Sigma-Tau Pharmasource
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Sigma-Tau Pharmasource Employees
Sigma Tau Pharmasource May 2014 - Present
Sigma-Tau Pharmasource October 2012 - April 2014
Skills
Pharmaceutical Industry, GMP, Biotechnology, Aseptic Processing, SOP
Education
Ball State University 2008 — 2010
Master's degree, Biology, General
Ball State University 2003 — 2008
Bachelor's degree, Biology, General
Sigma-Tau Pharmasource October 2014 - Present
Sigma-Tau Pharmasource February 2013 - October 2014
AIT Laboratories August 2011 - February 2013
AIT Laboratories October 2009 - August 2011
Skills
Protein Chemistry, LIMS, GLP, Laboratory, Sop, Quality Control, Chemistry, GMP, FDA, Pharmaceutical Industry, Chromatography, Analytical Chemistry, UV/Vis
Education
Indiana University Bloomington 2006 — 2009
BS, Biology
Sigma-Tau Pharmasource November 2002 - Present
Epilogue Players, Indianapolis 2005 - Present
Elwood Staffing Services, Inc. July 2000 - September 2002
Olsten Staffing Services April 1997 - May 2000
Target January 1991 - April 1997
Skills
Employee Relations, Recruiting, Payroll, Interviews, Employee Benefits, Benefits Administration, Training, Human Resources, Leadership, Applicant Tracking..., Hiring, Management, FMLA, Onboarding, Temporary Placement, Software Documentation, Talent Acquisition
Education
Indiana University-Purdue University at Indianapolis 1985 — 1989
Bachelors of Science in Education
Sigma-Tau Pharmasource December 2013 - Present
EtQ, Inc. July 2013 - November 2013
Cutler Solutions LLC April 2013 - June 2013
Duke Clinical Research Institute January 2013 - April 2013
Tedia Company, Inc July 2002 - January 2013
ASQ's International Team Excellence Award Process 2012 - 2013
ASQ Local Chapter 2010 - 2013
Genuity Inc. June 1999 - July 2002
Skills
Quality Assurance, Quality System, GMP, GLP, Analytical Chemistry, Iso 9000, Quality Management, Computer System..., Quality Control, Change Control, UV, Chemistry, Quality Auditing, GxP, V&V, Aseptic Processing, Information Management, Dissolution, HPLC, Chromatography, Validation, 21 CFR Part 11, Trackwise, Pharmaceutics, FDA, LIMS, Biotechnology, Laboratory, CQA, Technology Transfer, ISO 13485, Sop, Leadership, Pharmaceutical Industry, GCP, Cleaning Validation, Regulatory Affairs, ISO 14971, Regulatory Requirements, Gas Chromatography, Regulatory Submissions, UV/Vis, USP, Regulatory Complaince, Analytical Laboratory..., Process Improvement, Internal Audit, CAPA
Education
NC State University-BTEC (Biomanufacturing Training and Education Center)
Brandeis University 1998 — 1999
Master's degree, Software Engineering
Wesleyan University 1993 — 1998
Graduate Work, Chemistry
University of Maine 1991 — 1993
Master's degree, Chemistry
University of Sri Lanka at Peradeniya 1984 — 1988
Bachelor's degree, Chemistry
Eli Lilly and Company November 2012 - Present
Sigma Tau Pharmasource November 2011 - November 2012
Lancaster Laboratories September 2010 - November 2011
Schwarz Pharma October 2008 - August 2010
Purdue University September 2007 - April 2008
Baxter Pharmaceuticals May 2006 - July 2006
Skills
Pharmaceutical Industry, HPLC, GMP, Microbiology, Chemistry, GLP, Lifesciences, Sop, Biotechnology, UV/Vis, Validation, Analytical Chemistry, CAPA, Quality Assurance, 21 CFR Part 11
