Devices, Quality Auditing, Change Control, Microbiology, Documentation, Pharmaceuticals, Compliance, Cleaning Validation, Validations, Root Cause Analysis, Life Sciences, QC, Sop, V&V, Technology Transfer, Pharmaceutical Industry, Quality System, Lifesciences, Quality Control, 21 CFR Part 11, Aseptic Processing, 21 CFR, Software Documentation, GLP, Computer System..., Regulatory Affairs, Equipment Qualification, ISO 14971, Regulatory Submissions, LIMS, Trackwise, Biopharmaceuticals, GAMP, cGMP practices, Design Control, Quality Management, Analytical Chemistry
Education
Illinois Institute of Technology
MS, Microbiology
Purdue University
BS, Microbiology
Cassie Schaufele's MonoSol Rx, LLC Experience 2009 - 2011
Job Director, Alliance Management
Industry Pharmaceuticals
Experience
MonoSol Rx 2011 - Present
Monosol Rx, LLC 2009 - 2011
Monosol Rx, LLC 2008 - 2009
Skills
Pharmaceutical Industry
Education
Purdue University 1997 — 2002
Bachelor of Science, Management
MonoSol Rx 2011 - Present
Monosol Rx, LLC 2009 - 2011
Monosol Rx, LLC 2008 - 2009
Skills
Pharmaceutical Industry
Education
Purdue University 1997 — 2002
Bachelor of Science, Management
Tony Koranda's MonoSol Rx, LLC Experience February 2006 - October 2006
Job Senior Validation Engineer, Manufacturing Science & Technology at GlaxoSmithKline Consumer Healthcare
Industry Pharmaceuticals
Experience
GSK (formerly Novartis Consumer Health) January 2013 - Present
CSL Behring October 2006 - January 2013
Monosol Rx, LLC February 2006 - October 2006
CSL Behring June 2004 - February 2006
ZLB Behring Biopharmaceutical LLC July 2002 - June 2004
Aventis Behring April 2001 - July 2002
Aventis Behring September 1998 - April 2002
Centeon November 1996 - September 1998
Rhone-Poulenc Rorer April 1995 - November 1996
Skills
Cleaning Validation, Process Validation, 21 CFR Part 11, Validation, Protocol Writing, V&V, Sop, Aseptic Processing, Biopharmaceuticals, Sterilization, FDA, Quality Assurance, Microbiology, GMP, ISO, Change Control, Quality Control, CAPA, Computer System..., Aseptic Technique, GxP, GAMP, Trackwise, GLP, Software Documentation, Technology Transfer, FDA GMP, LIMS, Calibration, Quality System, Regulatory Affairs, Regulatory Requirements, ISO 13485, Chromatography, Pharmaceutical Industry, Biotechnology, USP, Pharmaceutics, Equipment Qualification, Deviations, FMEA, Deviation Management, Environmental Monitoring, Manufacturing, cGMP practices, cGMP manufacturing, Lyophilization, Testing, Lifesciences, Process Simulation
Education
Governors State University
Bachelor of Science (BS), Biology
Southern Illinois University, Carbondale
GSK (formerly Novartis Consumer Health) January 2013 - Present
CSL Behring October 2006 - January 2013
Monosol Rx, LLC February 2006 - October 2006
CSL Behring June 2004 - February 2006
ZLB Behring Biopharmaceutical LLC July 2002 - June 2004
Aventis Behring April 2001 - July 2002
Aventis Behring September 1998 - April 2002
Centeon November 1996 - September 1998
Rhone-Poulenc Rorer April 1995 - November 1996
Skills
Cleaning Validation, Process Validation, 21 CFR Part 11, Validation, Protocol Writing, V&V, Sop, Aseptic Processing, Biopharmaceuticals, Sterilization, FDA, Quality Assurance, Microbiology, GMP, ISO, Change Control, Quality Control, CAPA, Computer System..., Aseptic Technique, GxP, GAMP, Trackwise, GLP, Software Documentation, Technology Transfer, FDA GMP, LIMS, Calibration, Quality System, Regulatory Affairs, Regulatory Requirements, ISO 13485, Chromatography, Pharmaceutical Industry, Biotechnology, USP, Pharmaceutics, Equipment Qualification, Deviations, FMEA, Deviation Management, Environmental Monitoring, Manufacturing, cGMP practices, cGMP manufacturing, Lyophilization, Testing, Lifesciences, Process Simulation
