David Kellerman Email & Phone Number

I have been in the pharmaceutical industry since 2011. My time in this industry has been in GMP fields.I started as a Quality Control analyst at the Massachusetts Biological Laboratory, performing chemistry and biochemistry quality testing of product for release and stability, as well as raw materials. My lab experience included capillary and gel electrophoresis, HPLC, spectrophotometer and plate reader assays, FTIR, and osmometer, as well as general wet chemistry. Other duties included cleaning sampling, which involved sterile gowning and sampling techniques. I also wrote and revised SOPs and forms, and performed internal research.I moved to California in 2014 and began working at Genentech, doing QC method validation and method transfer for biochemistry test procedures. My experience included protocol development, SOP writing and revising, report writing, experiment design and performance, as well as method and equipment validation. During this time I performed work using CE, HPLC, UPLC, cIEF, spectrophotometer, FTIR, and NIR. Additional duties included product complaint investigation. This came to an end when the department decided no longer to perform labwork.In 2022 I began working for CAI, performing equipment validation. This included writing and preforming commissioning, installation and operational, and performance qualification protocols for lab and manufacturing equipment, as well as utilities and spaces, and writing summary reports for these. Additional skills developed during this period include temperature mapping and quality microbiology testing of cell cultures for product release (viability, plasmid retention, antibiotic resistance, and gram stain).

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  Umass Boston

  Biology