Sr Quality Technology Manager
CurrentProvide global business support and leadership for global laboratory applications and business processes to ensure standardization across manufacturing sites.
Jul 2016 - Present
AeroLeads people directory · profile
Linh Nguyen Email & Phone Number
R&D Pharma Scientist with hands-on experience from molecule to marketing of drug products. Visionary Entrepreneur.
at
GSK
1 work email found
@cnconsulting.com
6 phones found area 919
LinkedIn matched
4 data sources
Profile completeness 100%
Current company
Role
R&D Pharma Scientist with hands-on experience from molecule to marketing of drug products. Visionary Entrepreneur.
Location
Cary, North Carolina, United States
Who is Linh Nguyen? Overview
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Quick answer
Linh Nguyen is listed as R&D Pharma Scientist with hands-on experience from molecule to marketing of drug products. Visionary Entrepreneur. at GSK, based in Cary, North Carolina, United States. AeroLeads shows a work email signal at cnconsulting.com, phone signal with area code 919, and a matched LinkedIn profile for Linh Nguyen.
Linh Nguyen previously worked as Sr Quality Technology Manager at Gsk and Global CMC Regulatory Project Manager at Gsk. Linh Nguyen holds Bs, Chemistry from Virginia Commonwealth University.
Company email context
Email format at GSK
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{first}@cnconsulting.com
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Profile bio
About Linh Nguyen
LinhCary@gmail.comPharmaceutical Development Chemist with over 25 years of experience working for Fortune 500 corporations. Expertise in supporting API/drug product development and IND/NDA registrations from pilot plant scale to different phases of clinical trials. Proven abilities in analytical and critical thinking, technical training, mentoring, and process improvement . Business-focused with trusting relationship building and strategic planning skills. Specialties: Global supply chain support, global regulatory submission, method development and validation including instrument validation and 21 CFR part 11 compliance, experimental design, statistical analysis, and IT integration/UAT testing.
Listed skills include Validations, Methods Development And Transfer, Quality Assurance, It Integration, and 27 others.
Current workplace
Linh Nguyen's current company
Company context helps verify the profile and gives searchers a useful next step.
12 roles · 36 years
Linh Nguyen work experience
A career timeline built from the work history available for this profile.
Global Cmc Regulatory Project Manager
Worked with Local Operating Companies to submit new product registrations and source transfers in new markets including Asia Pacific, Latin America, and Europe.
Nov 2012 - Jun 2016
Subject Matter Expert
Fujifilm Diosynth Biotechnologies Usa
* Led new project transfer and provided technical support to the QC Chemistry laboratory including implementing of Empower 3, investigating deviations, atypical and OOS results, and authoring annual product quality reports.
Jul 2012 - Nov 2012
Qa/Qc Raw Material Specialist
Oversaw and setup the QC Raw Material laboratory to support US Novartis Vaccines and Diagnostics site-start-up.
2009 - 2011
~2 yrs
Qa Validation
Reviewed and approved validation protocols, reports, and SOPs. Provided technical guidance to the QC scientists as needed.
Jul 2009 - Nov 2009
Patient Recruitment Project Manager
Ppd, Inc.
Developed proposals and managed recruitment tactics to implement effective clinical trial patient recruitment strategy for pharmaceutical clients.
2008 - 2009
~1 yr
Lab Automation Consultant
Implemented equipment qualification and coordinated the method equivalent study to automate several laboratory instruments in accordance with ICH/FDA guidelines for a Fortune 500 GMP manufacturing site.
Mar 2007 - Jun 2008
Owner
Garments, Etc.
Purchased a small embroidery business and established a local uniform manufacturing, embroidery and screen printing business that certified as a women-owned business in the state of North Carolina. Self-taught and performed many business roles of a manager, buyer, accountant, marketer, producer, and service technician.
2005 - 2008
~3 yrs
Positive Certifying Group Leader
Labcorp
Reviewed and certified positive drug test results per FDA and GLP guidelines and oversaw the work assignment and scheduling for a group of seven data certifying scientists.
2006 - 2007
~1 yr
Sr. Patient Recruitment Project Manager/Strategist
Developed proposals and managed recruitment tactics to implement effective clinical trial patient recruitment strategy for the pediatric vaccine, HIV, gastrointestinal, and metabolic therapeutic areas. Researched and evaluated emerging patient recruitment tactics to strategically access the patient population who were most suitable trial candidates for the.
2000 - 2004
~4 yrs
Scientist
Participated in various technical activities to support the pilot plant scale up of Valtrex at Burroughs Wellcome. Developed analytical methods to support new chemical entity process development and cleaning validation. Developed and validated analytical methods to support the IND/NDA filing of several products including Combivir and Trizivir at Glaxo.
1993 - 2000
~7 yrs
Assistant To Operation
Provided technical support to manufacturing engineers and ensured ISO 9000 certification was maintained for the process control chemical laboratory. Provided technical supervision and coordinated technical training for 20 lab technicians. Performed instrument upgrade and method modification and oversaw instrument calibration activities for the chemical.
1990 - 1993
~3 yrs
3 education records
Linh Nguyen education
Bs, Chemistry
Virginia Commonwealth University
Biochemistry, Minor In Computer Science
Old Dominion University
As, Science
John Tyler Community College
FAQ
Frequently asked questions about Linh Nguyen
Quick answers generated from the profile data available on this page.
What company does Linh Nguyen work for?
Linh Nguyen works for GSK.
What is Linh Nguyen's role at GSK?
Linh Nguyen is listed as R&D Pharma Scientist with hands-on experience from molecule to marketing of drug products. Visionary Entrepreneur. at GSK.
What is Linh Nguyen's email address?
AeroLeads has found 1 work email signal at @cnconsulting.com for Linh Nguyen at GSK.
What is Linh Nguyen's phone number?
AeroLeads has found 6 phone signal(s) with area code 919 for Linh Nguyen at GSK.
Where is Linh Nguyen based?
Linh Nguyen is based in Cary, North Carolina, United States while working with GSK.
What companies has Linh Nguyen worked for?
Linh Nguyen has worked for Gsk, Fujifilm Diosynth Biotechnologies Usa, Novartis, Ppd, Inc., and Glaxosmithkline.
How can I contact Linh Nguyen?
You can use AeroLeads to view verified contact signals for Linh Nguyen at GSK, including work email, phone, and LinkedIn data when available.
What schools did Linh Nguyen attend?
Linh Nguyen holds Bs, Chemistry from Virginia Commonwealth University.
What skills is Linh Nguyen known for?
Linh Nguyen is listed with skills including Validations, Methods Development And Transfer, Quality Assurance, It Integration, V&V, Fda, Transfer, and Statistics.
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