Education
Governors State University
Bachelor of Science (BS), Biology
Southern Illinois University, Carbondale
Erica Lockhart, MBA's MonoSol Rx, LLC Experience March 2014 - Present
Job Production Manager at Monosol Rx, LLC
Industry Pharmaceuticals
Experience
Monosol Rx, LLC March 2014 - Present
Smiths Medical December 2011 - March 2014
Smiths Medical August 2010 - December 2011
Smiths Medical April 2007 - August 2010
Skills
Medical Devices, Lean Manufacturing, Six Sigma, ISO 13485, Quality System, FDA, Cross-functional Team..., Continuous Improvement, FMEA, Product Launch, Manufacturing, Root Cause Analysis, DMAIC, CAPA, Value Stream Mapping
Education
Purdue University Calumet 2001 — 2004
MBA, Management
Tri-State University 1994 — 1998
BS Engineering, Administrative Engineering
Monosol Rx, LLC March 2014 - Present
Smiths Medical December 2011 - March 2014
Smiths Medical August 2010 - December 2011
Smiths Medical April 2007 - August 2010
Skills
Medical Devices, Lean Manufacturing, Six Sigma, ISO 13485, Quality System, FDA, Cross-functional Team..., Continuous Improvement, FMEA, Product Launch, Manufacturing, Root Cause Analysis, DMAIC, CAPA, Value Stream Mapping
Education
Purdue University Calumet 2001 — 2004
MBA, Management
Tri-State University 1994 — 1998
BS Engineering, Administrative Engineering
ANJANI GOSSAIN's MonoSol Rx, LLC Experience 2013 - Present
Job GMP Quality, Compliance and Operations Management
Industry Pharmaceuticals
Experience
MonoSol Rx, LLC 2013 - Present
Bristol-Myers Squibb 2008 - 2013
Skills
Documentation Practices, Biopharmaceuticals, Validation, Quality System, Sop, Compliance Procedures, Biotechnology, Protein Chemistry, Continuous Improvement, Conti, Protein Purification, Upstream Processing, Downstream Processing, Protein Production, Protein Assays, Supply Chain, CMC, Regulatory Submissions, Regulatory Requirements, FDA GMP, Cross-functional Team..., Strategic Sourcing, Change Control, CAPA, 21 CFR Part 11, Computer System..., Biologics, GMP, GxP, FDA, Pharmaceutical Industry, GLP, Technology Transfer, Quality Control, Regulatory Affairs, Drug Development, Life Sciences, Quality Assurance, R&D, Quality Auditing, Clinical Development, Clinical Trials, Pharmaceutics, Management, SOP
Education
Temple University, Thrombosis Center 1995 — 1996
Post Doctoral Fellow
Thomas Jefferson University 1993 — 1995
Post Doctoral Fellow
Indian Institute of Technology
Ph.D.
MonoSol Rx, LLC 2013 - Present
Bristol-Myers Squibb 2008 - 2013
Skills
Documentation Practices, Biopharmaceuticals, Validation, Quality System, Sop, Compliance Procedures, Biotechnology, Protein Chemistry, Continuous Improvement, Conti, Protein Purification, Upstream Processing, Downstream Processing, Protein Production, Protein Assays, Supply Chain, CMC, Regulatory Submissions, Regulatory Requirements, FDA GMP, Cross-functional Team..., Strategic Sourcing, Change Control, CAPA, 21 CFR Part 11, Computer System..., Biologics, GMP, GxP, FDA, Pharmaceutical Industry, GLP, Technology Transfer, Quality Control, Regulatory Affairs, Drug Development, Life Sciences, Quality Assurance, R&D, Quality Auditing, Clinical Development, Clinical Trials, Pharmaceutics, Management, SOP
Education
Temple University, Thrombosis Center 1995 — 1996
Post Doctoral Fellow
Thomas Jefferson University 1993 — 1995
Post Doctoral Fellow
Indian Institute of Technology
Ph.D.
