Biota Pharmaceuticals
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Biota Pharmaceuticals Employees
Employee
Years
Job
Industry
Bindi Patel Bindi Patel's Biota Pharmaceuticals Experience November 2014 - Present
Job Clinical Research Professional
Industry Pharmaceuticals
Experience
Biota Pharmaceuticals November 2014 - Present
Sanuwave, Inc. August 2008 - November 2012
Sanuwave, Inc. November 2007 - August 2008
Sanuwave, Inc. (formerly HealthTronics) June 2003 - November 2007
Skills
Clinical Research, Clinical Trials, Clinical Monitoring, Clinical Protocols, SOP development, GCP, FDA, Regulatory Requirements, Regulatory Submissions, Medical Devices, Budgets, Orthopedic, Wound Care, Oracle Clinical, Remote Data Capture, Medical Terminology, Health Insurance, Medical Billing
Education
Life University 2000 — 2002
Bachelor of Science (B.S.), Healthcare Management
Biota Pharmaceuticals November 2014 - Present
Sanuwave, Inc. August 2008 - November 2012
Sanuwave, Inc. November 2007 - August 2008
Sanuwave, Inc. (formerly HealthTronics) June 2003 - November 2007
Skills
Clinical Research, Clinical Trials, Clinical Monitoring, Clinical Protocols, SOP development, GCP, FDA, Regulatory Requirements, Regulatory Submissions, Medical Devices, Budgets, Orthopedic, Wound Care, Oracle Clinical, Remote Data Capture, Medical Terminology, Health Insurance, Medical Billing
Education
Life University 2000 — 2002
Bachelor of Science (B.S.), Healthcare Management
Uday Patel, RAC (US, EU) Uday Patel, RAC (US, EU)'s Biota Pharmaceuticals Experience June 2014 - Present
Job Vice President Regulatory Affairs at Biota Pharmaceuticals
Industry Pharmaceuticals
Experience
Biota Pharmaceuticals June 2014 - Present
Independent September 2012 - June 2014
Inhibitex, Inc., a Subsidiary of Bristol-Myers Squibb July 2010 - August 2012
Peptimmune January 2009 - July 2010
Peptimmune, Inc. October 2004 - January 2009
Altus Pharmaceuticals July 1997 - October 2004
Biopure 1991 - 1997
Skills
Clinical Development, FDA, Clinical Trials, Regulatory Affairs, Pharmaceutical Industry, Supply Chain Management, Regulatory Submissions, Quality Assurance, GxP, Analytical Chemistry, eCTD, Quality Auditing, Due Diligence, GLP, GMP, ICH guidelines, API manufacturing, Solid Oral Dosage Forms, Parenteral, Stability Testing, CTAs, Documentum, eRoom, Analytical Method..., Clinical Research, Protocol Review, Investigator Brochures, Annual Reports, SAP, Safety Compliance, Archival Management, EMA, Training Programs, GCPs, Formulation, Drug Development, Biotechnology, Technology Transfer, Validation, CAPA, Sop, Change Control, Drug Discovery, IND, Biologics, Infectious Diseases, Employee Management, GCP, Quality System
Education
Harvard University 1997 — 2007
Masters (ALM), Biology
Suffolk University 1987 — 1991
BS, Biochemistry
Vidya Kunj Navasari 1975 — 1981
Biota Pharmaceuticals June 2014 - Present
Independent September 2012 - June 2014
Inhibitex, Inc., a Subsidiary of Bristol-Myers Squibb July 2010 - August 2012
Peptimmune January 2009 - July 2010
Peptimmune, Inc. October 2004 - January 2009
Altus Pharmaceuticals July 1997 - October 2004
Biopure 1991 - 1997
Skills
Clinical Development, FDA, Clinical Trials, Regulatory Affairs, Pharmaceutical Industry, Supply Chain Management, Regulatory Submissions, Quality Assurance, GxP, Analytical Chemistry, eCTD, Quality Auditing, Due Diligence, GLP, GMP, ICH guidelines, API manufacturing, Solid Oral Dosage Forms, Parenteral, Stability Testing, CTAs, Documentum, eRoom, Analytical Method..., Clinical Research, Protocol Review, Investigator Brochures, Annual Reports, SAP, Safety Compliance, Archival Management, EMA, Training Programs, GCPs, Formulation, Drug Development, Biotechnology, Technology Transfer, Validation, CAPA, Sop, Change Control, Drug Discovery, IND, Biologics, Infectious Diseases, Employee Management, GCP, Quality System
