NNDT Company

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NNDT Employees

Employee
Years
Job
Industry
Carsten Nicolai Petersen Carsten Nicolai Petersen Raleigh-Durham, North Carolina Area Details
Carsten Nicolai Petersen's NNDT Experience 2007 - 2008
Job Director at NNE Pharmaplan
Industry Pharmaceuticals
Experience
NNE Pharmaplan  April 1996 - Present
NNE Pharmaplan  January 2010 - January 2011
NNE Pharmaplan  January 2007 - January 2010
NNDT   2007 - 2008
PT. Sorini   November 1994 - April 1996
Pedersen Engineering Ltd.   November 1993 - November 1994
Kruger  1993 - 1993

Education
Stanford University Graduate School of Business   2009 — 2009
Finance & Accounting for Nonfinancial Executives

PMI   2007 — 2007
PMP - Project Management Professional

Pathfinder   2005 — 2005
The Pathfinder Programme

Danmarks Tekniske Universitet   1989 — 1993
B.Sc., Mechanical Engineering

Angelina Novion Angelina Novion San Francisco Bay Area Details
Angelina Novion's NNDT Experience 2005 - 2008
Job Commercial QA
Industry Pharmaceuticals
Experience
Gilead Sciences  May 2013 - Present
Depomed, Inc.   August 2008 - May 2013
Novo Nordisk Delivery Technologies  January 2005 - May 2008
NNDT   2005 - 2008
Aradigm Corporation  2001 - 2002

Education
Holy Names University   1997 — 2001
B.S., Biology

Amy Chu Guevara Amy Chu Guevara San Francisco Bay Area Details
Amy Chu Guevara's NNDT Experience July 2006 - July 2007
Job Sr. Manager Regulatory Affairs at Onyx Pharmaceuticals
Industry Pharmaceuticals
Experience
Genentech  September 2014 - Present
Onyx Pharmaceuticals  November 2013 - September 2014
Onyx Pharmaceuticals  September 2011 - November 2013
Depomed Inc  August 2007 - September 2011
Depomed, Inc.   August 2007 - August 2008
NNDT   July 2006 - July 2007
Aradigm Corp   April 2005 - June 2006

Skills
FDA, Validation, Regulatory Affairs, GxP, IND, CMC, Quality Control, Clinical Research, eCTD, CTAs, ICH guidelines, Clinical Development, EMEA, Product Development, NDA, Protocol

Education
University of San Francisco   1998 — 2003
BS, Chemistry

Steve Nierlich Steve Nierlich San Francisco Bay Area Details
Steve Nierlich's NNDT Experience 2005 - April 2008
Job Senior Project Engineer at Rainin Instrument LLC
Industry Pharmaceuticals
Experience
Rainin Instrument LLC  April 2008 - Present
NNDT   2005 - April 2008
Aradigm Corporation  2001 - 2005
Aradigm Corporation  1997 - 2001
Nellcor  1991 - 1997

Skills
Validation, Design of Experiments, GMP, Project Management, Metrology, Data Analysis, Biocompatibility, Medical Devices, Design Control, FDA, Pharmaceutical Industry, Biotechnology, Drug Delivery, R&D, Manufacturing, Automation, Design for Manufacturing, Injection Molding, CAPA, Manufacturing..., SPC, Product Development, Cross-functional Team..., Product Design, FMEA, Mechanical Engineering, Product Launch

Education
Massachusetts Institute of Technology   1989 — 1991
MS, Mechanical Engineering

Stanford University   1985 — 1989
BS, Mechanical Engineering

Edith Maverick Folger Edith Maverick Folger Greater Boston Area Details
Edith Maverick Folger's NNDT Experience 2004 - 2008
Job Principal Software QA Engineer at Boston Scientific
Industry Biotechnology
Experience
Boston Scientific  March 2008 - Present
Novo Nordisk Delivery Technologies  January 2004 - February 2008
Novo Nordisk  2005 - 2008
NNDT   2004 - 2008
Aradigm Corporation  October 2000 - January 2004
LifeScan  1997 - October 2000
Bio-Rad Laboratories  1992 - 1996
Bio-Rad  1990 - 1994
3M  1987 - 1991

Skills
FDA, Validation, 21 CFR Part 11, FMEA, Biotechnology, Requirements Analysis, Firmware, Planning, FMECA, Hazard Analysis, GMP, Software Validation, Quality Systems, Medical Devices, ISO 13485, CAPA, Quality Assurance, Design Control, cGMP, ISO, Manufacturing, Testing, Software Quality..., Process Validation, Computer System..., Process Development, R&D, SOP, V&V, Sop, Quality System, Cross-functional Team..., Change Control, Quality Control, Design of Experiments, SPC, Root Cause Analysis, Automation, Software Documentation, Iso 9000, Process Simulation, Project Planning