Daryl Dixon's MonoSol Rx, LLC Experience November 2010 - Present
Job Accounting Manager at Monosol Rx, LLC
Industry Accounting
Experience
Monosol Rx, LLC November 2010 - Present
Wockhardt USA, LLC July 2009 - November 2010
Reckitt Benckiser July 2008 - February 2009
Adams Respiratory Therapeutics June 2005 - July 2008
Education
County College of Morris
Accounting and Business
University of Vermont
BS, Biology
Monosol Rx, LLC November 2010 - Present
Wockhardt USA, LLC July 2009 - November 2010
Reckitt Benckiser July 2008 - February 2009
Adams Respiratory Therapeutics June 2005 - July 2008
Education
County College of Morris
Accounting and Business
University of Vermont
BS, Biology
Joseph Crusco's MonoSol Rx, LLC Experience June 2014 - Present
Job Business & Commercial Development Professional
Industry Medical Devices
Experience
Monosol Rx, LLC June 2014 - Present
Unilife Corporation October 2012 - June 2014
Datwyler - Pharma Packaging January 2012 - October 2012
BD 2002 - December 2011
Skills
Business Development, Sales Operations, Medical Devices, Sales Management, Product Launch, Biotechnology, Pharmaceutical Industry, Cross-functional Team..., Sales, Product Development, FDA, Commercialization, Project Management, R&D, Consultative and...
Education
University of Maryland College Park 1986 — 1989
BS, Human Ecology - Marketing & Consumer Economics
Monosol Rx, LLC June 2014 - Present
Unilife Corporation October 2012 - June 2014
Datwyler - Pharma Packaging January 2012 - October 2012
BD 2002 - December 2011
Skills
Business Development, Sales Operations, Medical Devices, Sales Management, Product Launch, Biotechnology, Pharmaceutical Industry, Cross-functional Team..., Sales, Product Development, FDA, Commercialization, Project Management, R&D, Consultative and...
Education
University of Maryland College Park 1986 — 1989
BS, Human Ecology - Marketing & Consumer Economics
Herb Luther's MonoSol Rx, LLC Experience January 2014 - September 2014
Job Regulatory and Clinical Consultant at Luther Associates
Industry Pharmaceuticals
Experience
Luther Associates October 2014 - Present
MonoSol Rx, LLC January 2014 - September 2014
MonoSol Rx, LLC October 2013 - January 2014
Luther Associates October 2008 - October 2013
Perrigo 2007 - 2008
KV Pharmaceutical 1996 - 2006
Barr Laboratories 1991 - 1996
Skills
Regulatory Affairs, CRO, Clinical Trials, Clinical Development, Clinical Research, NDA, FDA, IND, Regulatory Submissions, Pharmaceutical Industry, Regulatory Requirements, ANDA, Drug Delivery, Generic Programming
Education
University of Illinois at Urbana-Champaign 1976 — 1978
PhD, Pharmacology/Toxicology
University of Illinois at Urbana-Champaign 1971 — 1976
MS, Pharmacology/Toxicology
Drew University 1967 — 1971
BS, Biology
Luther Associates October 2014 - Present
MonoSol Rx, LLC January 2014 - September 2014
MonoSol Rx, LLC October 2013 - January 2014
Luther Associates October 2008 - October 2013
Perrigo 2007 - 2008
KV Pharmaceutical 1996 - 2006
Barr Laboratories 1991 - 1996
Skills
Regulatory Affairs, CRO, Clinical Trials, Clinical Development, Clinical Research, NDA, FDA, IND, Regulatory Submissions, Pharmaceutical Industry, Regulatory Requirements, ANDA, Drug Delivery, Generic Programming
Education
University of Illinois at Urbana-Champaign 1976 — 1978
PhD, Pharmacology/Toxicology
University of Illinois at Urbana-Champaign 1971 — 1976
MS, Pharmacology/Toxicology
Drew University 1967 — 1971
BS, Biology
Peter Boyd's MonoSol Rx, LLC Experience August 2013 - Present
Job VP, Operations at MonoSol Rx, LLC
Industry Financial Services
Experience
MonoSol Rx, LLC August 2013 - Present
Hewlett-Packard Financial Services February 1998 - August 2013
Skills
