Imclone Systems
Industry: Company
DescriptionImClone Systems Incorporated was a biopharmaceutical company dedicated to developing biologic medicines in the area of oncology. It was founded in 1984 and had its corporate headquarters in Bridgewater, New Jersey and its research headquarters in New York City. Founder: Samuel D. Waksal Founded: 1984 Headquarters: New York City, NY Parent organization: Eli Lilly and Company Number of employees: 1,128 Subsidiaries: ImClone Systems Corp, EndoClone Inc
Imclone Systems List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Imclone Systems. You can filter them based on skills, years of employment, job, education, department, and prior employment.
Imclone Systems Salaries. You can even request information on how much does Imclone Systems pay if you want to. Learn about salaries, pros and cons of working for Imclone Systems directly from the past employees.
Find People by Employers You can rekindle an old relationship, reconnect with a long-lost friend, former boss, business acquaintance who might be useful in your new line of work. With our employee database, the possibilities are endless. All you have to do is type in a couple of keywords and we'll bring you the exact information you wanted!
267 Imclone Systems employees in database. Find out everything there's to know about Imclone Systems employees. We offer you a great deal of unbiased information from the internal database, personal records, and many other details that might be of interest to you.
Imclone Systems Employees
Employee
Years
Job
Industry
Keila Rodriguez Keila Rodriguez's Imclone Systems Experience 2004 - 2006
Job Human Resources Manager at inVentiv Health
Industry Pharmaceuticals
Experience
inVentiv Health November 2013 - Present
Everest Reinsurance October 2010 - November 2013
Everest Reinsurance May 2008 - October 2010
ARAMARK September 2006 - May 2008
ImClone Systems 2004 - 2006
Skills
Employee Relations, Human Resources, Employee Benefits, Industrial Relations, Personnel Management, Onboarding, Deferred Compensation, Training, Workers Compensation, HRIS, Succession Planning, Benefits Administration, Compensation & Benefit, Labor Relations, Management, Leadership, Performance Management, Interviews, Employee Engagement
Education
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2004
B.A., Labor Studies & Employment Relations
New Brunswick High School
inVentiv Health November 2013 - Present
Everest Reinsurance October 2010 - November 2013
Everest Reinsurance May 2008 - October 2010
ARAMARK September 2006 - May 2008
ImClone Systems 2004 - 2006
Skills
Employee Relations, Human Resources, Employee Benefits, Industrial Relations, Personnel Management, Onboarding, Deferred Compensation, Training, Workers Compensation, HRIS, Succession Planning, Benefits Administration, Compensation & Benefit, Labor Relations, Management, Leadership, Performance Management, Interviews, Employee Engagement
Education
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2004
B.A., Labor Studies & Employment Relations
New Brunswick High School
Sina Rezvan's Imclone Systems Experience January 2008 - February 2010
Job Insights Account Manager at StreamSend
Industry Information Technology and Services
Experience
StreamSend 2015 - Present
Direct Eats September 2014 - July 2015
Pavé Life May 2014 - September 2014
Pavé Life May 2013 - April 2014
Genie's Hookah Lounge & Restaurant September 2010 - November 2012
ImClone Systems Inc. February 2010 - August 2010
ImClone Systems January 2008 - February 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2006 - December 2007
Skills
GMP, Sop, Validation, Cell Culture, Biopharmaceuticals, Aseptic Technique, V&V, Biotechnology, Quality Assurance, FDA, Technology Transfer, Sales, Lifesciences, Start-ups, National Accounts, Customer Acquisition, Social Media Consulting, Account Management, National Account..., Social Media, Social Media Marketing, Customer Service, Customer Retention, National Account..., Social Media Strategist, Social Media Advertising, Salesforce.com, Long-term Customer..., Marketing Strategy, Relationship Marketing, Sales Process, Vendor Relationships, Relationship Management, Direct Sales, Strategy, Training, CRM, Leadership, Management, Marketing, Event Planning
Education
Rutgers University-New Brunswick 2001 — 2006
BA, Genetics
University of Scranton 2014 — 2016
Master of Business Administration (M.B.A.), With a specialization in Operations Management, 3.94 GPA
Rutgers University-New Brunswick 2001 — 2006
BA, Psychology
StreamSend 2015 - Present
Direct Eats September 2014 - July 2015
Pavé Life May 2014 - September 2014
Pavé Life May 2013 - April 2014
Genie's Hookah Lounge & Restaurant September 2010 - November 2012
ImClone Systems Inc. February 2010 - August 2010
ImClone Systems January 2008 - February 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2006 - December 2007
Skills
GMP, Sop, Validation, Cell Culture, Biopharmaceuticals, Aseptic Technique, V&V, Biotechnology, Quality Assurance, FDA, Technology Transfer, Sales, Lifesciences, Start-ups, National Accounts, Customer Acquisition, Social Media Consulting, Account Management, National Account..., Social Media, Social Media Marketing, Customer Service, Customer Retention, National Account..., Social Media Strategist, Social Media Advertising, Salesforce.com, Long-term Customer..., Marketing Strategy, Relationship Marketing, Sales Process, Vendor Relationships, Relationship Management, Direct Sales, Strategy, Training, CRM, Leadership, Management, Marketing, Event Planning
Education
Rutgers University-New Brunswick 2001 — 2006
BA, Genetics
University of Scranton 2014 — 2016
Master of Business Administration (M.B.A.), With a specialization in Operations Management, 3.94 GPA
Rutgers University-New Brunswick 2001 — 2006
BA, Psychology
Adrienne Oertle Adrienne Oertle's Imclone Systems Experience 2005 - Present
Job Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems 2005 - Present
L'Oreal 1995 - 2005
Skills
Validation, GMP, 21 CFR Part 11, GxP, CAPA, Change Control, Sop, LIMS, Aseptic Processing, Computer System..., Trackwise
Education
Rutgers University-New Brunswick
BS, Chemistry
ImClone Systems 2005 - Present
L'Oreal 1995 - 2005
Skills
Validation, GMP, 21 CFR Part 11, GxP, CAPA, Change Control, Sop, LIMS, Aseptic Processing, Computer System..., Trackwise
Education
Rutgers University-New Brunswick
BS, Chemistry
Dan Bacehowski Dan Bacehowski's Imclone Systems Experience December 2000 - March 2001
Job Lead Environmental Scientist at Foth & Van Dyke
Industry Environmental Services
Experience
Foth & Van Dyke July 2010 - Present
ISOSWO (Iowa Chapter of SWANA) October 2011 - Present
Iowa Environmental Council December 2013 - December 2014
Terracon Consultants, Inc. June 2007 - July 2010
URSCorporation March 2001 - June 2007
ImClone Systems December 2000 - March 2001
Skills
Environmental Compliance, Phase I, Groundwater, Hydrogeology, Environmental, Permitting, Remediation, Strategic Planning, Stormwater Management, Environmental..., Construction, Environmental Management, Construction..., Project Management, Legislative Relations, Regulatory Requirements, Regulatory Analysis, Real Estate Due..., Environmental Awareness, Hazardous Waste..., Solid Waste, Business Strategy, Business Development, Environmental..., Groundwater Remediation, Environmental Issues, Waste, Environmental Consulting, Environmental Permitting, Soil, RCRA, Water Resources, CERCLA, Water, Water Quality, Sampling, Environmental..., Phase 1, NEPA, Hydrology, Contaminated Land, Environmental Impact..., Management, Environmental Science, Leadership
Education
University of Iowa 1996 — 2000
B.S., Environmental Science/ Biological-emphasis
Portland State University 2006 — 2007
Post-Baccalaureate Course Work, Hydrogeology
Carmel High School 1992 — 1996
Mundelein, IL
Foth & Van Dyke July 2010 - Present
ISOSWO (Iowa Chapter of SWANA) October 2011 - Present
Iowa Environmental Council December 2013 - December 2014
Terracon Consultants, Inc. June 2007 - July 2010
URSCorporation March 2001 - June 2007
ImClone Systems December 2000 - March 2001
Skills
Environmental Compliance, Phase I, Groundwater, Hydrogeology, Environmental, Permitting, Remediation, Strategic Planning, Stormwater Management, Environmental..., Construction, Environmental Management, Construction..., Project Management, Legislative Relations, Regulatory Requirements, Regulatory Analysis, Real Estate Due..., Environmental Awareness, Hazardous Waste..., Solid Waste, Business Strategy, Business Development, Environmental..., Groundwater Remediation, Environmental Issues, Waste, Environmental Consulting, Environmental Permitting, Soil, RCRA, Water Resources, CERCLA, Water, Water Quality, Sampling, Environmental..., Phase 1, NEPA, Hydrology, Contaminated Land, Environmental Impact..., Management, Environmental Science, Leadership
Education
University of Iowa 1996 — 2000
B.S., Environmental Science/ Biological-emphasis
Portland State University 2006 — 2007
Post-Baccalaureate Course Work, Hydrogeology
Carmel High School 1992 — 1996
Mundelein, IL
Bankim Patel Bankim Patel's Imclone Systems Experience December 2000 - January 2007
Job Senior Director, Engineering & Validation
Industry Biotechnology
Experience
Alexion Pharmaceuticals, Inc. April 2015 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - April 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2008 - January 2011
Bristol-Myers Squibb Co. January 2007 - February 2008
ImClone Systems December 2000 - January 2007
Merck February 1997 - December 2000
Skills
Engineering, Regulatory Requirements, Validation, 21 CFR Part 11, Project Management, Biotechnology, GMP, Project Engineering, Leadership, Pharmaceutical Industry, Automation, Biopharmaceuticals, Vendor Management, FDA, Quality Assurance, Management, Sop, Construction Management, Document Management, Facilities Management, Change Control, Process Improvement, V&V, Technology Transfer, Quality System, GLP, Regulatory Submissions, CAPA, Clinical Development, GxP, ISO 13485, Computer System..., Aseptic Processing, Process Simulation, SOP
Education
Rutgers, The State University of New Jersey-New Brunswick 1980 — 1984
Bachelor of Science, Mechanical Engineering
Alexion Pharmaceuticals, Inc. April 2015 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - April 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2008 - January 2011
Bristol-Myers Squibb Co. January 2007 - February 2008
ImClone Systems December 2000 - January 2007
Merck February 1997 - December 2000
Skills
Engineering, Regulatory Requirements, Validation, 21 CFR Part 11, Project Management, Biotechnology, GMP, Project Engineering, Leadership, Pharmaceutical Industry, Automation, Biopharmaceuticals, Vendor Management, FDA, Quality Assurance, Management, Sop, Construction Management, Document Management, Facilities Management, Change Control, Process Improvement, V&V, Technology Transfer, Quality System, GLP, Regulatory Submissions, CAPA, Clinical Development, GxP, ISO 13485, Computer System..., Aseptic Processing, Process Simulation, SOP
Education
Rutgers, The State University of New Jersey-New Brunswick 1980 — 1984
Bachelor of Science, Mechanical Engineering
Lia Goloff Lia Goloff's Imclone Systems Experience December 2008 - July 2011
Job Senior Clinical Research Associate at ICON plc
Industry Pharmaceuticals
Experience
ICON plc June 2015 - Present
Clinipace Worldwide December 2014 - April 2015
INC Research November 2012 - July 2014
PAREXEL January 2012 - November 2012
ImClone Systems December 2008 - July 2011
Duke Clinical Research Institute February 2008 - November 2008
RPS May 2007 - February 2008
Keryx Biopharmaceuticals June 2005 - April 2007
Kaiser Permanente Center for Health Research June 2002 - May 2005
UCSF February 1998 - December 1998
Skills
Oncology, Clinical Trials, Clinical Monitoring, ICH-GCP, Cardiovascular Disease, EDC, CRO, CTMS, Pharmaceutical Industry, Regulatory Affairs, Oracle Clinical, Psychiatry, Protocol, Clinical Research, Women's Health, Ophthalmology, Clinical Development, Medical Writing, GCP
Education
University of California, Santa Cruz 1993 — 2000
BA, Medical Anthropology
El Cerrito High School 1989 — 1993
High School
ICON plc June 2015 - Present
Clinipace Worldwide December 2014 - April 2015
INC Research November 2012 - July 2014
PAREXEL January 2012 - November 2012
ImClone Systems December 2008 - July 2011
Duke Clinical Research Institute February 2008 - November 2008
RPS May 2007 - February 2008
Keryx Biopharmaceuticals June 2005 - April 2007
Kaiser Permanente Center for Health Research June 2002 - May 2005
UCSF February 1998 - December 1998
Skills
Oncology, Clinical Trials, Clinical Monitoring, ICH-GCP, Cardiovascular Disease, EDC, CRO, CTMS, Pharmaceutical Industry, Regulatory Affairs, Oracle Clinical, Psychiatry, Protocol, Clinical Research, Women's Health, Ophthalmology, Clinical Development, Medical Writing, GCP
Education
University of California, Santa Cruz 1993 — 2000
BA, Medical Anthropology
El Cerrito High School 1989 — 1993
High School
Monica Kirk Monica Kirk's Imclone Systems Experience November 2005 - December 2010
Job Mnanger of Clinical QC at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - Present
ImClone Systems November 2005 - December 2010
Covance, Inc. June 1998 - September 2005
Skills
GMP, FDA, GLP, Biotechnology, GCP, Change Control, Sop, CAPA, Quality Assurance, Cooking School
Education
Thomas Edison State College 2005 — 2010
Pursuing a degree, Social Sciences
The French Culinary INstitite 1974 — 1995
Certificate in French Cooking, French Cooking, 2.75
American Medical Record Association, division of education 1974 — 1975
Registered Health Information Technician, Health Information/Medical Records Technology/Technician, 3.0
Bridgewatwer-Raritan H.S. 1964 — 1968
HS Diploma, Academic
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - Present
ImClone Systems November 2005 - December 2010
Covance, Inc. June 1998 - September 2005
Skills
GMP, FDA, GLP, Biotechnology, GCP, Change Control, Sop, CAPA, Quality Assurance, Cooking School
Education
Thomas Edison State College 2005 — 2010
Pursuing a degree, Social Sciences
The French Culinary INstitite 1974 — 1995
Certificate in French Cooking, French Cooking, 2.75
American Medical Record Association, division of education 1974 — 1975
Registered Health Information Technician, Health Information/Medical Records Technology/Technician, 3.0
Bridgewatwer-Raritan H.S. 1964 — 1968
HS Diploma, Academic
Laura Belanger Laura Belanger's Imclone Systems Experience January 2007 - January 2008
Job Manager, Quality Operations at Ortho Clinical Diagnostics
Industry Medical Devices
Experience
Ortho Clinical Diagnostics February 2015 - Present
Ortho Clinical Diagnostics December 2011 - February 2015
Ortho Clinical Diagnostics January 2008 - January 2012
Imclone Systems January 2007 - January 2008
Skills
Design of Experiments, Lifesciences, ISO 13485, Six Sigma, Process Excellence, Aseptic Processing, Quality System, GLP, Lean Manufacturing, Change Control, Medical Devices, 21 CFR Part 11, Sop, FDA, Continuous Improvement, Cross-functional Team..., Regulatory Requirements, SAP, Process Improvement, Microbiology, Sterilization, GMP, LIMS, CAPA, Quality Assurance, Manufacturing, Quality Control
Education
Rutgers Graduate School of Management 2009 — 2012
MBA, Supply Chain Management
The College of New Jersey 2001 — 2005
BS, Biology
Raritan Valley Community College
Certificate, Project Management
Ortho Clinical Diagnostics February 2015 - Present
Ortho Clinical Diagnostics December 2011 - February 2015
Ortho Clinical Diagnostics January 2008 - January 2012
Imclone Systems January 2007 - January 2008
Skills
Design of Experiments, Lifesciences, ISO 13485, Six Sigma, Process Excellence, Aseptic Processing, Quality System, GLP, Lean Manufacturing, Change Control, Medical Devices, 21 CFR Part 11, Sop, FDA, Continuous Improvement, Cross-functional Team..., Regulatory Requirements, SAP, Process Improvement, Microbiology, Sterilization, GMP, LIMS, CAPA, Quality Assurance, Manufacturing, Quality Control
Education
Rutgers Graduate School of Management 2009 — 2012
MBA, Supply Chain Management
The College of New Jersey 2001 — 2005
BS, Biology
Raritan Valley Community College
Certificate, Project Management
Stephen Davies Stephen Davies's Imclone Systems Experience April 2008 - February 2011
Job Research Director at Gartner
Industry Pharmaceuticals
Experience
Gartner March 2014 - Present
Savient Pharmaceuticals, Inc. February 2011 - August 2013
ImClone Systems April 2008 - February 2011
Boehringer Ingelheim Pharmaceuticals April 1993 - April 2008
Skills
Business Process..., Change Management, Enterprise Architecture, Business Strategy, SaaS, SOA, International Project..., Managerial Finance, Business Transformation, Executive Level..., Leadership, Staff Development, CRM, Team Building, Business Process, Management, Governance, Process Improvement, 21 CFR Part 11, Strategy, Software Development, Mergers & Acquisitions, Program Management, Business Intelligence, SAP, Data Center, Project Portfolio..., Pharmaceutical Industry, Integration, Information Technology, Business Process..., Project Management, Cross-functional Team..., Cloud Computing, Business Analysis, IT Strategy, Executive Management, Strategic Planning, Biotechnology, IT Management, ERP, FDA, Team Leadership, Performance Management, Enterprise Software, Change Control, Talent Management, Outsourcing, Computer System...
Education
Rowan University
Bachelor of Arts, Communications, Minor - Computer Science
Gartner March 2014 - Present
Savient Pharmaceuticals, Inc. February 2011 - August 2013
ImClone Systems April 2008 - February 2011
Boehringer Ingelheim Pharmaceuticals April 1993 - April 2008
Skills
Business Process..., Change Management, Enterprise Architecture, Business Strategy, SaaS, SOA, International Project..., Managerial Finance, Business Transformation, Executive Level..., Leadership, Staff Development, CRM, Team Building, Business Process, Management, Governance, Process Improvement, 21 CFR Part 11, Strategy, Software Development, Mergers & Acquisitions, Program Management, Business Intelligence, SAP, Data Center, Project Portfolio..., Pharmaceutical Industry, Integration, Information Technology, Business Process..., Project Management, Cross-functional Team..., Cloud Computing, Business Analysis, IT Strategy, Executive Management, Strategic Planning, Biotechnology, IT Management, ERP, FDA, Team Leadership, Performance Management, Enterprise Software, Change Control, Talent Management, Outsourcing, Computer System...
