Pearl Therapeutics
Industry: Commercial company
DescriptionHeadquarters: Redwood City, CA Founded: 2006 Parent organization: AstraZeneca
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Pearl Therapeutics Employees
VWR March 2015 - Present
Pearl Therapeutics April 2013 - June 2013
LS9, Inc. November 2011 - April 2013
LS9, Inc. September 2011 - October 2012
Genentech November 2009 - November 2011
Genencor, A Danisco Division May 2008 - April 2009
Skills
GMP, Cell, Fermentation, Laboratory, Protein Purification, Sop, Manufacturing, Product Development, Filtration, Quality Control, Chromatography, Aseptic Technique, Validation, Biopharmaceuticals, Assay Development, Purification, Biotechnology, LIMS
Education
Skyline College 2006 — 2008
Biomanufacturing GMP Cartified, Biology-Chemistry, 3.75
Skyline College 2006 — 2008
GMP Biotech Manufacturing Cetificate, Biology/Chemistry
Pearl Therapeutics March 2015 - Present
JMS Research Group October 2012 - December 2014
Skills
Teamwork, Microsoft Word, Time Management, Leadership, Matlab, Sample Preparation, Customer Service, Critical Thinking, Scanning Electron..., Microsoft Office, PowerPoint, CNC manufacturing, Lathe, Milling, Microsoft Excel, Data Entry, First Aid, Pharmaceutical process...
Education
UC Davis 2010 — 2014
Bachelor of Science (B.S.), Mechanical Engineering with a Minor in Materials Science, 4th Year
Pearl Therapeutics June 2014 - Present
The National Food Laboratory January 2014 - May 2014
Mattson & Co. November 2013 - December 2013
The Intrinsic Group August 2013 - October 2013
Cal Poly State University August 2011 - June 2013
Pearl Therapeutics January 2011 - July 2011
URL Pharma September 2008 - June 2010
Skills
HPLC, Analytical Chemistry, Chromatography, Regulatory Submissions, UV/Vis, GMP, Chemistry, Quality Control, GLP, IR, Statistics, JMP, Minitab, Quantitative Research, PowerPoint, Microsoft Excel, Microsoft Word, LC-MS/MS, TLC
Education
Cal Poly San Luis Obispo 2011 — 2013
M.S., Agriculture with Specialization in Dairy Products Technology
University of California, Santa Barbara 2004 — 2008
B.A., Chemistry
Pearl Therapeutics March 2013 - Present
Pearl Therapeutics November 2011 - March 2013
Skills
GMP, GLP, Biotechnology
Education
University of California, Davis 2004 — 2009
Bachelor's degree, Biotechnology - Microbiology
Pearl Therapeutics February 2015 - Present
Genentech July 2013 - February 2015
UC Davis Medical Center, Radiology April 2013 - June 2013
County Referral Committee June 2012 - April 2013
Paul Hom Asian Clinic March 2011 - April 2013
Dean Tantillo Lab January 2012 - September 2012
UC Davis February 2011 - July 2012
UC Davis Medical Center October 2011 - December 2011
American Red Cross August 2006 - August 2009
UCSF September 2008 - June 2009
Skills
Spectrophotometry, Enzyme Assays, Protein purification, Western blot analysis, HPLC, Communications, Leadership, Microsoft Office, Highly responsible, Highly self-motivated, Gel Electrophoresis, Protein Purification, Molecular Biology, Western Blotting
Education
University of California, Davis 2009 — 2013
Bachelor's degree, Biochemistry and Molecular Biology
Academia Sinica 2012 — 2012
Pharmaceutical Chemistry
George Washington High School 2006 — 2009
Novo Nordisk June 2013 - Present
Merck February 2012 - February 2013
Forest Laboratories November 2009 - November 2011
Roche September 2009 - October 2009
Pearl Therapeutics January 2009 - June 2009
Schering-Plough Research Institute January 2007 - December 2008
Forest Laboratories January 2002 - December 2006
Skills
Clinical Trials, ICH-GCP, GCP, CTMS, Clinical Research, IRB, Clinical Development, Therapeutic Areas, Clinical Data Management, EDC, Software Documentation, Oncology, Clinical Monitoring, Medical Writing, Regulatory Submissions, Sop, SOP
Education
Ashford University 2010 — 2012
M.A., Healthcare Administration
Ashford University 2008 — 2010
B.A., Sociology
Ashford University 2006 — 2008
B.A., Psychology
Pearl Therapeutics January 2014 - Present
Bayer HealthCare September 2001 - Present
Novartis 2003 - 2007
Chiron Corporation 2001 - 2003
Skills
FDA, GMP, Quality Assurance, Sop, Quality Control, Trackwise, Biopharmaceuticals, CAPA, 21 CFR Part 11, Manufacturing, GxP, Validation, Computer System..., Quality Auditing, Change Control, TrackWise, SOP, Pharmaceutical Industry
Education
Polytechnic University of the Philippines
Steno, Typing and Accounting
Pearl Therapeutics May 2014 - Present
Biogen Idec August 2013 - September 2013
PPD June 2013 - August 2013
Charles River Laboratories December 2011 - June 2012
Premier Research Group December 2010 - August 2011
Rho September 2005 - August 2010
Skills
Filing, Typing, Microsoft Office, Oracle Clinical, Excel, Outlook, Organizing, EDC, SAS, Data Entry, Lotus Notes, Queries, CRF design, Meeting Deadlines, Attention To Detail, Document Scanning, Microsoft Excel, GCP, Quality Assurance, Clinical Trials, Sop, Access, Data Management, Software Documentation, SOP
Education
North Carolina Central University 2009 — 2013
Bachelor of Science, Biology
Southern High School 1997 — 1999
High School Diploma, Computer Applications
Pearl Therapeutics March 2014 - Present
Merck August 2012 - March 2014
Novartis Pharmaceuticals March 2007 - July 2012
Novartis Pharmaceuticals November 2003 - March 2007
Skills
HPLC, UHPLC, GC, Dissolution, TLC, FTIR, LC/MS, Karl Fischer, Capillary separations, Quality by Design, Method development, Method validation, Method transfer, LC-MS, Method Transfer, Method Development, GMP, R&D, Gas Chromatography, Validation, V&V, Analytical Chemistry, Pharmaceutical Industry, Clinical Development, Sop, Formulation, Protein Chemistry, SOP
Education
University of North Carolina at Chapel Hill 1998 — 2003
Ph.D.
Illinois Wesleyan University 1994 — 1998
B.A.