Process Improvement, Business Analysis, Finance, Business Process..., Team Management, Risk Management, Vendor Management, Management, Financial Analysis, Strategy, Training, Leadership, Contract Negotiation, Accounting, Outsourcing, Forecasting, Business Development, Operations Management, Business Strategy, Cross-functional Team..., Account Management, Business Planning, Banking, CRM, Change Management, Program Management, Executive Management, New Business Development, Financial Services, Analysis, Mergers & Acquisitions, Pricing, Team Leadership, Strategic Planning, Start-ups, Negotiation, Management Consulting, Portfolio Management, Credit, Team Building, Financial Modeling, Business Intelligence, Relationship Management, Competitive Analysis, Budgets, Sales Management
Education
Seton Hall University 1997 — 2002
Master of Business Administration (M.B.A.), Finance, General
The New School 1993 — 1996
Master's Degree, Management and Urban Policy Analysis
Wittenberg University 1983 — 1987
Bachelor's Degree, History
MonoSol Rx, LLC August 2013 - Present
Hewlett-Packard Financial Services February 1998 - August 2013
Skills
Process Improvement, Business Analysis, Finance, Business Process..., Team Management, Risk Management, Vendor Management, Management, Financial Analysis, Strategy, Training, Leadership, Contract Negotiation, Accounting, Outsourcing, Forecasting, Business Development, Operations Management, Business Strategy, Cross-functional Team..., Account Management, Business Planning, Banking, CRM, Change Management, Program Management, Executive Management, New Business Development, Financial Services, Analysis, Mergers & Acquisitions, Pricing, Team Leadership, Strategic Planning, Start-ups, Negotiation, Management Consulting, Portfolio Management, Credit, Team Building, Financial Modeling, Business Intelligence, Relationship Management, Competitive Analysis, Budgets, Sales Management
Education
Seton Hall University 1997 — 2002
Master of Business Administration (M.B.A.), Finance, General
The New School 1993 — 1996
Master's Degree, Management and Urban Policy Analysis
Wittenberg University 1983 — 1987
Bachelor's Degree, History
Rachel (Ispas) Legler's MonoSol Rx, LLC Experience November 2007 - March 2012
Job Sr. Validation Scientist at CSL Behring
Industry Pharmaceuticals
Experience
CSL Behring April 2012 - Present
Monosol Rx, LLC November 2007 - March 2012
Monosol Rx, LLC December 2005 - November 2007
Skills
Cleaning Validation, Validation, Contamination Control, cGMP, 21 CFR Part 11, Quality Assurance, Calibration, GMP, Sop, Dissolution, Laboratory, Change Control, CAPA, Deviations, FDA, V&V, Pharmaceutical Industry, Quality System, SOP
Education
Purdue University 2000 — 2005
Chemistry/Biochemistry
Munster High School
CSL Behring April 2012 - Present
Monosol Rx, LLC November 2007 - March 2012
Monosol Rx, LLC December 2005 - November 2007
Skills
Cleaning Validation, Validation, Contamination Control, cGMP, 21 CFR Part 11, Quality Assurance, Calibration, GMP, Sop, Dissolution, Laboratory, Change Control, CAPA, Deviations, FDA, V&V, Pharmaceutical Industry, Quality System, SOP
Education
Purdue University 2000 — 2005
Chemistry/Biochemistry
Munster High School
bryan domnanovich's MonoSol Rx, LLC Experience 2004 - 2011
Job Production manager
Industry Food Production
Experience
Avatar Corporation November 2013 - Present
CSL Behring May 2011 - November 2013
Monosol Rx, LLC 2004 - 2011
Skills
FDA, Validation, GMP, CAPA, Quality System, Technology Transfer, Change Control, Sop, 21 CFR Part 11, Root Cause Analysis, R&D
Education
Northern Illinois University 2000 — 2003
BS, Physics
Avatar Corporation November 2013 - Present
CSL Behring May 2011 - November 2013
Monosol Rx, LLC 2004 - 2011
Skills
FDA, Validation, GMP, CAPA, Quality System, Technology Transfer, Change Control, Sop, 21 CFR Part 11, Root Cause Analysis, R&D
Education
Northern Illinois University 2000 — 2003
BS, Physics
Stephen Wargacki's MonoSol Rx, LLC Experience April 2015 - Present
Job Manager, Research and Development
Industry Pharmaceuticals
Experience
MonoSol Rx, LLC April 2015 - Present
LTS - Lohmann Therapy Systems April 2013 - April 2015
LTS - Lohmann Therapy Systems January 2011 - April 2013