Education
Indiana University - Kelley School of Business 2010 — 2013
Master, Business
Purdue University 2004 — 2008
Bachelor, Pharmaceutical science
Sigma-Tau Pharmasource May 2014 - Present
IUPUI June 2013 - May 2014
IUPUI May 2012 - June 2013
IUPUI Freshman Work Program September 2009 - May 2010
Skills
Microsoft Office, Customer Service, PowerPoint, Research, Microsoft Excel, Microsoft Word, Public Speaking, Critical Thinking, Social Media, Adobe Creative Suite, Data Analysis, Teamwork
Education
Indiana University-Purdue University at Indianapolis 2009 — 2014
Bachelor of Science, Biology
Sigma-Tau Pharmasource January 2015 - Present
Sigma-Tau Pharmasource April 2013 - January 2015
Sigma-Tau Pharmasource May 2012 - April 2013
Sigma-Tau Pharmasource through Kelly Scientific April 2011 - May 2012
Catalent Pharma Solutions October 2007 - October 2010
Tenacious Detail October 2006 - October 2007
Guest Services August 2004 - January 2007
Skills
Analytical Chemistry, Sop, FDA, Pharmaceutical Industry, HPLC, GMP, CAPA, Wet Chemistry, Aseptic Processing, Laboratory, Quality Assurance, Quality Control, LIMS, GLP, Validation, Technology Transfer, Regulatory Affairs, Raw Materials, Dissolution, UV/Vis, Karl Fisher, FTIR, UV, Dissolution Testing, Quality Auditing, USP, IR, Batch Records, TLC, Chemistry, Change Control, Method Transfer, Deviations, Analytical Method..., cGMP practices, Method Development, 21 CFR Part 11, OOS, Titration, Analytical Methods..., FDA GMP, SOP development, Chromatography, pH meter, Stability Testing, Batch Release, Investigation, Six Sigma, Green Belt
Education
Eastern Kentucky University
Bachelor's of Science, Forensic Science, Chemistry
Cardinal Health November 2014 - Present
Sigma-Tau Pharmasource June 2011 - November 2014
Sigma-Tau Pharmasource October 2008 - June 2011
Ball State University Archives May 2006 - June 2008
Skills
Sop, GMP, FDA, Pharmaceutical Industry, Software Documentation, Quality System, Quality Auditing, Biotechnology, CAPA, Quality Assurance, Regulatory Affairs, Validation, 21 CFR Part 11, LIMS, Quality Control, Technology Transfer, GLP, Change Control, Lifesciences, Aseptic Processing, Regulatory Requirements, Root Cause Analysis, SOP
Education
University of Denver 2008 — 2008
Certificate in Publishing, Denver Publishing Institute
Ball State University 2003 — 2008
Bachelor of Arts, English Literature, Classics, Spanish
Sigma-Tau Pharmasource September 2014 - Present
Sigma-Tau Pharmasource May 2013 - September 2014
Sigma Tau Pharamasource June 2012 - May 2013
Kelly Scientific Resources January 2012 - June 2012
Skills
Aseptic Processing, cGMP, SOP, GMP, Microbiology, GLP, Documentation, Environmental Monitoring, Aseptic Technique, Science, Life Sciences, LIMS, Lifesciences, Software Documentation, Technology Transfer, Sop, FDA, Laboratory, Pharmaceutical Industry, Validation, Molecular Biology, CAPA, Quality Control, Assay Development, Quality System, Quality Assurance, Change Control, 21 CFR Part 11, Regulatory Affairs, Pharmaceutics, Quality Auditing
Education
Butler University 2015 — 2016
Master of Business Administration (M.B.A.)
