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Luis Collazo-Malave Location
Detroit, MI, US
Luis Collazo-Malave Work
Owner @ Novi Consuting Expert (June 2025 - Present)
Director @ (May 2022 - May 2025)
Associate Director, Analytical Quality Control @ Regeneron Pharmaceutical Inc (February 2020 - May 2022)
Director, Quality Control @ (February 2016 - October 2019)
Consultant QC SME @ (October 2015 - February 2016)
Quality Control Director @ (December 2012 - September 2015)
Technical Service Director @ (April 2012 - November 2012)
Quality System Associate Director @ (October 2009 - April 2012)
QC Associate Director @ (May 2007 - October 2009)
QA LAboratory Director @ (October 2004 - April 2007)
Quality Laboratory Director @ (May 2003 - October 2004)
Tech Service Manager @ (January 1995 - January 2003)
Luis Collazo-Malave Education
New Mexico State University
Doctor of Philosophy - PhD (Organic Chemistry)
1993-1994
New Mexico State University
Phd (chemistry)
1990-1994
Luis Collazo-Malave Skills
GMP
Validation
FDA
Quality Assurance
Quality System
Change Control
V&V
Quality Control
Technology Transfer
Analytical Chemistry
Manufacturing
Process Improvement
Software Documentation
Microbiology
Pharmaceutics
Laboratory
Strategy
Program Management
SPC
Management
21 CFR Part 11
Aseptic Processing
Automation
Biopharmaceuticals
Biotechnology
Budgets
Business Strategy
CAPA
Chromatography
Chemistry
Cleaning Validation
Clinical Trials
Computer System Validation
Deviations
Engineering
FDA GMP
Formulation
GAMP
GLP
Gas Chromatography
GxP
HPLC
Human Resources
ISO 13485
LIMS
Leadership
Medical Devices
Pharmaceutical Industry
Project Planning
Protocol
Computer System
Luis Collazo-Malave Summary
Luis Collazo-Malave, based in Detroit, MI, US, is currently a Owner at Novi Consuting Expert. Luis Collazo-Malave brings experience from previous roles at Lachman Consultant Services, Regeneron Pharmaceutical Inc, Emergent BioDefense Operations Lansing LLC and Validant. Luis Collazo-Malave holds a 1993 - 1994 Doctor of Philosophy - PhD in Organic Chemistry @ New Mexico State University. With a robust skill set that includes GMP, Validation, FDA, Quality Assurance, Quality System and more. Luis Collazo-Malave has 1 emails and 1 mobile phone numbers on RocketReach.
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