5AM Ventures January 2005 - June 2013
Kinestral Technologies 2010 - 2013
DVS Sciences Inc. 2010 - 2013
Rennovia, Inc. 2009 - 2013
PhaseRx 2008 - 2013
KaloBios 2007 - 2013
Wildcat Discovery Technologies 2006 - 2013
Pearl Therapeutics 2006 - 2013
Ambrx 2005 - 2011
Achaogen 2005 - 2011
Skills
Lifesciences, Biotechnology, Commercialization, Business Strategy, Venture Capital, Corporate Development, Cleantech, Venture Financing, Mergers, Private Equity, Due Diligence, Start-ups, Pharmaceutical Industry, Technology Transfer, Strategy, Valuation, Licensing, Medical Devices, LBO, IPO, Entrepreneurship, Mergers & Acquisitions, Drug Development, Angel Investing, R&D, Clinical Development, Biopharmaceuticals, Drug Discovery
Education
Emory University 1996 — 2000
PhD, Chemistry
University of North Carolina at Chapel Hill 1990 — 1994
BS, Chemistry
Simon-Kucher & Partners August 2014 - Present
NYU Langone Medical Center June 2012 - August 2012
Pearl Therapeutics June 2011 - August 2011
Education
Princeton University 2010 — 2014
A.B., Anthropology, Global Health and Health Policy, Cum laude
Pearl Therapeutics September 2014 - Present
Express Scripts March 2013 - September 2014
Medco Health Solutions 2009 - 2011
MannKind Corporation 2007 - 2009
D & O PHARMACHEM 2003 - 2007
Skills
Microsoft Windows 98 -..., Excel 2003, Website Development, Training & Development, SharePoint, Affinium, JDEdwards, Trial Works (ClinPhone), Gelco / Concur /..., Enterprise Document..., Filemaker Developer 6..., Act 2000, Lotus Notes, Outlook, Invoicing, Sop, PowerPoint, Access, Administrative..., Software Documentation, Concur, Analysis, Coordination, Multitasking Skills, Organization, Outstanding time..., PeopleSoft, SOP, Self-starter
Education
Dover Business College 2003 — 2004
Certificate, Computer Information Specialist
Pearl Therapeutics February 2011 - Present
Covidien, Pharmaceutical Products 2008 - March 2011
Valeant Pharmaceuticals September 2004 - April 2008
GlaxoSmithKline 1983 - 2001
Education
University of Dayton 1984 — 1986
MBA, Finance
The Ohio State University Fisher College of Business 1980 — 1982
BS, Marketing
Pearl Therapeutics May 2014 - Present
AstraZeneca October 2000 - April 2014
Aventis 1997 - 2000
Magellan Laboratories Incorporated 1995 - 1997
Glaxo Inc. 1986 - 1988
Glaxo Inc. 1986 - 1988
Warner Lambert 1985 - 1986
Skills
CMC, Pharmaceutics, Regulatory Documentation, Regulatory Submissions, Drug Development, Regulatory Affairs, Pharmaceutical Industry, FDA
Education
University of Michigan 1981 — 1985
PharmD, Pharmacy
University of Illinois at Urbana-Champaign 1979 — 1981
Pearl Therapeutics March 2014 - Present
KBI BioPharma February 2010 - March 2014
Diosynth January 2008 - February 2010
Skills
Biopharmaceuticals, Protein Chemistry, Chromatography, GMP, HPLC, Biotechnology, Technology Transfer, Assay Development, UV/Vis, Microbiology, GLP, Quality Control, Aseptic Technique, Analytical Chemistry, Fermentation, LIMS, SDS-PAGE, ELISA, Protein Purification, Capillary..., Western Blotting, Analytical Method..., Glycobiology, DLS, Differential Scanning..., Formulation, Particle Size Analysis, Binding Assays, Monoclonal Antibodies, MS Excel Pivot Tables, Microsoft Excel, Data Analysis
Education
North Carolina State University 2004 — 2007
B.S., Chemistry, Food Science
Wake Technical Community College 2002 — 2004
Associate's Degree, Culinary Arts/Chef Training
Pearl Therapeutics August 2015 - Present
AstraZeneca August 2014 - Present
AstraZeneca June 2000 - July 2014
School of Pharmacy, University of North Carolina May 1994 - May 2000
School of Pharmacy, University of British Columbia July 1989 - May 1994
Skills
Clinical Trials, Medical Affairs, Pharmaceutical Industry, Clinical Development, Long-term Customer..., Clinical Research, Medical Writing, Asthma, Biologics, COPD, Medicine, Clinical Pharmacology, Therapeutic Areas, Biotechnology, Pediatrics, Strategic Partnerships, Healthcare, Scientific Training
Education
Purdue University 1981 — 1987
Doctor of Pharmacy (Pharm.D.), Pharmacy
Purdue University 1981 — 1986
B.S. Pharmacy, Pharmacy
Pearl Therapeutics March 2015 - Present
Onyx Pharmaceuticals April 2012 - September 2014
SciClone Pharmaceuticals, Inc. August 2008 - March 2012
Skills
Sarbanes-Oxley Act, Financial Reporting, Accounting, Healthcare, Financial Analysis, GAAP, General Ledger, Revenue Recognition, Clinical Accounting, US GAAP, Internal Controls, SEC filings, Financial Accounting, Auditing
Education
University of California, Berkeley
Bachelor's degree
Pearl Therapeutics April 2010 - Present
Intranasal Therapeutics August 2007 - March 2008
GlaxoSmithKline September 2006 - August 2007
GlaxoSmithKline February 2005 - August 2006
GlaxoSmithKline July 1999 - February 2005
Education
University of Maryland Baltimore 1991 — 1995
Doctor of Pharmacy, Pharmacy
University of Kentucky
University of North Carolina at Chapel Hill
Pearl Therapeutics November 2013 - Present
HiTech Construction Management and Design 2000 - Present
Gilead Sciences November 2010 - December 2013
Genentech March 2004 - 2011
Rudolph and Sletten 1988 - 1999
Peace Corps 1985 - 1987
Skills
Biopharmaceuticals, Validation, Biotechnology, Project Management, Pharmaceutical Industry, Change Control, Program Management, Process Improvement, Quality System, Quality Assurance, 21 CFR Part 11, Cross-functional Team..., Manufacturing, MS Project, Quality Management, Project Planning, Computer System..., Process Simulation, Software Documentation, Process Engineering, FDA, CAPA, Technology Transfer, GMP, Vendor Management, Contract Negotiation, Contract Management, Business Development, Project Coordination, Procurement
Education
Stanford University 1980 — 1982
MS, Civil Engineering - Construction Mgmt
Tufts University 1974 — 1977
BA, Economics
Retrophin February 2014 - Present
Pearl Therapeutics November 2013 - February 2014
Sangart 2011 - August 2013
Optimer Pharmaceuticals January 2009 - April 2011
Arena Pharmaceuticals 2007 - January 2009
Ligand Pharmaceuticals January 2005 - January 2007
Amgen February 2004 - November 2004
3M Pharmaceuticals January 2001 - November 2002
Skills
Drug Development, Drug Discovery, Chemistry, Biotechnology, HPLC, GMP, Analytical Chemistry, GLP, FDA, LC-MS, Pharmaceutical Industry, IND, Clinical Development, Clinical Trials, Quality Control, Regulatory Submissions, Chromatography, CMC, Quality System, Assay Development, Sop, Technology Transfer, Purification, Biopharmaceuticals, Validation, Laboratory, Lifesciences, Formulation, Life Sciences, SOP
Education
The Pennsylvania State University, University Park 1994 — 2000
PhD, Fuel Science/Chemistry
Kemerovo State University 1990 — 1994
MS, Chemistry
Pearl Therapeutics June 2014 - Present
Kelly Scientific Resources December 2011 - May 2014
Smithfield's Chicken 'N Bar-B-Q September 2005 - September 2012
Meredith College August 2009 - December 2010
Skills
Micropipetting, Performing Gram stains, Sterile Tissue Transfer, Preparation of Media..., Enzymatic Assays, Protein gel...