Purdue University 2013 — 2014
Master of Science (MS), Molecular Biology
Indiana University Bloomington 2006 — 2010
BS, Biology, Neuroscience
Sigma Tau PharmaSource January 2013 - Present
United Therapeutics November 2005 - December 2012
United Therapeutics March 2007 - July 2009
United Therapeutics November 2005 - March 2007
MedImmune May 2005 - November 2005
Human Genome Sciences November 2003 - May 2005
Wyeth Biotech June 2001 - November 2003
Skills
GMP, Validation, Aseptic Processing, Protein Purification, Biopharmaceuticals, 21 CFR Part 11, Aseptic Technique, Regulatory Submissions, FDA, Sterilization, Biotechnology, Pharmaceutical Industry, CAPA, Sop, Change Control, Manufacturing, GLP, Quality System, V&V, Lifesciences, LIMS, GxP, Purification, Technology Transfer, Chromatography, Cleaning Validation, Computer System..., Trackwise
Education
Merrimack College 1996 — 2001
AstraZeneca March 2015 - Present
AstraZeneca January 2014 - March 2015
MedImmune April 2012 - December 2013
MedImmune April 2010 - April 2012
Sigma-Tau Pharmasource February 2010 - April 2010
Enzon Pharmaceuticals March 2006 - April 2010
Invitrogen December 2003 - August 2005
Association of Public Health Laboratories October 2001 - December 2003
Skills
Microbiology, Genetics, Pharmaceuticals, qPCR, ELISA, Infectious Diseases, DNA, PCR, Diagnostics, Molecular Biology, Vaccines, LIMS, Life Sciences, Biotechnology, FDA, RT-PCR, Validation, Public Health, Pharmaceutical Industry, GMP, Lifesciences, CAPA, Hardware Diagnostics, Biopharmaceuticals, GLP, SOP, Technology Transfer
Education
The University of Salford 1998 — 2001
Doctor of Philosophy (Ph.D.), Parasitology
University of Leeds 1995 — 1998
BSc, Genetics with Microbiology
Sigma-Tau Pharmasource March 2015 - Present
Sigma-Tau Pharmasource April 2014 - May 2015
Sigma-Tau Pharmasource May 2012 - April 2014
Skills
Environmental Monitoring, Quality Control, Water, Bioburden, Endotoxin, Raw Materials, Conductivity, TOC, Testing, Sop, GMP, CAPA, Validation, FDA, GLP, Pharmaceutical Industry, Microbiology, Lifesciences, Aseptic Processing, Biotechnology, 21 CFR Part 11, Aseptic Technique, SOP
Education
Ball State University 2014 — 2016
Master of Business Administration (M.B.A.), Business Administration, Management and Operations
Purdue University 2011 — 2012
M.S., Molecular Biology
University of Southern Indiana 2007 — 2011
B.S., Biology
Sigma-Tau Pharmasource February 2015 - Present
Renewed Enterprises October 2003 - Present
Sigma-Tau Pharmasource, Inc. June 2011 - February 2015
Sigmatau Pharmasource, Inc. January 2009 - June 2011
Enzon Pharmaceuticals May 2006 - 2010
Simon Property Group May 2005 - May 2006
Skills
Aseptic Processing, GMP, FDA, Quality Control, Validation, CAPA, Lifesciences, Sop, Pharmaceutical Industry, GLP, 21 CFR Part 11, Biotechnology, Change Control, Chemistry, HPLC, Quality Auditing, Quality System, Technology Transfer, Regulatory Affairs, SOP
Education
Purdue University 2001 — 2005
B.S., Chemistry
Cardinal Health August 2015 - Present
Sigma-Tau Pharmasource December 2014 - August 2015
Sigma-Tau Pharmasource May 2014 - November 2014
Ingredion Incorporated April 2007 - September 2013
Skills
Quality Control, Customer Service, Quality Assurance, PowerPoint, GMP, Lean Six Sigma, Green Belt, Microsoft Excel, SOP, FDA, Change Control, Quality System, CAPA, Pharmaceutical Industry, Food Industry, LIMS, Quality Auditing, Regulatory Affairs, 21 CFR Part 11, Technology Transfer, GLP, GDP, Life Sciences, Aseptic Processing, Regulatory Requirements, Root Cause Analysis, Technical Writing, Software Documentation, Validation, Continuous Improvement, Measurement System..., SPC, Control Charts, Wet Chemistry, Supervisory Skills, Laboratory Techniques, Biotechnology
Education
Marian College 2002 — 2006
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Sigma-Tau Pharmasource September 2015 - Present
GRM Document Management 2015 - 2015
Hill-Rom / Randstad Technologies February 2014 - September 2014
Cintas Document Management January 2002 - July 2012
Eli Lilly/CTG July 2000 - January 2002
RW Armstrong January 1991 - July 2000
Skills
Training, Document Management, Management, Consulting, Salesforce.com, User Documentation, Instructional Manuals, Job Descriptions, Project Coordination, EDRMS, Business Development, Business Process..., Document Imaging, Procedure Development, Newsletters, Project Management, Account Management, Budgets, Customer Satisfaction, Time Management, Procedure Manuals, Multiple Project..., Six Sigma Green Belt, Relationship Management, Building Strong...