Education
Harvard University 1997 — 2007
Masters (ALM), Biology
Suffolk University 1987 — 1991
BS, Biochemistry
Vidya Kunj Navasari 1975 — 1981
John Vernachio John Vernachio's Biota Pharmaceuticals Experience September 2014 - Present
Job V.P. PreClinical Development at Biota Pharmaceuticals
Industry Biotechnology
Experience
Biota Pharmaceuticals September 2014 - Present
Arthritis Foundation April 2013 - October 2013
Inhibitex 2007 - August 2012
Inhibitex 2004 - 2007
Inhibitex 1998 - 2003
Valentis 1998 - 1998
Valentis 1997 - 1998
Baxter Healthcare 1994 - 1997
Baxter Healthcare 1993 - 1994
Baxter Healthcare 1991 - 1993
Skills
Assay Development, Protein Purification, Technology Transfer, Pharmaceutical Industry, Clinical Trials, GLP, Sop, Regulatory Affairs, Immunology, Protein Chemistry, Vaccines, Biology, Validation, FDA, Microbiology, Regulatory Submissions, Employee Management, SOP, Clinical Research
Education
The Johns Hopkins University School of Medicine 1984 — 1989
Ph.D., Biochemistry
University of Vermont 1980 — 1984
B.S., Animal Sciences
Biota Pharmaceuticals September 2014 - Present
Arthritis Foundation April 2013 - October 2013
Inhibitex 2007 - August 2012
Inhibitex 2004 - 2007
Inhibitex 1998 - 2003
Valentis 1998 - 1998
Valentis 1997 - 1998
Baxter Healthcare 1994 - 1997
Baxter Healthcare 1993 - 1994
Baxter Healthcare 1991 - 1993
Skills
Assay Development, Protein Purification, Technology Transfer, Pharmaceutical Industry, Clinical Trials, GLP, Sop, Regulatory Affairs, Immunology, Protein Chemistry, Vaccines, Biology, Validation, FDA, Microbiology, Regulatory Submissions, Employee Management, SOP, Clinical Research
Education
The Johns Hopkins University School of Medicine 1984 — 1989
Ph.D., Biochemistry
University of Vermont 1980 — 1984
B.S., Animal Sciences
Jimmy Humrich's Biota Pharmaceuticals Experience December 2013 - Present
Job IT Manager
Industry Information Technology and Services
Experience
Biota Pharmaceuticals December 2013 - Present
Interdev November 2012 - December 2013
Prudential Georgia Realty October 2010 - December 2012
Inhibitex 2010 - November 2012
B Virtual Inc April 2010 - October 2012
Inhibitex 2006 - 2010
Inhibitex May 2004 - 2006
STI Knowledge 2001 - 2004
Global Computer Supplies 1999 - 2001
Skills
HP Proliant, Cisco Call Manager, Sophos, Web Design, Metasys, Microsoft Exchange, Windows 8, Mitel 3300, Cudatel, Cisco VoIP, Lenovo, Office 365, Microsoft Office, iPhone, Dell PowerEdge Servers, VMware ESX, Fortigate, Cisco Routers, Enterasys, Barracuda Spam Filter, Ricoh, Symantec Endpoint..., Microsoft Dynamics
Education
Gwinnett Technical College 2002 — 2003
Network Administrator Certificate
Biota Pharmaceuticals December 2013 - Present
Interdev November 2012 - December 2013
Prudential Georgia Realty October 2010 - December 2012
Inhibitex 2010 - November 2012
B Virtual Inc April 2010 - October 2012
Inhibitex 2006 - 2010
Inhibitex May 2004 - 2006
STI Knowledge 2001 - 2004
Global Computer Supplies 1999 - 2001
Skills
HP Proliant, Cisco Call Manager, Sophos, Web Design, Metasys, Microsoft Exchange, Windows 8, Mitel 3300, Cudatel, Cisco VoIP, Lenovo, Office 365, Microsoft Office, iPhone, Dell PowerEdge Servers, VMware ESX, Fortigate, Cisco Routers, Enterasys, Barracuda Spam Filter, Ricoh, Symantec Endpoint..., Microsoft Dynamics
Education
Gwinnett Technical College 2002 — 2003
Network Administrator Certificate
Anne VanLent Anne VanLent's Biota Pharmaceuticals Experience May 2013 - Present
Job Financial consultant for emerging growth life sciences companies, public company director
Industry Pharmaceuticals
Experience
Onconova Therapeutics July 2013 - Present
Biota Pharmaceuticals May 2013 - Present
Aegerion Pharmaceuticals March 2013 - Present
AMV Advisors May 2008 - Present