Education
Meredith College 2007 — 2011
B.S., Biology
VMware March 2015 - Present
Cisco September 2014 - February 2015
Cisco Systems January 2014 - August 2014
Cisco Systems July 2012 - January 2014
City of San Jose December 2011 - June 2012
Pearl Therapeutics 2011 - 2011
Work2Future May 2009 - October 2009
Skills
Microsoft Excel, Project Planning, Management, Microsoft Office, Accounts Payable, Data Analysis, Coaching, CA Clarity, Oracle iProcurement, Planning Budgeting &..., Analysis, Vendor Management, Teamwork, Project Management, Customer Service, Leadership, Program Management
Education
University of California, Santa Cruz 2010 — 2011
Bachelor, Economics
Stanford University 2014 — 2015
Earning Professional Certificate, Advanced Project Management
Pearl Therapeutics July 2014 - Present
Catalent Pharma Solutions May 2011 - July 2014
Merck March 2001 - May 2011
Schering-Plough May 1999 - March 2001
Schering-Plough April 1995 - May 1999
Schering-Plough February 1991 - March 1995
Skills
GMP, Validation, Protein Chemistry, GLP, Analytical Chemistry, HPLC, Pharmaceutical Industry, Drug Development, LC-MS, Sop, CRO, UV/Vis, 21 CFR Part 11, IND, Clinical Trials, CMC, LIMS, Regulatory Submissions, GxP, Analytical Method..., Method Development, Cleaning Validation, Chemstation, Cell Culture, Regulatory Requirements, Stability Studies, Differential Scanning..., CAPA, Quality Control, Clinical Development, Trackwise, USP, Analytical Methods..., Protocol, Change Control
Education
Seton Hall University 2002 — 2005
M.S., Chemistry
Rutgers University-New Brunswick 1995 — 1999
B.S, Biochemistry
Merck 2013 - Present
Pearl Therapeutics March 2011 - August 2011
Kings Pharmacy March 2010 - March 2011
King's Pharmacy March 2010 - March 2011
McAlister's Deli February 2005 - January 2010
UNCW Chemistry Lab May 2007 - March 2009
UNCW Chemistry Lab March 2007 - July 2008
NHRMC Oleander Rehab Facility January 2005 - December 2006
Skills
GMP, HPLC, Clinical Trials, GCP, Gas Chromatography, Laboratory
Education
University of North Carolina at Wilmington 2006 — 2010
Chemistry, Biochemistry
University of North Carolina at Wilmington 2005 — 2010
Bachelor of Science, Chemistry
Pearl Therapeutics July 2015 - Present
Mylan Specialty L.P. (formerly Dey Pharma, L.P.) May 2010 - July 2015
Covance March 2009 - May 2010
Sanofi Pasteur June 2004 - February 2009
Pfizer June 2000 - June 2004
Triangle Pharmaceuticals March 2000 - June 2000
Glaxo Wellcome September 1994 - November 1999
ClinTrials Research June 1992 - September 1994
Skills
Biostatistics, GCP, CRO, Clinical Research, Clinical Development, Clinical Trials, FDA, Clinical Data Management, Oncology, Medical Writing, SAS, Pharmaceutical Industry, Biotechnology
Education
University of Kentucky, The Graduate School of Arts and Sciences 1990 — 1992
MS, Statistics
University of Kentucky 1984 — 1989
BA, Economics
Pearl Therapeutics February 2014 - Present
Schering-Plough Research Institute November 2001 - July 2008
Therics, Inc. April 1996 - November 2001
Johns Hopkins University September 1990 - March 1996
University of Virginia May 1989 - December 1989
Science Applications International Corporation June 1987 - August 1987
Skills
Pharmaceuticals, Formulation Development, Drug Delivery, Project Management, Pharmaceutical Industry, Scaffolds for tissue..., Tissue Engineering, Formulation, Technology Transfer, Drug Development, Cross-functional Team..., GMP, R&D, HPLC, Sop, Quality by Design, Medical Devices, Pharmaceutics, FDA, Validation
Education
The Johns Hopkins University 1990 — 1996
Ph.D., Chemical Engineering
University of Virginia 1986 — 1990
B.S., Chemical Engineering
Pearl Therapeutics June 2015 - Present
PAREXEL January 2015 - Present
Regado Biosciences March 2009 - December 2014
Memory Pharmaceuticals September 2005 - February 2008
Novartis 2003 - 2005
Skills
Clinical Development, Clinical Operations, Clinical Research, GCP, Clinical Trials, CTMS, Clinical Monitoring, Pharmaceutical Industry, EDC, Drug Development, CRO, Oncology, Therapeutic Areas
Education
Fairleigh Dickinson University 2002 — 2005
MBA, Marketing
Fairleigh Dickinson University 2000 — 2002
MA, Experimental Psychology
Tufts University 1993 — 1997
Pearl Therapeutics May 2015 - Present
Onyx Pharmaceuticals, an Amgen subsidiary January 2015 - May 2015
InterMune via Pro Unlimited September 2014 - December 2014
InterMune via Pro Unlimited August 2014 - October 2014
Thermo Fisher Scientific (Life Technologies) July 2006 - July 2014
Applied Biosystems October 2004 - June 2006
Life Technologies October 2004 - April 2006
Applied Biosystems January 1996 - October 2004
Life Technologies January 1990 - October 1996
Skills
Team Management, MS Office Suite, SAP / E1 User, Purchasing Management, Accounts Payable, Financial Accounting, Budget Management, Budget Preparation, Purchase Management, SAP, Project Management, Purchasing, Microsoft Office, Budgets, Finance, Global Sourcing, Program Management, Technology Transfer, Procurement, Project Planning, Contract Negotiation, Process Improvement, Contract Management, Analysis, Management, Lifesciences, Facilities Management, Change Management, Cross-functional Team..., Leadership, Continuous Improvement, Strategy, CRM, Validation, GMP, Negotiation, Mergers & Acquisitions, Life Sciences
Education
University of Phoenix 1998 — 2002
Bachelor of Science (B.S.), Management, 3.7
Heald College 1990 — 1992
Certified in various software use, Software Applications
American Red Cross September 2015 - Present
Pearl Therapeutics April 2015 - July 2015
Sapere Aude Classical Academy May 2008 - February 2015
Argos Therapeutics April 2006 - May 2008
Argos Therapeutics January 2004 - April 2006
Duke University Medical Center March 2002 - December 2004
Skills
