1. Michael A. Saavedra
44 Linden Ave. Apt 1
Belleville, NJ 07109
(973) 634-5517
michael.saavedra83@gmail.com
EDUCATION B.S. Biology. Graduation: August 2007
Montclair State University, Montclair, NJ 07043
GPA: 3.579 Overall, Cum Laude
3.536 Major
OBJECTIVE A position that will not only utilize my education, learning abilities, and scientific attributes but, also,
one that demands the application and utilization of my acquired skills of prioritizing, problem solving,
multitasking, leadership, as well as, possessing the potential for upward mobility within the company.
SKILLS
EXPERIENCE
PCR, Poisson Assay (manual amplification and detection), TC9600, TC9700, CTM9600, Cobas 4800,
CTM48, Calibrator Bracketing Method, Light Cycler (BRAF, KRAS, EGFR & MRSA testing), High Pure
DNA extraction, Ames Assay, reverse pipetting, aseptic techniques, media preparation, microscopy,
colony plate counting (manual, automated: Ames Study Manager/Sorcerer), bacterial culture
preparation, strain characterizations, cell culture, serial dilutions of working stocks, solution preparation,
titrations, pH, titratable acidity, reflectance, and transmittance, drug screening and dilution schemes.
Expert knowledge and execution of GMP and GLP. The use of SAP, NetDocs, DiaDocs, IsDocs and
GRIPS software. Microsoft Excel use for data collection, charts, trends and calculator tools for data
analysis. Preparing audit ready raw data books, assay protocol writing, preparing data reports,
manufacturing quality control, data analysis, data collection, data package validation, test method
validation (Drafting validation protocols, final reports and design history files)
Scientist, Roche Molecular Systems, Branchburg, NJ
July 20, 2009 – Present
• Responsibilities include and are not limited to: Writing test method validation protocols and reports,
writing of variances for process deviations, writing change process reports and change requests
through the use of TrackWise software, training new operators on Roche Diagnostics platforms,
method optimization of Roche Diagnostic platforms (i.e. virology, blood screening, Genomics,
Microbiology), writing and editing SOPs, validating data for release and stability products, create
Excel calculator tools for data analyzing, creating and updating trendlines on an ongoing basis,
perform PCR testing on multiple platforms that include: Microwell Plate, cobas Taqman 96, cobas
4800, cobas Taqman 48, Calibrator Bracketing Method (Ampliprep), and Light Cycler platforms,
Testing Method Transfer from obsoleted platforms to new platforms, Project leader on multiple
projects.
• Appointed Critical Process Leader for all AmpliPrep/TaqMan platforms in the functional testing
department. Responsibilities include and are not limited to: maintenance and troubleshooting of all
instruments, consolidation of all training requirements, creation of a training curriculum for new
analysts, instrument and assay error application and point of contact for all aspects of cobas
AmpliPrep/cobas Taqman application and Service certifications were obtained for servicing,
troubleshooting and maintenance of both instruments.
• Other responsibilities include: reagent procurement for all testing performed for manufacturing
purposes, SAP transactions for inventory inquiry, data entry, data validation, and support audit
preparation readiness by maintaining testing laboratories.
Research Assistant, GLP Study Representative, Johnson And Johnson Pharmaceuticals, Raritan, NJ
April 21, 2008 – May 13 2009
• Responsibilities included but were not limited to: Preparing for and independently running Ames
Assay and Drug screens from beginning to end, being the study representative for all GLP Ames
Assay studies, preparing dilution schemes, preparing raw data books, preparing all media for Ames
Assay and Drug screens, plate counting (manual and automated), and entering raw data and data
evaluations by GLP standards.
• Other responsibilities included: lab and office maintenance, inventory of lab supplies, ordering of lab
supplies, checking all equipment and maintenance of Instrument log books, and reviewing all data
books and reports before being sent out to Quality Assurance.
Laboratory Technician, Unilever, Englewood Cliffs, NJ
October 1, 2007- April 18, 2008
• Responsibilities included but were not limited to: product formulations, utilizing Excel to create and
access formulas, preparing and processing products according to formula and lab process
parameters, analyzing products through physical breakdown of components, pH, titratable acidity,
reflectance, transmittance, assisting in pilot plant, and the weighing of samples.