LTS - Lohmann Therapy Systems January 2009 - December 2010
Design West Technologies, Inc. 2007 - 2008
Air Force Research Laboratory 2005 - 2007
University of Tennessee 2000 - 2005
Skills
Chemistry, Differential Scanning..., Polymers, Polymer Science, Fomulation, Design of Experiments, Process Improvement, Quality by Design, Microscopy, Thin Film Coating, GLP, ANDA, Formulation, Drug Delivery, GMP, Rheology, Polymer Chemistry, Pharmaceutical Industry, HPLC, Validation, Organic Chemistry, Chromatography, R&D, Laboratory, Technology Transfer, Gas Chromatography
Education
University of Tennessee-Knoxville 2000 — 2005
PhD., Chemistry
Cumberland College 1996 — 1999
B.S., Chemistry, Physics
MonoSol Rx, LLC April 2015 - Present
LTS - Lohmann Therapy Systems April 2013 - April 2015
LTS - Lohmann Therapy Systems January 2011 - April 2013
LTS - Lohmann Therapy Systems January 2009 - December 2010
Design West Technologies, Inc. 2007 - 2008
Air Force Research Laboratory 2005 - 2007
University of Tennessee 2000 - 2005
Skills
Chemistry, Differential Scanning..., Polymers, Polymer Science, Fomulation, Design of Experiments, Process Improvement, Quality by Design, Microscopy, Thin Film Coating, GLP, ANDA, Formulation, Drug Delivery, GMP, Rheology, Polymer Chemistry, Pharmaceutical Industry, HPLC, Validation, Organic Chemistry, Chromatography, R&D, Laboratory, Technology Transfer, Gas Chromatography
Education
University of Tennessee-Knoxville 2000 — 2005
PhD., Chemistry
Cumberland College 1996 — 1999
B.S., Chemistry, Physics
Ava Melchionna's MonoSol Rx, LLC Experience November 2012 - Present
Job at
Industry Real Estate
Experience
Monosol Rx, LLC November 2012 - Present
Rakin Agency 2002 - Present
Rakin Agency 2002 - 2012
First State Bank February 2009 - November 2011
Skills
Administration, Administrative..., Banking
Education
Union County College
Monosol Rx, LLC November 2012 - Present
Rakin Agency 2002 - Present
Rakin Agency 2002 - 2012
First State Bank February 2009 - November 2011
Skills
Administration, Administrative..., Banking
Education
Union County College
Diane Icard's MonoSol Rx, LLC Experience July 2012 - November 2012
Job Quality/Validation Consultant at DICARD L.L.C.
Industry Pharmaceuticals
Experience
Philips Health Systems January 2015 - May 2015
Hill-Rom May 2014 - October 2014
Maquet Getinge Group December 2013 - April 2014
Novartis Consumer Health January 2013 - December 2013
Monosol Rx, LLC July 2012 - November 2012
Benvenue Medical April 2012 - July 2012
CareFusion October 2011 - April 2012
Mallinckrodt Pharmaceuticals April 2011 - June 2011
Luminex Corporation October 2010 - April 2011
Compliance Insight, Inc. February 2010 - October 2010
Skills
Quality Assurance, Quality Control, Medical Devices, GxP, Quality Auditing, Manufacturing, Cleaning Validation, ISO, Computer System..., Aseptic Processing, Technology Transfer, LIMS, Design Control, Quality Management, Design of Experiments, Biotechnology, FMEA, Process Improvement, Root Cause Analysis, Regulatory Submissions, Laboratory, Pharmaceutics, Biopharmaceuticals, SPC, GCP, R&D, Iso 9000, Calibration, CAPA, Chromatography, Raw Materials, Regulatory Requirements, Investigation, HPLC, Analytical Chemistry, GAMP, Chemistry, Drug Discovery, Continuous Improvement, Equipment Qualification, Pharmaceutical Industry, Analytical Method..., Clinical Trials, Change Control, Aseptic Cleaning..., CIP/SIP Validations, cGMP practices, Validation
Education
University of Southampton 2013 — 2015
Master of Business Administration (MBA)
University of Cincinnati
BS, Chemistry
Philips Health Systems January 2015 - May 2015
Hill-Rom May 2014 - October 2014
Maquet Getinge Group December 2013 - April 2014
Novartis Consumer Health January 2013 - December 2013
Monosol Rx, LLC July 2012 - November 2012
Benvenue Medical April 2012 - July 2012
CareFusion October 2011 - April 2012
Mallinckrodt Pharmaceuticals April 2011 - June 2011
Luminex Corporation October 2010 - April 2011
Compliance Insight, Inc. February 2010 - October 2010