GMP, Biotechnology, Clinical Trials, Technical Writing, Sop, Blogging, Technology Transfer, Research, Quality Control, Clinical Research, Cell Culture, IND, GLP, GCP, Validation, cGMP manufacturing, cGMP practices, 21 CFR Part 11, 21 CRF Part 210, 21 CFR Part 211, ECM, Agilent, Master Control, Document Management, Biopharmaceuticals, GxP, Immunoassays, PCR, PCR primer design, Northern Blotting, Gel Electrophoresis, Gel Extraction, Life Sciences, Molecular Biology, FDA, Pharmaceutical Industry, Microbiology, Quality Assurance, Laboratory, R&D, Quality System, Clinical Development, Protocol, CAPA, SOP
Education
North Carolina State University 1996 — 1999
BS, Biological Sciences
Erskine College 1994 — 1995
Biology/Biological Sciences, General
GalbraithWight July 2015 - Present
New Hope Foundation March 2015 - Present
Pearl Therapeutics January 2008 - May 2015
Pearl Therapeutics January 2009 - May 2014
Caliper 2006 - 2008
Skills
Administrative..., Office Management, Outlook, Microsoft Office, Microsoft Excel, Customer Service, Microsoft Word, PowerPoint, Data Entry, Office Administration, Human Resources, Accounts Payable, Event Planning, Payroll, Budgets, Invoicing, Management, Accounts Receivable, Spreadsheets, Research, Pharmaceutical Industry, Clinical Trials, Biotechnology, Healthcare, Clinical Research, Leadership, Clinical Development, Training
Education
Rutgers University-New Brunswick 2015 — 2018
Master’s Degree, Substance Abuse/Addiction Counseling
Brookdale Community College 2015 — 2016
Associate’s Degree, Counseling Psychology, 4.0
Pearl Therapeutics June 2014 - Present
Self-Employed June 2007 - Present
University of Sydney July 2012 - December 2014
Pearl Therapeutics June 2009 - July 2012
UC Berkeley April 2006 - August 2009
Pearl Therapeutics February 2009 - June 2009
Roche June 2008 - August 2008
3D Gourmet Catering June 2004 - August 2007
Skills
Inhalation, Formulation, Drug Delivery, Drug Development, R&D, Science, Research, Product Development, Biotechnology, Analytical Chemistry, Particle Engineering, Scale Up, GMP, Pharmaceutical..., Analysis, Project Management, Pharmaceutical Industry, Technology Transfer, Aerosol Science, Property Management, Pharmaceutical Sciences, Calorimetry, Research Analysis, Atomic Force Microscopy, Solidworks, Microscopy, Finite Element Modeling, Systems Biology Modeling, Matlab, AFM, Sop, SOP
Education
University of California, Berkeley 2005 — 2008
Bachelor of Science, BioEngineering
University of Sydney 2012 — 2014
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
Pearl Therapeutics October 2014 - Present
San Jose State University May 2013 - Present
Microbiology & Quality Associates, Inc. November 2013 - October 2014
San Jose State University August 2013 - January 2014
London School of Pharmacy September 2010 - November 2010
RESTECH Pharmaceuticals May 2008 - June 2008
TUTON Pharmaceuticals May 2007 - June 2007
Skills
Biotechnology, Formulation, Pharmacology, HPLC, Sop, PCR, Regulatory Affairs, Analytical Chemistry, Pharmaceutical Industry, SDS-PAGE, LCMS, Protein Purification, Marketing Management, Project Management, Drug Development, Pharmacokinetics, Biopharmaceuticals, SOP
Education
San Jose State University 2012 — 2014
Masters in Biotechnology
School of Pharmacy, U. of London 2009 — 2010
Msc, Drug Delivery, pharmaceutical science
L.J.Institute of Pharmacy, Gujarat University 2005 — 2009
Bachelor of Pharmacy
Pearl Therapeutics 2014 - Present
MedImmune 2011 - 2014
MedImmune 2009 - 2011
Genitope Corporation 2007 - 2008
Genitope Corporation 2002 - 2007
Quasar Engineering 1995 - 2002
Skills
GMP, Validation, Aseptic Processing, Vaccines, Technology Transfer, Sop, Quality Control, FDA, Quality System, Cell Culture, Biopharmaceuticals, Quality Assurance, Engineering, GLP, V&V, Manufacturing, Process Simulation, Purification, Pharmaceutical Industry, GxP, Formulation, Process Engineering, CAPA, Biotechnology, Change Control, Regulatory Submissions, 21 CFR Part 11, SOP
Education
Massachusetts Institute of Technology
ChE, Chemical Engineering
Massachusetts Institute of Technology
MS, Chemical Engineering Practice
University of California, Berkeley
BS, Chemical Engineering
Pearl Therapeutics April 2015 - Present
BD July 2013 - April 2015
RTI International May 2012 - July 2013
Duke University September 2009 - March 2012
VA NY Harbor Healthcare System October 2007 - September 2009
Skills
Matlab, Biomedical Engineering, Microfabrication, Simulations, Data Analysis, Molecular Biology, Microsoft Office, MEMS, Characterization, Optical Engineering, Mammalian Cell Culture, Teaching, Microsoft Excel, Fluorescence Microscopy, Cardiac..., Optical Imaging, AutoCAD, Stem Cell Research, Cell Lines, PowerPoint, English, Microsoft Word, Project Management, C++, Python, NI LabVIEW
Education
University of North Carolina at Chapel Hill 2002 — 2007
Doctor of Philosophy (Ph.D.), Biomedical Engineering
University of North Carolina at Chapel Hill 2002 — 2004
Master of Science (M.S.), Biomedical Engineering
Southeastern Louisiana University 1994 — 2001
Bachelor of Science (B.S.), Physics, Mathematics, and Microbiology
Pearl Therapeutics September 2015 - Present
Pearl Therapeutics March 2014 - August 2015
Actavis, Inc. February 2012 - March 2014
Novartis May 2010 - March 2012
Merck & Co., Inc. July 1997 - July 2010
Acer/Excel (Kendle) 1995 - 1997
Rhone-Poulenc Rorer 1995 - 1995
Skills
Statistics, Bioinformatics, Biostatistics, SAS, Genetics, Clinical Trials, Clinical Development, Research, Oncology, Pharmaceuticals, FDA, Experimental Design, Pharmacokinetics, Statistical Genetics, Pharmacodynamics, In Vitro Bioequivalence, Therapeutic Areas, Pharmaceutical Industry, Inhalation, Transdermal, CDISC, Clinical Study Design, Clinical Research, Statistical Programming
Education
University of Medicine and Dentistry of New Jersey -New Jersey Medical School 2002 — 2008
Ph.D., Bioinformatics, Genetic Epidemiology
University of Rochester 1994 — 1996
M.S., Statistics
University of Connecticut 1990 — 1994
BS, Psychology, Statistics
Cho's Tae Kwon Do
Dimensions in Occupational Health and Safety September 2012 - Present
Pearl Therapeutics 2011 - 2012
Pace Analytical March 2010 - February 2011