Ocera Therapeutics March 2011 - Present
Integra LifeSciences December 2004 - May 2013
Penwest Pharmaceuticals July 1997 - November 2010
Barrier Therapeutics May 2002 - May 2008
Sarnoff Corporation August 1997 - October 2001
The Liposome Company, Inc. March 1985 - February 1993
Skills
Venture Capital, IPO, Licensing, Intellectual Property, Managerial Finance, Lifesciences, Pharmaceutical Industry, Biotechnology, Due Diligence, Patents, Mergers, Medical Devices, Strategic Planning, Business Planning, Start-ups
Education
University de Strasbourg, France 1970 — 1971
graduate courses, Biophysics
Mount Holyoke College 1966 — 1970
Bachelor of Arts (B.A.), Physics
Onconova Therapeutics July 2013 - Present
Biota Pharmaceuticals May 2013 - Present
Aegerion Pharmaceuticals March 2013 - Present
AMV Advisors May 2008 - Present
Ocera Therapeutics March 2011 - Present
Integra LifeSciences December 2004 - May 2013
Penwest Pharmaceuticals July 1997 - November 2010
Barrier Therapeutics May 2002 - May 2008
Sarnoff Corporation August 1997 - October 2001
The Liposome Company, Inc. March 1985 - February 1993
Skills
Venture Capital, IPO, Licensing, Intellectual Property, Managerial Finance, Lifesciences, Pharmaceutical Industry, Biotechnology, Due Diligence, Patents, Mergers, Medical Devices, Strategic Planning, Business Planning, Start-ups
Education
University de Strasbourg, France 1970 — 1971
graduate courses, Biophysics
Mount Holyoke College 1966 — 1970
Bachelor of Arts (B.A.), Physics
Carlos Morejon Carlos Morejon's Biota Pharmaceuticals Experience 1997 - 2000
Job Senior Staff Accountant at DRB Capital
Industry Financial Services
Experience
DRB Capital 2015 - Present
DHL 2009 - 2015
DHL 2008 - 2009
DHL 2007 - 2008
Concord Camera 2005 - 2006
Honeywell Analytics (formally Zellweger Analytics Distribuition, Inc.) 2003 - 2005
Biota Pharmaceuticals (formally Nabi Biopharmaceuticals, Inc.) 2000 - 2003
Biota Pharmaceuticals 1997 - 2000
Blockbuster 1995 - 1996
Skills
Financial Analysis, Budget Management, Forecasting, Cost Variance Analysis, Financial Reporting, Monthly Close Process, SAP, Cost Control, Cost Reduction..., Process Improvement, Procurement, Supply Chain, Business Process..., Change Management, Operations Management, Project Management, Cross-functional Team..., Microsoft Excel, MS Excel Pivot Tables, Microsoft Word, Outlook, Trend Analysis
Education
Clemson University
Bachelor's Degree, Accounting and Business/Management
DRB Capital 2015 - Present
DHL 2009 - 2015
DHL 2008 - 2009
DHL 2007 - 2008
Concord Camera 2005 - 2006
Honeywell Analytics (formally Zellweger Analytics Distribuition, Inc.) 2003 - 2005
Biota Pharmaceuticals (formally Nabi Biopharmaceuticals, Inc.) 2000 - 2003
Biota Pharmaceuticals 1997 - 2000
Blockbuster 1995 - 1996
Skills
Financial Analysis, Budget Management, Forecasting, Cost Variance Analysis, Financial Reporting, Monthly Close Process, SAP, Cost Control, Cost Reduction..., Process Improvement, Procurement, Supply Chain, Business Process..., Change Management, Operations Management, Project Management, Cross-functional Team..., Microsoft Excel, MS Excel Pivot Tables, Microsoft Word, Outlook, Trend Analysis
Education
Clemson University
Bachelor's Degree, Accounting and Business/Management
Samantha Magazu's Biota Pharmaceuticals Experience September 2015 - Present
Job Regulatory Affairs Manager at Biota Pharmaceuticals
Industry Pharmaceuticals
Experience
Biota Pharmaceuticals September 2015 - Present
Alimera Sciences October 2014 - September 2015
Alimera Sciences June 2011 - October 2014
Alimera Sciences April 2009 - June 2011
Alimera Sciences July 2008 - April 2009
Kestrel Health Information September 2006 - February 2008
Skills