Skills
Quality Assurance, Quality Control, Medical Devices, GxP, Quality Auditing, Manufacturing, Cleaning Validation, ISO, Computer System..., Aseptic Processing, Technology Transfer, LIMS, Design Control, Quality Management, Design of Experiments, Biotechnology, FMEA, Process Improvement, Root Cause Analysis, Regulatory Submissions, Laboratory, Pharmaceutics, Biopharmaceuticals, SPC, GCP, R&D, Iso 9000, Calibration, CAPA, Chromatography, Raw Materials, Regulatory Requirements, Investigation, HPLC, Analytical Chemistry, GAMP, Chemistry, Drug Discovery, Continuous Improvement, Equipment Qualification, Pharmaceutical Industry, Analytical Method..., Clinical Trials, Change Control, Aseptic Cleaning..., CIP/SIP Validations, cGMP practices, Validation
Education
University of Southampton 2013 — 2015
Master of Business Administration (MBA)
University of Cincinnati
BS, Chemistry
Susan Shumard's MonoSol Rx, LLC Experience July 2014 - Present
Job Sr. Formulation Scientist at MonoSol Rx, LLC
Industry Pharmaceuticals
Experience
MonoSol Rx, LLC July 2014 - Present
Johnson & Johnson July 2008 - November 2012
Pfizer and Johnson & Johnson October 1999 - July 2008
Lavipharm Laboratories September 1998 - October 1999
Bayer HealthCare April 1995 - September 1998
Sterling Health div. of Sterling Winthrop January 1991 - April 1995
Lonza April 1990 - January 1991
Carter-Wallace, Carter OTC Products Division March 1986 - April 1990
Andrew Jergens Company August 1979 - January 1986
Skills
Pharmaceutical Industry, Cosmetics, GLP, R&D, GMP, Sop, LIMS, Formulation, Raw Materials, Drug Discovery, Lifesciences, Medical Devices, CAPA, Cross-functional Team..., Life Sciences, SOP, Validation
Education
St. Thomas Instititue (Institutum Divi Thomae) 1977 — 1979
MS, Biology & Experimental Medicine
St. Joseph's College (IN) 1973 — 1977
BS, Biology - Chemistry, Summa cum Laude
MonoSol Rx, LLC July 2014 - Present
Johnson & Johnson July 2008 - November 2012
Pfizer and Johnson & Johnson October 1999 - July 2008
Lavipharm Laboratories September 1998 - October 1999
Bayer HealthCare April 1995 - September 1998
Sterling Health div. of Sterling Winthrop January 1991 - April 1995
Lonza April 1990 - January 1991
Carter-Wallace, Carter OTC Products Division March 1986 - April 1990
Andrew Jergens Company August 1979 - January 1986
Skills
Pharmaceutical Industry, Cosmetics, GLP, R&D, GMP, Sop, LIMS, Formulation, Raw Materials, Drug Discovery, Lifesciences, Medical Devices, CAPA, Cross-functional Team..., Life Sciences, SOP, Validation
Education
St. Thomas Instititue (Institutum Divi Thomae) 1977 — 1979
MS, Biology & Experimental Medicine
St. Joseph's College (IN) 1973 — 1977
BS, Biology - Chemistry, Summa cum Laude
Patrick Dailey's MonoSol Rx, LLC Experience March 2004 - May 2011
Job Engineer at MonoSol, LLC
Industry Pharmaceuticals
Experience
MonoSol, LLC May 2011 - Present
Monosol Rx, LLC March 2004 - May 2011
Skills
Manufacturing, Validation, CAPA
Education
Purdue University Calumet 1998 — 2003
Chemistry
MonoSol, LLC May 2011 - Present
Monosol Rx, LLC March 2004 - May 2011
Skills
Manufacturing, Validation, CAPA
Education
Purdue University Calumet 1998 — 2003
Chemistry
Kurt Easton's MonoSol Rx, LLC Experience May 2006 - April 2011
Job Project Engineer at RA Jones
Industry Packaging and Containers
Experience
R.A Jones May 2011 - Present
Monosol Rx, LLC May 2006 - April 2011
Skills
Lean Manufacturing, Manufacturing, Six Sigma, Solidworks, Pro Engineer, Project Management, Process Validation, Installation..., Functional..., Sheet Metal, Mechanical Engineering, Modified Atmosphere..., Automation, Continuous Improvement, Design for Manufacturing, Cross-functional Team..., Engineering, Engineering Management, PTC Creo, Process Improvement, Root Cause Analysis, Product Development, V, SolidWorks
Education
Tri-State University 2000 — 2004
Bachelor of Science (B.S.), Mechanical Engineering
R.A Jones May 2011 - Present
Monosol Rx, LLC May 2006 - April 2011