Education
Rowan University
Bachelor of Arts, Communications, Minor - Computer Science
James Wescott James Wescott's Imclone Systems Experience February 1988 - May 1996
Job Vice President, Project Management & Planning at ALLERGAN plc
Industry Pharmaceuticals
Experience
Allergan, formerly Actavis plc December 2014 - Present
POTENZA Therapeutics, Inc, May 2014 - November 2014
Wescott BioPharma Services May 2011 - April 2014
Merck November 2009 - May 2011
Schering-Plough Research Institute May 1996 - November 2009
ImClone Systems February 1988 - May 1996
Rockefeller University 1987 - 1988
Skills
Pharmaceutical Industry, Clinical Development, Strategic Planning, Project Portfolio..., Analytics, Drug Development, Biotechnology, Oncology, Clinical Trials, Lifesciences, FDA, Cross-functional Team..., Regulatory Affairs, Drug Discovery, Technology Transfer, R&D, Infectious Diseases, CTMS, Biopharmaceuticals, Clinical Research, Commercialization, Vaccines, Validation, Biochemistry, CRO, Life Sciences, Medical Devices, Molecular Oncology, Pharmacology, Regulatory Submissions, Therapeutic Areas, Transition Planning
Education
University of Pennsylvania 1983 — 1987
Bachelor of Arts (B.A.), Biochemistry
New York University - Leonard N. Stern School of Business
MBA, Finance
Allergan, formerly Actavis plc December 2014 - Present
POTENZA Therapeutics, Inc, May 2014 - November 2014
Wescott BioPharma Services May 2011 - April 2014
Merck November 2009 - May 2011
Schering-Plough Research Institute May 1996 - November 2009
ImClone Systems February 1988 - May 1996
Rockefeller University 1987 - 1988
Skills
Pharmaceutical Industry, Clinical Development, Strategic Planning, Project Portfolio..., Analytics, Drug Development, Biotechnology, Oncology, Clinical Trials, Lifesciences, FDA, Cross-functional Team..., Regulatory Affairs, Drug Discovery, Technology Transfer, R&D, Infectious Diseases, CTMS, Biopharmaceuticals, Clinical Research, Commercialization, Vaccines, Validation, Biochemistry, CRO, Life Sciences, Medical Devices, Molecular Oncology, Pharmacology, Regulatory Submissions, Therapeutic Areas, Transition Planning
Education
University of Pennsylvania 1983 — 1987
Bachelor of Arts (B.A.), Biochemistry
New York University - Leonard N. Stern School of Business
MBA, Finance
John Esposto, Jr's Imclone Systems Experience December 2008 - April 2013
Job Purification Supervisor at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company April 2013 - Present
ImClone Systems December 2008 - April 2013
GlaxoSmithKline August 2006 - December 2008
John-Paul Builders LLC June 1998 - August 2006
Skills
Biopharmaceuticals, Aseptic Processing, GMP, Biotechnology, Sop, Validation, Technology Transfer, Change Control, Cleaning Validation, Chromatography, cGMP manufacturing, FDA, Filtration, LIMS, Pharmaceutical Industry, Purification, Life Sciences, CAPA, 21 CFR Part 11
Education
Rutgers University-New Brunswick 2011 — 2013
Master of Business and Science (MBS), Biotechnology and Genomics
Temple University 2004 — 2006
Bachelor of Science, Biology
Eli Lilly and Company April 2013 - Present
ImClone Systems December 2008 - April 2013
GlaxoSmithKline August 2006 - December 2008
John-Paul Builders LLC June 1998 - August 2006
Skills
Biopharmaceuticals, Aseptic Processing, GMP, Biotechnology, Sop, Validation, Technology Transfer, Change Control, Cleaning Validation, Chromatography, cGMP manufacturing, FDA, Filtration, LIMS, Pharmaceutical Industry, Purification, Life Sciences, CAPA, 21 CFR Part 11
Education
Rutgers University-New Brunswick 2011 — 2013
Master of Business and Science (MBS), Biotechnology and Genomics
Temple University 2004 — 2006
Bachelor of Science, Biology
Peggy Velardo Peggy Velardo's Imclone Systems Experience June 2004 - November 2010
Job QC Manager Stability and Regulatory Specification Management, Eli Lilly and Company New Jersey
Industry Biotechnology
Experience
Eli Lilly and Company November 2013 - Present
Eli Lilly and Company January 2012 - November 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2010 - January 2012
ImClone Systems June 2004 - November 2010
Centocor April 2002 - May 2004
Nextran 1992 - 2002
DNX 1992 - 2002
Skills
Sop, Technology Transfer, Quality Control, GMP, LIMS, Software Documentation, Laboratory, Biochemistry, Biopharmaceuticals, Assay Development, Validation, FDA, Biotechnology, HPLC, Quality System, SOP, 21 CFR Part 11, GLP, Change Control, Pharmaceutical Industry, CAPA, GxP, Life Sciences, Quality Assurance, Computer System...
Education
University of Notre Dame 1985 — 1992
MA, Biochemistry
Seton Hall University 1984 — 1988
BS, Chemistry, Physics, Cum Laude
Eli Lilly and Company November 2013 - Present
Eli Lilly and Company January 2012 - November 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2010 - January 2012
ImClone Systems June 2004 - November 2010
Centocor April 2002 - May 2004
Nextran 1992 - 2002
DNX 1992 - 2002
Skills
Sop, Technology Transfer, Quality Control, GMP, LIMS, Software Documentation, Laboratory, Biochemistry, Biopharmaceuticals, Assay Development, Validation, FDA, Biotechnology, HPLC, Quality System, SOP, 21 CFR Part 11, GLP, Change Control, Pharmaceutical Industry, CAPA, GxP, Life Sciences, Quality Assurance, Computer System...
Education
University of Notre Dame 1985 — 1992
MA, Biochemistry
Seton Hall University 1984 — 1988
BS, Chemistry, Physics, Cum Laude
Wray Myers Wray Myers's Imclone Systems Experience 2006 - 2009
Job Strategic Sourcing Leader | Global Sourcing | Outsourcing | Supplier & ProjectManagement | Organizational Transformation
Industry Pharmaceuticals
Experience
Princeton Plasma Physics Laboratory September 2014 - Present
GLG - Gerson Lehrman Group 2014 - 2014
Otsuka America Pharmaceutical, Inc. October 2010 - 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2009 - October 2010
ImClone Systems 2006 - 2009
Enzon Pharmaceuticals 2002 - 2006
Elan Pharmaceuticals 2000 - 2002
The Liposome Company, Inc. 1987 - 2000
Skills
Strategic Sourcing, Cross-functional Team..., Leadership, Supply Management, GMP, Project Planning, Budgets, Procurement, Vendor Management, Contract Negotiation, Sourcing, Contract Manufacturing, Negotiation, Outsourcing, Cost Reduction/Avoidance, Biotechnology, Supply Chain Management, Supply Chain, FDA, Relationship Management, Strategy, Supplier Negotiation, Spend Management, Spend Analysis, Team Leadership, Global Sourcing, RFP, RFx process, Business Process..., Risk Management, Supplier Risk Management, Change Management, Project Management, Sarbanes-Oxley, Pharmaceutical Industry, Management, Manufacturing, Supplier Evaluation, Supplier Performance, Supplier Quality, Supplier Diversity, Raw Materials, Policy, Sop, Biopharmaceuticals, SOP, Cost Reduction, Contract Management
Education
Rider University
MBA
Rutgers University-New Brunswick
BS - Industrial Engineering, BSIE
Princeton Plasma Physics Laboratory September 2014 - Present
GLG - Gerson Lehrman Group 2014 - 2014
Otsuka America Pharmaceutical, Inc. October 2010 - 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2009 - October 2010
ImClone Systems 2006 - 2009
Enzon Pharmaceuticals 2002 - 2006
Elan Pharmaceuticals 2000 - 2002
The Liposome Company, Inc. 1987 - 2000
Skills
Strategic Sourcing, Cross-functional Team..., Leadership, Supply Management, GMP, Project Planning, Budgets, Procurement, Vendor Management, Contract Negotiation, Sourcing, Contract Manufacturing, Negotiation, Outsourcing, Cost Reduction/Avoidance, Biotechnology, Supply Chain Management, Supply Chain, FDA, Relationship Management, Strategy, Supplier Negotiation, Spend Management, Spend Analysis, Team Leadership, Global Sourcing, RFP, RFx process, Business Process..., Risk Management, Supplier Risk Management, Change Management, Project Management, Sarbanes-Oxley, Pharmaceutical Industry, Management, Manufacturing, Supplier Evaluation, Supplier Performance, Supplier Quality, Supplier Diversity, Raw Materials, Policy, Sop, Biopharmaceuticals, SOP, Cost Reduction, Contract Management
Education
Rider University
MBA
Rutgers University-New Brunswick
BS - Industrial Engineering, BSIE
Ron Kissinger's Imclone Systems Experience August 1987 - May 1998
Job KSI ResearchConsulting
Industry Pharmaceuticals
Experience
KSI Research April 2013 - Present
TDG, Inc. April 1999 - February 2013
ImClone Systems August 1987 - May 1998
Ortho Clinical Diagnostics January 1983 - August 1987
Skills
Oncology, Clinical Development, Infectious Diseases, Biotechnology, Translational Medicine, Clinical Trials, Strategy, Oncology Biomarkers, Vaccines, Competitive Intelligence, Biomarkers, Pharmaceutical Industry, Cancer, Diabetes, Monoclonal Antibodies, Competitive Analysis, Immunology, Immunology and..., ELISA, Drug Discovery, Genomics, Medical Devices, Assay Development, Biologics, Commercialization, Biopharmaceuticals, Clinical Research, Product Development, Endocrinology, Antibodies, Biosimilars, Molecular Biology, Hematology, Translational Research, Life Sciences, Neuroscience, Diagnostics, Drug Delivery, Virology, Cell Biology, Science, Decision Support, Predictive and..., Drug Development
Education
Seton Hall University
M.H.S., Immunology
Pennsylvania State University
B.S., Human Biology
UMDNJ GSBS
PhD level courses, Microbiological Sciences and Immunology
KSI Research April 2013 - Present
TDG, Inc. April 1999 - February 2013
ImClone Systems August 1987 - May 1998
Ortho Clinical Diagnostics January 1983 - August 1987
Skills
Oncology, Clinical Development, Infectious Diseases, Biotechnology, Translational Medicine, Clinical Trials, Strategy, Oncology Biomarkers, Vaccines, Competitive Intelligence, Biomarkers, Pharmaceutical Industry, Cancer, Diabetes, Monoclonal Antibodies, Competitive Analysis, Immunology, Immunology and..., ELISA, Drug Discovery, Genomics, Medical Devices, Assay Development, Biologics, Commercialization, Biopharmaceuticals, Clinical Research, Product Development, Endocrinology, Antibodies, Biosimilars, Molecular Biology, Hematology, Translational Research, Life Sciences, Neuroscience, Diagnostics, Drug Delivery, Virology, Cell Biology, Science, Decision Support, Predictive and..., Drug Development
Education
Seton Hall University
M.H.S., Immunology
Pennsylvania State University
B.S., Human Biology
UMDNJ GSBS
PhD level courses, Microbiological Sciences and Immunology
Sagar Desai Sagar Desai's Imclone Systems Experience November 2007 - Present
Job Operator III at ImClone Systems
Industry Biotechnology
Experience
ImClone Systems November 2007 - Present
GENEWIZ January 2007 - April 2012
Stop & Shop Pharmacy 2004 - 2007
Skills
GLP, GMP, Biotechnology, FDA, Aseptic Processing, Quality Control, Biopharmaceuticals, Sop, LIMS, 21 CFR Part 11, Quality Assurance, CAPA, Validation, Change Control, Aseptic Technique, GxP, Cleaning Validation, Trackwise, Computer System..., Technology Transfer, FDA GMP, Environmental Monitoring, cGMP manufacturing, Laboratory, Clean Rooms, SOP development, Filtration, Cell Culture, Pharmaceutical Industry, Quality System, DNA sequencing, Laboratory Automation, cGMP practices, Oncology
Education
Rutgers University 2010 — 2010
Certificate, Mini-MBA: BioPharma Innovation
Kean University 1999 — 2005
B.S., Science
ImClone Systems November 2007 - Present
GENEWIZ January 2007 - April 2012
Stop & Shop Pharmacy 2004 - 2007
Skills
GLP, GMP, Biotechnology, FDA, Aseptic Processing, Quality Control, Biopharmaceuticals, Sop, LIMS, 21 CFR Part 11, Quality Assurance, CAPA, Validation, Change Control, Aseptic Technique, GxP, Cleaning Validation, Trackwise, Computer System..., Technology Transfer, FDA GMP, Environmental Monitoring, cGMP manufacturing, Laboratory, Clean Rooms, SOP development, Filtration, Cell Culture, Pharmaceutical Industry, Quality System, DNA sequencing, Laboratory Automation, cGMP practices, Oncology
Education
Rutgers University 2010 — 2010
Certificate, Mini-MBA: BioPharma Innovation
Kean University 1999 — 2005
B.S., Science
Liz Yamashita Liz Yamashita's Imclone Systems Experience April 2010 - June 2011
Job Vice President, Regulatory and Clinical Affairs at Oncobiologics Inc.
Industry Biotechnology
Experience
Oncobiologics Inc. April 2014 - Present
Savient Pharmaceuticals, Inc. June 2011 - January 2014
ImClone Systems April 2010 - June 2011
ImClone Systems, a Wholly-Owned Subsidiary of Eli Lilly & Co. May 2006 - June 2011
ImClone Systems May 2006 - April 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2006 - 2010
Bristol-Myers Squibb 2000 - 2006
Skills
Pharmaceutical Industry, Biotechnology, Clinical Development, IND, Regulatory Submissions, Biopharmaceuticals, Regulatory Affairs, Clinical Trials, Drug Development, GMP, FDA, Technology Transfer, Sop, CAPA, Strategy, Oncology, Biochemistry, Drug Discovery, GxP, Pharmaceutics, V&V, GCP, CRO, 21 CFR Part 11, Change Control, Pharmacology, Medical Affairs, Validation, Vaccines, GLP, Infectious Diseases, Therapeutic Areas, CTMS, Lifesciences, Regulatory Requirements, Commercialization, Pharmacovigilance, Medical Devices, Immunology, Formulation, Biologics, Medical Writing, Life Sciences, HPLC, Hematology, Biomarkers
Education
University of Rochester
Chemistry
Oncobiologics Inc. April 2014 - Present
Savient Pharmaceuticals, Inc. June 2011 - January 2014
ImClone Systems April 2010 - June 2011
ImClone Systems, a Wholly-Owned Subsidiary of Eli Lilly & Co. May 2006 - June 2011
ImClone Systems May 2006 - April 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2006 - 2010
Bristol-Myers Squibb 2000 - 2006
Skills
Pharmaceutical Industry, Biotechnology, Clinical Development, IND, Regulatory Submissions, Biopharmaceuticals, Regulatory Affairs, Clinical Trials, Drug Development, GMP, FDA, Technology Transfer, Sop, CAPA, Strategy, Oncology, Biochemistry, Drug Discovery, GxP, Pharmaceutics, V&V, GCP, CRO, 21 CFR Part 11, Change Control, Pharmacology, Medical Affairs, Validation, Vaccines, GLP, Infectious Diseases, Therapeutic Areas, CTMS, Lifesciences, Regulatory Requirements, Commercialization, Pharmacovigilance, Medical Devices, Immunology, Formulation, Biologics, Medical Writing, Life Sciences, HPLC, Hematology, Biomarkers
Education
University of Rochester
Chemistry
Lauren DePalma Lauren DePalma's Imclone Systems Experience July 2005 - September 2006
Job Bioengineer at Celgene
Industry Biotechnology
Experience
Celgene July 2008 - Present
ImClone Systems July 2005 - September 2006
Skills
Stem Cells, Biotechnology, Validation, FDA, Monoclonal Antibodies, Cell Culture, GMP, Lifesciences, Biopharmaceuticals, CAPA, Cell, ELISA, V&V, Sop, Aseptic Technique
Education
Stevens Institute of Technology 2000 — 2008
MS and BE, Biomedical Engineering
Celgene July 2008 - Present
ImClone Systems July 2005 - September 2006
Skills
Stem Cells, Biotechnology, Validation, FDA, Monoclonal Antibodies, Cell Culture, GMP, Lifesciences, Biopharmaceuticals, CAPA, Cell, ELISA, V&V, Sop, Aseptic Technique
Education
Stevens Institute of Technology 2000 — 2008
MS and BE, Biomedical Engineering
shimul shah shimul shah's Imclone Systems Experience May 2006 - October 2007
Job Production Support Engineer at Bloom Energy
Industry Chemicals
Experience
Bloom Energy April 2011 - Present
IBM, Almaden Research Center November 2008 - December 2010
Imclone Systems May 2006 - October 2007
Centocore August 2005 - May 2006
Education
San Jose State University 2008 — 2010
MS, Chemical Engineering
Rutgers, The State University of New Jersey-Newark 2002 — 2005
B.A, Chemistry
Bloom Energy April 2011 - Present
IBM, Almaden Research Center November 2008 - December 2010
Imclone Systems May 2006 - October 2007
Centocore August 2005 - May 2006
Education
San Jose State University 2008 — 2010
MS, Chemical Engineering
Rutgers, The State University of New Jersey-Newark 2002 — 2005
B.A, Chemistry
Danielle (Gimondo) Menniti Danielle (Gimondo) Menniti's Imclone Systems Experience 2005 - 2006
Job Senior Manager Quality Assurance at Celgene
Industry Biotechnology
Experience
Celgene August 2014 - Present
Forest Laboratories October 2010 - July 2014
Pfizer December 2009 - September 2010
Wyeth Pharmaceuticals June 2009 - December 2009
Wyeth Pharmaceuticals December 2006 - June 2009
ImClone Systems 2005 - 2006
Passaic Valley Water Commission 1999 - 2005
Skills
Quality Control, Biotechnology, Microbiology, Laboratory, Sterilization, Pharmaceutics, Continuous Improvement, Lean Manufacturing, Leadership, Management, Sop, GMP, GLP, LIMS, Validation
Education
Seton Hall University 2004 — 2007
MS, Microbiology
Rowan University 1993 — 1998
BS, Biology
Celgene August 2014 - Present
Forest Laboratories October 2010 - July 2014
Pfizer December 2009 - September 2010
Wyeth Pharmaceuticals June 2009 - December 2009
Wyeth Pharmaceuticals December 2006 - June 2009
ImClone Systems 2005 - 2006
Passaic Valley Water Commission 1999 - 2005
Skills
Quality Control, Biotechnology, Microbiology, Laboratory, Sterilization, Pharmaceutics, Continuous Improvement, Lean Manufacturing, Leadership, Management, Sop, GMP, GLP, LIMS, Validation
Education
Seton Hall University 2004 — 2007
MS, Microbiology
Rowan University 1993 — 1998
BS, Biology
John Zawad John Zawad's Imclone Systems Experience November 2007 - January 2009
Job Principal at Zawad Consulting LLC
Industry Biotechnology
Experience
Zawad Consulting LLC February 2013 - Present
Immunomedics, Inc. July 2011 - January 2013
PharmAboardPartners LLC May 2009 - July 2011
ImClone Systems November 2007 - January 2009
University of Pennsylvania 2006 - 2007
Aventis Pharma 2003 - 2005
Sanofi-Aventis 2003 - 2005
aventis 2000 - 2003
Hoechst Marion Roussel 1995 - 1999
Skills
Pharmaceutical Industry, Biotechnology, Drug Discovery, Technology Transfer, Mergers & Acquisitions, Business Development, Corporate Development, Licensing, Intellectual Property, Pharmaceutics, Cancer, Strategy, Management, Drug Development, Commercialization, Regulatory Affairs, Biopharmaceuticals, Clinical Trials, Biochemistry, Oncology, Chemistry, Competitive Intelligence, Strategic Planning, Clinical Research, CRO, Clinical Development, Start-ups, Lifesciences, Mergers, Negotiation, Infectious Diseases
Education
The University of Memphis
B.Sc., Chemistry
University of Tennessee-Health Science Center
Ph.D, Biochemistry
Vanderbilt University School of Medicine
Post Doctoral Fellowship, Pharmacology
Zawad Consulting LLC February 2013 - Present
Immunomedics, Inc. July 2011 - January 2013
PharmAboardPartners LLC May 2009 - July 2011
ImClone Systems November 2007 - January 2009
University of Pennsylvania 2006 - 2007
Aventis Pharma 2003 - 2005
Sanofi-Aventis 2003 - 2005
aventis 2000 - 2003
Hoechst Marion Roussel 1995 - 1999
Skills
Pharmaceutical Industry, Biotechnology, Drug Discovery, Technology Transfer, Mergers & Acquisitions, Business Development, Corporate Development, Licensing, Intellectual Property, Pharmaceutics, Cancer, Strategy, Management, Drug Development, Commercialization, Regulatory Affairs, Biopharmaceuticals, Clinical Trials, Biochemistry, Oncology, Chemistry, Competitive Intelligence, Strategic Planning, Clinical Research, CRO, Clinical Development, Start-ups, Lifesciences, Mergers, Negotiation, Infectious Diseases
Education
The University of Memphis
B.Sc., Chemistry
University of Tennessee-Health Science Center
Ph.D, Biochemistry
Vanderbilt University School of Medicine
Post Doctoral Fellowship, Pharmacology
Michael Bailey's Imclone Systems Experience 1999 - 2008
Job President and Chief Executive Officer at AVEO Oncology
Industry Pharmaceuticals
Experience
AVEO Oncology January 2015 - Present
AVEO Oncology June 2013 - January 2015
AVEO Pharmaceuticals September 2010 - June 2013
Synta Pharmaceuticals Corp. (Boston) August 2008 - September 2010
ImClone Systems 1999 - 2008
Genentech 1997 - 1999
GlaxoSmithKline 1992 - 1997
Skills
Oncology, Pharmaceutical Industry, Biotechnology, Lifesciences, Product Launch, Managed Care, Clinical Development, Biopharmaceuticals, Business Development, Pharmaceutical Sales, Infectious Diseases, Cancer, Clinical Trials, Neurology, Hematology, Marketing, Leadership, Commercialization, Immunology, Regulatory Affairs, Vaccines, Drug Development, Drug Discovery, Market Access, Life Sciences
Education
University of Notre Dame - Mendoza College of Business 1990 — 1992
MBA
St. Lawrence University 1983 — 1987
BS