Pharmaceutical Industry, Clinical Trials, Clinical Research, Drug Safety, Biotechnology, Clinical Development, FDA, Medical Devices, Regulatory Affairs, GCP, Argus Safety, Pharmacovigilance, SOP, Regulatory Requirements, Medical Affairs, Regulatory Submissions, MedDRA
Education
The University of Georgia 2011 — 2013
MS, Pharmacy with emphasis in Regulatory Affairs
The University of Georgia 2011 — 2012
Graduate Certificate, Clinical Trials Design and Management
The University of Georgia 2009 — 2010
Graduate Certificate, Regulatory Affairs
University of Vermont 2004 — 2006
Bachelor of Arts, English
University of Massachusetts, Amherst 2002 — 2004
Italian, English
Biota Pharmaceuticals September 2015 - Present
Alimera Sciences October 2014 - September 2015
Alimera Sciences June 2011 - October 2014
Alimera Sciences April 2009 - June 2011
Alimera Sciences July 2008 - April 2009
Kestrel Health Information September 2006 - February 2008
Skills
Pharmaceutical Industry, Clinical Trials, Clinical Research, Drug Safety, Biotechnology, Clinical Development, FDA, Medical Devices, Regulatory Affairs, GCP, Argus Safety, Pharmacovigilance, SOP, Regulatory Requirements, Medical Affairs, Regulatory Submissions, MedDRA
Education
The University of Georgia 2011 — 2013
MS, Pharmacy with emphasis in Regulatory Affairs
The University of Georgia 2011 — 2012
Graduate Certificate, Clinical Trials Design and Management
The University of Georgia 2009 — 2010
Graduate Certificate, Regulatory Affairs
University of Vermont 2004 — 2006
Bachelor of Arts, English
University of Massachusetts, Amherst 2002 — 2004
Italian, English
Kyle Callicott's Biota Pharmaceuticals Experience 2013 - Present
Job Consultant Medical Writer at Biota Pharmaceuticals
Industry Pharmaceuticals
Experience
Biota Pharmaceuticals 2013 - Present
Salamandra, LLC May 2008 - Present
UCB Pharma 1998 - 2008
Skills
Clinical Development, Pharmacovigilance, Pharmaceutical Industry, Medical Writing, Clinical Trials, FDA, Immunology, Regulatory Submissions, GCP, Clinical Research, Sop, Biotechnology, Oncology, Regulatory Affairs, Lifesciences, CRO, Infectious Diseases, SOP
Education
The University of Kansas 1987 — 1998
Biota Pharmaceuticals 2013 - Present
Salamandra, LLC May 2008 - Present
UCB Pharma 1998 - 2008
Skills
Clinical Development, Pharmacovigilance, Pharmaceutical Industry, Medical Writing, Clinical Trials, FDA, Immunology, Regulatory Submissions, GCP, Clinical Research, Sop, Biotechnology, Oncology, Regulatory Affairs, Lifesciences, CRO, Infectious Diseases, SOP
Education
The University of Kansas 1987 — 1998
Elizabeth Hobbs's Biota Pharmaceuticals Experience February 2014 - Present
Job at
Industry Pharmaceuticals
Experience
Biota Pharmaceuticals February 2014 - Present
ReSearch Pharmaceutical Services August 2012 - February 2014
ReSearch Pharmaceutical Services December 2011 - July 2012
Quintiles February 2011 - December 2011
Kforce dedicated to Takeda August 2009 - February 2011
UCB Pharma 2003 - March 2009
Sanuwave 2009 - 2009
WCT 1998 - 2001
Skills
Clinical Development, Clinical Trials, CRO, GCP, ICH-GCP, Clinical Monitoring, Pharmaceutical Industry, Clinical Research, Trial Management, Sop, Drug Development, Protocol, Rheumatology, Clinical Operations, Immunology, Psychiatry
Education
Emory University 1993 — 1997
Bachelor of Arts (B.A.), Psychology
Biota Pharmaceuticals February 2014 - Present
ReSearch Pharmaceutical Services August 2012 - February 2014
ReSearch Pharmaceutical Services December 2011 - July 2012
Quintiles February 2011 - December 2011
Kforce dedicated to Takeda August 2009 - February 2011
UCB Pharma 2003 - March 2009
Sanuwave 2009 - 2009
WCT 1998 - 2001
Skills
Clinical Development, Clinical Trials, CRO, GCP, ICH-GCP, Clinical Monitoring, Pharmaceutical Industry, Clinical Research, Trial Management, Sop, Drug Development, Protocol, Rheumatology, Clinical Operations, Immunology, Psychiatry
Education