Education
University of North Carolina at Asheville 2005 — 2009
Bachelor's of Science, Environmental Studies - Pollution Control
University of Waikato
Pearl Therapeutics October 2012 - Present
Pearl Therapeutics January 2010 - October 2012
Cato Research October 2007 - January 2010
Cato Research May 2005 - January 2010
Skills
Regulatory Agency..., Medical Writing &..., Department, Budget &..., Project Planning &..., regulatory strategy, global regulatory..., Investigational New..., eCTD, New Drug Applications, Clinical Trial..., drug development, Global Drug Development, Clinical Trials, neurology product..., respiratory product..., oncology therapeutic..., Medical Writing, Drug Development, Strategy, IND, Clinical Development, Oncology, Regulatory Submissions, Electronic Submissions, Regulatory Affairs
Education
University of North Carolina at Chapel Hill 1999 — 2005
PhD, Pharmacology
Duke University 1994 — 1998
B.S., Biology
Pearl Therapeutics February 2014 - Present
Pearl Therapeutics October 2011 - February 2014
Troxler Electronic Laboratories, Inc. May 2011 - October 2011
Cyrco, Inc July 2010 - August 2010
Institute for Maintenance Science and Technology October 2008 - August 2009
Skills
Microsoft Office, Design of Experiments, Quality Assurance, Patent Analysis, Options Strategies, Equity Trading, Pressure Vessels, Radiation Safety, Chemical Engineering
Education
North Carolina State University 2007 — 2011
Major: Chemical Engineering, Nanoscience
Zhejiang University 2010 — 2010
Physical Chemistry
Pearl Therapeutics September 2014 - Present
AAIPharma Services Corp. 2012 - 2014
Contract Client February 2013 - December 2013
Genzyme July 2005 - February 2012
United States Army Soldier Systems Center June 2004 - August 2004
Skills
Drug Discovery, Biotechnology, GLP, Assay Development, Lifesciences, R&D, Technology Transfer, Patents, FDA, CAPA, Laboratory, Regulatory Requirements, GMP, Pharmaceutical Industry, HPLC, Validation, SOP, Quality Auditing, Quality Assurance, Analytical Chemistry, Chromatography, Biopharmaceuticals
Education
Suffolk University Law School 2006 — 2010
JD, Intellectual Property
Stonehill College 2001 — 2005
B.S, Chemistry, Criminal Justice (minor)
Pearl Therapeutics January 2014 - Present
Pearl Therapeutics April 2008 - December 2013
Paddock Laboratories, Inc July 2001 - March 2008
Skills
GMP, Validation, Pharmaceutical Industry, FDA, Analytical Chemistry, Drug Development, R&D, GLP, SOP, Quality System, Laboratory, Technology Transfer, Chemistry, HPLC, CAPA
Education
St. Olaf College 1997 — 2001
B.A., Chemistry
Pearl Therapeutics March 2008 - Present
360Decisions 2008 - 2009
FinanceStaff April 2006 - September 2008
Kinetic Networks March 2006 - October 2007
Greg McKenney & Company April 2002 - August 2007
BASE Consulting Group January 1998 - September 2001
Skills
Account Reconciliation, Management, Employee Relations, Accounting, Professional Services, Sales Tax, Payroll, Invoicing, Accounts Payable, Accruals, Auditing, Analytics, Biotechnology
Education
Golden Gate University
MS, Human Resources Management
San Francisco State University
BS, Sports Nutrition
Pearl Therapeutics July 2015 - Present
GlaxoSmithKline June 2007 - June 2015
Syngenta Biotechnology January 2005 - June 2006
Nektar Therapeutics September 1999 - December 2002
Pacific BioDevelopment January 1997 - September 1999
XOMA Corporation November 1994 - January 1997
Johnson & Johnson April 1992 - November 1994
Bayer April 1991 - April 1992
Skills
Orphan Drugs, Monoclonal Antibodies, Pharmaceutics, Regulatory Affairs, Regulatory Submissions, Biotechnology, Clinical Development, FDA, Medical Devices, Pharmaceutical Industry, Ophthalmics, Respiratory Products, CNS disorders, Formulation, IND, Strategy, Clinical Trials, Life Sciences
Education
University of Colorado Boulder 1985 — 1989
BA
Mercersburg Academy 1982 — 1985
Spinal Modulation May 2008 - Present
Pearl Therapeutics May 2007 - June 2008
Theravance August 2005 - April 2007
Medtronic January 2003 - August 2005
Fusion Medical 2000 - 2003
Hewlett-Packard 1999 - 2000
J.P. Morgan 1996 - 1999
Skills
Start-ups, Medical Devices, Biotechnology, Strategic Planning, Business Strategy, Financial Modeling, Financial Analysis, Forecasting, Budgeting, Financial Planning, Business Planning, Fundraising, Negotiation, Due Diligence, Mergers, Corporate Finance, Accounting, HR Policies, Insurance, Risk Management, Treasury Management, Contract Negotiations, Planning, P&L Management, Microsoft Office, Excel, QAD, QuickBooks, Mas 90, Peachtree, 123R, Mergers & Acquisitions, Cross-functional Team..., Strategy, Finance, Acquisition Integration, Process Improvement
Education
Stanford University Graduate School of Business 1994 — 1996
MBA, Finance
Stanford University Graduate School of Business 1994 — 1996
mba, finance
Dartmouth College 1987 — 1991
BA, Economics & Government
St. Mark's School 1983 — 1987
Diploma
Celgene April 2015 - Present
Pearl Therapeutics November 2013 - April 2015
Eisai Pharmaceuticals May 2012 - November 2013
Merck March 2009 - December 2012
Schering Plough June 2001 - June 2004
Skills
CRO, CTMS, Clinical Development, Clinical Research, Clinical Study Design, Clinical Trials, EDC, GCP, Oncology, Pharmaceutical Industry, Regulatory Affairs, Therapeutic Areas, Biotechnology, ICH-GCP
Education
Kean University 1997 — 2001
University of Alberta April 2012 - Present
Pearl Therapeutics January 2009 - April 2012
Pearl Therapeutics August 2007 - January 2009
MedImmune November 2005 - August 2007
Aradigm Corporation June 2005 - September 2005
Skills
CFD, Fluid Mechanics, Particle Engineering, Spray Drying, Mass Transfer, Validation, Technology Transfer, R&D, GMP, FDA, Biotechnology, Mechanical Engineering, Drug Delivery, Medical Devices, CAPA, Formulation, Pharmaceutical Industry, Process Simulation
Education
University of California, Santa Barbara 1999 — 2004
BS, Mechanical Engineering
Pearl Therapeutics January 2008 - Present