AVEO Oncology January 2015 - Present
AVEO Oncology June 2013 - January 2015
AVEO Pharmaceuticals September 2010 - June 2013
Synta Pharmaceuticals Corp. (Boston) August 2008 - September 2010
ImClone Systems 1999 - 2008
Genentech 1997 - 1999
GlaxoSmithKline 1992 - 1997
Skills
Oncology, Pharmaceutical Industry, Biotechnology, Lifesciences, Product Launch, Managed Care, Clinical Development, Biopharmaceuticals, Business Development, Pharmaceutical Sales, Infectious Diseases, Cancer, Clinical Trials, Neurology, Hematology, Marketing, Leadership, Commercialization, Immunology, Regulatory Affairs, Vaccines, Drug Development, Drug Discovery, Market Access, Life Sciences
Education
University of Notre Dame - Mendoza College of Business 1990 — 1992
MBA
St. Lawrence University 1983 — 1987
BS
Christopher Plescia Christopher Plescia's Imclone Systems Experience January 2010 - January 2012
Job Molecular & Cellular Biology
Industry Pharmaceuticals
Experience
Epizyme August 2013 - Present
ImClone Systems January 2010 - January 2012
Aaron Diamond AIDS Research Center January 2009 - January 2010
Mount Sinai School of Medicine January 2007 - January 2009
Mount Sinai School of Medicine January 2003 - January 2007
Albert Einstein College of Medicine January 1998 - January 2001
Skills
Microarray, Confocal Microscopy, 3D Cell Culture Models, Immunology, In Vitro, In Vivo, qPCR, Cell Culture, Molecular Biology, Western Blotting, PCR, Flow Cytometry, Tissue Culture, Fluorescence Microscopy, Immunohistochemistry, RT-PCR, Gel Electrophoresis, SDS-PAGE, Molecular Cloning, DNA, Genomics, Transfection, DNA extraction, Stem Cells, Molecular Genetics, Animal Models, RNA isolation, Immunoprecipitation, Cell Biology, Drug Discovery, Life Sciences, Assay Development
Education
Boston College Law School 2012 — 2013
Mount Sinai School of Medicine
Master of Philosophy, Cell and Molecular Biology
University of Delaware 1994 — 1998
Bachelor of Arts, Neuroscience (Interdepartmental Biology and Psychology)
Epizyme August 2013 - Present
ImClone Systems January 2010 - January 2012
Aaron Diamond AIDS Research Center January 2009 - January 2010
Mount Sinai School of Medicine January 2007 - January 2009
Mount Sinai School of Medicine January 2003 - January 2007
Albert Einstein College of Medicine January 1998 - January 2001
Skills
Microarray, Confocal Microscopy, 3D Cell Culture Models, Immunology, In Vitro, In Vivo, qPCR, Cell Culture, Molecular Biology, Western Blotting, PCR, Flow Cytometry, Tissue Culture, Fluorescence Microscopy, Immunohistochemistry, RT-PCR, Gel Electrophoresis, SDS-PAGE, Molecular Cloning, DNA, Genomics, Transfection, DNA extraction, Stem Cells, Molecular Genetics, Animal Models, RNA isolation, Immunoprecipitation, Cell Biology, Drug Discovery, Life Sciences, Assay Development
Education
Boston College Law School 2012 — 2013
Mount Sinai School of Medicine
Master of Philosophy, Cell and Molecular Biology
University of Delaware 1994 — 1998
Bachelor of Arts, Neuroscience (Interdepartmental Biology and Psychology)
Adam Nock Adam Nock's Imclone Systems Experience May 2005 - August 2005
Job PhD Student at UVM
Industry Biotechnology
Experience
University of Vermont August 2011 - Present
Rockefeller University January 2006 - August 2011
ImClone Systems May 2005 - August 2005
Rutgers Food Science Department March 2004 - May 2005
The Great Atlantic & Pacific Tea Company 1999 - 2002
NJ Y Camps June 2000 - August 2000
Skills
Protein Purification, Cell Culture, Molecular Biology, Western Blotting, RT-PCR, PCR, Biochemistry, qPCR, Microbiology, Molecular Genetics, Chromatography, Aseptic Technique, Mammalian Cell Culture, Antibodies, Affinity Chromatography, Primer Design, Cancer, Laboratory, Tissue Culture, SDS-PAGE, ELISA, Molecular Cloning, Science, Lifesciences
Education
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2005
BA, Genetics and Microbiology
University of Vermont August 2011 - Present
Rockefeller University January 2006 - August 2011
ImClone Systems May 2005 - August 2005
Rutgers Food Science Department March 2004 - May 2005
The Great Atlantic & Pacific Tea Company 1999 - 2002
NJ Y Camps June 2000 - August 2000
Skills
Protein Purification, Cell Culture, Molecular Biology, Western Blotting, RT-PCR, PCR, Biochemistry, qPCR, Microbiology, Molecular Genetics, Chromatography, Aseptic Technique, Mammalian Cell Culture, Antibodies, Affinity Chromatography, Primer Design, Cancer, Laboratory, Tissue Culture, SDS-PAGE, ELISA, Molecular Cloning, Science, Lifesciences
Education
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2005
BA, Genetics and Microbiology
Dave Czerwonka Dave Czerwonka's Imclone Systems Experience May 2004 - September 2006
Job Sr. Project Manager at Amgen
Industry Biotechnology
Experience
Amgen September 2006 - Present
ImClone Systems May 2004 - September 2006
BASF October 1991 - December 2003
Skills
GMP, Biotechnology, Process Engineering, Project Engineering, Project Management, International Project..., Engineering, Engineering Management, Process Simulation, Biopharmaceuticals, Cross-functional Team...
Education
Stevens Institute of Technology 1985 — 1987
MS, Chemical Engineering
University of Rochester 1981 — 1985
BS, Chemical Engineering
Amgen September 2006 - Present
ImClone Systems May 2004 - September 2006
BASF October 1991 - December 2003
Skills
GMP, Biotechnology, Process Engineering, Project Engineering, Project Management, International Project..., Engineering, Engineering Management, Process Simulation, Biopharmaceuticals, Cross-functional Team...
Education
Stevens Institute of Technology 1985 — 1987
MS, Chemical Engineering
University of Rochester 1981 — 1985
BS, Chemical Engineering
Donald Evanoff Donald Evanoff's Imclone Systems Experience May 2011 - April 2012
Job
Industry Pharmaceuticals
Experience
Sharp Corporation (dba Sharp Packaging Solutions) June 2013 - Present
Sharp Corporation December 2012 - June 2013
Padtech July 2012 - November 2012
Noramco May 2012 - November 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2011 - April 2012
ImClone Systems May 2011 - April 2012
ValSource, LLC October 2009 - April 2012
Dendreon Corporation July 2010 - April 2011
Joseph L. Rosenberg CPA 2011 - 2011
Dendreon Corporation October 2009 - June 2010
Skills
Validation, cGMP, Facilities, SAP, SOP, Process Validation, CAPA, Change Control, GxP, FDA, Quality Assurance, Quality Systems, Technical Writing, Document Management, Pharmaceuticals, Documentation, Compliance, Problem Solving, Word, Excel, Microsoft Office, QC, GMP, CCT, Sop, Quality System, Pharmaceutical Industry, Biopharmaceuticals, Manufacturing, Computer System..., V&V
Education
Rutgers University 1991 — 1995
Bachelors
Rutgers, The State University of New Jersey-Camden 1991 — 1995
BA
Cherry Hill High School East 1988 — 1991
Diploma
Sharp Corporation (dba Sharp Packaging Solutions) June 2013 - Present
Sharp Corporation December 2012 - June 2013
Padtech July 2012 - November 2012
Noramco May 2012 - November 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2011 - April 2012
ImClone Systems May 2011 - April 2012
ValSource, LLC October 2009 - April 2012
Dendreon Corporation July 2010 - April 2011
Joseph L. Rosenberg CPA 2011 - 2011
Dendreon Corporation October 2009 - June 2010
Skills
Validation, cGMP, Facilities, SAP, SOP, Process Validation, CAPA, Change Control, GxP, FDA, Quality Assurance, Quality Systems, Technical Writing, Document Management, Pharmaceuticals, Documentation, Compliance, Problem Solving, Word, Excel, Microsoft Office, QC, GMP, CCT, Sop, Quality System, Pharmaceutical Industry, Biopharmaceuticals, Manufacturing, Computer System..., V&V
Education
Rutgers University 1991 — 1995
Bachelors
Rutgers, The State University of New Jersey-Camden 1991 — 1995
BA
Cherry Hill High School East 1988 — 1991
Diploma
Matt Toresco's Imclone Systems Experience November 2007 - November 2008
Job Ground breaking genetic testing, revolutionizing medicine
Industry Biotechnology
Experience
Counsyl June 2014 - Present
Counsyl June 2011 - June 2014
Genzyme Genetics January 2010 - July 2011
Eli Lilly and Company November 2008 - February 2010
ImClone Systems November 2007 - November 2008
Skills
Territory Analysis, Business Planning, SWOT analysis, Market Research, Competitive Analysis, Analysis, Biotechnology, Pharmaceutical Industry, Sales Operations, CRM, Genetics, Lifesciences, Competitive Intelligence, Hematology, Sales Presentations, Healthcare, Oncology, Sales Process, Hospitals, OB/GYN, Clinical Research, Sales, Business Development, Account Management, Selling, Strategy, Product Development, Medical Devices, Managed Care, Pharmaceutical Sales, Product Launch, Management, Capital Equipment, Customer Service, Life Sciences
Education
The Ohio State University 2003 — 2007
B.S., Biology
Hunterdon Central High School 1999 — 2003
Diploma
Counsyl June 2014 - Present
Counsyl June 2011 - June 2014
Genzyme Genetics January 2010 - July 2011
Eli Lilly and Company November 2008 - February 2010
ImClone Systems November 2007 - November 2008
Skills
Territory Analysis, Business Planning, SWOT analysis, Market Research, Competitive Analysis, Analysis, Biotechnology, Pharmaceutical Industry, Sales Operations, CRM, Genetics, Lifesciences, Competitive Intelligence, Hematology, Sales Presentations, Healthcare, Oncology, Sales Process, Hospitals, OB/GYN, Clinical Research, Sales, Business Development, Account Management, Selling, Strategy, Product Development, Medical Devices, Managed Care, Pharmaceutical Sales, Product Launch, Management, Capital Equipment, Customer Service, Life Sciences
Education
The Ohio State University 2003 — 2007
B.S., Biology
Hunterdon Central High School 1999 — 2003
Diploma
Kourtne Johnson's Imclone Systems Experience April 2009 - October 2011
Job Quality Assurance Specialist at McNeil Consumer Healthcare
Industry Biotechnology
Experience
McNeil Consumer Healthcare June 2015 - Present
McNeil Consumer Healthcare October 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2009 - October 2011
IMCLONE SYSTEMS April 2009 - October 2011
Tengion May 2008 - February 2009
Amgen April 2006 - April 2008
Amgen April 2006 - April 2008
MEDIMMUNE, INC August 2005 - April 2006
MedImmune March 2003 - April 2006
Neose Technology March 2004 - August 2005
Skills
CAPA, GMP, Sop, Aseptic Processing, Quality Assurance, Quality Control, Microbiology, Vaccines, Manufacturing, Environmental Monitoring, Sterilization, Biotechnology, 21 CFR Part 11, Pharmaceutical Industry, LIMS, Trackwise, SAP, Training, Clean Rooms, Quality System, GLP
Education
University of Maryland Eastern Shore 1998 — 2002
Bachelor of Applied Science (B.A.Sc.), Biology/Biological Sciences, General
University of Maryland Eastern Shore 1998 — 2002
Bachelor of Science, Biology
McNeil Consumer Healthcare June 2015 - Present
McNeil Consumer Healthcare October 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2009 - October 2011
IMCLONE SYSTEMS April 2009 - October 2011
Tengion May 2008 - February 2009
Amgen April 2006 - April 2008
Amgen April 2006 - April 2008
MEDIMMUNE, INC August 2005 - April 2006
MedImmune March 2003 - April 2006
Neose Technology March 2004 - August 2005
Skills
CAPA, GMP, Sop, Aseptic Processing, Quality Assurance, Quality Control, Microbiology, Vaccines, Manufacturing, Environmental Monitoring, Sterilization, Biotechnology, 21 CFR Part 11, Pharmaceutical Industry, LIMS, Trackwise, SAP, Training, Clean Rooms, Quality System, GLP
Education
University of Maryland Eastern Shore 1998 — 2002
Bachelor of Applied Science (B.A.Sc.), Biology/Biological Sciences, General
University of Maryland Eastern Shore 1998 — 2002
Bachelor of Science, Biology
Douglas Brong Douglas Brong's Imclone Systems Experience November 2006 - January 2010
Job Warehouse Supervisor at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
Eli Lilly and Company January 2010 - Present
ImClone Systems November 2006 - January 2010
Elementis Specialties October 2004 - October 2006
L'Oreal April 2003 - October 2004
Arch Chemicals February 2001 - October 2003
Fabricolor, Inc. March 1998 - February 2001
Fabricolor, Inc. October 1994 - March 1998
Skills
GMP, Manufacturing
Education
Rensselaer Polytechnic Institute 1988 — 1992
BS, Chemical Engineering
Eli Lilly and Company January 2010 - Present
ImClone Systems November 2006 - January 2010
Elementis Specialties October 2004 - October 2006
L'Oreal April 2003 - October 2004
Arch Chemicals February 2001 - October 2003
Fabricolor, Inc. March 1998 - February 2001
Fabricolor, Inc. October 1994 - March 1998
Skills
GMP, Manufacturing
Education
Rensselaer Polytechnic Institute 1988 — 1992
BS, Chemical Engineering
Jed Wiltzius Jed Wiltzius's Imclone Systems Experience May 2001 - January 2002
Job Associate Director at Kite Pharma
Industry Biotechnology
Experience
Kite Pharma August 2014 - Present
Amgen June 2010 - July 2014
Amgen December 2008 - June 2010
UCLA August 2008 - December 2008
Memorial Sloan-Kettering Cancer Center May 2002 - August 2004
ImClone Systems May 2001 - January 2002
Skills
Oncology, Protein Engineering, Monoclonal Antibodies, Experimental Design, Proteomics, Managerial Experience, Protein Purification, Protein Characterization, Molecular Biology, X-ray crystallography, Alzheimer's disease, Type 2 Diabetes, NextGen, Target Identification, ADCC, ADC, Melanoma, Antibodies, Biotechnology, Biochemistry, Assay Development, Cancer, Cell Biology, DNA sequencing, Cell, Drug Discovery, Protein Expression, Protein Chemistry
Education
University of California, Los Angeles 2004 — 2008
Ph.D., Biochemistry and Molecular Biology
University of Wisconsin-Madison 1997 — 2002
B.S., Biochemistry
MUHS 1994 — 1997
Kite Pharma August 2014 - Present
Amgen June 2010 - July 2014
Amgen December 2008 - June 2010
UCLA August 2008 - December 2008
Memorial Sloan-Kettering Cancer Center May 2002 - August 2004
ImClone Systems May 2001 - January 2002
Skills
Oncology, Protein Engineering, Monoclonal Antibodies, Experimental Design, Proteomics, Managerial Experience, Protein Purification, Protein Characterization, Molecular Biology, X-ray crystallography, Alzheimer's disease, Type 2 Diabetes, NextGen, Target Identification, ADCC, ADC, Melanoma, Antibodies, Biotechnology, Biochemistry, Assay Development, Cancer, Cell Biology, DNA sequencing, Cell, Drug Discovery, Protein Expression, Protein Chemistry
Education
University of California, Los Angeles 2004 — 2008
Ph.D., Biochemistry and Molecular Biology
University of Wisconsin-Madison 1997 — 2002
B.S., Biochemistry
MUHS 1994 — 1997
Adam Kiernan Adam Kiernan's Imclone Systems Experience January 2008 - July 2009
Job Manager, IT Governance & Risk at J.M. Huber Corporation
Industry Information Technology and Services
Experience
J.M. Huber Corporation June 2015 - Present
J.M. Huber Corporation September 2014 - June 2015
J.M. Huber Corporation September 2010 - September 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2009 - September 2010
ImClone Systems January 2008 - July 2009
ImClone Systems August 2006 - January 2008
ImClone Systems March 2004 - August 2006
Skills
VMware, Active Directory, SharePoint, Windows 7, Disaster Recovery, Windows Server
Education
Rutgers, The State University of New Jersey-New Brunswick 1999 — 2003
BA, Information Technology
J.M. Huber Corporation June 2015 - Present
J.M. Huber Corporation September 2014 - June 2015
J.M. Huber Corporation September 2010 - September 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2009 - September 2010
ImClone Systems January 2008 - July 2009
ImClone Systems August 2006 - January 2008
ImClone Systems March 2004 - August 2006
Skills
VMware, Active Directory, SharePoint, Windows 7, Disaster Recovery, Windows Server
Education
Rutgers, The State University of New Jersey-New Brunswick 1999 — 2003
BA, Information Technology
Sandra Bruening Sandra Bruening's Imclone Systems Experience July 2008 - November 2008
Job Research Scientist
Industry Biotechnology
Experience
The New York Botanical Garden June 2015 - Present
ImClone Systems July 2008 - November 2008
Weill Cornell Graduate School of Medical Sciences August 2003 - January 2008
Rockefeller University June 2002 - August 2003
Antigenics September 2001 - August 2002
Skills
qPCR, Microscopy, Mutagenesis, Genotyping, Microarray Analysis, Tissue Processing, Cell Culture, Molecular Biology, Pharmacology, Immunology, Biochemistry, Western Blotting, Oncology, Lifesciences, Neuroscience, Protein Purification
Education
Weill Cornell Graduate School of Medical Sciences 2003 — 2008
MS, Pharmacology
University of Michigan 1996 — 2002
BS, Biology, Women's Studies
The New York Botanical Garden June 2015 - Present
ImClone Systems July 2008 - November 2008
Weill Cornell Graduate School of Medical Sciences August 2003 - January 2008
Rockefeller University June 2002 - August 2003
Antigenics September 2001 - August 2002
Skills
qPCR, Microscopy, Mutagenesis, Genotyping, Microarray Analysis, Tissue Processing, Cell Culture, Molecular Biology, Pharmacology, Immunology, Biochemistry, Western Blotting, Oncology, Lifesciences, Neuroscience, Protein Purification
Education
Weill Cornell Graduate School of Medical Sciences 2003 — 2008
MS, Pharmacology
University of Michigan 1996 — 2002
BS, Biology, Women's Studies
Denis Scheper Denis Scheper's Imclone Systems Experience May 2005 - January 2007
Job Director, Project Management
Industry Pharmaceuticals
Experience
Aprecia Pharmaceuticals March 2015 - Present
Aprecia Pharmaceuticals March 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2007 - March 2012
ImClone Systems May 2005 - January 2007
ImClone Systems April 2004 - May 2005
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2003 - April 2004
BASF July 2000 - April 2003
Skills
GMP, Validation, HVAC, Process Engineering, cGMP, SOP, Biotechnology, Pharmaceuticals, Process Optimization, Process Validation, Cross-functional Team..., FDA, Change Control, Sop, Regulatory Affairs, Biopharmaceuticals, Engineering, 21 CFR Part 11, Process Simulation, LIMS, GAMP, Technology Transfer, R&D, Pharmaceutical Industry, CAPA, GxP, V&V, Facilities Engineering, Quality System, Computer System..., GLP
Education
Stevens Institute of Technology 1995 — 2000
Aprecia Pharmaceuticals March 2015 - Present
Aprecia Pharmaceuticals March 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2007 - March 2012
ImClone Systems May 2005 - January 2007
ImClone Systems April 2004 - May 2005
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2003 - April 2004
BASF July 2000 - April 2003
Skills
GMP, Validation, HVAC, Process Engineering, cGMP, SOP, Biotechnology, Pharmaceuticals, Process Optimization, Process Validation, Cross-functional Team..., FDA, Change Control, Sop, Regulatory Affairs, Biopharmaceuticals, Engineering, 21 CFR Part 11, Process Simulation, LIMS, GAMP, Technology Transfer, R&D, Pharmaceutical Industry, CAPA, GxP, V&V, Facilities Engineering, Quality System, Computer System..., GLP
Education
Stevens Institute of Technology 1995 — 2000
Samuel Herald Samuel Herald's Imclone Systems Experience October 2007 - January 2012
Job Associate Director CMC Regulatory Affairs at McNeil Consumer Healthcare
Industry Pharmaceuticals
Experience
McNeil Consumer Healthcare January 2012 - Present
Army National Guard September 2011 - Present
ImClone Systems October 2007 - January 2012
Army National Guard January 1995 - September 2011
Bristol-Myers Squibb 2005 - 2007
AstraZeneca Pharmaceuticals 2003 - 2005
Teva Pharmaceuticals 1999 - 2003
Skills
Regulatory Affairs
Education
Temple University 2002 — 2008
MS, Quality Assurance/Regulatory Affairs
Slippery Rock University of Pennsylvania 1994 — 1998
BS, Environmental Science
McNeil Consumer Healthcare January 2012 - Present
Army National Guard September 2011 - Present
ImClone Systems October 2007 - January 2012
Army National Guard January 1995 - September 2011
Bristol-Myers Squibb 2005 - 2007
AstraZeneca Pharmaceuticals 2003 - 2005
Teva Pharmaceuticals 1999 - 2003
Skills
Regulatory Affairs
Education
Temple University 2002 — 2008
MS, Quality Assurance/Regulatory Affairs
Slippery Rock University of Pennsylvania 1994 — 1998
BS, Environmental Science
Debra Henderson Debra Henderson's Imclone Systems Experience April 2007 - January 2009
Job at Senior Medical Center Sales Specialist SanofiAventis, U.S.
