Mike Herrera Email and Phone Number
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I drive for people to collaborate together to get work done. I love seeing people be successful in their current and future roles. I have a passion to serve as a leader, working for others and alongside them. I believe sharing knowledge is as important as gaining. I have led laboratories in the pharmaceutical and drug testing industries in the analytical chemistry field, with an emphasis in the analysis of pharmaceuticals and drugs of abuse in biological fluids. My expertise includes a broad range of disciplines:- Laboratory management, oversight, and SME in GLP bioanalytical (small and large molecule), GMP QC testing operations, and forensic toxicology.- Directed and hands-on method development, validation, and method transfers in GLP bioanalytical, GMP analytical testing, and in SAMHSA regulated drug testing- Directed the setup and operation of LC-MS/MS laboratories in GLP and non-regulatory settings.- Worked with computer validation teams on 21 CFR Part 11 compliant validations.- CRO, large pharma, and private analytical laboratory settingsSpecialties: HPLC, UPLC, LC-MS, LC-MS/MS, analytical chemistry, laboratory management, method development, method validation, GLP/GMP, forensic toxicology, QC testing, instrument installation and qualification, computer systems validation
Eli Lilly And Company
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Eli Lilly And CompanyIndianapolis, In, Us
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Associate Director - BioanalyticalEli Lilly And Company Mar 2021 - PresentIndianapolis, Indiana, UsLeading a team of individuals responsible for bioanalytical outsourcing and oversight across the portfolio, large and small molecule. Interfacing with several CROs utilizing a broad array of bioanalysis platforms from LC-MS, LC-MS/MS, ELISA, MSD, Gyros and other platforms to support PK and ADA analysis. Driving timelines for non-clinical and clinical study support and meeting scientific and regulatory requirements (ICH M10, FDA and EMA GLPs). Managing vendor relationships and performance expectations.
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Answering Questions, Discovering New Answers From Oral Fluid SamplesForensic Fluids Laboratories Jul 2020 - Mar 2021Kalamazoo, Michigan, Us -
Director, BioanalyticalCharles River Laboratories Oct 2015 - Jul 2020Wilmington, Massachusetts, UsAs Director of LC-MS/MS bioanalytical, responsible for the dynamic execution of preclinical and clinical bioanalytical studies including discovery, method development, validation, and sample analysis. Recognized significant revenue increase through reorganizing and refocusing the bioanalytical department to complete studies on time and within budget. Improved on-time reporting of data for validation and sample analysis studies from approximately 40% to over 95% of reports on-time. Captured data to develop metrics and set goals against those metrics to drive performance improvements. Expanded capabilities into large molecule biologics analysis by LC-MS/MS to complement the small molecule business. Led customer interactions including project scoping, scientific discussions, and providing regular project updates. Participated in industry meetings such as WRIIB and the AAPS Workshop on ICH M10 Guidance. Contributed to multiple corporate-wide, multi-site committees regarding Laboratory Science related initiatives. -
Director Lc-Ms/MsClinical Reference Laboratory Apr 2011 - Oct 2015Led innovation in the LC-MS/MS operation for drugs of abuse testing at CRL for workplace and insurance industries. Generated a tremendous increase in test panels/offerings for workplace drug testing including the analysis of more than 30 compounds each for synthetic cannabinoids ("K2” and "Spice") and "bath salts" designer drugs.Became one of the first forensic toxicology laboratories in the country to receive SAMHSA approval to analyze regulated federal workplace drug test samples by LC-MS/MS and the first to analyze regulated samples for methamphetamine enantiomers by LC-MS/MS without derivatization.Managed LC-MS/MS method development/R&D as well as day to day operation of the LC-MS/MS lab with a workload of over 30,000 samples/month. -