Inhalation Solutions, LLC January 2005 - January 2008
Magellan Labs/Cardinal Health 2001 - 2004
Magellan Laboratories 1992 - 2001
MDRI 1988 - 1992
Skills
Pharmaceutical Industry, Technology Transfer, Project Management, Inhalation, Formulation, Analytical Chemistry, Manufacturing, Quality Assurance, GMP, Commercialization, FDA, Validation
Education
Purdue University
PhD, Analytical Chemistry
Bradley University 1976 — 1980
Bachelor of Science (BS), Chemisty
Pearl Therapeutics June 2015 - Present
Novartis August 2012 - Present
Tournesol Siteworks, LLC December 2011 - July 2012
Nektar Therapeutics 1999 - April 2008
Nektar 1999 - April 2008
Skills
GMP
Education
Universidad Nacional Autónoma de Honduras
Hyperion Therapeutics May 2014 - December 2014
Pearl Therapeutics June 2008 - May 2014
Hyperion Therapeutics January 2008 - April 2008
Nektar Therapeutics 1997 - January 2008
Nektar Therapeutics 1997 - 2006
Chiron 1994 - 1997
MAST Immunosystems 1990 - 1994
Skills
GMP, Change Control, CAPA, Quality Assurance, Pharmaceutical Industry, FDA, Validation, Sop
Education
University of California, Davis 1985 — 1989
Bachelor of Science (BS), Biochemistry
Pearl Therapeutics September 2013 - Present
Pearl Therapeutics January 2009 - August 2013
Pearl Therapeutics April 2008 - January 2009
Nektar Therapeutics May 2006 - April 2008
Kosan Biosciences, Inc. July 2002 - March 2006
RMT July 1998 - June 2002
Toyota Motor Manufacturing North America 1994 - 1998
Skills
GMP, Manufacturing, Leadership, Validation, Biotechnology, Technology Transfer, Pharmaceutical Industry, FDA, Change Control, R&D, CAPA, Process Engineering, Chemical Engineering, Chromatography, Product Development
Education
Georgia Institute of Technology 1992 — 1998
BS, Chemical Engineering
Pearl Therapeutics August 2011 - Present
Novartis July 2007 - August 2011
novartis inc July 2002 - July 2007
Hospital de la Santa Creu i Sant Pau 1995 - 1999
Hospital Sant Pau 1995 - 1999
Skills
French, Pulmonology, Data Analysis, Epidemiology, Drug Development, Clinical Research, Clinical Trials, Biotechnology, Clinical Development, Infectious Diseases, Project Management, Medicine, Management, Pharmaceutical Industry, Pharmacoepidemiology, GCP, Spanish, Statistics, Oncology, Life Sciences, CRO
Education
Cornell University - S.C. Johnson Graduate School of Management 2008 — 2010
MBA
The Johns Hopkins University 2000 — 2001
MPH, Public Health
Universidad de Navarra 1986 — 1992
MD
Pearl Therapeutics December 2013 - Present
Pearl Therapeutics September 2008 - December 2013
Talecris Biotheraputics November 2006 - August 2008
Cardinal Health April 2002 - November 2006
Magellan Labs June 1998 - April 2002
University of Delaware Plant Pathology Department March 1996 - May 1998
Education
Salisbury University 1993 — 1997
ACS Accredited BS in Chemistry
LIU Post 1995 — 1996
Chemistry
Nassau Community College 1995 — 1995
Physics
Pearl Therapeutics May 2008 - Present
Nektar Therapeutics March 2002 - September 2007
Objective Insights, Inc February 1995 - March 2002
Syntex Labs September 1990 - December 1994
Education
University of Notre Dame
Bachelor of Arts (B.A.), San Jose State University, MBA
Piedmont Biofuels June 2011 - February 2015
Pearl Therapeutics April 2010 - January 2011
Closure Medical January 2008 - December 2009
Kannapolis City Schools July 2006 - June 2007
Skills
Analytical Chemistry, HPLC, GC-FID, Design of Experiments, Microsoft Excel, Wet Chemistry, Organic Synthesis, Reaction Kinetics, Scientific Writing, Scientific Reports, Grant Writing, Enzyme Technology, Manufacturing Scale-up, Laboratory, GMP, GLP, ISO 9001, Statistical Data..., Troubleshooting, Office Administration, Research, Medical Device R&D, Renewable Energy, Renewable Fuels, Polymer Chemistry
Education
University of North Carolina at Charlotte 2002 — 2005
Bachelor’s Degree, Chemistry
North Carolina State University
Chemistry
Pearl Therapeutics 2014 - Present
Education
University of California, Davis
B.S.
Grifols July 2015 - Present
Pearl Therapeutics January 2015 - July 2015
North Carolina Department of Commerce April 2014 - January 2015
Enterprise Logic/CSC March 2013 - January 2014
Talent Logic/GlaxoSmithKline December 2012 - March 2013
Biogen Idec May 2011 - May 2012
Takeda Pharmaceuticals North America, Inc. September 2000 - March 2011
Pharmacia Corporation March 1998 - September 2000
Skills
Documentum, Document Management, Computer System..., 21 CFR Part 11, Validation, SDLC, FDA, eCTD, Pharmaceutical Industry, Change Control, Software Documentation, Enterprise Content..., Requirements Gathering, Quality Assurance, MasterControl
Education
DePaul University 1995 — 1998
Bachelor of Science (BS), Information Systems
Pearl Therapeutics July 2010 - Present
Diosynth Biotechnology/ Merck 2008 - 2010
GSK 1996 - 2008
GlaxoSmithKline 1996 - 2008
Skills
GMP, Quality Assurance, 21 CFR Part 11, Quality System, Change Control, LIMS, Auditing, Quality Systems, Internal Audit, Compliance, Investigations, cGMP, Quality Management, Inspection Readiness,...
Education
Appalachian State University 1989 — 1994
BS, Chemistry
Pearl Therapeutics 2008 - Present
GSK August 2000 - February 2008
Protein Delivery 1993 - 1995
Sphinx Pharmaceuticals April 1991 - June 1993
Skills
Gas Chromatography, Chromatography, Formulation, HPLC, GMP, Drug Delivery, Analytical Chemistry, R&D, Technology Transfer, Drug Discovery, Differential Scanning..., Characterization, FDA, UV/Vis, GLP, Validation, Protein Chemistry
Education
University of North Carolina at Chapel Hill 1996 — 2000
Ph.D., Pharmaceutics
Case Western Reserve University
Virginia Polytechnic Institute and State University
Pearl Therapeutics April 2009 - Present
Catalent Pharma Solutions August 2001 - April 2009
Education
North Carolina State University 1997 — 2002
Pearl Therapeutics November 2013 - Present
MAP Pharmaceuticals January 2011 - August 2013
MAP Pharmaceuticals February 2009 - January 2011
Aradigm Corporation June 2008 - February 2009