Skills
Lean Manufacturing, Manufacturing, Six Sigma, Solidworks, Pro Engineer, Project Management, Process Validation, Installation..., Functional..., Sheet Metal, Mechanical Engineering, Modified Atmosphere..., Automation, Continuous Improvement, Design for Manufacturing, Cross-functional Team..., Engineering, Engineering Management, PTC Creo, Process Improvement, Root Cause Analysis, Product Development, V, SolidWorks
Education
Tri-State University 2000 — 2004
Bachelor of Science (B.S.), Mechanical Engineering
Gabriela Olimpia Siszer's MonoSol Rx, LLC Experience QC analystNufarmMarch 2013 - Present
Job QC analyst at Nufarm
Industry Chemicals
Experience
Monosol Rx, LLC QC analystNufarmMarch 2013 - Present
Rosalind Franklin University 2007 - 2009
Skills
Biochemistry, Protein Chemistry, PCR, Cell Culture, Western Blotting, Molecular Biology, Microscopy, Science, Confocal Microscopy, Fluorescence Microscopy, Protein Purification, Microbiology, ELISA, Agarose Gel..., Aseptic Technique, RNA isolation, Protein Expression, RT-PCR, Transfection, Laboratory
Education
Lake Forest College
Chemistry, Chemistry
Monosol Rx, LLC QC analystNufarmMarch 2013 - Present
Rosalind Franklin University 2007 - 2009
Skills
Biochemistry, Protein Chemistry, PCR, Cell Culture, Western Blotting, Molecular Biology, Microscopy, Science, Confocal Microscopy, Fluorescence Microscopy, Protein Purification, Microbiology, ELISA, Agarose Gel..., Aseptic Technique, RNA isolation, Protein Expression, RT-PCR, Transfection, Laboratory
Education
Lake Forest College
Chemistry, Chemistry
Barry Sheehan's MonoSol Rx, LLC Experience August 2004 - October 2005
Job Technical Writer, Technology Transfer
Industry Pharmaceuticals
Experience
Fresenius Kabi USA September 2013 - Present
CIBA Vision a Novartis Company October 2011 - September 2013
U.S. Smokeless Tobacco Company October 2005 - October 2011
Monosol Rx, LLC August 2004 - October 2005
Skills
CAPA Process, Calibration, TrackWise, FMEA, Root Cause Analysis, Quality Auditing, Ishikawa, 5 Why's
Education
Eastern Illinois University 2001 — 2003
Bachelor of Applied Science (B.A.Sc.), Industrial Technology
Northern Illinois University 1998 — 2001
N/A, Technology
Brother Rice High School 1994 — 1998
Fresenius Kabi USA September 2013 - Present
CIBA Vision a Novartis Company October 2011 - September 2013
U.S. Smokeless Tobacco Company October 2005 - October 2011
Monosol Rx, LLC August 2004 - October 2005
Skills
CAPA Process, Calibration, TrackWise, FMEA, Root Cause Analysis, Quality Auditing, Ishikawa, 5 Why's
Education
Eastern Illinois University 2001 — 2003
Bachelor of Applied Science (B.A.Sc.), Industrial Technology
Northern Illinois University 1998 — 2001
N/A, Technology
Brother Rice High School 1994 — 1998
Helen Grigoriadis's MonoSol Rx, LLC Experience November 2007 - September 2013
Job QAO Specialist at CSL
Industry Pharmaceuticals
Experience
CSL September 2013 - Present
Monosol Rx, LLC November 2007 - September 2013
Skills
ELISA, CAPA, Calibration, Root Cause Analysis, FDA, V&V, Sop, Quality System, Biotechnology, Quality Auditing, Quality Assurance, Pharmaceutical Industry, Analytical Chemistry, Change Control, GMP, Clinical Development, Quality Control, ISO, Quality Management, Regulatory Submissions, Chemistry, Regulatory Requirements, R&D, Laboratory, Dissolution, SOP, Validation
Education
DePaul University 1996 — 1999
Master of Science (M.S.), Biology/Developmental Toxicology
Loyola University of Chicago 1992 — 1996
Bachelor of Science (BS), Biology, General
CSL September 2013 - Present
Monosol Rx, LLC November 2007 - September 2013
Skills
ELISA, CAPA, Calibration, Root Cause Analysis, FDA, V&V, Sop, Quality System, Biotechnology, Quality Auditing, Quality Assurance, Pharmaceutical Industry, Analytical Chemistry, Change Control, GMP, Clinical Development, Quality Control, ISO, Quality Management, Regulatory Submissions, Chemistry, Regulatory Requirements, R&D, Laboratory, Dissolution, SOP, Validation