Industry Biotechnology
Experience
sanofi-aventis May 2009 - Present
ImClone Systems April 2007 - January 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2007 - 2009
Eli Lilly January 2001 - April 2007
Ortho-McNeil Pharmaceutical March 1995 - January 2001
Mercy Health Partners September 1991 - March 1995
Skills
Sales, Pharmaceutical Industry, Oncology, Pharmaceutical Sales, Sales Operations, Urology, Managed Care, Sales Effectiveness, Hospital Sales, Cardiology, Biotechnology, Cross-functional Team..., Neurology, Competitive Analysis, Medical Devices, Market Access, Diabetes, Product Launch, Commercialization, Rheumatology, Clinical Trials, Pulmonology, Lifesciences, Dermatology, Gastroenterology, Hematology, Endocrinology, Allergy
Education
Wright State University 1991 — 1996
MBA, Management
The Ohio State University 1985 — 1989
BS, Medical Dietetics
sanofi-aventis May 2009 - Present
ImClone Systems April 2007 - January 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2007 - 2009
Eli Lilly January 2001 - April 2007
Ortho-McNeil Pharmaceutical March 1995 - January 2001
Mercy Health Partners September 1991 - March 1995
Skills
Sales, Pharmaceutical Industry, Oncology, Pharmaceutical Sales, Sales Operations, Urology, Managed Care, Sales Effectiveness, Hospital Sales, Cardiology, Biotechnology, Cross-functional Team..., Neurology, Competitive Analysis, Medical Devices, Market Access, Diabetes, Product Launch, Commercialization, Rheumatology, Clinical Trials, Pulmonology, Lifesciences, Dermatology, Gastroenterology, Hematology, Endocrinology, Allergy
Education
Wright State University 1991 — 1996
MBA, Management
The Ohio State University 1985 — 1989
BS, Medical Dietetics
Dvorit Samid Dvorit Samid's Imclone Systems Experience 2005 - 2009
Job SVP, Medical Affairs at NantKwest
Industry Pharmaceuticals
Experience
NantKwest September 2015 - Present
Synta Pharmaceuticals February 2012 - August 2015
Allos Therapeutics 2009 - 2011
ImClone Systems 2005 - 2009
Abraxis BioScience 2003 - 2005
Hoffmann-La Roche 1998 - 2003
University of Virginia 1995 - 1998
National Cancer Institute 1990 - 1995
Uniformed Services University of the Health Sciences 1982 - 1990
Skills
Oncology, Medical Affairs, Clinical Development, Hematology, Medical Education, Clinical Trials, Informatics, Medicine, Cancer, Immunology, Life Sciences, Pharmaceutical Industry, Biotechnology, Drug Development, Lifesciences
Education
The Catholic University of America 1980 — 1985
PhD
Technion - Israel Institute of Technology
Graduate studies
The Hebrew University
BSc
NantKwest September 2015 - Present
Synta Pharmaceuticals February 2012 - August 2015
Allos Therapeutics 2009 - 2011
ImClone Systems 2005 - 2009
Abraxis BioScience 2003 - 2005
Hoffmann-La Roche 1998 - 2003
University of Virginia 1995 - 1998
National Cancer Institute 1990 - 1995
Uniformed Services University of the Health Sciences 1982 - 1990
Skills
Oncology, Medical Affairs, Clinical Development, Hematology, Medical Education, Clinical Trials, Informatics, Medicine, Cancer, Immunology, Life Sciences, Pharmaceutical Industry, Biotechnology, Drug Development, Lifesciences
Education
The Catholic University of America 1980 — 1985
PhD
Technion - Israel Institute of Technology
Graduate studies
The Hebrew University
BSc
Imara Charles's Imclone Systems Experience July 2002 - May 2004
Job Director, Integrated Development Team Leaders and Program Management Office at BristolMyers Squibb
Industry Biotechnology
Experience
Bristol-Myers Squibb August 2014 - Present
Bristol-Myers Squibb July 2012 - August 2014
Laureate Biopharmaceutical Services April 2010 - July 2012
Laureate Pharma January 2005 - February 2011
Barr Laboratories May 2004 - January 2005
ImClone Systems July 2002 - May 2004
Skills
Process Simulation, Project Management, Biopharmaceuticals, Biotechnology, GMP, Technology Transfer, Validation, Sop, FDA, Pharmaceutical Industry, Chromatography, GLP, HPLC, Lifesciences, Purification, Protein Chemistry, LIMS, Quality Assurance, Antibodies, Assay Development, 21 CFR Part 11, CAPA, Cell Culture, Public Speaking
Education
Seton Hall University 1999 — 2003
Ph.D., Analytical Chemistry
Seton Hall University 1999 — 2001
M.S, Biochemistry
University of Scranton 1994 — 1998
B.S., Biophysics
Bristol-Myers Squibb August 2014 - Present
Bristol-Myers Squibb July 2012 - August 2014
Laureate Biopharmaceutical Services April 2010 - July 2012
Laureate Pharma January 2005 - February 2011
Barr Laboratories May 2004 - January 2005
ImClone Systems July 2002 - May 2004
Skills
Process Simulation, Project Management, Biopharmaceuticals, Biotechnology, GMP, Technology Transfer, Validation, Sop, FDA, Pharmaceutical Industry, Chromatography, GLP, HPLC, Lifesciences, Purification, Protein Chemistry, LIMS, Quality Assurance, Antibodies, Assay Development, 21 CFR Part 11, CAPA, Cell Culture, Public Speaking
Education
Seton Hall University 1999 — 2003
Ph.D., Analytical Chemistry
Seton Hall University 1999 — 2001
M.S, Biochemistry
University of Scranton 1994 — 1998
B.S., Biophysics
K. Michael Pelitere's Imclone Systems Experience July 2007 - March 2010
Job Associate Director, Payer and Market Access at Seattle Genetics, Inc.
Industry Pharmaceuticals
Experience
Seattle Genetics March 2011 - Present
Lilly USA, LLC March 2010 - March 2011
ImClone Systems July 2007 - March 2010
Skills
Oncology, Biotechnology, Commercialization, Pharmaceutical Industry, Managed Care, Cardiology, Key Account Management, Market Access, Pharmaceutical Sales, Hematology, Biopharmaceuticals, Neurology, Hospital Sales, Healthcare, Product Launch
Education
St. Edward's University 1975 — 1979
Bachelor of Business Administration, Marketing Major
Holy Cross High School
Holy Cross High School
Seattle Genetics March 2011 - Present
Lilly USA, LLC March 2010 - March 2011
ImClone Systems July 2007 - March 2010
Skills
Oncology, Biotechnology, Commercialization, Pharmaceutical Industry, Managed Care, Cardiology, Key Account Management, Market Access, Pharmaceutical Sales, Hematology, Biopharmaceuticals, Neurology, Hospital Sales, Healthcare, Product Launch
Education
St. Edward's University 1975 — 1979
Bachelor of Business Administration, Marketing Major
Holy Cross High School
Holy Cross High School
Asra Malikzay's Imclone Systems Experience 2003 - 2005
Job Scientist at Merck
Industry Pharmaceuticals
Experience
Merck November 2010 - Present
Schering Plough Research 2005 - November 2010
ImClone Systems 2003 - 2005
Skills
Assay Development, In Vitro, RT-PCR, Protein Chemistry, Drug Discovery, Laboratory Automation, Cell, High Throughput..., ELISA, Antibodies, Immunology, Monoclonal Antibodies, Biochemistry, Cell Culture, In Vivo
Education
State University of New York at Stony Brook 2000 — 2003
MS, Cell/Cellular and Molecular Biology, at Cold Spring Harbor Labs
Rutgers, The State University of New Jersey-New Brunswick 1993 — 1998
Biochemistry and French
Merck November 2010 - Present
Schering Plough Research 2005 - November 2010
ImClone Systems 2003 - 2005
Skills
Assay Development, In Vitro, RT-PCR, Protein Chemistry, Drug Discovery, Laboratory Automation, Cell, High Throughput..., ELISA, Antibodies, Immunology, Monoclonal Antibodies, Biochemistry, Cell Culture, In Vivo
Education
State University of New York at Stony Brook 2000 — 2003
MS, Cell/Cellular and Molecular Biology, at Cold Spring Harbor Labs
Rutgers, The State University of New Jersey-New Brunswick 1993 — 1998
Biochemistry and French
Jim Huber's Imclone Systems Experience February 1996 - May 2007
Job Director, Project and Alliance Management at Advaxis, Inc.
Industry Biotechnology
Experience
Advaxis, Inc. June 2015 - Present
Drais Pharmaceuticals August 2013 - June 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2007 - August 2013
ImClone Systems February 1996 - May 2007
Medarex 1994 - 1996
Regeneron Pharmaceuticals 1993 - 1994
Skills
GLP, Sop, Drug Development, Biopharmaceuticals, Biotechnology, Project Management, Monoclonal Antibodies, Project Portfolio..., Process Improvement, Immunology, Clinical Data Management, CTMS, Clinical Trials, Lifesciences, Clinical Development, Assay Development, Change Control, Cell, ICH-GCP, Cell Biology, GxP, Oncology, Drug Discovery, Pharmaceutical Industry, FDA, 21 CFR Part 11, R&D, CRO, Genomics, Regulatory Submissions, Clinical Monitoring, Validation, Biochemistry, Cell Culture, Technology Transfer, ELISA, Quality System, Clinical Research, GMP, Regulatory Affairs, EDC, Regulatory Requirements, Commercialization, Data Management, Cross-functional Team..., GCP, Molecular Biology, IND, Therapeutic Areas
Education
Rutgers University-New Brunswick 1990 — 1993
bs, biochemistry
Advaxis, Inc. June 2015 - Present
Drais Pharmaceuticals August 2013 - June 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2007 - August 2013
ImClone Systems February 1996 - May 2007
Medarex 1994 - 1996
Regeneron Pharmaceuticals 1993 - 1994
Skills
GLP, Sop, Drug Development, Biopharmaceuticals, Biotechnology, Project Management, Monoclonal Antibodies, Project Portfolio..., Process Improvement, Immunology, Clinical Data Management, CTMS, Clinical Trials, Lifesciences, Clinical Development, Assay Development, Change Control, Cell, ICH-GCP, Cell Biology, GxP, Oncology, Drug Discovery, Pharmaceutical Industry, FDA, 21 CFR Part 11, R&D, CRO, Genomics, Regulatory Submissions, Clinical Monitoring, Validation, Biochemistry, Cell Culture, Technology Transfer, ELISA, Quality System, Clinical Research, GMP, Regulatory Affairs, EDC, Regulatory Requirements, Commercialization, Data Management, Cross-functional Team..., GCP, Molecular Biology, IND, Therapeutic Areas
Education
Rutgers University-New Brunswick 1990 — 1993
bs, biochemistry
Patrick Rojas, PhD's Imclone Systems Experience 2007 - 2010
Job PT Lecturer in Statistics, Rutgers University, NJ
Industry Research
Experience
Rutgers, The State University of New Jersey January 1994 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2007 - 2014
ImClone Systems 2007 - 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2007 - 2010
Skills
Clinical Trials, Biotechnology, Clinical Development, Pharmaceutical Industry, Biostatistics, CRO, Program Management, Clinical Data Management, Data Management, FDA, GCP, Oncology, SAS, EDC, CTMS, 21 CFR Part 11, Regulatory Submissions
Education
University of Iowa 1982 — 1987
PhD, Biostatistics, Epidemiology
Rutgers, The State University of New Jersey January 1994 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2007 - 2014
ImClone Systems 2007 - 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2007 - 2010
Skills
Clinical Trials, Biotechnology, Clinical Development, Pharmaceutical Industry, Biostatistics, CRO, Program Management, Clinical Data Management, Data Management, FDA, GCP, Oncology, SAS, EDC, CTMS, 21 CFR Part 11, Regulatory Submissions
Education
University of Iowa 1982 — 1987
PhD, Biostatistics, Epidemiology
Jamie Devoogd Saeed's Imclone Systems Experience January 2009 - January 2011
Job ImClone Systems, Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company April 2015 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - Present
ImClone Systems January 2009 - January 2011
eli lilly January 2001 - January 2009
eli lilly 2001 - 2008
Skills
Computer System..., GCP, Technical Writing, SDLC, Validation, Drug Development, 21 CFR Part 11, Change Control, FDA, Process Automation, Clinical Trials, ITIL, Documentum, Process Control, CAPA, Regulatory Submissions, Quality Assurance, Oncology, Biopharmaceuticals, Regulatory Affairs, GAMP, Sop, GxP, GMP, Pharmacovigilance, V&V, Informatics, Lifesciences, LIMS, Regulatory Requirements, Analytical Chemistry, Chromatography, Requirements Analysis, Technology Transfer, Automation, CRO, Pharmaceutical Industry, Quality Management, Process Engineering, Data Management, Software Documentation, Software Quality..., GLP, Cross-functional Team..., CTMS, Aseptic Processing, Document Management, R&D, Root Cause Analysis, HPLC
Education
University of Pittsburgh
Eli Lilly and Company April 2015 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - Present
ImClone Systems January 2009 - January 2011
eli lilly January 2001 - January 2009
eli lilly 2001 - 2008
Skills
Computer System..., GCP, Technical Writing, SDLC, Validation, Drug Development, 21 CFR Part 11, Change Control, FDA, Process Automation, Clinical Trials, ITIL, Documentum, Process Control, CAPA, Regulatory Submissions, Quality Assurance, Oncology, Biopharmaceuticals, Regulatory Affairs, GAMP, Sop, GxP, GMP, Pharmacovigilance, V&V, Informatics, Lifesciences, LIMS, Regulatory Requirements, Analytical Chemistry, Chromatography, Requirements Analysis, Technology Transfer, Automation, CRO, Pharmaceutical Industry, Quality Management, Process Engineering, Data Management, Software Documentation, Software Quality..., GLP, Cross-functional Team..., CTMS, Aseptic Processing, Document Management, R&D, Root Cause Analysis, HPLC
Education
University of Pittsburgh
Joseph Sulovski's Imclone Systems Experience October 2008 - March 2011
Job Clinical Trial Head at Novartis
Industry Pharmaceuticals
Experience
Novartis March 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - March 2013
ImClone Systems October 2008 - March 2011
Abbott January 2008 - October 2008
Medarex, Inc. August 2005 - December 2007
Medarex 2004 - 2005
Skills
Clinical Trials, Clinical Monitoring, Clinical Development, Oncology, Biotechnology, CTMS, EDC, CRO, GCP, Pharmaceutical Industry, Therapeutic Areas, Drug Discovery, GLP, Sop, Oracle Clinical, Regulatory Affairs, Medical Affairs, Clinical Study Design, Clinical Data Management, Medical Writing, Pharmacovigilance, FDA, ICH-GCP, GMP, Protocol, IND, GxP, Lifesciences, Clinical Research, Cancer, Drug Development, Biopharmaceuticals, 21 CFR Part 11, Regulatory Submissions, Hematology, Clinical Operations
Education
University of Maryland College Park 2000 — 2003
Bachelor of Science (B.S.), Biology
Novartis March 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - March 2013
ImClone Systems October 2008 - March 2011
Abbott January 2008 - October 2008
Medarex, Inc. August 2005 - December 2007
Medarex 2004 - 2005
Skills
Clinical Trials, Clinical Monitoring, Clinical Development, Oncology, Biotechnology, CTMS, EDC, CRO, GCP, Pharmaceutical Industry, Therapeutic Areas, Drug Discovery, GLP, Sop, Oracle Clinical, Regulatory Affairs, Medical Affairs, Clinical Study Design, Clinical Data Management, Medical Writing, Pharmacovigilance, FDA, ICH-GCP, GMP, Protocol, IND, GxP, Lifesciences, Clinical Research, Cancer, Drug Development, Biopharmaceuticals, 21 CFR Part 11, Regulatory Submissions, Hematology, Clinical Operations
Education
University of Maryland College Park 2000 — 2003
Bachelor of Science (B.S.), Biology
Naseem Zojwalla's Imclone Systems Experience August 2008 - May 2011
Job Vice President of Clinical Development at Peloton Therapeutics
Industry Pharmaceuticals
Experience
Peloton Therapeutics March 2015 - Present
Onyx Pharmaceuticals June 2011 - Present
ImClone Systems August 2008 - May 2011
Eisai Medical Research June 2005 - June 2008
Education
Stanford University 1990 — 1994
Peloton Therapeutics March 2015 - Present
Onyx Pharmaceuticals June 2011 - Present
ImClone Systems August 2008 - May 2011
Eisai Medical Research June 2005 - June 2008
Education
Stanford University 1990 — 1994
Peter Bohlen's Imclone Systems Experience 1996 - 2005
Job Biotechnology Consultant and Contractor
Industry Biotechnology
Experience
ImClone Systems 1996 - 2005
Skills
Biotechnology
Education
1963 — 1971
ImClone Systems 1996 - 2005
Skills
Biotechnology
Education
1963 — 1971
Imroz Ghangas's Imclone Systems Experience 1999 - 2006
Job OneGE Account Manager at GE Healthcare
Industry Biotechnology
Experience
GE Healthcare July 2015 - Present
GE Healthcare October 2010 - June 2015
Amgen 2006 - 2010
ImClone Systems 1999 - 2006
Skills
Purification, Biopharmaceuticals, GMP, Lifesciences, Biotechnology, Chromatography, Protein Purification, Technology Transfer, Protein Chemistry, Monoclonal Antibodies, Cell Culture, GLP, ELISA, Antibodies, Assay Development, Life Sciences
Education
Penn State University 1993 — 1997
GE Healthcare July 2015 - Present
GE Healthcare October 2010 - June 2015
Amgen 2006 - 2010
ImClone Systems 1999 - 2006
Skills
Purification, Biopharmaceuticals, GMP, Lifesciences, Biotechnology, Chromatography, Protein Purification, Technology Transfer, Protein Chemistry, Monoclonal Antibodies, Cell Culture, GLP, ELISA, Antibodies, Assay Development, Life Sciences
Education
Penn State University 1993 — 1997
Timothy Daly's Imclone Systems Experience December 2004 - December 2006
Job VP, Finance & Corporate Controller at Ovid Therapeutics
Industry Accounting
Experience
Ovid Therapeutics September 2015 - Present
Advanced Health Media (AHM) August 2013 - September 2015
Enzon Pharmaceuticals December 2011 - August 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2006 - December 2011
ImClone Systems December 2004 - December 2006
ImClone Systems December 2003 - December 2004
ImClone Systems December 2002 - December 2003
ImClone Systems August 1999 - December 2002
Pathmark Stores, Inc. 1997 - 1999
Skills