Novo Nordisk Delivery Technologies January 2005 - May 2008
Skills
GMP, Validation, CAPA, Drug Delivery, FDA, Biotechnology, Sop, GLP, Pharmaceutical Industry, HPLC, Technology Transfer, Change Control, R&D, Computer System..., GxP, Chromatography, SOP
Education
California State University-East Bay 1998 — 2001
Bachelors, Biology
Pearl Therapeutics April 2015 - Present
Covidien May 2014 - Present
Elixir Medical Corporation September 2011 - March 2014
Cordis Corporation Johnson & Johnson Company (Previously Conor Medsystems) June 2009 - August 2011
Conor Medsystems April 2007 - June 2009
Dionex Corporation August 2004 - April 2007
Nektar Therapeutics 2000 - 2004
Oread Labs 1999 - 2000
Roche Bioscience (formerly Syntex Pharmaceutical) 1994 - 1999
Henkel Research Corporation 1987 - 1993
Skills
GMP, Analytical Chemistry, GLP, HPLC, Chromatography, FDA, Validation, CAPA, V&V, Technology Transfer, Sop, Formulation, R&D, Biotechnology, Drug Delivery
Education
Jami'at Al-Basrah
Master's degree
Pearl Therapeutics June 2014 - Present
Quality Chemical Laboratories July 1999 - May 2014
Skills
HPLC, UV/Vis, Analytical Chemistry, Gas Chromatography, GMP, Wet Chemistry, Chemistry, GLP, Sop, Pharmaceutical Industry, Validation, FDA, Titration, ELISA, Cleaning Validation
Education
University of North Carolina at Wilmington 1994 — 1999
Bachelor's degree, Chemistry
Pearl Therapeutics August 2013 - Present
GlaxoSmithKline 1992 - 2013
Education
Davidson College
Westover
STEALTH BIOTHERAPEUTICS April 2014 - Present
Pearl Therapeutics February 2011 - April 2014
Ikaria July 2008 - March 2011
Medarex January 1998 - June 2008
Skills
Oncology, Clinical Operations, CTMS, Clinical Research, Clinical Trials, EDC, Clinical Development, Biotechnology, ICH-GCP, Therapeutic Areas, Drug Development, Pharmaceutical Industry, Lifesciences, GCP, Regulatory Submissions, Regulatory Affairs, Sop, CRO, Clinical Monitoring, FDA
Education
Montclair State University
Bachelor of Science (B.S.), Biology/Chemistry
Creighton University August 2011 - Present
Pearl Therapeutics January 2008 - August 2011
Environmental Health and Safety, UCSD May 2007 - October 2007
Skills
Biotechnology, cGMP, Clinical Trials, Start-ups, Medical Devices
Education
University of California, San Diego 2003 — 2007
BS, Biochemistry and Cell Biology
University of Alberta September 2009 - Present
Pearl Therapeutics July 2007 - November 2013
Medimmune 2005 - 2007
Nektar Therapeutics 1998 - 2005
Skills
Drug Delivery, Technology Transfer, Particle Engineering, R&D, Drug Development, Formulation, Pharmaceutical Industry, Biotechnology, FDA, Raman Spectroscopy, HPLC, Vaccines, GMP, Analytical Chemistry
Education
Ruhr University Bochum 1989 — 1995
Doctorate, Mechanical Engineering
Universität Duisburg-Essen, Standort Duisburg
Diploma, Mechanical Engineering
Pearl Therapeutics March 2013 - Present
Ferring Pharmaceuticals 2010 - 2013
Skills
Pharmacovigilance, Clinical Trials, Pharmaceutical Industry, GCP, Medical Writing
Education
University of Medicine and Dentistry of New Jersey 2005 — 2006
nursing
Pearl Therapeutics May 2014 - Present
FibroGen July 2008 - October 2013
Celera November 2003 - June 2007
Celera Diagnostics November 2003 - June 2007
Genzyme February 1999 - November 2002
Skills
Biotechnology, FDA, Validation, Sop, CAPA, Biopharmaceuticals, Technology Transfer, GLP, Lifesciences, Pharmaceutical Industry, GMP, Clinical Development, 21 CFR Part 11, V&V, Change Control, Life Sciences, SOP
Education
San Beda College
Bachelor of Science (BS), Marketing
Don Bosco Technical Institute, Makati
Electronics
Pearl Therapeutics February 2011 - Present
Morrison & Foerster LLP July 2007 - November 2010
Renovis 2001 - 2007
InterMedia Partners March 1990 - March 2000
Skills
SEC filings, Sarbanes-Oxley Act
Education
San Francisco State University 1983 — 1987
BS, Accounting
Impact Pharmaceutical Services 2014 - Present
Impact Pharmaceutical Services 2010 - 2014
Pearl Therapeutics 2009 - 2010
SRA International 2007 - 2009
Constella Group 2006 - 2007
Lineberry Research Associates 2005 - 2006
Lineberry Research Associates 2001 - 2005
Education
Emory University 1996 — 2001
PhD, Pharmacology
Long Island University, Brooklyn Campus 1993 — 1996
BS, Pharmacy
Pearl Theraputics 2009 - Present
Pearl Therapeutics April 2009 - August 2010
Catalent July 2001 - April 2009
Cardinal Health 2003 - 2007
Magellan Labs 2001 - 2002
Skills
Pharmaceutical Industry, Analytical Chemistry, Validation, Sop, GLP, GMP, HPLC, Chemistry, Chromatography, FDA
Education
University of North Carolina at Wilmington 1995 — 2001
Chemistry, Chemistry
Teresa Chambers Consulting October 2009 - Present
Pearl Therapeutics January 2010 - May 2013
Exelixis, Inc. November 2009 - February 2011
FibroGen March 2009 - November 2009
InterMune 2002 - 2004
Roche Biosciences 2001 - 2001
Genentech 1991 - 2001
Skills
Clinical Development, Biotechnology, Clinical Research, Clinical Trials, GCP, Pharmaceutical Industry, Life Sciences
Education
San Francisco State University, College of Business
B.A., Business, Marketing, International Business
Pearl Therapeutics March 2014 - Present
Catalent November 2006 - March 2014
AstraZeneca June 2002 - August 2006
AstraZeneca September 1996 - September 1998
Sanofi July 1994 - September 1998
Skills
Formulation Development, GMP, Technology Transfer, Process Development, Characterization, Validation, cGMP, Pharmaceuticals, R&D
Education
Sheffield Hallam University 1989 — 1993
BSc, Chemistry
Celgene Corporation May 2013 - Present
Celgene Corporation July 2010 - June 2013
Pearl Therapeutics February 2009 - July 2010
Celgene Corporation May 2004 - February 2009
Human Genome Sciences August 2003 - May 2004
Pequot Ventures October 2000 - May 2003
Bristol-Myers Squibb October 1995 - October 2000
Genentech October 1993 - October 1995
Abbott Laboratories January 1983 - October 1993
Education
Northwestern University - Kellogg School of Management 1985 — 1988
Master of Business Administration (M.B.A.)
