Michael D. Email & Phone Number

Emeryville CA

• Grifols / Novartis: May 2013 – August 2023Yoh Scientific: February 2012 – May 2013
• Consistently met project deadlines by delivering system verification and validation protocols and reports for Grifols NAT products (Panther, Xpress, Reagent Equilibration System, NAT Manager, Bloodstream). Conducted.
• Authored test protocols based on product requirements or specifications. Proactively reviewed requirements or specifications, ensuring alignment with testable criteria. Collaborated closely with Systems Engineers to.
• Installed pre-released software for assays, firmware, and system software, adhering to draft or established procedures. Conducted Installation Qualification (IQ), Operational Qualification (OQ), and Performance.
• Independently executed verification and validation test protocols using approved test cases, either through the JAMA platform or Documentum (DCM). Demonstrated analytical skills by reviewing and analyzing test data.
• Employed laboratory techniques, including serial dilution to achieve precise target concentrations and gravimetric testing to assess pipetting parameters of the liquid handling instruments.

• Assisted in maintaining daily operations of the QC Control Center by receiving and distributing samples, standards of analysis of raw materials, and assuring compliance with FDA regulations and cGMP requirements.
• Received samples for distribution QC Laboratories, managed accountability of samples and issued documents for testing in QC Laboratories.
• Conducted routine testing including FTIR, HPLC, Ash Weight, Seal Strength, and Differential Scanning Calorimetry for incoming raw materials and in-process and finished manufacturing products.
• Performed monthly environmental monitoring and weekly water sampling, and recommended revision of procedures and material specifications.

• Validated Novartis’ proprietary pooling software by executing test cases on Tecan instruments. Entered results in approved test protocols.
• Identified and documented observable test case anomalies, report anomalies to test leads.
• Performed gravimetric testing using Mettler Toledo balances.

• Analyzed oligonucleotide and protein materials to support the Analytical/Development and Discovery groups in compliance with company protocols and Standard Operating Procedures.
• Retrieved dried oligo samples and performed stability testing.
• Performed UV-Vis spectrophotometry, LAL endotoxin, pH, assays, and osmolality testing and prepared buffers.
• Monitored weekly storage chamber temperature monitoring and inventory control functions

• Celera: March 2005 – August 2007West Valley Staffing (Contractor): January 2005 – March 2005
• Analyzed raw materials in process and finished goods of oligonucleotides in a GMP environment, complying with specifications and test methods using Perkin Elmer HPLC System Series 200 and Agilent 1100 Series ABI.
• Inspected finished products and modules; entered final results in batch records. Reviewed and verified QC entries made by another QC personnel.
• Reported non-conforming materials and products and compiled data for documentation of test procedures. Reviewed past QC testing reports as needed.
• Maintained laboratory equipment and calibrations required, performed troubleshooting of instruments, and implemented equipment change and operational test reports as needed.
• Attended meetings to provide testing updates to different departments.

Foster City, California, United States

• Accountable for executing and processing of various Single Nucleotide Polymorphism (SNP) assays in a high through put laboratory. All studies and projects, either for customers or Research and Development group.
• Performed Post-PCR duties, including operation of various robots such as Tomtec Quadra3, Tomtec Auto-Wash2, Tecan Power Washer, and 3730xl DNA Analyzer/Sequencer, simple calculations, and LIMS tracking.
• Operated GeneAmp PCR System 9700.
• Assisted Pre-PCR laboratory in assay preparation and processing, familiar with instruments such as Beckman Coulter Biomek FX and Tecan Genesis RSP 200.
• Updated and reviewed current SNPlex laboratory protocols.
• Performed laboratory safety contact duties, updated MSDS binders and chemical inventory database (Chemtracker).

Palo Alto, California, United States

Served as a team member responsible for the creation of cellular samples of specific genes requested by pharmaceutical companies and research institutions.· Performed bacterial transformation, plated and spread transformation mixes on agar plates.· Checked for cell growth, selectively picked a single, representative colony from solid agar media.· Performed.