Education
Indiana University-Purdue University at Indianapolis 1990 — 2000
Ball State University
Bloomington High School North
Sigma-Tau Pharmasource December 2012 - Present
Skills
GMP, SOP, Chemistry, HPLC, Pharmaceutical Industry, GLP, Chromatography, Microsoft Office, Quality Control, Data Analysis, Laboratory, Analytical Chemistry, Analysis, UV/Vis, 21 CFR Part 11, Validation, CAPA, Biotechnology, FDA
Education
Ball State University 2010 — 2015
Master of Science (M.S.), Chemistry
Ball State University 2006 — 2010
Bachelor of Science (B.S.), Chemistry
Sigma-Tau Pharmasource August 2015 - Present
Sigma-Tau Pharmasource January 2013 - August 2015
Sigma-Tau Pharmasource August 2011 - January 2013
Sigma-Tau Pharmasource January 2010 - August 2011
Enzon Pharmaceuticals May 2007 - January 2010
Skills
Validation, Sop, CAPA, FDA, SAP, Quality Control, Microbiology, GMP, 21 CFR Part 11, Aseptic Processing, GLP, Biotechnology, Pharmaceutical Industry, Quality System, SOP, Technology Transfer
Education
Indiana University - Kelley School of Business 2014 — 2015
Executive Certificate in the Business of Life Sciences, Business Administration and Management, General
Indiana University 2008 — 2009
Graduate Certificate in Biotechnology, Biotechnology
College of Charleston 2001 — 2004
B.S., Marine Biology
Akorn, Inc September 2013 - Present
Purdue University January 2010 - May 2014
Archer Daniels Midland June 2011 - September 2013
Sigma-Tau Pharmasource February 2010 - June 2011
Enzon Pharmaceuticals June 2007 - February 2010
Nice Pak June 2006 - June 2007
Skills
cGMP, SOP, Validation, Pharmaceuticals, Compliance, Project Coordination, Regulatory Affairs, Regulatory Requirements, Change Management, Q7A, Lean manufacturing, ISO 22000, FDA, HPLC, Quality Assurance, Quality Management, Biotechnology, Quality Control, CAPA, LIMS, Chemistry, Change Control, Pharmaceutics, Protein Chemistry, SAP, Sop, Lean Manufacturing, Pharmaceutical Industry, GMP, Software Documentation, Aseptic Processing, Technology Transfer, Analytical Chemistry, Chromatography, GLP, UV/Vis, Quality System, Quality Auditing, Manufacturing, Microbiology, Laboratory, R&D, Lifesciences, Aseptic Technique, ELISA, Mass Spectrometry, Purification
Education
Purdue University 2010 — 2014
Master of Science (MS), Regulatory and Quality Compliance
Indiana University Bloomington 2004 — 2005
Inorganic chemistry
St. Francis University 2000 — 2004
Bachelor of Science (B.S.), Chemistry
Aldevron May 2015 - Present
Swanson Health Products May 2014 - May 2015
Sigma-Tau Pharmasource July 2011 - May 2014
Sigma-Tau Pharmasource July 2008 - July 2011
Replidyne 2005 - 2008
Skills
GMP, Validation, Quality Assurance, Process Improvement, Aseptic Processing, Sop, CAPA, Pharmaceutical Industry, FDA, Biopharmaceuticals, Biotechnology, Change Control, GLP, HPLC, LIMS, Manufacturing, Microbiology, Quality System, Technology Transfer, 21 CFR Part 11, Lifesciences, V&V, Regulatory Affairs, Quality Auditing, SOP
Education
Colorado State University 1999 — 2002
Bachelor of Science (BS), Biology/Biological Sciences, General
City Colleges of Chicago-Wilbur Wright College 1997 — 1999
Associate's degree, General Studies
Kedrion Biopharma Inc. July 2015 - Present
Sigma-Tau Pharmaceuticals, Inc. August 2012 - June 2015
Sigma-Tau Pharmaceuticals, Inc. September 2010 - August 2012