Accounting, Finance, Sarbanes-Oxley Act, Financial Reporting, Financial Analysis, Internal Controls, Process Improvement, Pharmaceutical Industry, SEC filings, Auditing, Sarbanes-Oxley, US GAAP, Revenue Recognition, Financial Accounting, Mergers & Acquisitions, Forecasting, Internal Audit, Budgets, Biotechnology, Cash Management, Project Management, General Ledger, Cross-functional Team..., Financial Modeling, SAP, Payroll, GAAP, Due Diligence, Variance Analysis, Managerial Finance, Corporate Finance, Consolidation, Account Reconciliation, Strategic Financial..., Financial Planning
Education
Rider University
Bachelor of Science, Accounting
Ovid Therapeutics September 2015 - Present
Advanced Health Media (AHM) August 2013 - September 2015
Enzon Pharmaceuticals December 2011 - August 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2006 - December 2011
ImClone Systems December 2004 - December 2006
ImClone Systems December 2003 - December 2004
ImClone Systems December 2002 - December 2003
ImClone Systems August 1999 - December 2002
Pathmark Stores, Inc. 1997 - 1999
Skills
Accounting, Finance, Sarbanes-Oxley Act, Financial Reporting, Financial Analysis, Internal Controls, Process Improvement, Pharmaceutical Industry, SEC filings, Auditing, Sarbanes-Oxley, US GAAP, Revenue Recognition, Financial Accounting, Mergers & Acquisitions, Forecasting, Internal Audit, Budgets, Biotechnology, Cash Management, Project Management, General Ledger, Cross-functional Team..., Financial Modeling, SAP, Payroll, GAAP, Due Diligence, Variance Analysis, Managerial Finance, Corporate Finance, Consolidation, Account Reconciliation, Strategic Financial..., Financial Planning
Education
Rider University
Bachelor of Science, Accounting
Christine Triolo's Imclone Systems Experience May 2004 - July 2006
Job Sr. Manager, Stock Plan Administration at NPS Pharmaceuticals
Industry Pharmaceuticals
Experience
PSEG January 2010 - Present
NPS Pharmaceuticals May 2014 - January 2015
Alpharma May 2008 - April 2009
Alpharma/King Pharmaceuticals May 2008 - April 2009
Computershare September 2006 - May 2008
ImClone Systems May 2004 - July 2006
DAVP - Plans Team Leader March 2001 - May 2004
UBS 2001 - 2004
UBS Financial Services 2001 - 2004
Dun & Bradstreet 1996 - 2001
Skills
HRIS, Performance Management
Education
Governor Livingston High School
Seton Hall University
PSEG January 2010 - Present
NPS Pharmaceuticals May 2014 - January 2015
Alpharma May 2008 - April 2009
Alpharma/King Pharmaceuticals May 2008 - April 2009
Computershare September 2006 - May 2008
ImClone Systems May 2004 - July 2006
DAVP - Plans Team Leader March 2001 - May 2004
UBS 2001 - 2004
UBS Financial Services 2001 - 2004
Dun & Bradstreet 1996 - 2001
Skills
HRIS, Performance Management
Education
Governor Livingston High School
Seton Hall University
David Pitts's Imclone Systems Experience 2004 - 2007
Job Partner at Argot Partners, President at Little Emperor
Industry Public Relations and Communications
Experience
Argot Partners LLC March 2007 - Present
Little Emperor March 2007 - March 2014
ImClone Systems 2004 - 2007
The Abernathy MacGregor Group 2000 - 2004
Sard Verbinnen & Co 1999 - 2000
Skills
Investor Relations, Crisis Communications, Media Relations, Corporate Communications, Public Relations, Strategic Communications, Social Media, Internal Communications, Event Planning, Research, Financial Analysis, Strategic Planning, Mergers, Venture Capital, Executive Management, Strategic Partnerships, Strategy, Awesomeness, Mergers & Acquisitions, Entrepreneurship, Start-ups, Lifesciences
Education
Trinity College-Hartford 1995 — 1999
BA, Asian Studies
Argot Partners LLC March 2007 - Present
Little Emperor March 2007 - March 2014
ImClone Systems 2004 - 2007
The Abernathy MacGregor Group 2000 - 2004
Sard Verbinnen & Co 1999 - 2000
Skills
Investor Relations, Crisis Communications, Media Relations, Corporate Communications, Public Relations, Strategic Communications, Social Media, Internal Communications, Event Planning, Research, Financial Analysis, Strategic Planning, Mergers, Venture Capital, Executive Management, Strategic Partnerships, Strategy, Awesomeness, Mergers & Acquisitions, Entrepreneurship, Start-ups, Lifesciences
Education
Trinity College-Hartford 1995 — 1999
BA, Asian Studies
Joseph Rogalewicz's Imclone Systems Experience 1993 - 1995
Job Director, Biologics Compliance at Bristol Meyers Squibb
Industry Pharmaceuticals
Experience
Bristol Myers Squibb 2014 - Present
GlaxoSmithKline Biopharmaceuticals 2002 - Present
GlaxoSmithKline 2002 - Present
Aventis Pasteur 1990 - 1999
ImClone Systems 1993 - 1995
Education
Temple University 1998 — 2000
Master of Science (MS), Quality Assurance and Regulatory Affairs
Temple University
Masters, Quality Assuarnce and Regulatory Affairs
Bristol Myers Squibb 2014 - Present
GlaxoSmithKline Biopharmaceuticals 2002 - Present
GlaxoSmithKline 2002 - Present
Aventis Pasteur 1990 - 1999
ImClone Systems 1993 - 1995
Education
Temple University 1998 — 2000
Master of Science (MS), Quality Assurance and Regulatory Affairs
Temple University
Masters, Quality Assuarnce and Regulatory Affairs
Kim McFarland's Imclone Systems Experience 2001 - 2007
Job Director of Quality Control Microbiology at Alexion Pharmaceuticals, Inc.
Industry Biotechnology
Experience
Alexion Pharmaceuticals, Inc. November 2014 - Present
Shire HGT October 2011 - November 2014
Bristol-Myers Squibb/Biotechnology 2007 - October 2011
ImClone Systems 2001 - 2007
Skills
Microbiology, CAPA, Quality Control, Biotechnology, Validation, GMP, FDA, Sop, Change Control, Biopharmaceuticals, 21 CFR Part 11, GLP, LIMS, SOP, Technology Transfer, Pharmaceutical Industry
Education
Seton Hall University
Master in Science, Microbiology
University of Denver
B.A.
Alexion Pharmaceuticals, Inc. November 2014 - Present
Shire HGT October 2011 - November 2014
Bristol-Myers Squibb/Biotechnology 2007 - October 2011
ImClone Systems 2001 - 2007
Skills
Microbiology, CAPA, Quality Control, Biotechnology, Validation, GMP, FDA, Sop, Change Control, Biopharmaceuticals, 21 CFR Part 11, GLP, LIMS, SOP, Technology Transfer, Pharmaceutical Industry
Education
Seton Hall University
Master in Science, Microbiology
University of Denver
B.A.
Roger Perkowski's Imclone Systems Experience November 2004 - July 2007
Job Solution Preperation Technician at Medarex
Industry Biotechnology
Experience
Medarex August 2007 - Present
ImClone Systems November 2004 - July 2007
Lohmann Therapy Systems June 2000 - November 2004
Education
Pennsylvania State University-Great Valley Graduate Center 2000 — 2002
Medarex August 2007 - Present
ImClone Systems November 2004 - July 2007
Lohmann Therapy Systems June 2000 - November 2004
Education
Pennsylvania State University-Great Valley Graduate Center 2000 — 2002
Felice Ginsburg's Imclone Systems Experience January 2008 - December 2008
Job Director, Oncology Sales Learning & Development at Janssen Biotech, Inc.
Industry Pharmaceuticals
Experience
Janssen Biotech, Inc. July 2013 - Present
Aveo Pharmaceuticals March 2012 - June 2013
Allos Therapeutics January 2009 - March 2012
ImClone Systems January 2008 - December 2008
GPC Biotech October 2006 - January 2008
MMT Solutions 2003 - 2006
Pharmacia October 2001 - May 2003
Pharmacia 1999 - September 2001
Ortho Biotech 1992 - 1999
Education
The College of New Jersey 1985 — 1989
BA, Communications
Janssen Biotech, Inc. July 2013 - Present
Aveo Pharmaceuticals March 2012 - June 2013
Allos Therapeutics January 2009 - March 2012
ImClone Systems January 2008 - December 2008
GPC Biotech October 2006 - January 2008
MMT Solutions 2003 - 2006
Pharmacia October 2001 - May 2003
Pharmacia 1999 - September 2001
Ortho Biotech 1992 - 1999
Education
The College of New Jersey 1985 — 1989
BA, Communications
Ryan Dolbec's Imclone Systems Experience March 2009 - May 2011
Job CSR at Fastenal
Industry Renewables & Environment
Experience
Fastenal March 2014 - Present
Forest Research October 2012 - January 2014
YBM Education May 2011 - May 2012
ImClone Systems March 2009 - May 2011
ImClone November 2008 - March 2009
Cc Peppers August 2005 - August 2008
Banana Republic December 2002 - December 2004
Skills
Outlook, Word, Excel, Microsoft Office, PowerPoint, Teaching English, Lesson Planning, Microsoft Excel, Microsoft Word, Team Leadership, Teaching English as a..., Public Speaking, Software Documentation, Clinical Trials, Data Analysis, Human Resources, Leadership, Process Improvement
Education
Penn State University 2003 — 2008
BS, Environmental and Renewable Resource Economics
Fastenal March 2014 - Present
Forest Research October 2012 - January 2014
YBM Education May 2011 - May 2012
ImClone Systems March 2009 - May 2011
ImClone November 2008 - March 2009
Cc Peppers August 2005 - August 2008
Banana Republic December 2002 - December 2004
Skills
Outlook, Word, Excel, Microsoft Office, PowerPoint, Teaching English, Lesson Planning, Microsoft Excel, Microsoft Word, Team Leadership, Teaching English as a..., Public Speaking, Software Documentation, Clinical Trials, Data Analysis, Human Resources, Leadership, Process Improvement
Education
Penn State University 2003 — 2008
BS, Environmental and Renewable Resource Economics
Allyson Knox's Imclone Systems Experience May 2008 - August 2010
Job QA Specialist at TrisPharma
Industry Biotechnology
Norm Moffett's Imclone Systems Experience January 2006 - January 2011
Job Supervisor, Facilities Resource Controls and Services at Eli Lilly and Company
Industry Biotechnology
Experience
Eli Lilly and Company April 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - April 2014
ImClone Systems January 2006 - January 2011
ImClone Systems March 2004 - January 2006
Baxter 2001 - 2003
Skills
Validation, GMP, Auditing, Quality Assurance, Software Documentation, GLP, Technology Transfer, Change Control, Sop, CAPA, Quality Control, Biopharmaceuticals, Aseptic Technique, FDA, Purification, 21 CFR Part 11, Pharmaceutical Industry, Cross-functional Team..., Manufacturing, Biotechnology, Inspection, Formulation, cGMP manufacturing, Process Simulation, SOP
Education
Mary Washington College 1994 — 1998
Bachelor of Science, Molecular Biology
Eli Lilly and Company April 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - April 2014
ImClone Systems January 2006 - January 2011
ImClone Systems March 2004 - January 2006
Baxter 2001 - 2003
Skills
Validation, GMP, Auditing, Quality Assurance, Software Documentation, GLP, Technology Transfer, Change Control, Sop, CAPA, Quality Control, Biopharmaceuticals, Aseptic Technique, FDA, Purification, 21 CFR Part 11, Pharmaceutical Industry, Cross-functional Team..., Manufacturing, Biotechnology, Inspection, Formulation, cGMP manufacturing, Process Simulation, SOP
Education
Mary Washington College 1994 — 1998
Bachelor of Science, Molecular Biology
Danielle Dennis's Imclone Systems Experience April 2005 - October 2006
Job EHS Professional Product Regulatory at Ashland Inc
Industry Chemicals
Experience
Ashland Inc September 2014 - Present
Ashland, Inc. December 2010 - Present
Johnson & Johnson September 2010 - December 2010
Merck Research Laboratories, Rahway, New Jersey October 2006 - August 2010
ImClone Systems April 2005 - October 2006
International Specialty Products July 2001 - April 2005
Marypaul Laboratories September 1999 - July 2001
Skills
GMP, Validation, Microbiology, LIMS, Sop, GLP, Pharmaceutical Industry, FDA, R&D, Laboratory, Quality Control, Technology Transfer, Quality Assurance, CAPA, Raw Materials, Lifesciences, Environmental Monitoring, Quality System, USP, Regulatory Affairs, Marketing Strategy, Cross-functional..., Cross-platform..., Personal Care, Technical Writing, eCTD, Product Launch, Project Management, ISO, Technical Documentation, Preservatives, Mycology, Cosmetics, Life Sciences, SAP, Excipients, Food Additives, Adhesives, SOP
Education
Regulatory Affairs Professionals Society 2015 — 2016
Regulatory Affairs Certificate, Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
Seton Hall University 2002 — 2005
MS, Microbiology
Virginia Polytechnic Institute and State University 1996 — 1999
Bachelor of Science (BSc), Biology, General
Jefferson Township High School 1991 — 1995
High school diploma
Ashland Inc September 2014 - Present
Ashland, Inc. December 2010 - Present
Johnson & Johnson September 2010 - December 2010
Merck Research Laboratories, Rahway, New Jersey October 2006 - August 2010
ImClone Systems April 2005 - October 2006
International Specialty Products July 2001 - April 2005
Marypaul Laboratories September 1999 - July 2001
Skills
GMP, Validation, Microbiology, LIMS, Sop, GLP, Pharmaceutical Industry, FDA, R&D, Laboratory, Quality Control, Technology Transfer, Quality Assurance, CAPA, Raw Materials, Lifesciences, Environmental Monitoring, Quality System, USP, Regulatory Affairs, Marketing Strategy, Cross-functional..., Cross-platform..., Personal Care, Technical Writing, eCTD, Product Launch, Project Management, ISO, Technical Documentation, Preservatives, Mycology, Cosmetics, Life Sciences, SAP, Excipients, Food Additives, Adhesives, SOP
Education
Regulatory Affairs Professionals Society 2015 — 2016
Regulatory Affairs Certificate, Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
Seton Hall University 2002 — 2005
MS, Microbiology
Virginia Polytechnic Institute and State University 1996 — 1999
Bachelor of Science (BSc), Biology, General
Jefferson Township High School 1991 — 1995
High school diploma
Elizabeth Wescott's Imclone Systems Experience September 2007 - Present
Job QA Compliance Senior Specialist at ImClone Systems
Industry Biotechnology
Experience
ImClone Systems September 2007 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2005 - September 2007
Wyeth 2004 - 2005
Skills
Quality Assurance, Validation, CAPA, Manufacturing, GMP, Pharmaceutical Industry, Six Sigma, Sop, Biopharmaceuticals, 21 CFR Part 11, CQA, Computer System..., FDA
Education
Stevens Institute of Technology 2007 — 2010
Master of Science, Pharmaceutical Manufacturing
Rutgers, The State University of New Jersey-New Brunswick 1996 — 2000
Bachelor of Science, Environmental Policy, Institutions & Behavior
ImClone Systems September 2007 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2005 - September 2007
Wyeth 2004 - 2005
Skills
Quality Assurance, Validation, CAPA, Manufacturing, GMP, Pharmaceutical Industry, Six Sigma, Sop, Biopharmaceuticals, 21 CFR Part 11, CQA, Computer System..., FDA
Education
Stevens Institute of Technology 2007 — 2010
Master of Science, Pharmaceutical Manufacturing
Rutgers, The State University of New Jersey-New Brunswick 1996 — 2000
Bachelor of Science, Environmental Policy, Institutions & Behavior
Michelle McLaughlin's Imclone Systems Experience March 2008 - August 2008
Job Bioengineer I at Celgene Cellular Therapeutics
Industry Biotechnology
Experience
Celgene Cellular Therapeutics December 2012 - Present
Celgene Cellular Therapeutics May 2010 - December 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2010 - May 2010
The Wistar Institute September 2008 - December 2009
Celgene Cellular Therapeutics May 2009 - August 2009
The Wistar Institute January 2009 - May 2009
ImClone Systems March 2008 - August 2008
ImClone Systems May 2007 - March 2008
Rutgers University February 2006 - December 2006
Skills
Cell, Cell Culture, HPLC, Molecular Biology, Biochemistry, Flow Cytometry, Assay Development, Purification, Protein Expression
Education
University of Pennsylvania 2008 — 2009
M.S., Molecular Biotechnology
Rutgers University-New Brunswick 2003 — 2007
B.S., Biotechnology
Celgene Cellular Therapeutics December 2012 - Present
Celgene Cellular Therapeutics May 2010 - December 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2010 - May 2010
The Wistar Institute September 2008 - December 2009
Celgene Cellular Therapeutics May 2009 - August 2009
The Wistar Institute January 2009 - May 2009
ImClone Systems March 2008 - August 2008
ImClone Systems May 2007 - March 2008
Rutgers University February 2006 - December 2006
Skills
Cell, Cell Culture, HPLC, Molecular Biology, Biochemistry, Flow Cytometry, Assay Development, Purification, Protein Expression
Education
University of Pennsylvania 2008 — 2009
M.S., Molecular Biotechnology
Rutgers University-New Brunswick 2003 — 2007
B.S., Biotechnology
Courtney Veeck's Imclone Systems Experience October 2008 - February 2012
Job at
Industry Research
Experience
Paragon Bioservices, Inc. April 2015 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2008 - Present
ImClone Systems October 2008 - February 2012
Celgene 2002 - 2007
Skills
Quality Control, GMP, Sop, 21 CFR Part 11, Biotechnology, FDA, LIMS, Laboratory, Microbiology, Pharmaceutical Industry, SOP
Education
Susquehanna University 2004 — 2008
BS, Biology
Paragon Bioservices, Inc. April 2015 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2008 - Present
ImClone Systems October 2008 - February 2012
Celgene 2002 - 2007
Skills
Quality Control, GMP, Sop, 21 CFR Part 11, Biotechnology, FDA, LIMS, Laboratory, Microbiology, Pharmaceutical Industry, SOP
Education
Susquehanna University 2004 — 2008
BS, Biology
Bill Vasiliadis's Imclone Systems Experience 2004 - 2007
Job Manager, Quality Projects, Sanofi Pasteur