Head Of ChemistryEurofins Pharma Services Jun 2010 - May 2011Department Head of operations for the GMP Chemistry group at Eurofins Pharma Services. Responsibilities included:- Directed the operations of the GMP QC testing.This group has two divisions: finished product testing (human pharma) and animal health medicated feed testing. A GMP group for routine analytical testing with capabilities for HPLC and GC for assay and degradants/impurities, dissolution, friability, disintegration, hardness, FTIR, Karl Fisher for moisture, and more.- Worked directly with customers to maintain strong relationships and manage customer expectations.- Wrote and ensured proper SOPs were in place in line with cGMPs.- Hired and managed laboratory staff workflow, schedules, training, and performance reviews.- Improved workflow efficiency through the reorganization/realignment of equipment and work areas
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Laboratory Manager, Bioanalytical And Animal HealthEurofins Avtech Laboratories Jan 2007 - Jun 2010Luxembourg, Luxembourg, LuA contract research laboratory providing high-quality service with a great reputation for regulatory compliance for almost 20 years. As Laboratory Manager, Bioanalytical and Animal Health having expertise in bioanalytical chemistry with method development and analysis background using HPLC and LC-MS/MS. - Proactively engaged in day-to day operation of the lab including method development, method validation, and workload prioritization/scheduling for routine sample analysis for both the GLP bioanalytical and GMP Animal Health departments.- Held discussions with clients regarding further business opportunities, project status, and problem resolution.- Managed personnel for hiring and promotion as well as performance evaluations and personnel training/development.- Engage staff in method development projects and troubleshooting methods.- Ensured that SOPs and study protocols are followed. Write/revise SOPs as necessary to maintain laboratory operation and regulatory compliance with GLPs and GMPs.- Reviewed and approved validation and client data reports. -
Associate Bioanalytical ChemistEli Lilly - Elanco Sep 2004 - Jan 2007Indianapolis, Indiana, UsWorked as a bioanalytical chemist at Elanco Animal Health, a Division of Eli Lilly and Co. Elanco is one of the major players in the animal health industry providing innovative pharmaceutical solutions to both the food animal and companion animal markets. I helped design and implement two new mass spec facilities for Elanco which at the time did not have significant internal LC-MS/MS resources. I also was involved in computer software validation for those systems. I was a major contributor to establishing the use of LC-MS/MS at Elanco for support of PK/TK studies through method development, validation, and sample analysis using new methods. I had the opportunity to teach several chemists and technicians how to use the LC-MS/MS platform.
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Chemist IiiAvtech Laboratories, Inc. May 1998 - Aug 2004AvTech Laboratories was a small pharmaceutical contract research laboratory performing analytical support for drug development. The company was started in 1990 by former Upjohn Company people who wanted to start a reliable CRO. AvTech was purchased by Eurofins in 2006.Primary responsibilities included development and validation of new methods using various analytical techniques including HPLC and LC/MS/MS. Trained new analysts in separation and extraction techniques for bioanalytical methods. Wrote validation protocols and reports. All work performed in FDA-GLP regulated environment.
Mike Herrera Skills
Mike Herrera Education Details
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University Of MichiganChemistry
Frequently Asked Questions about Mike Herrera
What company does Mike Herrera work for?
Mike Herrera works for Eli Lilly And Company
What is Mike Herrera's role at the current company?
Mike Herrera's current role is Associate Director - Bioanalytical at Eli Lilly and Company.
What is Mike Herrera's email address?
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What is Mike Herrera's direct phone number?
Mike Herrera's direct phone number is 126959*****
What schools did Mike Herrera attend?
Mike Herrera attended University Of Michigan.
What are some of Mike Herrera's interests?
Mike Herrera has interest in Bowling, Running, Singing.
What skills is Mike Herrera known for?
Mike Herrera has skills like Hplc, Analytical Chemistry, Glp, Validation, Lc Ms, Chemistry, Laboratory, Mass Spectrometry, Pharmaceutical Industry, Troubleshooting, High Performance Liquid Chromatography, Good Laboratory Practice.
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