Education
Mills College   1983 — 1984
Bachelors or Arts, Computer Science

Rendie Borje Rendie Borje San Francisco Bay Area Details
Rendie Borje's NNDT Experience January 2005 - February 2008
Job Quality Engineering Supervisor at Impax Laboratories
Industry Pharmaceuticals
Experience
Impax Laboratories  November 2014 - Present
Impax Laboratories  April 2014 - November 2014
Impax Laboratories  May 2012 - April 2014
Genomic Health  June 2008 - April 2012
Novo Nordisk Delivery Technologies  January 2005 - February 2008
NNDT   January 2005 - February 2008
Aradigm Corporation  June 2001 - January 2005
Kaiser Permanente  October 1994 - May 2001

Skills
Lean Manufacturing, LIMS, CAPA, HPLC, Spectroscopy, Enzyme Assays, FDA, GMP, Medical Devices, Quality Control, Pharmaceutical Industry, Validation, UV/Vis, Biotechnology, Sop, Quality Management, SOP

Education
California State University-East Bay
BS, Biology

Allen Lam Allen Lam San Francisco Bay Area Details
Allen Lam's NNDT Experience 2005 - 2008
Job Scientist at NNDT
Industry Pharmaceuticals
Experience
Abaxis  2008 - 2009
Novo Nordisk Delivery Technologies  2005 - 2008
NNDT   2005 - 2008
Aradigm Corporation  1998 - 2005
Genentech  1985 - 1998

Education
Southern Illinois University, Edwardsville   1979 — 1982
M. Sc, Chemistry, Environmental Sciences

Nagwa Mohamed Nagwa Mohamed San Francisco Bay Area Details
Nagwa Mohamed's NNDT Experience 2005 - 2008
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Heron Therapeutics (Formally known as A.P.Pharma)   November 2013 - Present
A.P.Pharma   June 2008 - November 2013
Lab support  2008 - 2008
NNDT   2005 - 2008

Skills
Drug Delivery, Research, GMP, Analytical Chemistry, Biotechnology, Chromatography, GLP, Clinical Development, Formulation, Pharmaceutical Industry, Gas Chromatography, HPLC, Lifesciences, FDA, CRO, Sop, Validation, Drug Development, Technology Transfer, Chemistry, Drug Discovery, Regulatory Submissions, Clinical Trials, Organic Chemistry, LIMS, Biopharmaceuticals, IND, CAPA, Life Sciences, SOP

Education
California State University-East Bay   1997 — 2002
Bachelor of Science (BS) in Biology minor in Chemistry

Elizabeth (Lisa) Erdos Elizabeth (Lisa) Erdos San Francisco Bay Area Details
Elizabeth (Lisa) Erdos's NNDT Experience 1997 - 2008
Job Master Gardener
Industry Farming
Experience
Independent  December 2009 - Present
Novo Nordisk  2005 - 2008
NNDT   1997 - 2008
Aradigm Corporation  1997 - 2005
Syntex  1984 - 1995

Skills
GMP, Validation

Education
Case Western Reserve University   1974 — 1978

Nancy Gertlar, MS, MBA,FRAPS, RAC: US, EU, CAN Nancy Gertlar, MS, MBA,FRAPS, RAC: US, EU, CAN Spokane, Washington Area Details
Nancy Gertlar, MS, MBA,FRAPS, RAC: US, EU, CAN's NNDT Experience 2005 - 2007
Job Regulatory and Quality Professional for the Medical Device Industry
Industry Medical Devices
Experience
McKesson  October 2014 - Present
Conmed Corporation  June 2009 - Present
Hoana Medical  2007 - 2009
NNDT   2005 - 2007
Diagnostic Ultrasound  2002 - 2005
Bioject   1999 - 2002
Spacelabs Medical  1994 - 1999

Skills
V&V, FDA, ISO 13485, Medical Devices, Regulatory Affairs, Design Control, ISO 14971, Regulatory Submissions, GMP, CAPA, Quality System, ISO, Quality Assurance, Continuous Improvement, Six Sigma, Quality Management, Root Cause Analysis, 21 CFR Part 11, Change Control, FMEA, Injection Molding, Product Development, Quality Auditing, Supplier Quality, Validation

Education
University of Washington   2003 — 2006
Bachelor of Arts - Business, International Business, Innovation and Technology

ESC Rouen France   1997 — 1998
Master of Business Administration

Purdue University - Krannert School of Management   1997 — 1998
Master of Science in Management, International Business

West Valley High School Spokane Valley   1969 — 1972
Diploma, General Studies