Industry Pharmaceuticals
Experience
Sanofi Pasteur January 2013 - Present
Sanofi Pasteur January 2007 - April 2013
Validation Technologies Inc. 2007 - 2008
ImClone Systems 2004 - 2007
Lockwood Greene 2001 - 2002
Skills
V&V, Cleaning Validation, Validation, GMP, Aseptic Processing, 21 CFR Part 11, GAMP, Change Control, CAPA, FDA, Sop
Education
Stevens Institute of Technology 1993 — 2007
masters, pharmaceutical manufacturing
Sanofi Pasteur January 2013 - Present
Sanofi Pasteur January 2007 - April 2013
Validation Technologies Inc. 2007 - 2008
ImClone Systems 2004 - 2007
Lockwood Greene 2001 - 2002
Skills
V&V, Cleaning Validation, Validation, GMP, Aseptic Processing, 21 CFR Part 11, GAMP, Change Control, CAPA, FDA, Sop
Education
Stevens Institute of Technology 1993 — 2007
masters, pharmaceutical manufacturing
Bruce Kilgore's Imclone Systems Experience February 2008 - December 2008
Job Scientist at Merck
Industry Biotechnology
Experience
Merck September 2009 - Present
ImClone Systems February 2008 - December 2008
CuraGen Corporation February 2007 - July 2007
Alexion Pharmaceuticals 2000 - 2007
Education
Trinity College-Hartford 1996 — 1999
B.S., Chemistry
Merck September 2009 - Present
ImClone Systems February 2008 - December 2008
CuraGen Corporation February 2007 - July 2007
Alexion Pharmaceuticals 2000 - 2007
Education
Trinity College-Hartford 1996 — 1999
B.S., Chemistry
Wilson Caldwell III's Imclone Systems Experience August 2008 - August 2011
Job Clinical Trial Manager at Regeneron Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
Regeneron Pharmaceuticals, Inc. April 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2011 - April 2014
ImClone Systems August 2008 - August 2011
Advanced Biomedical Research, Inc. (ABR) October 2004 - March 2008
CoreLab Partners, Inc. October 2003 - October 2004
Skills
Clinical Trial..., Clinical Monitoring, GCP, EDC, Oncology, Clinical Trials, Clinical Research, CRO, Biotechnology, CTMS, Clinical Data Management, Clinical Development, Clinical Operations, Hematology, Drug Development, Medical Writing, ICH-GCP, Pharmacovigilance, Pharmaceutical Industry, Regulatory Submissions, Sop, Therapeutic Areas
Education
Rider University
Master of Business Administration (MBA)
The College of New Jersey
Bachelor of Science (BS), Biology/Biological Sciences, General
Regeneron Pharmaceuticals, Inc. April 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2011 - April 2014
ImClone Systems August 2008 - August 2011
Advanced Biomedical Research, Inc. (ABR) October 2004 - March 2008
CoreLab Partners, Inc. October 2003 - October 2004
Skills
Clinical Trial..., Clinical Monitoring, GCP, EDC, Oncology, Clinical Trials, Clinical Research, CRO, Biotechnology, CTMS, Clinical Data Management, Clinical Development, Clinical Operations, Hematology, Drug Development, Medical Writing, ICH-GCP, Pharmacovigilance, Pharmaceutical Industry, Regulatory Submissions, Sop, Therapeutic Areas
Education
Rider University
Master of Business Administration (MBA)
The College of New Jersey
Bachelor of Science (BS), Biology/Biological Sciences, General
Joseph Papini's Imclone Systems Experience May 2005 - March 2011
Job Facility Manager at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - Present
ImClone Systems May 2005 - March 2011
Aker Kvaerner 1994 - 2005
Kvaerner 1994 - 2005
Aker Kvaerner Pharmaceuticals 1994 - 2005
Kvaerner Process 1994 - 2005
Jacobs Engineering 1990 - 1994
Skills
GMP, Change Control, FDA, Validation, SOP, CAPA, Biotechnology, 21 CFR Part 11, Technology Transfer, Biopharmaceuticals, Chemical Engineering, Commissioning, Engineering, Pharmaceutical Industry, Process Engineering, Process Simulation, Project Engineering, Project Management, Quality System, Sop
Education
Rensselaer Polytechnic Institute 1986 — 1989
BS, Chemical Engineering
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - Present
ImClone Systems May 2005 - March 2011
Aker Kvaerner 1994 - 2005
Kvaerner 1994 - 2005
Aker Kvaerner Pharmaceuticals 1994 - 2005
Kvaerner Process 1994 - 2005
Jacobs Engineering 1990 - 1994
Skills
GMP, Change Control, FDA, Validation, SOP, CAPA, Biotechnology, 21 CFR Part 11, Technology Transfer, Biopharmaceuticals, Chemical Engineering, Commissioning, Engineering, Pharmaceutical Industry, Process Engineering, Process Simulation, Project Engineering, Project Management, Quality System, Sop
Education
Rensselaer Polytechnic Institute 1986 — 1989
BS, Chemical Engineering
Roderick Chiasson's Imclone Systems Experience 2002 - Present
Job Manager, Quality Assurance Auditing at Eli Lilly
Industry Biotechnology
Experience
ImClone Systems 2002 - Present
Education
Rider University 1995 — 1999
ImClone Systems 2002 - Present
Education
Rider University 1995 — 1999
Akos Simsik's Imclone Systems Experience October 2004 - April 2010
Job Senior Scientist, AS&T at Novartis
Industry Biotechnology
Experience
Novartis October 2014 - Present
Novartis January 2013 - Present
Dendreon Corp. April 2010 - January 2013
ImClone Systems October 2004 - April 2010
Skills
LIMS, GMP, FDA, Sop, ELISA, Endotoxin, Validation, Laboratory, Aseptic Processing, Protein Chemistry, Cell, Aseptic Technique, Quality Control, cGMP practices, Flow Cytometry
Education
Rutgers, The State University of New Jersey-New Brunswick 1999 — 2004
Bachelor of Science (B.S.), Biotechnology
Novartis October 2014 - Present
Novartis January 2013 - Present
Dendreon Corp. April 2010 - January 2013
ImClone Systems October 2004 - April 2010
Skills
LIMS, GMP, FDA, Sop, ELISA, Endotoxin, Validation, Laboratory, Aseptic Processing, Protein Chemistry, Cell, Aseptic Technique, Quality Control, cGMP practices, Flow Cytometry
Education
Rutgers, The State University of New Jersey-New Brunswick 1999 — 2004
Bachelor of Science (B.S.), Biotechnology
Nicholas Osto's Imclone Systems Experience Manufacturing Engineer
Job Analyst at ImClone Systems
Industry Biotechnology
Experience
ImClone Systems Manufacturing Engineer
Flarion Technologies July 2003 - November 2004
Education
Touro College 2000 — 2004
ImClone Systems Manufacturing Engineer
Flarion Technologies July 2003 - November 2004
Education
Touro College 2000 — 2004
Ron Charles, PE's Imclone Systems Experience 2005 - 2007
Job Associate at Jaros Baum & Bolles
Industry Design
Experience
Jaros Baum & Bolles December 2010 - Present
Jaros Baum & Bolles February 2007 - December 2010
ImClone Systems 2005 - 2007
Skills
AutoCAD, Engineering, CAD, MEP, LEED, Revit, Construction, LEED AP, Green Building, BIM, Microsoft Excel, Microsoft Office, Microsoft Word, PowerPoint, Budgets
Education
Penn State University - University Park 1999 — 2003
Bachelor of Science (B.S.), Mechanical Engineering
Jaros Baum & Bolles December 2010 - Present
Jaros Baum & Bolles February 2007 - December 2010
ImClone Systems 2005 - 2007
Skills
AutoCAD, Engineering, CAD, MEP, LEED, Revit, Construction, LEED AP, Green Building, BIM, Microsoft Excel, Microsoft Office, Microsoft Word, PowerPoint, Budgets
Education
Penn State University - University Park 1999 — 2003
Bachelor of Science (B.S.), Mechanical Engineering
Vienna Lo's Imclone Systems Experience 2005 - 2008
Job Senior Scientist at Novartis
Industry Pharmaceuticals
Experience
Novartis November 2013 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson April 2013 - November 2013
Laureate Biopharmaceutical Services August 2012 - December 2012
Celgene July 2010 - August 2012
Centocor 2008 - 2010
Johnson & Johnson 2008 - 2010
ImClone Systems 2005 - 2008
Rutgers University 1998 - 2005
Roche 2001 - 2001
Skills
Molecular Biology, Clinical, Cell, GLP, Cell Culture, cGMP, Cell Biology, GMP, Validation, Biotechnology, Drug Discovery, SOP, Technology Transfer, Life Sciences, Aseptic Technique, Clinical Research, Biopharmaceuticals, FDA, Pharmaceuticals, Clinical Trials, R&D, Process Validation, Microbiology, Regulatory Submissions, Sop, Pharmaceutical Industry, Lifesciences, Purification, Biochemistry, High Throughput..., Laboratory, Oncology, Monoclonal Antibodies, IND
Education
Rutgers University-New Brunswick 1997 — 2001
NBTHS
Raritan Valley Community College
Biotech business ethic and time management
Stevens Institute of Technology
Intermediate Concept in Project Management
Novartis November 2013 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson April 2013 - November 2013
Laureate Biopharmaceutical Services August 2012 - December 2012
Celgene July 2010 - August 2012
Centocor 2008 - 2010
Johnson & Johnson 2008 - 2010
ImClone Systems 2005 - 2008
Rutgers University 1998 - 2005
Roche 2001 - 2001
Skills
Molecular Biology, Clinical, Cell, GLP, Cell Culture, cGMP, Cell Biology, GMP, Validation, Biotechnology, Drug Discovery, SOP, Technology Transfer, Life Sciences, Aseptic Technique, Clinical Research, Biopharmaceuticals, FDA, Pharmaceuticals, Clinical Trials, R&D, Process Validation, Microbiology, Regulatory Submissions, Sop, Pharmaceutical Industry, Lifesciences, Purification, Biochemistry, High Throughput..., Laboratory, Oncology, Monoclonal Antibodies, IND
Education
Rutgers University-New Brunswick 1997 — 2001
NBTHS
Raritan Valley Community College
Biotech business ethic and time management
Stevens Institute of Technology
Intermediate Concept in Project Management
Neil Goldstein's Imclone Systems Experience 1987 - 1997
Job Chief Operating Officer at HelioGenetics
Industry Biotechnology
Experience
HelioGenetics July 2013 - Present
Antyra 1999 - Present
PanMetics January 2012 - January 2013
GenQuest 1997 - 1998
ImClone Systems 1987 - 1997
Skills
Pharmaceuticals, Drug Discovery, Oncology, Diagnostics, Infectious Diseases, New Business Development, Business Strategy, Small Business, Medical Diagnostics, Validation, Monoclonal Antibodies, Biopharmaceuticals, Molecular Biology, Lifesciences, Cell, Clinical Trials, Immunology, Cancer, Clinical Development, Hardware Diagnostics, Vaccines
Education
Rutgers University-New Brunswick 1970 — 1975
PhD, Microbiology
City College of New York 1965 — 1969
BS, Biology
HelioGenetics July 2013 - Present
Antyra 1999 - Present
PanMetics January 2012 - January 2013
GenQuest 1997 - 1998
ImClone Systems 1987 - 1997
Skills
Pharmaceuticals, Drug Discovery, Oncology, Diagnostics, Infectious Diseases, New Business Development, Business Strategy, Small Business, Medical Diagnostics, Validation, Monoclonal Antibodies, Biopharmaceuticals, Molecular Biology, Lifesciences, Cell, Clinical Trials, Immunology, Cancer, Clinical Development, Hardware Diagnostics, Vaccines
Education
Rutgers University-New Brunswick 1970 — 1975
PhD, Microbiology
City College of New York 1965 — 1969
BS, Biology
Franklin Romero's Imclone Systems Experience July 2008 - December 2008
Job Teacher of Chemistry
Industry Higher Education
Experience
West New York Board of Education September 2014 - Present
West New York Board of Education September 2009 - June 2014
ImClone Systems July 2008 - December 2008
Emisphere Technologies June 2003 - June 2008
Aton Pharma Inc. August 2002 - May 2003
Pfizer Pharmaceuticals July 2000 - April 2002
Warner Lambert September 1998 - July 2000
Skills
Teaching Experience, Tutoring, Immunoassays, ELISA, GLP, HPLC, Research, Biotechnology, Assay Development, Teacher Training, Science, Toxicology, LC-MS, Protein Chemistry, Drug Discovery, Dissolution, Chromatography, Formulation, Analytical Chemistry
Education
Seton Hall University 1998 — 2001
M.S., Chemistry
Stevens Institute of Technology 1994 — 1998
B.S., Chemistry with Thesis
West New York Board of Education September 2014 - Present
West New York Board of Education September 2009 - June 2014
ImClone Systems July 2008 - December 2008
Emisphere Technologies June 2003 - June 2008
Aton Pharma Inc. August 2002 - May 2003
Pfizer Pharmaceuticals July 2000 - April 2002
Warner Lambert September 1998 - July 2000
Skills
Teaching Experience, Tutoring, Immunoassays, ELISA, GLP, HPLC, Research, Biotechnology, Assay Development, Teacher Training, Science, Toxicology, LC-MS, Protein Chemistry, Drug Discovery, Dissolution, Chromatography, Formulation, Analytical Chemistry
Education
Seton Hall University 1998 — 2001
M.S., Chemistry
Stevens Institute of Technology 1994 — 1998
B.S., Chemistry with Thesis
Kathy Buchanan's Imclone Systems Experience May 2009 - Present
Job QA Contract Manufacturing Specialist at ImClone Systems
Industry Pharmaceuticals
Experience
ImClone Systems May 2009 - Present
Polaris Compliance Consultants, Inc. September 2008 - May 2009
PTC 2009 - 2009
Enzon Pharmaceutical Inc. June 1992 - June 2008
Beckman Instruments 1982 - 1992
Skills
CAPA, GMP, Sop, FDA, Validation, Change Control, 21 CFR Part 11, Quality Assurance, Software Documentation, GxP, Aseptic Processing, LIMS, Clinical Development
Education
Rider University 1964 — 1966
ImClone Systems May 2009 - Present
Polaris Compliance Consultants, Inc. September 2008 - May 2009
PTC 2009 - 2009
Enzon Pharmaceutical Inc. June 1992 - June 2008
Beckman Instruments 1982 - 1992
Skills
CAPA, GMP, Sop, FDA, Validation, Change Control, 21 CFR Part 11, Quality Assurance, Software Documentation, GxP, Aseptic Processing, LIMS, Clinical Development
Education
Rider University 1964 — 1966
Rosa Vianelly Lantigua's Imclone Systems Experience 2005 - 2006
Job GCP Consultant at DSI (Foster McKay)
Industry Pharmaceuticals
Experience
DSI (Foster McKay) October 2012 - Present
GSK 2011 - 2012
Eisai 2010 - 2011
Sepracor October 2008 - September 2010
Azopharma June 2008 - April 2010
Bioheart Inc November 2006 - February 2008
ImClone Systems 2005 - 2006
Huntingdon Life Sciences 2002 - 2004
Medarex 2002 - 2004
Skills
FDA, GMP, Sop, GLP, Quality Assurance, Quality Control, ICH-GCP, V&V, GCP, Medical Devices, 21 CFR Part 11, Project Management, ISO 13485, Process Improvement, Gap Analysis, Risk Assessment, Clinical Trials, SOP, CRO, Pharmaceutical Industry
Education
Saint Joseph's University - Erivan K. Haub School of Business 2013 — 2015
Executive MBA - in progress, Pharmaceutical Marketing and Management
Rutgers, The State University of New Jersey-New Brunswick 1995 — 2000
Bachelor of Science (BSc), Biological Sciences
DSI (Foster McKay) October 2012 - Present
GSK 2011 - 2012
Eisai 2010 - 2011
Sepracor October 2008 - September 2010
Azopharma June 2008 - April 2010
Bioheart Inc November 2006 - February 2008
ImClone Systems 2005 - 2006
Huntingdon Life Sciences 2002 - 2004
Medarex 2002 - 2004
Skills
FDA, GMP, Sop, GLP, Quality Assurance, Quality Control, ICH-GCP, V&V, GCP, Medical Devices, 21 CFR Part 11, Project Management, ISO 13485, Process Improvement, Gap Analysis, Risk Assessment, Clinical Trials, SOP, CRO, Pharmaceutical Industry
Education
Saint Joseph's University - Erivan K. Haub School of Business 2013 — 2015
Executive MBA - in progress, Pharmaceutical Marketing and Management
Rutgers, The State University of New Jersey-New Brunswick 1995 — 2000
Bachelor of Science (BSc), Biological Sciences
Edward Patten's Imclone Systems Experience 1995 - 2000
Job Associate Director Manufacturing Science at CBER, FDA
Industry Biotechnology
Experience
CBER, FDA July 2008 - Present
Wellstat Biologics July 2006 - July 2008
Nabi Biopharmaceuticals 2003 - 2006
Palatin Technologies 2000 - 2003
ImClone Systems 1995 - 2000
Ortho Biotech 1981 - 1994
Skills
CAPA, cGMP, Biopharmaceuticals, FDA, Pharmaceuticals, Biotechnology, GMP, Quality Management, Change Control, Validation, GLP, Sop, Pharmaceutical Industry, Biologics, 21 CFR Part 11, Quality Assurance, Technology Transfer, Regulatory Affairs, Vaccines, Regulatory Requirements, V&V, Quality System, Regulatory Submissions, Drug Development, Clinical Trials, Clinical Development, Lifesciences, IND, Microbiology, ISO 13485, Analytical Chemistry, Life Sciences
Education
Seton Hall University 1980 — 1990
MS, Biology/Microbiology
CBER, FDA July 2008 - Present
Wellstat Biologics July 2006 - July 2008
Nabi Biopharmaceuticals 2003 - 2006
Palatin Technologies 2000 - 2003
ImClone Systems 1995 - 2000
Ortho Biotech 1981 - 1994
Skills
CAPA, cGMP, Biopharmaceuticals, FDA, Pharmaceuticals, Biotechnology, GMP, Quality Management, Change Control, Validation, GLP, Sop, Pharmaceutical Industry, Biologics, 21 CFR Part 11, Quality Assurance, Technology Transfer, Regulatory Affairs, Vaccines, Regulatory Requirements, V&V, Quality System, Regulatory Submissions, Drug Development, Clinical Trials, Clinical Development, Lifesciences, IND, Microbiology, ISO 13485, Analytical Chemistry, Life Sciences
Education
Seton Hall University 1980 — 1990
MS, Biology/Microbiology
Malcolm Moore's Imclone Systems Experience April 2007 - January 2009
Job Hematology Oncology Consultant at Celgene
Industry Biotechnology
Experience
Celgene February 2011 - Present
Genzyme August 2009 - November 2010
Imclone Systems April 2007 - January 2009
Aventis September 1995 - April 2003
Education
Syracuse University 1986 — 1990
Bachelors of Science, Management
Syracuse University - Martin J. Whitman School of Management 1986 — 1990
Celgene February 2011 - Present
Genzyme August 2009 - November 2010
Imclone Systems April 2007 - January 2009
Aventis September 1995 - April 2003
Education
Syracuse University 1986 — 1990
Bachelors of Science, Management
Syracuse University - Martin J. Whitman School of Management 1986 — 1990