Sigma-Tau Pharmasource February 2010 - November 2010
Enzon Pharmaceuticals June 2008 - January 2010
Skills
Supply Chain, Supply Chain Management, MRP, Pharmaceutical Industry, Forecasting, Sop, GMP, Cross-functional Team..., SAP, Lean Manufacturing, Manufacturing, CAPA, Validation, Supply, Inventory Management, Process Improvement, Supply Chain..., Operations Management, Materials Management, Quality Assurance, ERP, Pharmaceuticals, Problem Solving, Strategic Planning, Procurement, Logistics, Distribution, SOP
Education
Rutgers, The State University of New Jersey-Newark 2001 — 2006
Political Science
Bristol-Myers Squibb August 2013 - Present
Endo Pharmaceuticals September 2012 - June 2013
Endo Pharmaceuticals February 2012 - September 2012
Sigma-Tau Pharmasource November 2008 - February 2012
Catalent February 2006 - June 2008
Microtest Laboratories 2008 - 2008
Ben Venue Laboratories February 2002 - February 2006
Skills
Aseptic Processing, GMP, Quality System, Pharmaceutical Industry, Lean Manufacturing, Six Sigma, Validation, Manufacturing, Quality Auditing, FDA, Continuous Improvement, Biotechnology, V&V, CAPA, Sop
Education
University of Rochester - Simon Business School 2000 — 2002
MBA, Operations Management
Rochester Institute of Technology 1986 — 1989
BS, Chemistry
PureCars January 2014 - Present
PureCars March 2013 - December 2013
Sigma-Tau Pharmaceuticals, Inc. November 2005 - February 2012
Sigma-Tau Pharmasource January 2010 - November 2011
AstenJohnson September 1997 - November 2005
Rhodia April 1989 - September 1997
PharmaKinetics March 1985 - April 1989
Touche Ross January 1984 - March 1985
Skills
Financial Reporting, Budgeting, Accounting, Forecasting, Tax, Strategic Planning, Internal Controls, Financial Analysis, Revenue Recognition, Pharmaceuticals, Consolidation, Financial Management, Cost Accounting, Due Diligence, Financial Forecasting, Financial Operations, Monthly Close, Monthly Reporting, Budgets, Contract Management, Risk Management, Managerial Finance, Start-ups, Strategy, Mergers & Acquisitions, Auditing, Sarbanes-Oxley Act
Education
Penn State University 1980 — 1984
BS, Accounting
Sigma-Tau PharmaSource, Inc October 2012 - Present
Sigma-Tau Pharmasource February 2011 - October 2012
Roche Diagnostics August 1988 - February 2011
Boehringer Mannheim 1988 - 1998
Vaser 1986 - 1988
American Monitor 1979 - 1986
Skills
GMP, Quality Systems, FDA, Medical Devices, Pharmaceuticals, Quality Assurance, CAPA, Quality Management, cGMP, ISO 13485, SAP, Compliance, Root Cause Analysis, Process Improvement, Documentation, Regulatory Affairs, Document Management, Change Management, Diagnostics, Life Sciences, SOP, Technology Transfer, Risk Management, Quality Auditing, 21 CFR Part 11
Education
Indiana University-Purdue University at Indianapolis 1982 — 1988
English, Journalism, Technical Writing
University of Phoenix 2005 — 2007
MBA
Cook Pharmica July 2013 - Present
Sigma-Tau Pharmasource June 2012 - July 2013
Enzon Pharmaceuticals 2003 - 2013
Sigma-Tau Pharmasource August 2003 - June 2012
Sigma-tau 2003 - 2012
Skills
cGMP, Environmental Monitoring, Pharmaceuticals, GMP, SOP, Batch record review,..., Perform internal and..., Write and execute..., Quality System, Regulatory Affairs, Quality Auditing, Deviations, Sterilization, Quality Assurance, Microbiology, Quality Control, CAPA, FDA, Regulatory Requirements, 21 CFR Part 11, Change Control
