Heather Danforth Email & Phone Number

San Ramon, Ca, Us

Pleasanton, Ca

Execute production operations according to defined procedures and ensure the integrity and quality of products under ISO requirement. Performs QC of consumables and instrumentation to defined procedures. Perform standard molecular biology techniques such as pipetting, microscopy, qPCR, PAGE analysis, HPLC, and flow cytometry. Ability to quickly come up to speed on novel assembly procedures and custom test methods.Follow procedures and assemble in-process parts into final configurations.Operate robotic system and complex manufacturing equipment for processes.Process work orders accurately using an ERP system in a timely manner.Maintenance of production batch records and good documentation under ISO requirement.Accurate tracking of production data, test data and inventory.

Pleasanton,Ca

Assay Development and BioSpecimen Management Team (BSM) - Work processes include operations associated with the implementation of panel production projects to meet the RMD's Life Cycle Teams, Projects, and Functional Areas panel needs. Supports the acquisition and management of biological samples, and production of panels, for use in R&D. Hands –on experience in Molecular Biology and PCR, including RT-PCR on the Taqman®, cobas® 4800 (Semi-throughput) and 68/8800 (High-throughput) systems.-Experience handling clinical specimens such as blood products, oncology (FFPET tissue), viruses, and bacteria.-Familiarity with nucleic acid extraction/purification technology.Obtain sequence information from clinical samples, and nucleic acid extraction and amplification information.

Emeryville, Ca

Contract employee working in diagnostics validation at Novartis Vaccines and Diagnostics located in Emeryville, CA.•Execution of method development protocols using the TECAN Evo Freedom robotic dilutor. Management of data sets and basic laboratory operations for document authors and project investigators.•Partner with validation specialists to finalize validation documentation followed by implementation of validation studies.

Berkeley, Ca

Quality Control Associate with 11 years of experience at a large pharmaceutical company manufacturing recombinant Factor VIII protein. Cross-trained in multiple labs - Microbiology, Potency, and ELISA. Desired as an active participant in cross functional teams responsible for assay testing. Highly motivated with a passion to deliver outstanding company service and performance.Performed testing on in-process, stability and final drug product samples via Potency Determination. Responsible for instrument maintenance and troubleshooting. Performed investigations of invalid, OOS, and unexpected test failures. Ensured the laboratory is cGMP and FDA compliant