Claudine Sivilla's Imclone Systems Experience 2002 - 2004
Job Quality Assurance Manager at Cased Hole Well Services
Industry Chemicals
Experience
Cased Hole Well Services July 2015 - Present
Kinder Morgan February 2007 - October 2013
KPA LLC 2006 - 2007
KPA LLC 2006 - 2007
KPA LLC 2006 - 2007
KPA LLC 2006 - 2007
KPA LLC 2006 - 2007
KPA LLC 2006 - 2007
ImClone Systems 2002 - 2004
Waste Management 2000 - 2002
Skills
Industrial Safety, Environmental Awareness, Environmental Compliance, Hazardous Waste..., EHS, Safety Management..., Process Safety, Industrial Hygiene, Environmental..., Inspection, Occupational Health, Emergency Management, Hazard Analysis, Accident Investigation, Construction Safety, Ergonomics, Fire Safety, HAZWOPER, Hazardous Materials, ISO 14001, Root Cause Analysis
Education
Rutgers University-New Brunswick 1995 — 1999
Cased Hole Well Services July 2015 - Present
Kinder Morgan February 2007 - October 2013
KPA LLC 2006 - 2007
KPA LLC 2006 - 2007
KPA LLC 2006 - 2007
KPA LLC 2006 - 2007
KPA LLC 2006 - 2007
KPA LLC 2006 - 2007
ImClone Systems 2002 - 2004
Waste Management 2000 - 2002
Skills
Industrial Safety, Environmental Awareness, Environmental Compliance, Hazardous Waste..., EHS, Safety Management..., Process Safety, Industrial Hygiene, Environmental..., Inspection, Occupational Health, Emergency Management, Hazard Analysis, Accident Investigation, Construction Safety, Ergonomics, Fire Safety, HAZWOPER, Hazardous Materials, ISO 14001, Root Cause Analysis
Education
Rutgers University-New Brunswick 1995 — 1999
Deepa Dadlani Karnani's Imclone Systems Experience 2008 - Present
Job at
Industry Biotechnology
Experience
ImClone Systems 2008 - Present
Skills
Biotechnology, Management, Biopharmaceuticals, Leadership, Matlab, Change Management, Cross-functional Team..., Business Analysis, Strategy, Strategic Planning, Data Analysis, Research, Marketing Strategy, Process Improvement
Education
Rutgers University-New Brunswick 2005 — 2008
Master of Science, Biomedical Engineering
University of Mumbai
Bachelor of Engineering, Biomedical Engineering
ImClone Systems 2008 - Present
Skills
Biotechnology, Management, Biopharmaceuticals, Leadership, Matlab, Change Management, Cross-functional Team..., Business Analysis, Strategy, Strategic Planning, Data Analysis, Research, Marketing Strategy, Process Improvement
Education
Rutgers University-New Brunswick 2005 — 2008
Master of Science, Biomedical Engineering
University of Mumbai
Bachelor of Engineering, Biomedical Engineering
Luipa Khandker's Imclone Systems Experience 2005 - 2007
Job PhD Candidate at Rutgers University
Industry Biotechnology
Experience
Rutgers University August 2014 - Present
Rutgers University September 2013 - May 2014
Celgene March 2011 - August 2013
PTC Therapeutics 2007 - 2010
ImClone Systems 2005 - 2007
Memorial Sloan-Kettering Cancer Center July 2002 - October 2005
Skills
Biotechnology, Cell, In Vitro, Assay Development, Stem Cell Research, Bioreactor, Flow Cytometry, Laboratory, Drug Discovery, Western Blotting
Education
Rutgers, The State University of New Jersey-New Brunswick 1998 — 2001
Bachelor of Science, Biology
Rutgers University August 2014 - Present
Rutgers University September 2013 - May 2014
Celgene March 2011 - August 2013
PTC Therapeutics 2007 - 2010
ImClone Systems 2005 - 2007
Memorial Sloan-Kettering Cancer Center July 2002 - October 2005
Skills
Biotechnology, Cell, In Vitro, Assay Development, Stem Cell Research, Bioreactor, Flow Cytometry, Laboratory, Drug Discovery, Western Blotting
Education
Rutgers, The State University of New Jersey-New Brunswick 1998 — 2001
Bachelor of Science, Biology
Claudia (Corky) Roman's Imclone Systems Experience February 2001 - April 2010
Job Head QC Microbiology at GlaxoSmithKline
Industry Biotechnology
Experience
GlaxoSmithKline January 2013 - Present
Human Genome Sciences April 2011 - Present
Painted Creek Farm, LLC August 2007 - Present
Red Oak Premium Meat Processors, LLC June 2010 - August 2011
ImClone Systems, wholly-owned subsidiary of Eli Lilly & Co. 2008 - April 2010
ImClone Systems February 2001 - April 2010
Osteotech October 1998 - January 2000
Ortho Clinical Diagnostics February 1994 - October 1998
Ethicon March 1983 - January 1994
Skills
QC, GMP, Microbiology, Aseptic Processing, LIMS, Supplier Quality, Validation, Environmental Monitoring, Sterilization, HACCP, cGMP practices, Medical Devices, Regulatory Requirements, Aseptic Technique, Chemistry, Trackwise, GxP, Quality Auditing, FDA, Quality Control
Education
Rider University 1980 — 1982
BA, Biology
GlaxoSmithKline January 2013 - Present
Human Genome Sciences April 2011 - Present
Painted Creek Farm, LLC August 2007 - Present
Red Oak Premium Meat Processors, LLC June 2010 - August 2011
ImClone Systems, wholly-owned subsidiary of Eli Lilly & Co. 2008 - April 2010
ImClone Systems February 2001 - April 2010
Osteotech October 1998 - January 2000
Ortho Clinical Diagnostics February 1994 - October 1998
Ethicon March 1983 - January 1994
Skills
QC, GMP, Microbiology, Aseptic Processing, LIMS, Supplier Quality, Validation, Environmental Monitoring, Sterilization, HACCP, cGMP practices, Medical Devices, Regulatory Requirements, Aseptic Technique, Chemistry, Trackwise, GxP, Quality Auditing, FDA, Quality Control
Education
Rider University 1980 — 1982
BA, Biology
Pallavi Pasupuleti's Imclone Systems Experience June 2006 - December 2008
Job Senior Specialist, QA Compliance at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Pharmaceuticals
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2009 - December 2010
ImClone Systems June 2006 - December 2008
URL Pharma, Inc. 2003 - 2005
URL Pharma, Inc. 2000 - 2003
URL Pharma, Inc. 1998 - 2000
Skills
GMP, CAPA, FDA, Trackwise, Change Control, Quality Assurance, Contract Manufacturing..., Metrology, Quality Control, Non conformance events
Education
Temple University 2007 — 2010
Master's degree, QA/RA, Regulatory Affairs
Temple University 1994 — 1998
Bachelor of Science (BS), Chemistry
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2009 - December 2010
ImClone Systems June 2006 - December 2008
URL Pharma, Inc. 2003 - 2005
URL Pharma, Inc. 2000 - 2003
URL Pharma, Inc. 1998 - 2000
Skills
GMP, CAPA, FDA, Trackwise, Change Control, Quality Assurance, Contract Manufacturing..., Metrology, Quality Control, Non conformance events
Education
Temple University 2007 — 2010
Master's degree, QA/RA, Regulatory Affairs
Temple University 1994 — 1998
Bachelor of Science (BS), Chemistry
Lawrence Deetz's Imclone Systems Experience January 2009 - September 2011
Job Director, Clinical Operations at Lexicon Pharmaceuticals
Industry Pharmaceuticals
Experience
Lexicon Pharmaceuticals January 2014 - Present
Lexicon Pharmaceuticals July 2013 - January 2014
Celsion Corporation September 2011 - July 2013
ImClone Systems January 2009 - September 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2009 - September 2011
Eisai Medical Research November 2001 - April 2008
Hoechst October 1988 - November 2001
Skills
Clinical Research, Oncology, Clinical Development, Pharmaceutical Industry, Sop, Cross-functional Team..., Clinical Trials, CTMS, R&D, Data Management, CRO, Quality Assurance, Clinical Data Management, FDA, Clinical Operations, Regulatory Affairs, Clinical Study Design, Medical Affairs
Education
Penn State University 1975 — 1979
PhD, Nutrition
Lexicon Pharmaceuticals January 2014 - Present
Lexicon Pharmaceuticals July 2013 - January 2014
Celsion Corporation September 2011 - July 2013
ImClone Systems January 2009 - September 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2009 - September 2011
Eisai Medical Research November 2001 - April 2008
Hoechst October 1988 - November 2001
Skills
Clinical Research, Oncology, Clinical Development, Pharmaceutical Industry, Sop, Cross-functional Team..., Clinical Trials, CTMS, R&D, Data Management, CRO, Quality Assurance, Clinical Data Management, FDA, Clinical Operations, Regulatory Affairs, Clinical Study Design, Medical Affairs
Education
Penn State University 1975 — 1979
PhD, Nutrition
Darius Pillsbury's Imclone Systems Experience Process Development EngineerTKT2000 - 2002
Job Principal Engineer at ImClone Systems
Industry Biotechnology
Experience
ImClone Systems Process Development EngineerTKT2000 - 2002
Education
Tufts University
BSChE, Chemical Engineering
ImClone Systems Process Development EngineerTKT2000 - 2002
Education
Tufts University
BSChE, Chemical Engineering
Ryan Mould's Imclone Systems Experience August 2005 - May 2010
Job Senior Associate, Formulation Development
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2010 - Present
ImClone Systems August 2005 - May 2010
Skills
LIMS, GMP, Validation, Aseptic Technique, FDA, Biopharmaceuticals, HPLC, Biotechnology, GLP, SDS-PAGE, Formulation, ELISA, Sop, Quality Control, 21 CFR Part 11, Aseptic Processing, GxP, CAPA, Technology Transfer
Education
Rutgers University-New Brunswick 2000 — 2005
B.S., Biological Sciences
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2010 - Present
ImClone Systems August 2005 - May 2010
Skills
LIMS, GMP, Validation, Aseptic Technique, FDA, Biopharmaceuticals, HPLC, Biotechnology, GLP, SDS-PAGE, Formulation, ELISA, Sop, Quality Control, 21 CFR Part 11, Aseptic Processing, GxP, CAPA, Technology Transfer
Education
Rutgers University-New Brunswick 2000 — 2005
B.S., Biological Sciences
Rori Hodges's Imclone Systems Experience October 2005 - Present
Job Operator at ImClone Systems
Industry Biotechnology
Experience
ImClone Systems October 2005 - Present
Education
Rutgers University-New Brunswick
ImClone Systems October 2005 - Present
Education
Rutgers University-New Brunswick
Mark Koehler's Imclone Systems Experience May 1995 - May 1996
Job Associate Director, Upstream PD, Novavax, Inc.
Industry Biotechnology
Experience
Novavax, Inc. December 2013 - Present
Teva Biopharmaceuticals USA June 2007 - December 2013
CoGenesys, Inc. June 2006 - June 2007
Human Genome Sciences February 1999 - June 2006
Pfizer May 1996 - January 1999
ImClone Systems May 1995 - May 1996
R W Johnson Pharmaceutical Research Institue May 1992 - May 1995
Centocor May 1989 - May 1992
Skills
Biotechnology, Validation, Technology Transfer, SOP, Manufacturing, Microbiology, Sop, Cell, Cell Culture, Purification, Biopharmaceuticals, GLP, GMP, Fermentation, Protein Chemistry, Lifesciences, Life Sciences
Education
Penn State University 1984 — 1988
BS, Biology
Novavax, Inc. December 2013 - Present
Teva Biopharmaceuticals USA June 2007 - December 2013
CoGenesys, Inc. June 2006 - June 2007
Human Genome Sciences February 1999 - June 2006
Pfizer May 1996 - January 1999
ImClone Systems May 1995 - May 1996
R W Johnson Pharmaceutical Research Institue May 1992 - May 1995
Centocor May 1989 - May 1992
Skills
Biotechnology, Validation, Technology Transfer, SOP, Manufacturing, Microbiology, Sop, Cell, Cell Culture, Purification, Biopharmaceuticals, GLP, GMP, Fermentation, Protein Chemistry, Lifesciences, Life Sciences
Education
Penn State University 1984 — 1988
BS, Biology
Danielle Duva's Imclone Systems Experience QA Document Control CoordinatorImclone SystemsApril 2003 - April 2008
Job Medical Writing Associate at Imclone Systems
Industry Biotechnology
Experience
Imclone Systems QA Document Control CoordinatorImclone SystemsApril 2003 - April 2008
P.F. Laboratories July 2000 - April 2003
Skills
Validation, Regulatory Submissions, Lifesciences, Medical Writing, Software Documentation, Oncology, Pharmaceutical Industry, Change Control, Process Engineering, Clinical Trials, FDA, Clinical Development, Quality Assurance, CTMS, CAPA, Biotechnology, GMP, Sop, Vendor Management, 21 CFR Part 11, GCP
Education
Stockton University 1995 — 1997
BA, Psychology
Imclone Systems QA Document Control CoordinatorImclone SystemsApril 2003 - April 2008
P.F. Laboratories July 2000 - April 2003
Skills
Validation, Regulatory Submissions, Lifesciences, Medical Writing, Software Documentation, Oncology, Pharmaceutical Industry, Change Control, Process Engineering, Clinical Trials, FDA, Clinical Development, Quality Assurance, CTMS, CAPA, Biotechnology, GMP, Sop, Vendor Management, 21 CFR Part 11, GCP
Education
Stockton University 1995 — 1997
BA, Psychology
Yujie Wang's Imclone Systems Experience March 2007 - July 2009
Job Manager at Johnson & Johnson
Industry Pharmaceuticals
Experience
Janssen, Pharmaceutical Companies of Johnson and Johnson 2012 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson 2011 - 2012
Medco 2010 - 2010
Imclone Systems March 2007 - July 2009
University of Wisconsin-Madison 2003 - 2006
Skills
Lifesciences, Data Analysis, Clinical Research, Research, Life Sciences, Biotechnology
Education
Yale University - Yale School of Management 2009 — 2011
MBA, Healthcare
University of Wisconsin-Madison 2003 — 2006
M.S., Genetics
University of Science and Technology of China 1997 — 2002
B.S., Biological Sciences
Janssen, Pharmaceutical Companies of Johnson and Johnson 2012 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson 2011 - 2012
Medco 2010 - 2010
Imclone Systems March 2007 - July 2009
University of Wisconsin-Madison 2003 - 2006
Skills
Lifesciences, Data Analysis, Clinical Research, Research, Life Sciences, Biotechnology
Education
Yale University - Yale School of Management 2009 — 2011
MBA, Healthcare
University of Wisconsin-Madison 2003 — 2006
M.S., Genetics
University of Science and Technology of China 1997 — 2002
B.S., Biological Sciences
Marilyn Rodriguez's Imclone Systems Experience October 2007 - March 2009
Job Associate Director, Global Regulatory CMC at Celgene
Industry Biotechnology
Experience
Celgene Corporation March 2009 - Present
ImClone Systems October 2007 - March 2009
Kyowa Pharmaceutical, Inc. May 2005 - October 2007
Schering-Plough Research Institute May 2000 - May 2005
Schering-Plough Research Institute 2000 - 2005
Block Drug Company 1988 - 1995
Education
Rutgers, The State University of New Jersey-Newark 1981 — 1985
BA, Chemistry
Academic High School
Celgene Corporation March 2009 - Present
ImClone Systems October 2007 - March 2009
Kyowa Pharmaceutical, Inc. May 2005 - October 2007
Schering-Plough Research Institute May 2000 - May 2005
Schering-Plough Research Institute 2000 - 2005
Block Drug Company 1988 - 1995
Education
Rutgers, The State University of New Jersey-Newark 1981 — 1985
BA, Chemistry
Academic High School
Kevin Peacock's Imclone Systems Experience January 2009 - October 2009
Job VP of Business Development at Lycera
Industry Biotechnology
Experience
Lycera April 2015 - Present
Dendreon April 2012 - April 2015
Savient Pharmaceuticals, Inc. April 2011 - March 2012
Allos Therapeutics October 2009 - April 2011
ImClone Systems January 2009 - October 2009
ImClone Systems Incorporated January 2008 - January 2009
ImClone Systems Incorporated October 2006 - January 2008
ImClone Systems Incoproated May 2005 - October 2006
sanofi-aventis July 2004 - May 2005
sanofi-aventis July 2002 - July 2004
Skills
Business Development, Market Research, Pharmaceutical Sales, Project Management, Pharmaceutical Industry, Strategy, Product Development, Marketing, Marketing Strategy, Biotechnology, Oncology, Cross-functional Team..., Product Launch, Sales
Education
Temple University 1991 — 1995
BBA, Finance; Risk Management
Lycera April 2015 - Present
Dendreon April 2012 - April 2015
Savient Pharmaceuticals, Inc. April 2011 - March 2012
Allos Therapeutics October 2009 - April 2011
ImClone Systems January 2009 - October 2009
ImClone Systems Incorporated January 2008 - January 2009
ImClone Systems Incorporated October 2006 - January 2008
ImClone Systems Incoproated May 2005 - October 2006
sanofi-aventis July 2004 - May 2005
sanofi-aventis July 2002 - July 2004
Skills
Business Development, Market Research, Pharmaceutical Sales, Project Management, Pharmaceutical Industry, Strategy, Product Development, Marketing, Marketing Strategy, Biotechnology, Oncology, Cross-functional Team..., Product Launch, Sales
Education
Temple University 1991 — 1995
BBA, Finance; Risk Management
Saddef Haq's Imclone Systems Experience October 2008 - February 2009
Job Graduate Research Assistant
Industry Research
Experience
University of Maryland, Baltimore July 2013 - Present
Columbia University, Center for Infection and Immunity September 2010 - May 2013
Unigene March 2009 - December 2009
ImClone Systems October 2008 - February 2009
Rutgers University September 2007 - May 2008
Skills
HPLC, Assay Development, Mass Spectrometry, Biotechnology, PCR, Biochemistry, Sop, Validation, Pharmaceutical Industry, GMP, Laboratory, Microbiology, Molecular Biology, Cell Culture
Education
Rutgers University-New Brunswick 2006 — 2008
B.S.
University of Maryland Baltimore
University of Maryland, Baltimore July 2013 - Present
Columbia University, Center for Infection and Immunity September 2010 - May 2013
Unigene March 2009 - December 2009
ImClone Systems October 2008 - February 2009
Rutgers University September 2007 - May 2008
Skills
HPLC, Assay Development, Mass Spectrometry, Biotechnology, PCR, Biochemistry, Sop, Validation, Pharmaceutical Industry, GMP, Laboratory, Microbiology, Molecular Biology, Cell Culture
Education
Rutgers University-New Brunswick 2006 — 2008
B.S.