Education
DePaul University 1996 — 1999
Master of Science (M.S.), Biology/Developmental Toxicology
Loyola University of Chicago 1992 — 1996
Bachelor of Science (BS), Biology, General
Yanjing (Jan) Jiang's MonoSol Rx, LLC Experience June 2012 - Present
Job Principal Scientist at Monosol Rx, LLC
Industry Pharmaceuticals
Experience
Monosol Rx, LLC June 2012 - Present
Novartis January 2004 - June 2012
West ward pharmaceutical October 1996 - January 2004
Skills
HPLC, GC, LCMS, FTIR, UV-Vis, dissolution, Quality by Design, Methods Development, method validation, Technology Transfer, CMC document writing, LIMS, health authority..., People Management, Empower, Chromeleon, Project Management, Working knowledge of..., Validation, GMP, Dissolution, Analytical Chemistry, V&V, Method Development, R&D, UV/Vis, Drug Development, Gas Chromatography, Drug Delivery, CMC, LC-MS, Management
Education
Arkansas State University 1994 — 1996
MS, chemistry
Monosol Rx, LLC June 2012 - Present
Novartis January 2004 - June 2012
West ward pharmaceutical October 1996 - January 2004
Skills
HPLC, GC, LCMS, FTIR, UV-Vis, dissolution, Quality by Design, Methods Development, method validation, Technology Transfer, CMC document writing, LIMS, health authority..., People Management, Empower, Chromeleon, Project Management, Working knowledge of..., Validation, GMP, Dissolution, Analytical Chemistry, V&V, Method Development, R&D, UV/Vis, Drug Development, Gas Chromatography, Drug Delivery, CMC, LC-MS, Management
Education
Arkansas State University 1994 — 1996
MS, chemistry
Brenda Forrest's MonoSol Rx, LLC Experience 2012 - 2013
Job Quality Assurance Manager at Sonoco
Industry Consumer Goods
Experience
Sonoco November 2013 - Present
Monosol Rx, LLC 2012 - 2013
Blistex Inc. 2007 - 2012
Skills
Regulatory Affairs, GLP, 21 CFR Part 11, Consumer Products, Lean Manufacturing, LIMS, Six Sigma, Product Development, Manufacturing, Process Improvement, Ingredients, Analytical Chemistry, GMP, ISO, Quality Management, Root Cause Analysis
Education
Keller Graduate School of Management of DeVry University 2007 — 2009
Master's degree, Project Management
Eckerd College 1974 — 1978
Bachelor of Science
Sonoco November 2013 - Present
Monosol Rx, LLC 2012 - 2013
Blistex Inc. 2007 - 2012
Skills
Regulatory Affairs, GLP, 21 CFR Part 11, Consumer Products, Lean Manufacturing, LIMS, Six Sigma, Product Development, Manufacturing, Process Improvement, Ingredients, Analytical Chemistry, GMP, ISO, Quality Management, Root Cause Analysis
Education
Keller Graduate School of Management of DeVry University 2007 — 2009
Master's degree, Project Management
Eckerd College 1974 — 1978
Bachelor of Science
patricia lasquinha's MonoSol Rx, LLC Experience May 2012 - Present
Job Executive Assistant to CEO/COO Office Manager at Monosol Rx, LLC
Industry Banking
Experience
Monosol Rx, LLC May 2012 - Present
First State Bank 2005 - 2011
Bentley/Rolls-Royce Motorcars Corp August 1983 - January 2003
Skills
Commercial Banking, Commercial Loan..., Executive/Personal..., Customer Service, Project Management, PowerPoint, Microsoft Excel, Office Management
Education
New Jersey City University 1978 — 1980
Associate's degree, Psychology
Monosol Rx, LLC May 2012 - Present
First State Bank 2005 - 2011
Bentley/Rolls-Royce Motorcars Corp August 1983 - January 2003
Skills
Commercial Banking, Commercial Loan..., Executive/Personal..., Customer Service, Project Management, PowerPoint, Microsoft Excel, Office Management
Education
New Jersey City University 1978 — 1980
Associate's degree, Psychology
Emma Geiger's MonoSol Rx, LLC Experience July 2014 - August 2014
Job Student at Boston College
Industry
Experience
MonoSol Rx, LLC July 2014 - August 2014
Education
Boston College 2013 — 2017
Biology B.S., Biology, General
Cazenovia High School 2009 — 2013
MonoSol Rx, LLC July 2014 - August 2014
Education
Boston College 2013 — 2017
Biology B.S., Biology, General
Cazenovia High School 2009 — 2013