Education
Indiana Wesleyan University
Bachelors Degree Business Management, Business
Mapp Biopharmaceutical Inc May 2015 - Present
Sigma-Tau Pharmasource February 2005 - May 2015
Cordis 2003 - 2005
Cardinal Health 2000 - 2003
Abbott Laboratories 1995 - 2000
Education
Georgia State University - J. Mack Robinson College of Business 1992 — 1994
MBA
Universidad de Puerto Rico 1977 — 1981
BS
Sigma-Tau PharmaSource January 2009 - Present
Enzon Pharmaceuticals October 2001 - January 2009
Fisher Scientific at Eli Lilly and Company August 1998 - June 2001
Skills
SOP authoring, Editing, Batch Records, Batch Release, Microsoft Office, SAP, Pilgrim, Inventory Control, Transportation, Supply Chain, Payroll, Accounts Payable, AQL, CAPA, cGMP manufacturing, GLP, Software Documentation, 21 CFR Part 11, Quality Assurance, Sop, Validation, Aseptic Processing, GMP, FDA, SOP, Biotechnology, Change Control, Pharmaceutical Industry, Technology Transfer, Quality System
Education
Ball State University 1992 — 1996
Bachelor's Degree, Pre-Professional English
Sigma-Tau Pharmasource September 2007 - Present
Sigma Tau Pharmasource February 2010 - February 2014
King Pharmaceuticals 1998 - 2007
Skills
FDA, Aseptic Processing, Pharmaceutical Industry, Pharmacy Benefit..., GMP, CAPA, Sop, Technology Transfer, GLP, Regulatory Affairs, Biotechnology, LIMS, 21 CFR Part 11, Change Control, Lifesciences, Regulatory Submissions, Quality System, Cleaning Validation, Aseptic Technique, Quality Auditing, Microbiology, V&V, Quality Control, Laboratory, Environmental Monitoring, Computer System..., Biopharmaceuticals, Quality Assurance, Regulatory Requirements, Vaccines, GAMP, SOP, Life Sciences
Education
Rochester College
Bachelor of Business Administration (BBA), Business Administration and Management, General
Oncobiologics Inc. April 2015 - Present
Belrose Pharma 2013 - 2015
Ziopharm Oncology 2012 - 2013
Savient Pharmaceuticals, Inc. 2012 - 2012
Sigma-Tau Pharmasource 2011 - 2012
Enzon Pharmaceuticals 2003 - 2011
Baxter Healthcare 1999 - 2003
Skills
Validation, GMP, GLP, HPLC, Protein Chemistry, Mass Spectrometry, IND, Biotechnology, Quality Control, Pharmaceutical Industry, Analytical Techniques, Method Development, Analytical Method..., R&D, Biopharmaceuticals, CMC, Drug Development, Technical Transfers, Protein Characterization, Protein Analysis, Drug Discovery
Education
Rutgers, The State University of New Jersey-New Brunswick
PhD
Sigma-Tau Pharmasource April 2014 - Present
Indiana University February 2007 - January 2013
Cold Spring Harbor Laboratory February 2003 - January 2007
Skills
Protein Purification, Protein Characterization, Protein Crystallography, Drug Discovery and..., Biochemistry, Molecular Biology, FPLC and HPLC, HIAC and FlowCAM, GMP, Pharmarceutical Industry
Education
Tsinghua University
Doctor of Philosophy (Ph.D.), Biophysics
Sigma-Tau Pharmasource Utility operatorSigma-Tau PharmasourceNovember 1998 - Present
Skills
GMP, Manufacturing, SAP, Aseptic Processing, Pharmaceutical Industry, Aseptic Technique, Preventive Maintenance, Forklift Operator, Steam, Factory, Sop, Water, Root Cause Analysis, Validation
Education
Ivy Tech Community College
Associate of Science (A.S.), Electrical/Electronics Maintenance and Repair Technology