Sigma-Tau Pharmasource

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Sigma-Tau Pharmasource Employees

Employee
Years
Job
Industry
Nathan Bunch Nathan Bunch Brownsburg, Indiana Details
Nathan Bunch's Sigma-Tau Pharmasource Experience May 2014 - Present
Job QA Compliance Associate at Sigma Tau Pharmasource
Industry Pharmaceuticals
Experience
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

Heather Orick Heather Orick Indianapolis, Indiana Details
Heather Orick's Sigma-Tau Pharmasource Experience October 2014 - Present
Job QA Compliance Associate at SigmaTau PharmaSource
Industry Pharmaceuticals
Experience
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

Rann DeStefano Rann DeStefano Indianapolis, Indiana Area Details
Rann DeStefano's Sigma-Tau Pharmasource Experience November 2002 - Present
Job Human Resources Supervisor, Sigmatau Pharmasource
Industry Pharmaceuticals
Experience
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

Ravi Nadarajah Ravi Nadarajah Indianapolis, Indiana Details
Ravi Nadarajah's Sigma-Tau Pharmasource Experience December 2013 - Present
Job M.S., CMQ/OE, CQA
Industry Pharmaceuticals
Experience
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

Brady Allen Brady Allen Indianapolis, Indiana Area Details
Brady Allen's Sigma-Tau Pharmasource Experience November 2011 - November 2012
Job Quality assurance representative materials at Eli Lilly and Company
Industry Pharmaceuticals
Experience
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

Brock Harris Brock Harris Indianapolis, Indiana Details
Brock Harris's Sigma-Tau Pharmasource Experience May 2014 - Present
Job Microbiologist at SigmaTau Pharmasource
Industry Research
Experience
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

Bryan Dunaway Bryan Dunaway Indianapolis, Indiana Area Details
Bryan Dunaway's Sigma-Tau Pharmasource Experience January 2015 - Present
Job Change Control Specialist II at SigmaTau Pharmasource
Industry Pharmaceuticals
Experience
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

Alexandra Kuhlman Alexandra Kuhlman Washington D.C. Metro Area Details
Alexandra Kuhlman's Sigma-Tau Pharmasource Experience June 2011 - November 2014
Job Senior Specialist Quality Systems Management at Cardinal Health
Industry Pharmaceuticals
Experience
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

Adam Lake Adam Lake Indianapolis, Indiana Area Details
Adam Lake's Sigma-Tau Pharmasource Experience September 2014 - Present
Job Sr. Quality Systems Associate
Industry Pharmaceuticals
Experience
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

Matthew P. VonEsch Matthew P. VonEsch Indianapolis, Indiana Area Details
Matthew P. VonEsch's Sigma-Tau Pharmasource Experience January 2013 - Present
Job Sr. Director, Manufacturing at Sigma Tau PharmaSource
Industry Biotechnology
Experience
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

Phil Duncanson Phil Duncanson Greater Philadelphia Area Details
Phil Duncanson's Sigma-Tau Pharmasource Experience February 2010 - April 2010
Job Aseptic Manufacturing Lead at AstraZeneca
Industry Pharmaceuticals
Experience
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

Alexander Aust Alexander Aust Indianapolis, Indiana Details
Alexander Aust's Sigma-Tau Pharmasource Experience March 2015 - Present
Job Quality Assurance Investigation Specialist II at SigmaTau Pharmasource
Industry Pharmaceuticals
Experience
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

Patrick Saunders Patrick Saunders Indianapolis, Indiana Area Details
Patrick Saunders's Sigma-Tau Pharmasource Experience February 2015 - Present
Job Manager, QC Chemistry at SigmaTau Pharmasource
Industry Pharmaceuticals
Experience
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

Amy Koliba Amy Koliba Plainfield, Indiana Details
Amy Koliba's Sigma-Tau Pharmasource Experience December 2014 - August 2015
Job Senior Specialist, Quality Systems Management
Industry Pharmaceuticals
Experience
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

Karen Wogenstahl Karen Wogenstahl Indianapolis, Indiana Details
Karen Wogenstahl's Sigma-Tau Pharmasource Experience September 2015 - Present
Job Sr. Document Control Coordinator at SigmaTau Pharmasource
Industry Pharmaceuticals
Experience
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

