LAZARO HERRERA-HERBERT

*** ******** **

Wallingford Pa. 19086

aczd55@r.postjobfree.com

484-***-****

Scientist/Chemist with 20 years of practical and educational experience in laboratory and management, including 18 years in the pharmaceutical industry. An efficient team leader and team player with good communication skills and solid knowledge of GMP’s and GLP's. An excellent background of analytical laboratory instrumentation and automation. design and implementation of training laboratory staff.

CORE COMPETENCIES

Tech Transfer Specialist: Gap analysis, Method remediation, validation and Transfer,

Development and optimization. Protocol writing.

Analytical Chemist: QC Laboratory testing in a GMP and GLP environments. Analytical laboratory instrumentation HPLC/UV/VIS/PDA and GC. Software Empower, HPChem-Station. Protocol and SOP writing. Analytical results review and OOS investigation and reporting.

Training Coordinator: Design of training programs for the efficient use of analytical methodologies and instrumentation.

PROFESSIONAL EXPERIENCE

Ethicon, Ga(Jonhson & Johnson) Sep, 2015 to Present

Senior Validation Specialist

Responsible for overseeing the remediation, gap analysis and validation of analytical methods.

Review of validation protocols and feasibility studies from CMO’s.

Revision of analytical results and final reporting.

Coordinating the needs for the validation process including: process materials, review and circulation of validation/transfer protocols and completion reports.

IRCEP (International Research Center for Ecological Preservation)/Mexico Dec, 2012 to Present

Executive Director

Fieldwork on marine preservation species. Overseeing 6 technicians for the ecological preservation project in Mexico.

Designed and implemented research plans for Mexican and US universities

Successfully designed implemented fundraising programs for marine species in Mexico and US.

Organized and designed International research center for ecological preservation in Veracruz, Mexico.

Created long and short term operation plans for the functioning of the eco center.

Responsible for the annual operation and coordination of Research groups

Elaborated, coordinated and implemented talks related to sea turtle and marine preservation projects in Veracruz, Mexico.

Roche Pharmaceutical/Mexico June 2014 to November 2014.

Senior chemist QC laboratory

Responsible for gap analysis, remediation and validation of HPLC and Dissolution methods.

Accomplished the revision of HPLC and dissolution analytical methods, from gap analysis to execution of validation, revision of analytical results and final reporting.

Successfully identified analytical inefficiencies in the methodologies and proposed strategies to modify and improve them.

Utilized Empower software for HPLC/PDA and Dissolution for the analytical automation.

Avid Radiopharmaceuticals/Philadelphia, Pa Aug 2012 to May 2014.

R&D and QC laboratory Chemist

Research and Analysis of radiopharmaceutical samples and QC release of clinical doses. HPLC and GC techniques along with wet chemistry. Method validation and tech transfer.

Successfully finished training for oversees assignments for transferring analytical techniques to CMO’s.

Accomplished the training and tech transfer of methodologies to CMO’s in Europe, Canada and Latin America.

Increased the efficiency of training by designing training modules for local and oversees CMO’s personnel

ACCU-PAC Labs/ Lansdale, Pa Sep 2011 to August 2012

QC Chemist

Responsible for Analysis of in-process, raw material, bulk and finished product samples. Testing comprised density, viscosity, water content, IR identification, specific gravity, etc.

Utilized HPLC, GC and Wet Chemistry techniques

Designed training modules that increased productivity and release of products nearly 20%.

Successfully established channels of communication with production to better plan the analysis of product and release to avoid last minute rush analysis.

DPT Laboratories/ Lakewood, NJ Sep 2009 to May 2010

QC Analytical Chemist

Responsible for control substances stability testing and staging. colorimetric, gravimetric, particulate matter, GC and HPLC w/ Empower software testing. OOS investigation and report. Wet chemistry and chromatographic analysis of in-process and finish products.

McNeil Healthcare J&J/Forth Washington, Pa April 2007 to June 2008

Transfer Analytical supervisor

Responsible for the technical transfer process of OTC methods from Pfizer to McNeil in a GMP environment. Overseeing and performing HPLC, UV, ICP, FTIR and Dissolution analysis according to USP guidelines and methodologies, as well as all the analytical aspects of method validation, OOS investigation, report and corrective action, method optimization and protocol writing.

Supervised 8 analysts. Attending regular meetings and decision making throughout the entire process. Coordinating with QA and formulators for batch production, stability, development and analysis of product.

Created Designed and implemented the method transfer program for solid and liquid OTC's which included: Tracking methodologies and protocols, meetings, distribution and planning of tasks, method gap analysis, method validation and reporting, method validation protocol writing and final method transfer reports.

These tasks also included oversees Tech transfer to Mexico and Puerto Rico. Trained other analysts on transfer techniques and protocol writing.

Successfully achieved the method transfer in the estimated time line.

Glaxo Smith Kline/Conshohocken, Pa Sep 2006 to April 2007

Training Coordinator

Research Data management Department. Responsible for coordinating, organizing, implementing and teaching training sessions on electronic Laboratory Notebooks for Scientific Staff at the Upper Merion Site.

Successfully Completed the training of 380 scientists before the timelines.

A comprehensive utilization of acquired laboratory skills including GLP’s and GMP’s in order to successfully achieve the training of the scientific staff.

URL/Mutual Pharmaceuticals/Philadelphia, Pa Sep 2005 to Sep 2006

Sr. Analytical chemist

Technology laboratory of R&D. Drug formulation support, HPLC with Empower software and Dissolution method development. Method writing, data processing, planning, training and coordination with formulation group for new drug development.

Lehigh Valley Technologies/ Allentown, Pa Dec 2003 to Nov 2004

Analytical Services Supervisor

Responsible for the daily planning of the Analytical Services Laboratory( QC and R& D). Analysis of raw material, finished and in-process products, supervising 4 chemist staff. Technology transfer, method and protocol writing, method development and optimization, OOS investigation and Proposal for corrective actions.laboratory of R&D. Drug formulation support, HPLC with Empower software and Dissolution method development. Method writing, data processing, planning, training and coordination with formulation group for new drug development.

Operation and qualification of AA, HPLC’s, UV, FT-IR, TOC (Total Organic Carbon Analyzer), dissolution equipment, and general laboratory equipment. GMP environment. Trained all personnel on laboratory techniques according to assigned tasks. Efficiency of laboratory personnel increased with new implementation of solidification of skills and task assignment.

Johnson-Matthey, West Deptford March 1999 to Nov 2003

Sr. Chemist

Development), a Division of the QC Department. Responsible for method development and method optimization, R & D and testing groups support, method validation for ICP, GC and HPLC with Empower software systems, data acquisition, Sample processing and data interpretation.

Writing of method transferring, method validation protocols and final documents for newely developed methods. Designed training modules for new personeel. Spotted and corrected needs for training.

ADDITIONAL EXPERIENCE UPON REQUEST

EDUCATION

Drexel University, Philadelphia, Pa. MS in Sciences.

Autonomous Metropolitan University of Mexico, Mexico City- BS in Biological Sciences.

PERSONAL PREFERENCES

Achieved 2nd degree Black belt in Karate (Tang-So-Do). Enjoy playing and composing music. Enjoy playing and coaching soccer. Running.

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