Emory University 1993 — 1997
Bachelor of Arts (B.A.), Psychology
Kathy Dorsey's Biota Pharmaceuticals Experience March 2014 - Present
Job Sr. Clinical Project Manager Biota Pharmaceuticals
Industry Pharmaceuticals
Experience
Biota Pharmaceuticals March 2014 - Present
Inventive Health Clinical - on assignment with Takeda Pharmaceuticals September 2011 - March 2014
Quintiles September 2010 - September 2011
Alimera Sciences August 2009 - August 2010
UCB Pharma September 2004 - June 2008
Skills
CTMS, Clinical Development, GCP, CRO, Clinical Trials, EDC, Drug Development, Regulatory Submissions, ICH-GCP, Therapeutic Areas, Clinical Monitoring, Clinical Data Management, Pharmaceutical Industry, Oncology, Medical Affairs, Medical Writing, Pharmacovigilance, Clinical Research, Clinical Operations
Education
Southern Connecticut State University 1997 — 2000
Bachelors, Physiology
Biota Pharmaceuticals March 2014 - Present
Inventive Health Clinical - on assignment with Takeda Pharmaceuticals September 2011 - March 2014
Quintiles September 2010 - September 2011
Alimera Sciences August 2009 - August 2010
UCB Pharma September 2004 - June 2008
Skills
CTMS, Clinical Development, GCP, CRO, Clinical Trials, EDC, Drug Development, Regulatory Submissions, ICH-GCP, Therapeutic Areas, Clinical Monitoring, Clinical Data Management, Pharmaceutical Industry, Oncology, Medical Affairs, Medical Writing, Pharmacovigilance, Clinical Research, Clinical Operations
Education
Southern Connecticut State University 1997 — 2000
Bachelors, Physiology
Vicki Cloutier's Biota Pharmaceuticals Experience January 2015 - Present
Job Associate Director of Quality at Biota Pharmaceuticals
Industry Pharmaceuticals
Experience
Biota Pharmaceuticals January 2015 - Present
Abbott September 2010 - January 2015
Abbott April 2006 - September 2010
Abbott Vascular Devices April 1996 - June 2004
Guidant 1999 - 2002
Skills
Quality System, Quality Assurance, GMP, Quality Management, ISO 13485, Medical Devices, 21 CFR Part 11, SDLC, FDA, Testing, Computer System..., Process Improvement, Software Project..., Project Management, Strategic Planning, Organizational..., Team Leadership, CAPA, Validation, Quality Sustem..., FDA GMP, GLP Auditing, Quality System Auditing, Software Validation, Organization, Supervisory Skills, Quality Auditing, Software Quality..., Complaince, Standards Compliance, Auditing, Procedure Development, Procedure Review, Risk Management, Training, Development & delivery..., V&V
Education
Ashford University 2008 — 2009
BA Organizational Management, Management and Strategic Palnning
Palomar College 1991 — 1994
AA Quality Assurance Technology, Quality Control Technology/Technician
Edinboro University of Pennsylvania 1983 — 1986
Biology / Secondary Education
Biota Pharmaceuticals January 2015 - Present
Abbott September 2010 - January 2015
Abbott April 2006 - September 2010
Abbott Vascular Devices April 1996 - June 2004
Guidant 1999 - 2002
Skills
Quality System, Quality Assurance, GMP, Quality Management, ISO 13485, Medical Devices, 21 CFR Part 11, SDLC, FDA, Testing, Computer System..., Process Improvement, Software Project..., Project Management, Strategic Planning, Organizational..., Team Leadership, CAPA, Validation, Quality Sustem..., FDA GMP, GLP Auditing, Quality System Auditing, Software Validation, Organization, Supervisory Skills, Quality Auditing, Software Quality..., Complaince, Standards Compliance, Auditing, Procedure Development, Procedure Review, Risk Management, Training, Development & delivery..., V&V
Education
Ashford University 2008 — 2009
BA Organizational Management, Management and Strategic Palnning
Palomar College 1991 — 1994
AA Quality Assurance Technology, Quality Control Technology/Technician
Edinboro University of Pennsylvania 1983 — 1986
Biology / Secondary Education