Duke University 1978 — 1979
Master's Degree
University of Illinois at Urbana-Champaign 1973 — 1977
Bachelor's Degree
Pearl Therapeutics November 2014 - April 2015
Warner Chilcott January 2013 - March 2015
Warner Chilcott January 2013 - December 2014
sanofi-aventis February 2011 - January 2013
Celgene September 2010 - December 2010
sanofi-aventis 2008 - October 2010
Eisai Pharmaceuticals July 2007 - January 2009
Skills
GCP, Clinical Research, Clinical Study Design, Medical Writing, Oncology, Clinical Development, Clinical Trials, Regulatory Submissions, Pharmaceutical Industry, Diabetes, CRO, IND, Pharmacovigilance
Education
University of Manitoba 1969 — 1989
MEd, Health Education Program Planning and Evaluation
Pearl Therapeutics November 2014 - Present
GSK September 2006 - November 2014
Skills
Chemistry, GMP, Pharmaceutical Industry, Analytical Chemistry, HPLC, Technology Transfer, Validation, NGI, Dry Powder Inhalers, Analytical Method..., Chromatography, Drug Discovery, Quality by Design, Clinical Development
Education
Michigan State University 2003 — 2006
MS, Chemistry
University of South Carolina-Columbia 1999 — 2002
BS, Chemistry
Pearl Therapeutics December 2014 - Present
Regado Biosciences August 2010 - November 2014
Aerie Pharmaceuticals January 2010 - September 2010
Intercytex 2007 - 2009
Cytyc 2006 - December 2007
Covance 2004 - 2006
Theradex 2003 - 2004
Skills
Clinical Trials, Clinical Monitoring, GCP, Clinical Development, CTMS, Trial Management, Oncology, Clinical Research, Clinical Data Management, Pharmaceutical Industry, Biotechnology, CRO, FDA, ICH-GCP, EDC, Regulatory Submissions
Education
The College of New Jersey 1999 — 2003
BS, Biology
Pearl Therapeutics October 2014 - Present
Catalent Pharma Solutions December 2010 - Present
Pfizer July 2008 - December 2010
Conservation Concepts August 2005 - July 2008
Cardinal Health September 2001 - 2005
Sanyo Denki 1997 - 2001
The Hamner Institutes for Health Sciences 1990 - 1997
Education
Western Carolina University 2005 — 2007
Master's Degree
North Carolina State University 1989 — 1990
Post Baccalaureate Course Work
Mars Hill University 1985 — 1989
Bachelor's Degree
Qualitest Pharmaceuticals September 2012 - Present
Quintiles February 2012 - September 2012
Pearl Therapeutics January 2011 - January 2012
Catalent Pharma Solutions January 2009 - January 2011
Tunnell Consulting February 2009 - August 2009
Wyeth Vaccines January 2004 - January 2009
Pfizer January 1995 - January 2004
Skills
CAPA, Validation, GMP, Sop, Change Control, Biotechnology, Biopharmaceuticals, SAP, MES, LIMS, Trackwise, EMCA Regulations, Pharmaceutical process..., Fermentation, cGMP practices, cGMP manufacturing, Internal Audit, Quality Auditing, Batch Records, Lyophilization, Filtration, Quality Assurance, Aseptic Technique, 21 CFR Part 11, FDA, Pharmaceutical Industry, SOP, TrackWise
Education
ECPI College of Technology
AAS, Applied Science
University of Phoenix
Bachelor of Science (B.S.), Industrial Technology
Pearl Therapeutics August 2011 - September 2014
Pearl Therapeutics February 2010 - August 2011
Pearl Therapeutics April 2009 - February 2010
Catalent Pharma Solutions June 2007 - April 2009
Catalent Pharma Solutions June 2005 - June 2007
Catalent Pharma Solutions June 2003 - June 2005
Catalent Pharma Solutions June 2002 - June 2003
Catalent Pharma Solutions June 2001 - June 2002
Skills
HPLC, Inhalation, Analytical Chemistry, GC-FID, Supervisory Skills, Team Leadership, GMP, GLP
Education
University of North Carolina at Wilmington 1995 — 2001
Bachelor of Arts (B.A.), Chemistry
Pearl Therapeutics July 2014 - Present
Novartis May 2013 - June 2014
Integrium 2012 - 2013
Roche Pharmaceuticals November 2006 - July 2012
Skills
CTMS, Clinical Development, GCP, Clinical Trials, EDC, CRO, ICH-GCP, Therapeutic Areas, Clinical Operations, Clinical Monitoring, Clinical Data Management, Protocol, Oncology, Drug Development, Clinical Research
Education
Montclair State University 2006 — 2011
MA, Health Education
Rutgers University-New Brunswick 2002 — 2006
BA, Biology
Pearl Therapeutics July 2015 - Present
Sanofi Pasteur May 2004 - July 2015
Skills
GCP, Clinical Development, Regulatory Affairs, Vaccines, Biotechnology, Clinical Trials, ICH-GCP, Pharmaceutical Industry, CTMS, FDA, CRO, EDC, SOP, Clinical Research, Infectious Diseases, Regulatory Submissions
Education
Allentown Hospital School of Nursing
Lebanon Valley College
Bachelor's Degree, Science and Nursing
Clinical rotation at Pardee Hospital August 2012 - Present
Midtown Farmers Market August 2009 - May 2012
Interfaith Food Shuttle March 2011 - December 2011
Pearl Therapeutics September 2009 - December 2010
Peidmont Biofuels January 2009 - August 2009
Quiet Creek Farm at the Rodale Institute April 2008 - November 2008
Peace Corps September 2005 - March 2008
Skills
Environmental Education, Public Health, Program Development, Nutrition, Research, Microsoft Office, Health Education, Spanish
Education
Western Carolina University 2012 — 2013
Dietetic Intern, Nutrition and Dietetics
Meredith College 2010 — 2012
Masters of Science, Nutrition
Goucher College 2000 — 2004
Bachelor of Arts, Biological Sciences
University of East Anglia 2003 — 2003
Biological Sciences, Study abroad
Pearl Therapeutics June 2012 - Present
Bio Architecture Lab May 2012 - June 2012
Universal Biomining January 2012 - April 2012
PuraCath November 2011 - January 2012
UC Berkeley August 2010 - June 2011
Education
University of California, Berkeley 2010 — 2011
Master's degree, Biomedical/Medical Engineering
University of California, San Francisco 2010 — 2011
Master's degree, Biomedical/Medical Engineering
California Polytechnic State University-San Luis Obispo 2008 — 2009
Bachelor's degree, Biomedical/Medical Engineering
Pearl Therapeutics September 2014 - Present
Pearl Therapeutics July 2013 - Present
Education
California Polytechnic State University-San Luis Obispo 2006 — 2010
B.S., City and Regional Planning
Pearl Therapeutics May 2014 - Present
Pearl Therapeutics October 2013 - May 2014
University of North Carolina at Chapel Hill August 2013 - October 2013
University of North Carolina at Chapel Hill April 2012 - April 2013
Frankel Staffing Partners September 2011 - April 2012
Skills
Employee Relations, Recruiting, Outlook, Human Resources, Customer Service, PowerPoint, Office Management, Research, Data Analysis, Microsoft Excel, SOP
Education
Methodist College 2003 — 2008
Bachelor of Science (BS), Middle Grades Education (Science & Social Studies Concentrations)
cape fear 1999 — 2003
Diploma
Pearl Therapeutics July 2014 - Present
BD Technologies June 2002 - July 2014
GlaxoSmithKline 1996 - 2002
Carter Products 1994 - 1996
Skills
Analytical Chemistry, Biotechnology, CAPA, FDA, GLP, GMP, HPLC, Lifesciences, Medical Devices, Pharmaceutical Industry, R, Technology Transfer, V, Validation
Education
SUNY at Buffalo 1985 — 1990
Bachelor's of Science, Chemistry
Rider University
Business
Pearl Therapeutics February 2014 - Present
GSK November 2013 - February 2014
Catalent Pharma Solutions October 2012 - October 2013
Parion Sciences January 2009 - September 2012
IDEXX Phamaceuticals November 2002 - December 2008
Skills
Research, Chromatography, Sop, Dissolution Testing, HPLC, GC, Method Development, Analytical Method..., UV/Vis
Education
Sardar Patel University
Master of Science (MS), Organic Chemistry
Pearl Therapeutics April 2013 - Present
Amyris Inc January 2011 - April 2013
UCSF October 2010 - January 2011
Skills
Technology Transfer, Fermentation, Biotechnology, Biofuels, Process Simulation, Purification, Chemical Engineering, Protein Purification, Cell Culture, GMP, Process Optimization, Lifesciences
Education
University of California, San Diego 2006 — 2010
Bachelor's degree, Chemical Engineering
Presence Saint Joseph Hospital 2014 - Present
Pearl Therapeutics 2008 - 2010
Skills
Pharmaceutical Industry, Pharmaceutical Research, Analytical Chemistry, Epic Systems
Education
California School of Podiatric Medicine 2010 — 2014
Doctor of Podiatric Medicine
University of California, Santa Barbara 1999 — 2004
Bachelor's Degree, Geography and Anthropology