University of Maryland Baltimore
Kim Daves's Imclone Systems Experience 2004 - 2006
Job Biotechnology Professional
Industry Biotechnology
Doug Swan's Imclone Systems Experience 2003 - 2008
Job VP, Commercial Operations at Biodesix
Industry Biotechnology
Experience
Biodesix October 2008 - Present
ImClone Systems 2003 - 2008
Baxter Healthcare July 1999 - July 2003
Genentech 1996 - 1999
Skills
Oncology, Biotechnology, Pharmaceutical Industry, Lifesciences, Pharmaceutical Sales, Biopharmaceuticals, Commercialization
Education
University of New England 1977 — 1979
Medical Biology, Pre-Medicine/Pre-Medical Studies
Biodesix October 2008 - Present
ImClone Systems 2003 - 2008
Baxter Healthcare July 1999 - July 2003
Genentech 1996 - 1999
Skills
Oncology, Biotechnology, Pharmaceutical Industry, Lifesciences, Pharmaceutical Sales, Biopharmaceuticals, Commercialization
Education
University of New England 1977 — 1979
Medical Biology, Pre-Medicine/Pre-Medical Studies
Aaron Burns's Imclone Systems Experience 2003 - 2004
Job Scientist I at Dart NeuroScience LLC
Industry Pharmaceuticals
Experience
Dart NeuroScience LLC January 2015 - Present
Pfizer August 2012 - January 2015
Stanford University June 2010 - July 2012
ImClone Systems 2003 - 2004
Skills
Organic Synthesis, Organic Chemistry, Medicinal Chemistry, Synthetic Organic..., Drug Design, Organometallic Chemistry
Education
University of Minnesota-Twin Cities 2004 — 2010
Doctor of Philosophy (Ph.D.), Organic Chemistry
University of Missouri-Saint Louis 1996 — 2000
Bachelor of Science (BS), Chemistry
Dart NeuroScience LLC January 2015 - Present
Pfizer August 2012 - January 2015
Stanford University June 2010 - July 2012
ImClone Systems 2003 - 2004
Skills
Organic Synthesis, Organic Chemistry, Medicinal Chemistry, Synthetic Organic..., Drug Design, Organometallic Chemistry
Education
University of Minnesota-Twin Cities 2004 — 2010
Doctor of Philosophy (Ph.D.), Organic Chemistry
University of Missouri-Saint Louis 1996 — 2000
Bachelor of Science (BS), Chemistry
David Sack's Imclone Systems Experience 2006 - 2010
Job Lead Consultant at Wipro
Industry Pharmaceuticals
Experience
Wipro May 2014 - Present
ALKU-Assigned to a Major Pharmaceutical Company December 2013 - April 2014
LifeCell Corporation 2010 - 2013
ImClone Systems 2006 - 2010
Skills
21 CFR Part 11, Trackwise, GMP, CAPA, GxP, Sop, Computer System..., Change Control, FDA, V&V, LIMS, Validation, Aseptic Processing, GAMP, GLP
Education
Rutgers University-New Brunswick
Wipro May 2014 - Present
ALKU-Assigned to a Major Pharmaceutical Company December 2013 - April 2014
LifeCell Corporation 2010 - 2013
ImClone Systems 2006 - 2010
Skills
21 CFR Part 11, Trackwise, GMP, CAPA, GxP, Sop, Computer System..., Change Control, FDA, V&V, LIMS, Validation, Aseptic Processing, GAMP, GLP
Education
Rutgers University-New Brunswick
Leroy Huang's Imclone Systems Experience April 2005 - Present
Job Senior Process Controls Engineer at ImClone Systems
Industry Biotechnology
Experience
ImClone Systems April 2005 - Present
Eisai Machinery USA January 2003 - April 2005
Watson Machinery International March 1994 - December 2001
Cincinnati Milacron June 1988 - March 1994
Skills
FDA, 21 CFR Part 11, Change Control, Validation, GMP, Computer System..., NCEs, GAMP, Sop, Biotechnology, V&V, CAPA, Quality System, GxP, Process Simulation, Pharmaceutical Industry
Education
Stevens Institute of Technology 1988 — 1992
MS, Information Management
Stevens Institute of Technology 1984 — 1988
BE, Electrical Engineering/Computer Science
ImClone Systems April 2005 - Present
Eisai Machinery USA January 2003 - April 2005
Watson Machinery International March 1994 - December 2001
Cincinnati Milacron June 1988 - March 1994
Skills
FDA, 21 CFR Part 11, Change Control, Validation, GMP, Computer System..., NCEs, GAMP, Sop, Biotechnology, V&V, CAPA, Quality System, GxP, Process Simulation, Pharmaceutical Industry
Education
Stevens Institute of Technology 1988 — 1992
MS, Information Management
Stevens Institute of Technology 1984 — 1988
BE, Electrical Engineering/Computer Science
Rob Schinagl's Imclone Systems Experience September 2004 - January 2013
Job Vice President, Project Management at Drais Pharmaceuticals
Industry Biotechnology
Experience
Drais Pharmaceuticals, Inc. February 2013 - Present
ImClone Systems September 2004 - January 2013
Yamanouchi Pharma America July 2000 - September 2004
Quintiles February 2000 - July 2000
Osiris Therapeutics 1997 - 2000
University of California at San Diego 1992 - 1997
Electro-Biology, Inc. 1991 - 1993
Electro-Biology, Incorporated 1990 - 1991
Skills
Biotechnology, Pharmaceuticals, Project Portfolio..., Pharmaceutical..., Product Development, Business Alliances, Biomarker Development, Valuation, Business Modeling, Organizational..., Pharmaceutical Industry, R&D, Commercialization, Clinical Monitoring, GMP, CRO, Validation, Project Management, Clinical Development, IND, Medical Devices, Lifesciences, Regulatory Affairs, Oncology, CTMS, Biomarkers, Protocol, Sop, Translational Medicine, Technology Transfer, Change Control, GLP, FDA, Regulatory Submissions, Biopharmaceuticals, Drug Development, Clinical Research, Clinical Trials, GxP, Tissue Engineering, Drug Discovery, Assay Development, GCP, Genomics, Cancer, Monoclonal Antibodies, Cross-functional Team..., 21 CFR Part 11, Clinical Data Management, Protein Chemistry
Education
University of California, San Diego
Ph.D.
University of California, San Diego
MSE
University of Pennsylvania
BSE
Drais Pharmaceuticals, Inc. February 2013 - Present
ImClone Systems September 2004 - January 2013
Yamanouchi Pharma America July 2000 - September 2004
Quintiles February 2000 - July 2000
Osiris Therapeutics 1997 - 2000
University of California at San Diego 1992 - 1997
Electro-Biology, Inc. 1991 - 1993
Electro-Biology, Incorporated 1990 - 1991
Skills
Biotechnology, Pharmaceuticals, Project Portfolio..., Pharmaceutical..., Product Development, Business Alliances, Biomarker Development, Valuation, Business Modeling, Organizational..., Pharmaceutical Industry, R&D, Commercialization, Clinical Monitoring, GMP, CRO, Validation, Project Management, Clinical Development, IND, Medical Devices, Lifesciences, Regulatory Affairs, Oncology, CTMS, Biomarkers, Protocol, Sop, Translational Medicine, Technology Transfer, Change Control, GLP, FDA, Regulatory Submissions, Biopharmaceuticals, Drug Development, Clinical Research, Clinical Trials, GxP, Tissue Engineering, Drug Discovery, Assay Development, GCP, Genomics, Cancer, Monoclonal Antibodies, Cross-functional Team..., 21 CFR Part 11, Clinical Data Management, Protein Chemistry
Education
University of California, San Diego
Ph.D.
University of California, San Diego
MSE
University of Pennsylvania
BSE
Deepa Dass, MS's Imclone Systems Experience March 2007 - October 2009
Job Regulatory Affairs at Amicus Therapeutics
Industry Pharmaceuticals
Experience
Amicus Therapeutics April 2015 - Present
Eli Lilly and Company November 2012 - April 2015
Eli Lilly and Company October 2009 - October 2012
ImClone Systems March 2007 - October 2009
Skills
FDA, Cell Culture, Clinical Research, Quality Assurance, Regulatory Affairs, Regulatory Submissions, Biotechnology, Cancer, Pharmaceutical Industry
Education
Rutgers University
Master of Science (MS)
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Science (BS)
Amicus Therapeutics April 2015 - Present
Eli Lilly and Company November 2012 - April 2015
Eli Lilly and Company October 2009 - October 2012
ImClone Systems March 2007 - October 2009
Skills
FDA, Cell Culture, Clinical Research, Quality Assurance, Regulatory Affairs, Regulatory Submissions, Biotechnology, Cancer, Pharmaceutical Industry
Education
Rutgers University
Master of Science (MS)
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Science (BS)
Kathy Grzybowski's Imclone Systems Experience December 2002 - June 2011
Job Senior Accountant at NPS Pharmaceuticals
Industry Biotechnology
Experience
NPS Pharmaceuticals January 2014 - Present
IKARIA, Inc. June 2011 - January 2014
ImClone Systems December 2002 - June 2011
Doris Duke Charitable Foundation 2001 - 2002
DEK USA, Inc. 1999 - 2001
C.M. Offray & Son, Inc. 1993 - 1999
Revlon October 1991 - August 1993
Revlon February 1990 - October 1991
Revlon November 1987 - February 1990
Skills
General Ledger, Accounting, Account Reconciliation, Payroll, Accounts Payable, Forecasting, Finance, Analysis, Budgets, Accounts Receivable, Fixed Assets
Education
Rutgers University-New Brunswick 1983 — 1987
BS, Economics/Accounting
NPS Pharmaceuticals January 2014 - Present
IKARIA, Inc. June 2011 - January 2014
ImClone Systems December 2002 - June 2011
Doris Duke Charitable Foundation 2001 - 2002
DEK USA, Inc. 1999 - 2001
C.M. Offray & Son, Inc. 1993 - 1999
Revlon October 1991 - August 1993
Revlon February 1990 - October 1991
Revlon November 1987 - February 1990
Skills
General Ledger, Accounting, Account Reconciliation, Payroll, Accounts Payable, Forecasting, Finance, Analysis, Budgets, Accounts Receivable, Fixed Assets
Education
Rutgers University-New Brunswick 1983 — 1987
BS, Economics/Accounting
Meghan Brown's Imclone Systems Experience September 2008 - July 2010
Job Associate Director, Global Regulatory Affairs, Head of Regulatory Affairs at Symphogen
Industry Biotechnology
Experience
Symphogen August 2015 - Present
Genzyme January 2013 - July 2015
Genzyme July 2010 - January 2013
ImClone Systems September 2008 - July 2010
Temple University September 2004 - July 2008
Skills
Biochemistry, ELISA, Protein Chemistry, Protein Purification, PCR, In Vitro, Western Blotting, Transfection, In Vivo, Oncology, HPLC, Clinical Trials, FDA, GMP, Biotechnology, Clinical Development, Regulatory Submissions, Pharmaceutical Industry, Regulatory Affairs, IND, Biopharmaceuticals, Life Sciences, Drug Development, SOP
Education
Temple University 2004 — 2008
PhD, Biology
Temple University 2001 — 2004
B.S., Biochemistry
Symphogen August 2015 - Present
Genzyme January 2013 - July 2015
Genzyme July 2010 - January 2013
ImClone Systems September 2008 - July 2010
Temple University September 2004 - July 2008
Skills
Biochemistry, ELISA, Protein Chemistry, Protein Purification, PCR, In Vitro, Western Blotting, Transfection, In Vivo, Oncology, HPLC, Clinical Trials, FDA, GMP, Biotechnology, Clinical Development, Regulatory Submissions, Pharmaceutical Industry, Regulatory Affairs, IND, Biopharmaceuticals, Life Sciences, Drug Development, SOP
Education
Temple University 2004 — 2008
PhD, Biology
Temple University 2001 — 2004
B.S., Biochemistry
Babita Parekh's Imclone Systems Experience
Job Director at ImClone Systems
Industry Biotechnology
Experience
ImClone Systems
Skills
Technology Transfer, Biotechnology, 21 CFR Part 11, GMP, Validation, Lifesciences, Biopharmaceuticals, Sop, Pharmaceutical Industry, Drug Development, Drug Discovery, FDA, Clinical Development, CAPA, GLP, Regulatory Submissions, Chromatography, Life Sciences, SOP
Education
The Maharaja Sayajirao University of Baroda
Doctor of Philosophy (Ph.D.), Microbiology, General
ImClone Systems
Skills
Technology Transfer, Biotechnology, 21 CFR Part 11, GMP, Validation, Lifesciences, Biopharmaceuticals, Sop, Pharmaceutical Industry, Drug Development, Drug Discovery, FDA, Clinical Development, CAPA, GLP, Regulatory Submissions, Chromatography, Life Sciences, SOP
Education
The Maharaja Sayajirao University of Baroda
Doctor of Philosophy (Ph.D.), Microbiology, General
Robert Westney, M.S., RAC, CMQ/OE's Imclone Systems Experience March 2006 - October 2010
Job President, Director of Quality and Operations at Cryologics, Inc.
Industry Biotechnology
Experience
Cryologics, Inc. October 2010 - Present
Westney & Associates Consulting, LLC December 2010 - Present
ImClone Systems March 2006 - October 2010
Charles River Laboratories August 2005 - January 2006
MedImmune Vaccines June 2003 - August 2005
Diosynth August 1999 - May 2003
Certified Laboratories January 1998 - July 1999
Millennium Microbiology July 1996 - December 1997
Vitex July 1995 - July 1996
Alpharma May 1991 - July 1995
Skills
GMP, Aseptic Processing, Quality System, Microbiology, Environmental Monitoring, Regulatory Requirements, CAPA, Change Control, FDA, Quality Auditing, Biotechnology, Pharmaceutical Industry, Aseptic Technique, Quality Assurance, Quality Control, Dietary Supplements, Auditing, Consultants, Medical Devices, Pharmaceutical..., Vaccines, Deviations, Fermentation, Regulatory Submissions, Trackwise, Supplements, Manufacturing, Contract Manufacturing, Sterilization, Laboratory, FDA GMP, Biopharmaceuticals, USP, Lifesciences, Life Sciences
Education
Temple University 2004 — 2006
M.S., Quality Assurance/Regulatory Affairs
University of Vermont 1982 — 1987
B.A.
Cryologics, Inc. October 2010 - Present
Westney & Associates Consulting, LLC December 2010 - Present
ImClone Systems March 2006 - October 2010
Charles River Laboratories August 2005 - January 2006
MedImmune Vaccines June 2003 - August 2005
Diosynth August 1999 - May 2003
Certified Laboratories January 1998 - July 1999
Millennium Microbiology July 1996 - December 1997
Vitex July 1995 - July 1996
Alpharma May 1991 - July 1995
Skills
GMP, Aseptic Processing, Quality System, Microbiology, Environmental Monitoring, Regulatory Requirements, CAPA, Change Control, FDA, Quality Auditing, Biotechnology, Pharmaceutical Industry, Aseptic Technique, Quality Assurance, Quality Control, Dietary Supplements, Auditing, Consultants, Medical Devices, Pharmaceutical..., Vaccines, Deviations, Fermentation, Regulatory Submissions, Trackwise, Supplements, Manufacturing, Contract Manufacturing, Sterilization, Laboratory, FDA GMP, Biopharmaceuticals, USP, Lifesciences, Life Sciences
Education
Temple University 2004 — 2006
M.S., Quality Assurance/Regulatory Affairs
University of Vermont 1982 — 1987
B.A.
Haijun Sun's Imclone Systems Experience March 2010 - December 2012
Job Vice President, Biological Products at FStar Biotechnology Ltd
Industry Biotechnology
Experience
F-Star Biotechnology Ltd December 2012 - Present
ImClone Systems March 2010 - December 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2009 - March 2010
Skills
Project Portfolio..., Business Alliances, Research, Biotechnology, Drug Discovery, Drug Development, Oncology
Education
New York University - Leonard N. Stern School of Business 1999 — 2004
MBA, Management and Finance
University of Cincinnati 1991 — 1996
PhD, Biochemistry
UC Berkeley
Project Management Workshop
BD Basic course
BD course in Boston
F-Star Biotechnology Ltd December 2012 - Present
ImClone Systems March 2010 - December 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2009 - March 2010
Skills
Project Portfolio..., Business Alliances, Research, Biotechnology, Drug Discovery, Drug Development, Oncology
Education
New York University - Leonard N. Stern School of Business 1999 — 2004
MBA, Management and Finance
University of Cincinnati 1991 — 1996
PhD, Biochemistry
UC Berkeley
Project Management Workshop
BD Basic course
BD course in Boston
Diane Judkins's Imclone Systems Experience 2007 - March 2013
Job Executive Assistant & Office Coordinator at Taiho Pharma USA Inc
Industry Biotechnology
Experience
Taiho Oncology Inc. January 2014 - Present
Dendreon Corporation April 2013 - November 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2007 - March 2013
ImClone Systems 2007 - March 2013
GPC Biotech April 2008 - August 2008
OneBeacon Insurance May 1995 - March 2004
OneBeacon Insurance May 1995 - March 2004
Atlantic Mutual Companies May 1995 - March 2004
Atlantic Mutual 1974 - 2004
Skills
Access, Quality Assurance, Underwriting, Insurance, Outlook, Concur, Administrative..., Commercial Insurance, Pharmaceutical Industry, Software Documentation, Office Management, Microsoft Excel, Marketing, Human Resources, Time Management, PowerPoint
Education
Union County College
Finance
Taiho Oncology Inc. January 2014 - Present
Dendreon Corporation April 2013 - November 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2007 - March 2013
ImClone Systems 2007 - March 2013
GPC Biotech April 2008 - August 2008
OneBeacon Insurance May 1995 - March 2004
OneBeacon Insurance May 1995 - March 2004
Atlantic Mutual Companies May 1995 - March 2004
Atlantic Mutual 1974 - 2004
Skills
Access, Quality Assurance, Underwriting, Insurance, Outlook, Concur, Administrative..., Commercial Insurance, Pharmaceutical Industry, Software Documentation, Office Management, Microsoft Excel, Marketing, Human Resources, Time Management, PowerPoint
Education
Union County College
Finance
Eva Henry's Imclone Systems Experience January 2007 - November 2008
Job Manger, QA Operations at the Clinical Cell and Vaccine Production Facility at the University of Pennsylvania
Industry Biotechnology
Experience
Clinical Cell and Vaccine Production Facility at the University of Pennsylvania August 2014 - Present
Hospital of the University of Pennsylvania November 2008 - August 2014
IMCLONE SYSTEMS January 2007 - November 2008
IMCLONE SYSTEMS August 2004 - December 2006
INSTITUTE OF MARINE AND COASTAL SCIENCES January 2003 - August 2004
IBM May 2001 - January 2004
COOK January 2001 - May 2002
Skills
GMP, Sop, LIMS, FDA, Biochemistry, Validation, Quality Assurance, Laboratory, CAPA, Clinical Trials
Education
University of Medicine and Dentistry of New Jersey 2008 — 2010
Graduate Certificate, Clinical Trials Informatics
University of Maryland University College 2005 — 2007
MS, Biotechnology Management
Rutgers University-New Brunswick 2000 — 2004
BS, Biotechnology
Clinical Cell and Vaccine Production Facility at the University of Pennsylvania August 2014 - Present
Hospital of the University of Pennsylvania November 2008 - August 2014
IMCLONE SYSTEMS January 2007 - November 2008
IMCLONE SYSTEMS August 2004 - December 2006
INSTITUTE OF MARINE AND COASTAL SCIENCES January 2003 - August 2004
IBM May 2001 - January 2004
COOK January 2001 - May 2002
Skills
GMP, Sop, LIMS, FDA, Biochemistry, Validation, Quality Assurance, Laboratory, CAPA, Clinical Trials
Education
University of Medicine and Dentistry of New Jersey 2008 — 2010
Graduate Certificate, Clinical Trials Informatics
University of Maryland University College 2005 — 2007
MS, Biotechnology Management
Rutgers University-New Brunswick 2000 — 2004
BS, Biotechnology
Brian Testa's Imclone Systems Experience May 2013 - Present
Job Validation Engineer at Imclone Systems
Industry Pharmaceuticals
Experience
Imclone Systems May 2013 - Present
Imclone Systems April 2008 - April 2013
Skills
Validation, Lifesciences, Biotechnology, GLP, Cell Culture, GMP
Education
Stevens Institute of Technology 2002 — 2007
BE, Biomedical Engineering
Stevens Institute of Technology 2002 — 2007
Bachelor of Engineering (B.E.), Biomedical/Medical Engineering
Imclone Systems May 2013 - Present
Imclone Systems April 2008 - April 2013
Skills
Validation, Lifesciences, Biotechnology, GLP, Cell Culture, GMP
Education
Stevens Institute of Technology 2002 — 2007
BE, Biomedical Engineering
Stevens Institute of Technology 2002 — 2007
Bachelor of Engineering (B.E.), Biomedical/Medical Engineering
Jared McGuckin's Imclone Systems Experience December 2009 - July 2011
Job Experienced Office Operations Professional
Industry Facilities Services
Experience
ImClone Systems December 2009 - July 2011
HIT Entertainment June 2007 - April 2009
Plattsburgh State University October 2004 - May 2007
Upward Bound April 2006 - August 2006
Transworld Entertainment May 2000 - October 2003
Skills
Customer Service, Social Media, Microsoft Office, Event Planning, Event Management, Management, Inventory Management, Sales, Microsoft Excel, Time Management, Process Scheduler, Retail, Outlook, Microsoft Word, PowerPoint, Public Speaking, Budgets, Customer Satisfaction, Marketing, Critical Thinking, Facilities Management, Problem Solving, Dispatching
Education
SUNY Plattsburgh 2004 — 2007
Bachelor of Applied Science (B.A.Sc.), History, 3.5
ImClone Systems December 2009 - July 2011
HIT Entertainment June 2007 - April 2009
Plattsburgh State University October 2004 - May 2007
Upward Bound April 2006 - August 2006
Transworld Entertainment May 2000 - October 2003
Skills
Customer Service, Social Media, Microsoft Office, Event Planning, Event Management, Management, Inventory Management, Sales, Microsoft Excel, Time Management, Process Scheduler, Retail, Outlook, Microsoft Word, PowerPoint, Public Speaking, Budgets, Customer Satisfaction, Marketing, Critical Thinking, Facilities Management, Problem Solving, Dispatching
Education
SUNY Plattsburgh 2004 — 2007
Bachelor of Applied Science (B.A.Sc.), History, 3.5
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY