Pharmatech Associates
Description
Address: 22320 Foothill Blvd #330, Hayward, CA 94541 Hours: Closed ⋅ Opens 9AM Mon SaturdayClosedSundayClosedMonday9AM–5PMTuesday9AM–5PMWednesday9AM–5PMThursday9AM–5PMFriday9AM–5PMSuggest an edit Unable to add this file. Please check that it is a valid photo. Phone: (510) 732-0177: : Category: Place name: Website: : : : : Website: http://www.pharmatechassociates.com/ Category: Consultant Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Pharmatech Associates Posting publicly on the Web Write a review Reviews"They have an extremely knowledgeable and professional staff." "They bring them home." View all Google reviews
Pharmatech Associates List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Pharmatech Associates. You can filter them based on skills, years of employment, job, education, department, and prior employment.
Pharmatech Associates Salaries. You can even request information on how much does Pharmatech Associates pay if you want to. Learn about salaries, pros and cons of working for Pharmatech Associates 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!
34 Pharmatech Associates employees in database. Find out everything there's to know about Pharmatech Associates 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.
Pharmatech Associates Employees
Employee
Years
Job
Industry
Denise Bautista Denise Bautista's Pharmatech Associates Experience June 2003 - August 2003
Job CMMS Manager JPMC at CBRE
Industry Pharmaceuticals
Experience
CBRE April 2012 - Present
CBRE February 2015 - Present
CBRE April 2013 - February 2015
EMCOR Facilities Services July 2010 - April 2012
Denise Bautista Consulting June 2009 - July 2010
Gilead Sciences May 2008 - May 2009
Gilead Sciences October 2007 - May 2008
Gilead Sciences March 2004 - January 2007
JDAK Enterprises October 2003 - February 2004
Pharmatech Associates June 2003 - August 2003
Skills
GMP, Sop, Quality Assurance, CAPA, Computer System..., Maximo, Validation, Customer Service, FDA, Change Control, Quality System, Root Cause Analysis, SOP, Software Documentation, Project Management, Budgets, Calibration, Preventive Maintenance, Contract Negotiation, Facilities Management, Manufacturing, Management
Education
De Anza College 1995 — 2000
Computer Engineering
CBRE April 2012 - Present
CBRE February 2015 - Present
CBRE April 2013 - February 2015
EMCOR Facilities Services July 2010 - April 2012
Denise Bautista Consulting June 2009 - July 2010
Gilead Sciences May 2008 - May 2009
Gilead Sciences October 2007 - May 2008
Gilead Sciences March 2004 - January 2007
JDAK Enterprises October 2003 - February 2004
Pharmatech Associates June 2003 - August 2003
Skills
GMP, Sop, Quality Assurance, CAPA, Computer System..., Maximo, Validation, Customer Service, FDA, Change Control, Quality System, Root Cause Analysis, SOP, Software Documentation, Project Management, Budgets, Calibration, Preventive Maintenance, Contract Negotiation, Facilities Management, Manufacturing, Management
Education
De Anza College 1995 — 2000
Computer Engineering
Michele Levenson, PMP Michele Levenson, PMP's Pharmatech Associates Experience February 2012 - Present
Job Manager at Pharmatech Associates
Industry Pharmaceuticals
Experience
Pharmatech Associates February 2012 - Present
Pharmatech Associates July 2011 - February 2012
ALZA Corporation July 2010 - June 2011
Centocor (Johnson & Johnson) June 2004 - June 2011
GlaxoSmithKline March 2003 - June 2004
GlaxoSmithKline Biopharmaceuticals June 2001 - March 2003
Skills
Computer System..., Six Sigma, Auditing, PMP, Cell Culture, Equipment Qualification, Process Qualification, Solid Oral Dosage Forms, Protein Purification, GMP, Validation, Change Control, Biopharmaceuticals, CAPA, Sop, V&V, 21 CFR Part 11, GxP, Technology Transfer, Pharmaceutical Industry, Biotechnology, GLP, LIMS, Quality System, GAMP, SOP
Education
Penn State University 1996 — 2001
Bachelor of Science, General Life Sciences
North Allegheny High School 1992 — 1996
Long Branch Elementary...
Pharmatech Associates February 2012 - Present
Pharmatech Associates July 2011 - February 2012
ALZA Corporation July 2010 - June 2011
Centocor (Johnson & Johnson) June 2004 - June 2011
GlaxoSmithKline March 2003 - June 2004
GlaxoSmithKline Biopharmaceuticals June 2001 - March 2003
Skills
Computer System..., Six Sigma, Auditing, PMP, Cell Culture, Equipment Qualification, Process Qualification, Solid Oral Dosage Forms, Protein Purification, GMP, Validation, Change Control, Biopharmaceuticals, CAPA, Sop, V&V, 21 CFR Part 11, GxP, Technology Transfer, Pharmaceutical Industry, Biotechnology, GLP, LIMS, Quality System, GAMP, SOP
Education
Penn State University 1996 — 2001
Bachelor of Science, General Life Sciences
North Allegheny High School 1992 — 1996
Long Branch Elementary...
Michelle Snoeberger Michelle Snoeberger's Pharmatech Associates Experience November 2007 - August 2008
Job QA Complaint Specialist II / Mandarin, chinese / parttime Glamour and Commercial Print Model
Industry Medical Devices
Experience
KEY REVENGE April 2015 - Present
Actress / Filmmaker November 2013 - Present
Glamour Model 2009 - Present
QRCC,LLC January 2009 - Present
Pharmatech Associates November 2007 - August 2008
Skills
Pharmaceutical Industry, 21 CFR Part 11, Cleaning Validation, CAPA, Medical Devices, Complaint Handling, Deviations, Investigations, Quality Assurance, DCS, ISO 13485, GMP, gdp, Sop, Oracle, Agile, Trackwise, Complaint Management, GAMP, GLP, GxP, Design Control, Lyophilization, Aseptic Processing, Sterilization, FDA, Change Control, Quality Management, Quality System, Technology Transfer, Quality by Design, FDA GMP, USP, LIMS, CQA, Biopharmaceuticals, ISO, ISO 14971, Regulatory Affairs, SOP development, Root Cause Analysis, Computer System..., Private Investigations, PMA, Validation, Biotechnology, Regulatory Submissions, Quality Auditing, 21 CFR, Equipment Qualification
Education
Ashford University
Fullerton College
KEY REVENGE April 2015 - Present
Actress / Filmmaker November 2013 - Present
Glamour Model 2009 - Present
QRCC,LLC January 2009 - Present
Pharmatech Associates November 2007 - August 2008
Skills
Pharmaceutical Industry, 21 CFR Part 11, Cleaning Validation, CAPA, Medical Devices, Complaint Handling, Deviations, Investigations, Quality Assurance, DCS, ISO 13485, GMP, gdp, Sop, Oracle, Agile, Trackwise, Complaint Management, GAMP, GLP, GxP, Design Control, Lyophilization, Aseptic Processing, Sterilization, FDA, Change Control, Quality Management, Quality System, Technology Transfer, Quality by Design, FDA GMP, USP, LIMS, CQA, Biopharmaceuticals, ISO, ISO 14971, Regulatory Affairs, SOP development, Root Cause Analysis, Computer System..., Private Investigations, PMA, Validation, Biotechnology, Regulatory Submissions, Quality Auditing, 21 CFR, Equipment Qualification
Education
Ashford University
Fullerton College
Dave Edgren Dave Edgren's Pharmatech Associates Experience June 2010 - November 2010
Job Chief Scientist at SinuSys
Industry Pharmaceuticals
Experience
SinuSys Corp. November 2010 - Present
Pharmatech Associates June 2010 - November 2010
XenoPort October 2007 - May 2010
ALZA Corporation / Johnson & Johnson 2003 - 2007
ALZA Corporation / Johnson & Johnson 1979 - 2003
ALZA Corporation / Johnson & Johnson 1975 - 1979
Skills
Drug Delivery, FDA, Biomedical Engineering, Nanoparticles, Commercialization, GMP, Formulation, Medical Devices, Patents, Pharmaceutical Industry, Dissolution, Product Development, Biotechnology, R&D, Validation, In Vivo, Lifesciences, HPLC, Biomaterials, Technology Transfer, Chemistry, Analytical Chemistry, Clinical Trials, Drug Development, Clinical Development, Leadership, Drug Discovery, Biopharmaceuticals, GLP, Regulatory Submissions, Chromatography, Controlled Release, V&V, CRO, Life Sciences
Education
University of California, Santa Barbara 1968 — 1972
Bachelor of Science Chemistry
SinuSys Corp. November 2010 - Present
Pharmatech Associates June 2010 - November 2010
XenoPort October 2007 - May 2010
ALZA Corporation / Johnson & Johnson 2003 - 2007
ALZA Corporation / Johnson & Johnson 1979 - 2003
ALZA Corporation / Johnson & Johnson 1975 - 1979
Skills
Drug Delivery, FDA, Biomedical Engineering, Nanoparticles, Commercialization, GMP, Formulation, Medical Devices, Patents, Pharmaceutical Industry, Dissolution, Product Development, Biotechnology, R&D, Validation, In Vivo, Lifesciences, HPLC, Biomaterials, Technology Transfer, Chemistry, Analytical Chemistry, Clinical Trials, Drug Development, Clinical Development, Leadership, Drug Discovery, Biopharmaceuticals, GLP, Regulatory Submissions, Chromatography, Controlled Release, V&V, CRO, Life Sciences
Education
University of California, Santa Barbara 1968 — 1972
Bachelor of Science Chemistry
Carl Darling Carl Darling's Pharmatech Associates Experience April 2014 - November 2014
Job Project Engineer at Genentech
Industry Biotechnology
Experience
Pharmatech Associates April 2014 - November 2014
Fourstep Automation, Inc. May 2013 - March 2014
Hyde Engineering & Consultants June 2004 - April 2013
Genentech 2012 - 2013
Novartis 2011 - 2012
Intarcia Therapeutics June 2009 - 2010
Bayer 2007 - 2009
Chiron Corporation 2004 - 2007
Swat Engineering Group June 2003 - June 2004
Quasar Engineering Services July 2002 - June 2003
Skills
GMP, Validation, Biotechnology, Engineering, Manufacturing, Project Management, Change Control, Commissioning, Automation, Root Cause Analysis, Biopharmaceuticals, V&V, Quality System, Cleaning Validation, ISO 13485, Cross-functional Team..., Quality Assurance, 21 CFR Part 11, Six Sigma, CAPA, Technology Transfer, Chromatography, GAMP, Sop, Process Engineering, R&D, FDA, Computer System..., FMEA, Process Simulation, Aseptic Processing, GxP, Design of Experiments, SOP
Education
San Jose State University 1974 — 1980
B.S. Industrial Engineering, Industrial Technology
Pharmatech Associates April 2014 - November 2014
Fourstep Automation, Inc. May 2013 - March 2014
Hyde Engineering & Consultants June 2004 - April 2013
Genentech 2012 - 2013
Novartis 2011 - 2012
Intarcia Therapeutics June 2009 - 2010
Bayer 2007 - 2009
Chiron Corporation 2004 - 2007
Swat Engineering Group June 2003 - June 2004
Quasar Engineering Services July 2002 - June 2003
Skills
GMP, Validation, Biotechnology, Engineering, Manufacturing, Project Management, Change Control, Commissioning, Automation, Root Cause Analysis, Biopharmaceuticals, V&V, Quality System, Cleaning Validation, ISO 13485, Cross-functional Team..., Quality Assurance, 21 CFR Part 11, Six Sigma, CAPA, Technology Transfer, Chromatography, GAMP, Sop, Process Engineering, R&D, FDA, Computer System..., FMEA, Process Simulation, Aseptic Processing, GxP, Design of Experiments, SOP
Education
San Jose State University 1974 — 1980
B.S. Industrial Engineering, Industrial Technology
Raj Radhakrishnan Raj Radhakrishnan's Pharmatech Associates Experience February 2006 - October 2008
Job
Industry Management Consulting
Experience
Free lance April 2015 - Present
The Louis Berger Group March 2010 - Present
The Louis Berger Group October 2008 - February 2010
Pharmatech Associates February 2006 - October 2008
Faithful & Gould October 2005 - February 2006
Black & Veatch January 2001 - July 2005
Taisei Corporation September 1999 - December 2000
James N. Gray Co 1998 - 1999
Skills
Change Management, Project Control, Project Planning, Water, Project Management, Management Systems, Earned Value Management, Ecosys, Primavera Project..., Contract Manager Expert, SharePoint, Project Controls, Value Engineering, Cost Engineering, Subcontracting, WBS, Cost Management, Commercial Management, Construction Management, Quantity Surveying, Project Coordination, Cost Control, Risk Analysis, Training, Contract Management, Concrete, PMP, Risk Assessment, Energy, Infrastructure, Program Management, Management, Construction, P3, Civil Engineering, MS Project, Management System, Primavera P6, Analysis, EPC, Process Scheduler, Risk Management, Feasibility Studies, Procurement, Project Estimation, Consulting, Rail, Project Portfolio..., Project Delivery, Proposal Writing
Education
University of Kentucky 1996 — 1998
Master of Science, Civil Engineering
College of Engineering, Trivandrum 1990 — 1994
B. Tech, Civil Engineering
Free lance April 2015 - Present
The Louis Berger Group March 2010 - Present
The Louis Berger Group October 2008 - February 2010
Pharmatech Associates February 2006 - October 2008
Faithful & Gould October 2005 - February 2006
Black & Veatch January 2001 - July 2005
Taisei Corporation September 1999 - December 2000
James N. Gray Co 1998 - 1999
Skills
Change Management, Project Control, Project Planning, Water, Project Management, Management Systems, Earned Value Management, Ecosys, Primavera Project..., Contract Manager Expert, SharePoint, Project Controls, Value Engineering, Cost Engineering, Subcontracting, WBS, Cost Management, Commercial Management, Construction Management, Quantity Surveying, Project Coordination, Cost Control, Risk Analysis, Training, Contract Management, Concrete, PMP, Risk Assessment, Energy, Infrastructure, Program Management, Management, Construction, P3, Civil Engineering, MS Project, Management System, Primavera P6, Analysis, EPC, Process Scheduler, Risk Management, Feasibility Studies, Procurement, Project Estimation, Consulting, Rail, Project Portfolio..., Project Delivery, Proposal Writing
Education
University of Kentucky 1996 — 1998
Master of Science, Civil Engineering
College of Engineering, Trivandrum 1990 — 1994
B. Tech, Civil Engineering
Kenneth Brandt Kenneth Brandt's Pharmatech Associates Experience 2006 - 2009
Job Director of Manufacturing at Avrio Biopharmaceuticals
Industry Biotechnology
Experience
Quintiles Transnational 2011 - Present
Avrio Biopharmaceuticals January 2010 - October 2011
Cell Therapeutics, Inc. 2009 - 2010
Boston Scientific 2008 - 2009
Pharmatech Associates 2006 - 2009
Aradigm Corporation 1999 - 2005
Genentech, Inc. 1990 - 1996
Skills
GMP, FDA, Pharmaceutical Industry, V&V, Validation, CAPA, Technology Transfer, Sop, Change Control, Quality System, 21 CFR Part 11, GLP, Medical Devices, Biotechnology, Computer System..., Aseptic Processing, Biopharmaceuticals, Regulatory Affairs, GxP, Cleaning Validation, Lifesciences, R&D, ISO 13485, Quality Assurance, LIMS, Pharmaceutics, Regulatory Submissions, Manufacturing, Quality Auditing, Clinical Development, Contract Manufacturing, Continuous Improvement, Formulation, Analytical Chemistry, Process Simulation, Regulatory Requirements, Quality Control, Clinical Trials, CRO, Chemistry, GCP, HPLC, GAMP, Sterilization, IND, Commercialization, Drug Delivery, Oncology, Design Control, Chromatography
Education
Century University
B.S. Business Adminstration
City College of San Francisco
Organic Chemistry
Quintiles Transnational 2011 - Present
Avrio Biopharmaceuticals January 2010 - October 2011
Cell Therapeutics, Inc. 2009 - 2010
Boston Scientific 2008 - 2009
Pharmatech Associates 2006 - 2009
Aradigm Corporation 1999 - 2005
Genentech, Inc. 1990 - 1996
Skills
GMP, FDA, Pharmaceutical Industry, V&V, Validation, CAPA, Technology Transfer, Sop, Change Control, Quality System, 21 CFR Part 11, GLP, Medical Devices, Biotechnology, Computer System..., Aseptic Processing, Biopharmaceuticals, Regulatory Affairs, GxP, Cleaning Validation, Lifesciences, R&D, ISO 13485, Quality Assurance, LIMS, Pharmaceutics, Regulatory Submissions, Manufacturing, Quality Auditing, Clinical Development, Contract Manufacturing, Continuous Improvement, Formulation, Analytical Chemistry, Process Simulation, Regulatory Requirements, Quality Control, Clinical Trials, CRO, Chemistry, GCP, HPLC, GAMP, Sterilization, IND, Commercialization, Drug Delivery, Oncology, Design Control, Chromatography
Education
Century University
B.S. Business Adminstration
City College of San Francisco
Organic Chemistry
Janette Buechler's Pharmatech Associates Experience November 2006 - Present
Job Executive Assistant to CEO and President of Pharmatech Associates & Office Manager
Industry Biotechnology
Experience
Pharmatech Associates November 2006 - Present
Coldwell Banker Residential Brokerage 2004 - 2006
The Village Realtors 2002 - 2004
Millenium Realty 1996 - 2001
Skills
Event Planning, Project Management, Event Management, Microsoft Office, Outlook, Project Planning, Process Scheduler, Office Management, Appointment Scheduling, Travel Management, Facilities Management, Choreography, Theatrical Production, Organization, Marketing, Administrative..., Management, Microsoft Word, PowerPoint, Editing, Customer Service, Sales, Salesforce.com, Human Resources, Corportate Events, Project Reporting, Administrative Writting, Board Leadership, Document Management, Heavy Calendaring, Trade Shows, Marketing Strategy, Trade Show Exhibitor, Trade Show..., Trade Show Planning, Corporate Branding, WordPress, Website Updating, LinkedIn Recruiter
Education
San Jose State University
Pharmatech Associates November 2006 - Present
Coldwell Banker Residential Brokerage 2004 - 2006
The Village Realtors 2002 - 2004
Millenium Realty 1996 - 2001
Skills
Event Planning, Project Management, Event Management, Microsoft Office, Outlook, Project Planning, Process Scheduler, Office Management, Appointment Scheduling, Travel Management, Facilities Management, Choreography, Theatrical Production, Organization, Marketing, Administrative..., Management, Microsoft Word, PowerPoint, Editing, Customer Service, Sales, Salesforce.com, Human Resources, Corportate Events, Project Reporting, Administrative Writting, Board Leadership, Document Management, Heavy Calendaring, Trade Shows, Marketing Strategy, Trade Show Exhibitor, Trade Show..., Trade Show Planning, Corporate Branding, WordPress, Website Updating, LinkedIn Recruiter
Education
San Jose State University
Josue Molina's Pharmatech Associates Experience July 2007 - May 2008
Job Director, Quality Assurance & GMP at Garden of Life
Industry Pharmaceuticals
Experience
Garden of Life April 2015 - Present
Garden of Life May 2008 - Present
Pharmatech Associates July 2007 - May 2008
Boston Scientific 2007 - 2008
Banner Pharmacaps September 2006 - July 2007
Andrx Pharmaceuticals September 2001 - August 2006
Skills
GMP, GLP, Chemistry, FDA, Validation, CAPA, Cleaning Validation, 21 CFR Part 11, Pharmaceutical Industry, V&V, Sop, Quality System, Quality Assurance, Medical Devices, Regulatory Affairs, Biotechnology, ISO 13485, Change Control, LIMS, Quality Auditing, Quality Control
Education
Kriger Research Center 2007 — 2008
CRA, CRA, GCP, GLP
Palm Beach Atlantic University 2000 — 2003
Masters, M.B.A
Universidad de Puerto Rico 1994 — 2000
BS, Chemistry
Garden of Life April 2015 - Present
Garden of Life May 2008 - Present
Pharmatech Associates July 2007 - May 2008
Boston Scientific 2007 - 2008
Banner Pharmacaps September 2006 - July 2007
Andrx Pharmaceuticals September 2001 - August 2006
Skills
GMP, GLP, Chemistry, FDA, Validation, CAPA, Cleaning Validation, 21 CFR Part 11, Pharmaceutical Industry, V&V, Sop, Quality System, Quality Assurance, Medical Devices, Regulatory Affairs, Biotechnology, ISO 13485, Change Control, LIMS, Quality Auditing, Quality Control
Education
Kriger Research Center 2007 — 2008
CRA, CRA, GCP, GLP
Palm Beach Atlantic University 2000 — 2003
Masters, M.B.A
Universidad de Puerto Rico 1994 — 2000
BS, Chemistry
Darlene Meier Darlene Meier's Pharmatech Associates Experience March 2015 - Present
Job Associate Consultant at Pharmatech Associates
Industry Biotechnology
Experience
Pharmatech Associates March 2015 - Present
Marrone Bio Innovations September 2013 - March 2015
Marrone Bio Innovations May 2012 - September 2013
Marrone Bio Innovations February 2012 - May 2012
Skills
Microbiology, Fermentation, Aseptic Technique, Agarose Gel..., Downstream Processing, Fermentation Process..., Scale-up, Process Optimization, PCR, Batch Records, Gel Electrophoresis, Laboratory, Biotechnology, Flask, SIP, Cryopreservation, SOP authoring, Optical Microscopy, Validation, Qualification Testing
Education
University of California, Davis 2007 — 2011
Bachelor of Science (B.S.), Biological Sciences
Pharmatech Associates March 2015 - Present
Marrone Bio Innovations September 2013 - March 2015
Marrone Bio Innovations May 2012 - September 2013
Marrone Bio Innovations February 2012 - May 2012
Skills
Microbiology, Fermentation, Aseptic Technique, Agarose Gel..., Downstream Processing, Fermentation Process..., Scale-up, Process Optimization, PCR, Batch Records, Gel Electrophoresis, Laboratory, Biotechnology, Flask, SIP, Cryopreservation, SOP authoring, Optical Microscopy, Validation, Qualification Testing
Education
University of California, Davis 2007 — 2011
Bachelor of Science (B.S.), Biological Sciences
Gail Christine Gannon Gail Christine Gannon's Pharmatech Associates Experience October 2008 - January 2014
Job Healthcare Business Strategy & Partnering
Industry Management Consulting
Experience
TellSpec Inc. September 2014 - Present
California Life Sciences Association (CLSA) 2013 - Present
BayBio June 2008 - Present
Ensanté June 1996 - Present
Pharmatech Associates October 2008 - January 2014
Operculum September 2008 - January 2014
NantMobile™ January 2012 - April 2013
Living Well Assisted Living at Home March 2009 - January 2012
Phyllom March 2009 - September 2011
Institute for OneWorld Health/ PATH April 2010 - April 2011
Skills
Management Consulting, Strategic Partnerships, Healthcare Consulting, New Business Development, Policy, Biotechnology, Health, Start-ups, Healthcare, Lifesciences, Start-up Ventures, Strategy, Product Management, Training, Cross-functional Team..., Program Management, Pharmaceutical Industry, Business Strategy, Leadership, Medical Devices, Entrepreneurship, Process Improvement, Business Development, Strategic Planning, Product Launch, Consulting, CRM, Executive Management, Corporate Development, Competitive Analysis, Venture Capital, Product Development, Commercialization, Mergers & Acquisitions, Fundraising, Go-to-market Strategy, Product Marketing, Analytics, Management, Drug Development, Angel Investing, Strategic Alliances, SaaS, Infectious Diseases, Clinical Research, R&D, Thought Leadership, Clinical Trials, Business Planning, Technology Transfer
Education
University of California, Santa Cruz 2006 — 2008
Certificate of Honor in Biotechnology, Certificate of Honor in Biotechnology, 4.0
University of California, Berkeley 2005 — 2005
Bachelor of Arts (BA), Biotechnology Marketing
Harvard University 1991 — 1993
MSPH, International Health, Statistics, Behavioral Epidemiology, Research & Evaluation
University of California, Berkeley 1987 — 1992
AB, Social Sciences, Health Care Policies & Ethics
TellSpec Inc. September 2014 - Present
California Life Sciences Association (CLSA) 2013 - Present
BayBio June 2008 - Present
Ensanté June 1996 - Present
Pharmatech Associates October 2008 - January 2014
Operculum September 2008 - January 2014
NantMobile™ January 2012 - April 2013
Living Well Assisted Living at Home March 2009 - January 2012
Phyllom March 2009 - September 2011
Institute for OneWorld Health/ PATH April 2010 - April 2011
Skills
Management Consulting, Strategic Partnerships, Healthcare Consulting, New Business Development, Policy, Biotechnology, Health, Start-ups, Healthcare, Lifesciences, Start-up Ventures, Strategy, Product Management, Training, Cross-functional Team..., Program Management, Pharmaceutical Industry, Business Strategy, Leadership, Medical Devices, Entrepreneurship, Process Improvement, Business Development, Strategic Planning, Product Launch, Consulting, CRM, Executive Management, Corporate Development, Competitive Analysis, Venture Capital, Product Development, Commercialization, Mergers & Acquisitions, Fundraising, Go-to-market Strategy, Product Marketing, Analytics, Management, Drug Development, Angel Investing, Strategic Alliances, SaaS, Infectious Diseases, Clinical Research, R&D, Thought Leadership, Clinical Trials, Business Planning, Technology Transfer
Education
University of California, Santa Cruz 2006 — 2008
Certificate of Honor in Biotechnology, Certificate of Honor in Biotechnology, 4.0
University of California, Berkeley 2005 — 2005
Bachelor of Arts (BA), Biotechnology Marketing
Harvard University 1991 — 1993
MSPH, International Health, Statistics, Behavioral Epidemiology, Research & Evaluation
University of California, Berkeley 1987 — 1992
AB, Social Sciences, Health Care Policies & Ethics
Pauly Kavalakatt Pauly Kavalakatt's Pharmatech Associates Experience November 2011 - June 2012
Job Manager, Innovative Process and Product development at Shaklee Corporation
Industry Pharmaceuticals
Experience
Shaklee Corporation June 2015 - Present
Shaklee Corporation June 2014 - June 2015
Impax Laboratories Hayward, California June 2012 - December 2013
Pharmatech Associates November 2011 - June 2012
Transcept Pharmaceuticals, Inc. November 2007 - October 2011
Transcept Pharmaceuticals January 2006 - November 2007
NHK Laboratories, Inc. November 2003 - January 2006
Zenon Environmental Inc, a GE company November 1998 - June 2003
Skills
Formulation, Drug Delivery, Technology Transfer, HPLC, Analytical Chemistry, FDA, Sop, Pharmaceutical Industry, V&V, Pharmaceutics, Drug Development, Organic Chemistry, Design of Experiments, Polymers, FTIR, Regulatory Submissions, Clinical Trials, IR, Chemistry, NMR, Generic Programming, Biopharmaceuticals, Lifesciences, Process Simulation, Regulatory Affairs, Chromatography, GMP, Assay Development, GLP, Validation, IND, Change Control
Education
Calicut University, India
M.Sc, Pure and Applied Chemisty
Cochin Unversity of Science & Technology, India
B.Tech, Polymer Science & Rubber Technolgy
McMaster University
Master of Science (MS), Polymer Chemisty
Shaklee Corporation June 2015 - Present
Shaklee Corporation June 2014 - June 2015
Impax Laboratories Hayward, California June 2012 - December 2013
Pharmatech Associates November 2011 - June 2012
Transcept Pharmaceuticals, Inc. November 2007 - October 2011
Transcept Pharmaceuticals January 2006 - November 2007
NHK Laboratories, Inc. November 2003 - January 2006
Zenon Environmental Inc, a GE company November 1998 - June 2003
Skills
Formulation, Drug Delivery, Technology Transfer, HPLC, Analytical Chemistry, FDA, Sop, Pharmaceutical Industry, V&V, Pharmaceutics, Drug Development, Organic Chemistry, Design of Experiments, Polymers, FTIR, Regulatory Submissions, Clinical Trials, IR, Chemistry, NMR, Generic Programming, Biopharmaceuticals, Lifesciences, Process Simulation, Regulatory Affairs, Chromatography, GMP, Assay Development, GLP, Validation, IND, Change Control
Education
Calicut University, India
M.Sc, Pure and Applied Chemisty
Cochin Unversity of Science & Technology, India
B.Tech, Polymer Science & Rubber Technolgy
McMaster University
Master of Science (MS), Polymer Chemisty
Jeffrey Phan Jeffrey Phan's Pharmatech Associates Experience December 2014 - Present
Job Senior Consultant/Project Manager
Industry Pharmaceuticals
Experience
Pharmatech Associates December 2014 - Present
Pharmatech Associates, at Thermo Fisher Scientific April 2014 - November 2014
Pharmatech Associates, at Innovent Biologics November 2013 - April 2014
Pharmatech Associates, at Hybio Pharmaceuticals May 2013 - November 2013
Validant June 2012 - April 2013
Pharmatech Associates May 2011 - June 2012
Novartis Vaccines and Diagnostics April 2008 - March 2011
Novartis June 2006 - April 2008
Chiron Corporation June 2003 - May 2006
Bayer Berkeley December 2000 - June 2003
Skills
Validation, Risk Assessment, Deviation..., CAPA, Quality by Design, Project Management, FDA, Change Control, V&V, Quality Auditing, Commissioning, 21 CFR Part 11, Computer System..., GMP, GxP, Deviations, Cleaning Validation, Continuous Improvement, Process Improvement, Technology Transfer, Quality Control, Cross-functional Team..., Manufacturing, Quality System, Sop, Medical Devices, ISO 13485, Pharmaceutical Industry, LIMS, Biopharmaceuticals, Aseptic Processing, GAMP, Regulatory Affairs, Engineering, Quality Assurance, Design Control, Design of Experiments, Lean Manufacturing, Process Simulation, Trackwise, Regulatory Submissions, ISO, Biotechnology, Quality Management, Root Cause Analysis, Regulatory Requirements, Lifesciences, GLP, Pharmaceutics, R&D
Education
University of Arkansas
Industrial Engineering
Pharmatech Associates December 2014 - Present
Pharmatech Associates, at Thermo Fisher Scientific April 2014 - November 2014
Pharmatech Associates, at Innovent Biologics November 2013 - April 2014
Pharmatech Associates, at Hybio Pharmaceuticals May 2013 - November 2013
Validant June 2012 - April 2013
Pharmatech Associates May 2011 - June 2012
Novartis Vaccines and Diagnostics April 2008 - March 2011
Novartis June 2006 - April 2008
Chiron Corporation June 2003 - May 2006
Bayer Berkeley December 2000 - June 2003
Skills
Validation, Risk Assessment, Deviation..., CAPA, Quality by Design, Project Management, FDA, Change Control, V&V, Quality Auditing, Commissioning, 21 CFR Part 11, Computer System..., GMP, GxP, Deviations, Cleaning Validation, Continuous Improvement, Process Improvement, Technology Transfer, Quality Control, Cross-functional Team..., Manufacturing, Quality System, Sop, Medical Devices, ISO 13485, Pharmaceutical Industry, LIMS, Biopharmaceuticals, Aseptic Processing, GAMP, Regulatory Affairs, Engineering, Quality Assurance, Design Control, Design of Experiments, Lean Manufacturing, Process Simulation, Trackwise, Regulatory Submissions, ISO, Biotechnology, Quality Management, Root Cause Analysis, Regulatory Requirements, Lifesciences, GLP, Pharmaceutics, R&D
Education
University of Arkansas
Industrial Engineering
Bakul Patel Bakul Patel's Pharmatech Associates Experience October 2009 - August 2014
Job Senior Validation Engineer at Grifols
Industry Biotechnology
Experience
Grifols August 2014 - Present
Pharmatech Associates October 2009 - August 2014
MedImmune September 2008 - March 2009
Baxter Healthcare August 2007 - September 2008
International Medication Systems, Limited 2006 - 2007
Skills
Validation, CAPA, 21 CFR Part 11, Computer System..., Aseptic Processing, FDA, GMP, GxP, Biotechnology, GAMP, Biopharmaceuticals, V&V, Change Control, Cleaning Validation, Sop, Pharmaceutical Industry, Technology Transfer, LIMS, Quality System, Medical Devices, Analytical Chemistry, SOP, CRO, Quality Management, Chemistry, Deviation Management, Design Control, Software Documentation, Clinical Trials, Clinical Development, Purification, Equipment Qualification, Environmental Monitoring, CTMS, Deviations, Regulatory Submissions, Document Management, GLP, Quality Auditing, Quality Assurance, Oncology, Calibration, ISO 14971, GCP
Education
University of Southern California 2002 — 2006
Bachelor of Science, Biological Sciences
Troy High School
Grifols August 2014 - Present
Pharmatech Associates October 2009 - August 2014
MedImmune September 2008 - March 2009
Baxter Healthcare August 2007 - September 2008
International Medication Systems, Limited 2006 - 2007
Skills
Validation, CAPA, 21 CFR Part 11, Computer System..., Aseptic Processing, FDA, GMP, GxP, Biotechnology, GAMP, Biopharmaceuticals, V&V, Change Control, Cleaning Validation, Sop, Pharmaceutical Industry, Technology Transfer, LIMS, Quality System, Medical Devices, Analytical Chemistry, SOP, CRO, Quality Management, Chemistry, Deviation Management, Design Control, Software Documentation, Clinical Trials, Clinical Development, Purification, Equipment Qualification, Environmental Monitoring, CTMS, Deviations, Regulatory Submissions, Document Management, GLP, Quality Auditing, Quality Assurance, Oncology, Calibration, ISO 14971, GCP
Education
University of Southern California 2002 — 2006
Bachelor of Science, Biological Sciences
Troy High School
Minda Grucela, CPP's Pharmatech Associates Experience November 2009 - March 2010
Job Staff Packaging Engineer at Dexcom
Industry Medical Devices
Experience
Dexcom March 2014 - Present
Dexcom August 2012 - March 2014
Sangart March 2010 - August 2012
Sangart March 2010 - June 2011
Pharmatech Associates November 2009 - March 2010
Sangart August 2008 - June 2009
Sani-Tech West April 2006 - July 2008
Bosch Packaging Technology June 2004 - March 2006
Cingular Wireless 2000 - 2000
Skills
Validation, GMP, cGMP, SOP, Packaging, Pharmaceuticals, Biotechnology, Packaging Engineering, Process Engineering, Process Optimization, Serialization, Aseptic Processing, Sop, Technology Transfer, Pharmaceutical Industry, Product Development, FDA, Change Control, 21 CFR Part 11, CAPA, Manufacturing, Medical Devices, V&V
Education
Drexel University 1999 — 2004
BSEE, Electrical Engineering
Drexel University 1999 — 2004
BSEE, Electrical, Electronics and Communications Engineering
Dexcom March 2014 - Present
Dexcom August 2012 - March 2014
Sangart March 2010 - August 2012
Sangart March 2010 - June 2011
Pharmatech Associates November 2009 - March 2010
Sangart August 2008 - June 2009
Sani-Tech West April 2006 - July 2008
Bosch Packaging Technology June 2004 - March 2006
Cingular Wireless 2000 - 2000
Skills
Validation, GMP, cGMP, SOP, Packaging, Pharmaceuticals, Biotechnology, Packaging Engineering, Process Engineering, Process Optimization, Serialization, Aseptic Processing, Sop, Technology Transfer, Pharmaceutical Industry, Product Development, FDA, Change Control, 21 CFR Part 11, CAPA, Manufacturing, Medical Devices, V&V
Education
Drexel University 1999 — 2004
BSEE, Electrical Engineering
Drexel University 1999 — 2004
BSEE, Electrical, Electronics and Communications Engineering
Moria Feighery-Ross's Pharmatech Associates Experience 2007 - Present
Job Senior Consultant with Pharmatech Associates
Industry Pharmaceuticals
Experience
Pharmatech Associates 2007 - Present
ALZA Corporation June 2008 - January 2015
Centocor (Johnson & Johnson) 2008 - 2009
Novo Nordisk 2007 - 2008
SIPR 2002 - 2007
Skills
Quality System, GMP, FDA, Technology Transfer, Validation, Sop, CAPA, Pharmaceutical Industry, Manufacturing, CIP, ISO 14971, Calibration, Analytical Chemistry, Lean Manufacturing, Quality Management, Design of Experiments, Change Control, 21 CFR Part 11, Biotechnology, Medical Devices, USP, Quality Auditing, Process Engineering, cGMP practices, FDA GMP, Cleaning Validation, Computer System..., Equipment Qualification, ISO, Lifesciences, Root Cause Analysis, GxP, GAMP, Pharmacovigilance, V&V, 21 CFR, Trackwise, Quality Control, FMEA, Sterilization, Six Sigma, Pharmaceutical..., Quality Assurance, Deviations, Chemistry, Document Management, Design Control, ISO 13485, SOP development, Testing
Education
University of California, San Diego 1996 — 2002
Pharmatech Associates 2007 - Present
ALZA Corporation June 2008 - January 2015
Centocor (Johnson & Johnson) 2008 - 2009
Novo Nordisk 2007 - 2008
SIPR 2002 - 2007
Skills
Quality System, GMP, FDA, Technology Transfer, Validation, Sop, CAPA, Pharmaceutical Industry, Manufacturing, CIP, ISO 14971, Calibration, Analytical Chemistry, Lean Manufacturing, Quality Management, Design of Experiments, Change Control, 21 CFR Part 11, Biotechnology, Medical Devices, USP, Quality Auditing, Process Engineering, cGMP practices, FDA GMP, Cleaning Validation, Computer System..., Equipment Qualification, ISO, Lifesciences, Root Cause Analysis, GxP, GAMP, Pharmacovigilance, V&V, 21 CFR, Trackwise, Quality Control, FMEA, Sterilization, Six Sigma, Pharmaceutical..., Quality Assurance, Deviations, Chemistry, Document Management, Design Control, ISO 13485, SOP development, Testing
Education
University of California, San Diego 1996 — 2002
Suman Dutta CMQ,CQE,CQA RABQSA Lead Auditor's Pharmatech Associates Experience 2007 - Present
Job Quality Consultant at Boston Scientific
Industry Pharmaceuticals
Experience
Boston Scientific April 2007 - Present
Pharmatech Associates 2007 - Present
Banner Pharmacaps 2006 - 2007
Andrx Pharmaceuticals 2002 - 2006
Apotex Inc. May 2000 - August 2002
Post Graduate Institute Of Medical Education and Research 1990 - 1996
Education
San Diego State University-California State University 2006 — 2009
Central School 1985 — 1990
XII, Physics, Chemistry, Biology, Mathematics, English
Kendriya Vidyalaya Sector-31, Chandigarh 1985 — 1990
XII, Physics, Chemistry, Biology, Mathematics, English
Ontario Collage of Computer Science
Boston Scientific April 2007 - Present
Pharmatech Associates 2007 - Present
Banner Pharmacaps 2006 - 2007
Andrx Pharmaceuticals 2002 - 2006
Apotex Inc. May 2000 - August 2002
Post Graduate Institute Of Medical Education and Research 1990 - 1996
Education
San Diego State University-California State University 2006 — 2009
Central School 1985 — 1990
XII, Physics, Chemistry, Biology, Mathematics, English
Kendriya Vidyalaya Sector-31, Chandigarh 1985 — 1990
XII, Physics, Chemistry, Biology, Mathematics, English
Ontario Collage of Computer Science
Hoc Nguyen's Pharmatech Associates Experience April 2009 - February 2010
Job Pharmaceutical Consultant
Industry Biotechnology
Experience
HoNu Consulting Services, Inc. January 2012 - Present
Independent Consultant February 2010 - December 2012
Pharmatech Associates April 2009 - February 2010
San Francisco Merionettes 2000 - 2010
San Francisco Merionettes 2000 - 2010
Pain Therapeutics, Inc. March 2005 - April 2009
Avigen January 2001 - September 2004
Elan August 1997 - December 2001
Genentech January 1986 - August 1997
Skills
Technology Transfer, Process Development, Validation, GMP, Change Control, Manufacturing Management, Quality Assurance, Strategic Planning, FDA, Process Validation, CAPA, cGMP, Cleaning Validation, SOP, Quality Systems, Team Building, Formulation Development, Process Improvement, Biopharmaceuticals, Lyophilization, Pharmaceuticals, Manufacturing, Biotechnology, Medical Devices, Regulatory Submissions, Pharmaceutical..., Commercialization, Contract Manufacturing, Drug Delivery, Regulatory Affairs, R&D, Diagnostics, Quality Auditing, Regulatory Requirements, Cell Culture, Six Sigma, Sop, Drug Development, V&V, Process Simulation, Pharmaceutical Industry, Quality System
Education
University of Washington 1979 — 1981
M.S., Chemical Engineering
Purdue University 1977 — 1979
B.S., Chemical Engineering
HoNu Consulting Services, Inc. January 2012 - Present
Independent Consultant February 2010 - December 2012
Pharmatech Associates April 2009 - February 2010
San Francisco Merionettes 2000 - 2010
San Francisco Merionettes 2000 - 2010
Pain Therapeutics, Inc. March 2005 - April 2009
Avigen January 2001 - September 2004
Elan August 1997 - December 2001
Genentech January 1986 - August 1997
Skills
Technology Transfer, Process Development, Validation, GMP, Change Control, Manufacturing Management, Quality Assurance, Strategic Planning, FDA, Process Validation, CAPA, cGMP, Cleaning Validation, SOP, Quality Systems, Team Building, Formulation Development, Process Improvement, Biopharmaceuticals, Lyophilization, Pharmaceuticals, Manufacturing, Biotechnology, Medical Devices, Regulatory Submissions, Pharmaceutical..., Commercialization, Contract Manufacturing, Drug Delivery, Regulatory Affairs, R&D, Diagnostics, Quality Auditing, Regulatory Requirements, Cell Culture, Six Sigma, Sop, Drug Development, V&V, Process Simulation, Pharmaceutical Industry, Quality System
Education
University of Washington 1979 — 1981
M.S., Chemical Engineering
Purdue University 1977 — 1979
B.S., Chemical Engineering
Marvin Kumashiro's Pharmatech Associates Experience 1995 - 2000
Job Validation Manager at Revance Therapeutics
Industry Biotechnology
Experience
Revance Therapeutics January 2014 - Present
Revance Therapeutics March 2010 - January 2014
ValidPath June 2008 - March 2010
Genitope October 2002 - May 2008
Therma 2000 - 2002
Pharmatech Associates 1995 - 2000
Skills
GMP, Validation, FDA, Change Control, 21 CFR Part 11, Sop, Biotechnology, GxP, Biopharmaceuticals, Pharmaceutical Industry
Education
California Polytechnic State University-San Luis Obispo 1987 — 1993
Bachelor of Science (BS), Mechanical Engineering
Revance Therapeutics January 2014 - Present
Revance Therapeutics March 2010 - January 2014
ValidPath June 2008 - March 2010
Genitope October 2002 - May 2008
Therma 2000 - 2002
Pharmatech Associates 1995 - 2000
Skills
GMP, Validation, FDA, Change Control, 21 CFR Part 11, Sop, Biotechnology, GxP, Biopharmaceuticals, Pharmaceutical Industry
Education
California Polytechnic State University-San Luis Obispo 1987 — 1993
Bachelor of Science (BS), Mechanical Engineering
Debbie Heng's Pharmatech Associates Experience December 2009 - October 2011
Job Quality Validation Engineer at Advanced Bionics
Industry Pharmaceuticals
Experience
DPoon Quality Consultant January 2008 - Present
Excellent Pharma Consulting October 2011 - March 2012
Pharmatech Associates December 2009 - October 2011
Advanced Bionics March 2011 - September 2011
Quintiles June 2009 - December 2009
Pharmatech Associates January 2007 - June 2009
Avema Pharmaceutical January 2009 - March 2009
Pharmatech Associates August 2008 - October 2008
Pharmatech Associates March 2008 - August 2008
Skills
Cleaning Validation, ISO 13485, Regulatory Affairs, CAPA, Quality System, Medical Devices, V&V, Sop, GMP, FDA, Pharmaceutical Industry, Change Control, 21 CFR Part 11, ISO 14971, GCP, Biopharmaceuticals, Technology Transfer, Auditing, 21 CFR, Quality Control, GxP, Manufacturing, Regulatory Submissions, Quality Assurance, Sterilization, Design of Experiments, GLP, Root Cause Analysis, Computer System..., HPLC, Trackwise, Chromatography, Biotechnology, Risk Assessment, Software Documentation, GAMP, Clinical Trials, ISO, USP, Pharmaceutics, LIMS, Analytical Chemistry, Cross-functional Team..., Quality Auditing, Calibration, Document Management, Dissolution, Design Control, Minitab, R&D
Education
San Francisco State University 1999 — 2003
BS, Molecular and Cell Biology
City College of San Francisco
Certificate, Forensic Identification
DPoon Quality Consultant January 2008 - Present
Excellent Pharma Consulting October 2011 - March 2012
Pharmatech Associates December 2009 - October 2011
Advanced Bionics March 2011 - September 2011
Quintiles June 2009 - December 2009
Pharmatech Associates January 2007 - June 2009
Avema Pharmaceutical January 2009 - March 2009
Pharmatech Associates August 2008 - October 2008
Pharmatech Associates March 2008 - August 2008
Skills
Cleaning Validation, ISO 13485, Regulatory Affairs, CAPA, Quality System, Medical Devices, V&V, Sop, GMP, FDA, Pharmaceutical Industry, Change Control, 21 CFR Part 11, ISO 14971, GCP, Biopharmaceuticals, Technology Transfer, Auditing, 21 CFR, Quality Control, GxP, Manufacturing, Regulatory Submissions, Quality Assurance, Sterilization, Design of Experiments, GLP, Root Cause Analysis, Computer System..., HPLC, Trackwise, Chromatography, Biotechnology, Risk Assessment, Software Documentation, GAMP, Clinical Trials, ISO, USP, Pharmaceutics, LIMS, Analytical Chemistry, Cross-functional Team..., Quality Auditing, Calibration, Document Management, Dissolution, Design Control, Minitab, R&D
Education
San Francisco State University 1999 — 2003
BS, Molecular and Cell Biology
City College of San Francisco
Certificate, Forensic Identification
Phyllis Newman's Pharmatech Associates Experience March 2012 - November 2014
Job Senior Compliance Consultant
Industry Pharmaceuticals
Experience
Pharmatech Associates March 2012 - November 2014
Internet Services Corporation / International Pharma Packaging and Distribution October 2007 - May 2012
Leiner Health Products 1996 - 2008
Skills
Sop, FDA, GMP, Pharmaceutical Industry, CAPA
Education
State University of New York College of Agriculture and Technology at Morrisville 1989 — 1991
Associate's degree, Dietetics
Pharmatech Associates March 2012 - November 2014
Internet Services Corporation / International Pharma Packaging and Distribution October 2007 - May 2012
Leiner Health Products 1996 - 2008
Skills
Sop, FDA, GMP, Pharmaceutical Industry, CAPA
Education
State University of New York College of Agriculture and Technology at Morrisville 1989 — 1991
Associate's degree, Dietetics
Jason Otwell's Pharmatech Associates Experience November 2013 - Present
Job Senior Consultant at Pharmatech Associates
Industry Pharmaceuticals
Experience
Pharmatech Associates November 2013 - Present
Heartflow, Inc April 2012 - March 2013
Abbott Medical Optics April 2010 - February 2012
Abbott Hematology December 2007 - April 2010
Pharmatech Associates August 2005 - November 2007
Pharmatech Associates 2005 - 2007
ALZA Corporation 2005 - 2007
Genitope 2002 - 2005
Validation Systems Inc 2002 - 2005
Skills
Regulatory Affairs, Biopharmaceuticals, Sterilization, LIMS, Design Control, Cleaning Validation, Root Cause Analysis, Quality Control, Computer System..., Sop, Aseptic Processing, Quality Auditing, 21 CFR Part 11, Equipment Qualification, Biotechnology, ISO 13485, GMP, ISO 14971, Technology Transfer, Pharmaceutical Industry, Change Control, V&V, Validation, GxP, GLP, Trackwise, FDA, Quality Assurance, R&D, Quality System, Medical Devices, GAMP, USP, OOS, Design of Experiments, Minitab, Purified Water, Instrument Validation, Testing, Software Documentation, Six Sigma, Sterility Assurance, Deviation Management, Deviations, FDA GMP, cGMP practices, 21 CFR, ISO, cGLP, FMEA
Education
University of California, Davis 1998 — 2002
BS, Microbiology
Piedmont Hills High School
Pharmatech Associates November 2013 - Present
Heartflow, Inc April 2012 - March 2013
Abbott Medical Optics April 2010 - February 2012
Abbott Hematology December 2007 - April 2010
Pharmatech Associates August 2005 - November 2007
Pharmatech Associates 2005 - 2007
ALZA Corporation 2005 - 2007
Genitope 2002 - 2005
Validation Systems Inc 2002 - 2005
Skills
Regulatory Affairs, Biopharmaceuticals, Sterilization, LIMS, Design Control, Cleaning Validation, Root Cause Analysis, Quality Control, Computer System..., Sop, Aseptic Processing, Quality Auditing, 21 CFR Part 11, Equipment Qualification, Biotechnology, ISO 13485, GMP, ISO 14971, Technology Transfer, Pharmaceutical Industry, Change Control, V&V, Validation, GxP, GLP, Trackwise, FDA, Quality Assurance, R&D, Quality System, Medical Devices, GAMP, USP, OOS, Design of Experiments, Minitab, Purified Water, Instrument Validation, Testing, Software Documentation, Six Sigma, Sterility Assurance, Deviation Management, Deviations, FDA GMP, cGMP practices, 21 CFR, ISO, cGLP, FMEA
Education
University of California, Davis 1998 — 2002
BS, Microbiology
Piedmont Hills High School
Andy Duong's Pharmatech Associates Experience August 2007 - July 2013
Job Manufacturing Technical Specialist III at Genentech
Industry Medical Devices
Experience
Genentech July 2013 - Present
Pharmatech Associates August 2007 - July 2013
Abbott 2010 - 2013
Skills
21 CFR Part 11, ISO 13485, V&V, FDA, Validation, GMP, CAPA, Quality System, Sop, FMEA, Root Cause Analysis, ISO, GAMP, Quality Management, GxP, Medical Devices, Quality Assurance, Cleaning Validation, GLP, Deviations, Design Control, Biopharmaceuticals, Lifesciences, Chemistry, Quality Control, Pharmaceutical Industry, Manufacturing, Change Control, Calibration, USP, Continuous Improvement, Document Management, Sterilization, Equipment Qualification, 21 CFR, cGMP practices, FDA GMP, SOP development, CQA, Deviation Management
Education
University of California, Davis
BS, Biological Sciences
Genentech July 2013 - Present
Pharmatech Associates August 2007 - July 2013
Abbott 2010 - 2013
Skills
21 CFR Part 11, ISO 13485, V&V, FDA, Validation, GMP, CAPA, Quality System, Sop, FMEA, Root Cause Analysis, ISO, GAMP, Quality Management, GxP, Medical Devices, Quality Assurance, Cleaning Validation, GLP, Deviations, Design Control, Biopharmaceuticals, Lifesciences, Chemistry, Quality Control, Pharmaceutical Industry, Manufacturing, Change Control, Calibration, USP, Continuous Improvement, Document Management, Sterilization, Equipment Qualification, 21 CFR, cGMP practices, FDA GMP, SOP development, CQA, Deviation Management
Education
University of California, Davis
BS, Biological Sciences
Jim Norton's Pharmatech Associates Experience 2012 - 2012
Job Board Member at Bluegrass Reentry Council
Industry Pharmaceuticals
Experience
Kentucky Faith Based Coalition September 2015 - Present
Episcopal Prison Ministry Commission April 2011 - Present
Norton Pharma Consulting July 2010 - Present
Bluegrass Reentry Council 2010 - Present
Bluegrass Families of the Incarcerated 2009 - Present
Pharmatech Associates 2012 - 2012
Catalent Pharma Solutions January 2007 - January 2011
Cardinal Health January 2001 - January 2007
International Processing Company January 1998 - January 2001
Roxane Laboratories January 1993 - January 1998
Skills
Solid Oral Dosage Forms, FDA, Pharmaceutical Industry, GMP, Technology Transfer, Drug Discovery, Quality Control, Process Simulation, Biotechnology, Patents, Manufacturing, Formulation, Cleaning Validation, Biopharmaceuticals, Clinical Development, Validation, Project Management, GLP, Change Control, Analytical Chemistry, Product Development, Process Optimization, Medical Devices, V&V, CAPA, Quality by Design, Coatings, Sop, Oncology, Quality Assurance, Contract Manufacturing, Computer System..., Commercialization, Business Development, Laboratory, Regulatory Affairs, Packaging, Pharmaceutics, Drug Delivery, Clinical Trials, CRO, Chemistry, ISO 13485, Drug Development, Vaccines, Polymers, Quality System, Regulatory Submissions, Lifesciences, Leadership
Education
The Ohio State University 1984 — 1987
MS, Pharmaceutical Administration
Chemical EducationCalvin College
BA
Various
Kentucky Faith Based Coalition September 2015 - Present
Episcopal Prison Ministry Commission April 2011 - Present
Norton Pharma Consulting July 2010 - Present
Bluegrass Reentry Council 2010 - Present
Bluegrass Families of the Incarcerated 2009 - Present
Pharmatech Associates 2012 - 2012
Catalent Pharma Solutions January 2007 - January 2011
Cardinal Health January 2001 - January 2007
International Processing Company January 1998 - January 2001
Roxane Laboratories January 1993 - January 1998
Skills
Solid Oral Dosage Forms, FDA, Pharmaceutical Industry, GMP, Technology Transfer, Drug Discovery, Quality Control, Process Simulation, Biotechnology, Patents, Manufacturing, Formulation, Cleaning Validation, Biopharmaceuticals, Clinical Development, Validation, Project Management, GLP, Change Control, Analytical Chemistry, Product Development, Process Optimization, Medical Devices, V&V, CAPA, Quality by Design, Coatings, Sop, Oncology, Quality Assurance, Contract Manufacturing, Computer System..., Commercialization, Business Development, Laboratory, Regulatory Affairs, Packaging, Pharmaceutics, Drug Delivery, Clinical Trials, CRO, Chemistry, ISO 13485, Drug Development, Vaccines, Polymers, Quality System, Regulatory Submissions, Lifesciences, Leadership
Education
The Ohio State University 1984 — 1987
MS, Pharmaceutical Administration
Chemical EducationCalvin College
BA
Various
Rich Pascual's Pharmatech Associates Experience October 1995 - January 2001
Job Quality Systems Engineer at Gen Probe
Industry Pharmaceuticals
Experience
Gen Probe August 2009 - Present
Pacira Pharmaceuticals, Inc. November 2002 - July 2009
Therma January 2001 - September 2002
Pharmatech Associates October 1995 - January 2001
Quasar Engineering, Inc January 1995 - October 1995
Education
California Polytechnic State University-San Luis Obispo
BS, Mech E
Gen Probe August 2009 - Present
Pacira Pharmaceuticals, Inc. November 2002 - July 2009
Therma January 2001 - September 2002
Pharmatech Associates October 1995 - January 2001
Quasar Engineering, Inc January 1995 - October 1995
Education
California Polytechnic State University-San Luis Obispo
BS, Mech E
Ken Lew's Pharmatech Associates Experience October 2005 - August 2008
Job Business Process Development at BioMarin
Industry Pharmaceuticals
Experience
Centellax August 2008 - August 2011
Pharmatech Associates October 2005 - August 2008
Agilent Technologies January 2000 - September 2005
Hewlett-Packard March 1984 - January 2000
Fairchild Semiconductor October 1976 - March 1984
Skills
Lean Manufacturing, Six Sigma, Continuous Improvement, Process Improvement, Process Engineering, Engineering Management, Cross-functional Team..., FMEA, Project Management, Engineering, Project Planning
Education
University of California, Berkeley 1972 — 1976
BA, Physics
Centellax August 2008 - August 2011
Pharmatech Associates October 2005 - August 2008
Agilent Technologies January 2000 - September 2005
Hewlett-Packard March 1984 - January 2000
Fairchild Semiconductor October 1976 - March 1984
Skills
Lean Manufacturing, Six Sigma, Continuous Improvement, Process Improvement, Process Engineering, Engineering Management, Cross-functional Team..., FMEA, Project Management, Engineering, Project Planning
Education
University of California, Berkeley 1972 — 1976
BA, Physics
Jenni Martinez's Pharmatech Associates Experience July 2002 - June 2005
Job Senior Validation Engineer at Genentech
Industry Biotechnology
Experience
Genentech June 2005 - Present
Pharmatech Associates July 2002 - June 2005
Lab Support, a division of On Assignment October 2000 - June 2002
Education
University of Idaho 1996 — 1997
Chemistry
Eastern Oregon University 1992 — 1996
Bachelor of Science, Chemistry
Genentech June 2005 - Present
Pharmatech Associates July 2002 - June 2005
Lab Support, a division of On Assignment October 2000 - June 2002
Education
University of Idaho 1996 — 1997
Chemistry
Eastern Oregon University 1992 — 1996
Bachelor of Science, Chemistry