Breanna Robinson Breanna Robinson Indianapolis, Indiana Details
Breanna Robinson's Sigma-Tau Pharmasource Experience December 2012 - Present
Job Analyst II at SigmaTau Pharmasource
Industry Pharmaceuticals
Experience
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

Tom Busby Tom Busby Indianapolis, Indiana Area Details
Tom Busby's Sigma-Tau Pharmasource Experience August 2015 - Present
Job Manager of Quality Systems at SigmaTau Pharmasource
Industry Pharmaceuticals
Experience
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

Jamie McClellan Jamie McClellan Decatur, Illinois Details
Jamie McClellan's Sigma-Tau Pharmasource Experience February 2010 - June 2011
Job QA Manager Investigations and Technical Transfers
Industry Pharmaceuticals
Experience
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

Jim Andeway Jim Andeway Fargo, North Dakota Area Details
Jim Andeway's Sigma-Tau Pharmasource Experience July 2011 - May 2014
Job QA Specialist
Industry Pharmaceuticals
Experience
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

Arlone Macatangay Arlone Macatangay Greater New York City Area Details
Arlone Macatangay's Sigma-Tau Pharmasource Experience February 2010 - November 2010
Job Senior Supply Chain Manager at Kedrion Biopharma Inc.
Industry Pharmaceuticals
Experience
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

Greg Barnard Greg Barnard Syracuse, New York Area Details
Greg Barnard's Sigma-Tau Pharmasource Experience November 2008 - February 2012
Job Director, Biologics Manufacturing at BristolMyers Squibb
Industry Pharmaceuticals
Experience
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

Don DeLillo Don DeLillo Charleston, South Carolina Area Details
Don DeLillo's Sigma-Tau Pharmasource Experience January 2010 - November 2011
Job Finance Executive
Industry Information Technology and Services
Experience
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

Mandy Redmond Mandy Redmond Indianapolis, Indiana Area Details
Mandy Redmond's Sigma-Tau Pharmasource Experience February 2011 - October 2012
Job Director, Quality Assurance SigmaTau Pharma
Industry Pharmaceuticals
Experience
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

Tramone Millard Tramone Millard Bloomington, Indiana Area Details
Tramone Millard's Sigma-Tau Pharmasource Experience June 2012 - July 2013
Job Quality Assurance Specialist at COOK PHARMICA
Industry Pharmaceuticals
Experience
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

Hector Rosa Hector Rosa Indianapolis, Indiana Area Details
Hector Rosa's Sigma-Tau Pharmasource Experience February 2005 - May 2015
Job Quality Assurance Director at Mapp Biopharmaceutical Inc
Industry Pharmaceuticals
Experience
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

Jennifer Woolums Jennifer Woolums Indianapolis, Indiana Area Details
Jennifer Woolums's Sigma-Tau Pharmasource Experience January 2009 - Present
Job QA Compliance Associate II, Product Release
Industry Pharmaceuticals
Experience
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

Lee Althoff Lee Althoff Indianapolis, Indiana Area Details
Lee Althoff's Sigma-Tau Pharmasource Experience September 2007 - Present
Job Director Material/Maintenance at SigmaTau Pharmasource (retired)
Industry Pharmaceuticals
Experience
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

Eun Jang, PhD Eun Jang, PhD Greater New York City Area Details
Eun Jang, PhD's Sigma-Tau Pharmasource Experience 2011 - 2012
Job Associate Director at Oncobiologics Inc.
Industry Biotechnology
Experience
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

He Hongzhen He Hongzhen Indianapolis, Indiana Area Details
He Hongzhen's Sigma-Tau Pharmasource Experience April 2014 - Present
Job Quality Control Analyst at SigmaTau Pharmasource
Industry Pharmaceuticals
Experience
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

Adam Stinson Adam Stinson Indianapolis, Indiana Details
Adam Stinson's Sigma-Tau Pharmasource Experience Utility operatorSigma-Tau PharmasourceNovember 1998 - Present
Job Senior Utility operator at SigmaTau Pharmasource
Industry Pharmaceuticals
Experience
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