Steve Guthrie Email & Phone Number

Carlsbad, California, United States

To formulate, fill, label, and package all consumable products for capillary electrophoresis. Formulations include the making of reagents, buffers, gels, and controls all under strict GMP and 5S guidelines. Pulling all material needed for the jobs scheduled that day (this would be making sure we have all material needed before starting any job) and removing what we use in oracle.

United States

Under operations the ordering of all supplies and equipment for the manufacturing team. To ensure the maintenance and calibration of all manufacturing equipment and pipets. Setting up of temperature monitoring devices with 24-hour alarms. Making sure we were GMP compliant.Under materials the maintaining of all inventory received and on hand. This includes the tissue culture suites (BLS2), clean room (class 7), and the QC area in the laboratory. The receiving of all incoming material and equipment – quarantine, release, and any dispositions required. This would include NCMR’s and CAPA’s. Shipping of samples and equipment for testing/calibration or to other sites for production.Cycle counts and working with manufacturing and QC on current and future needs. Making sure all procedures were under GMP / ISO guidelines

Rancho Bernardo, Ca

Zoetis is a world leader in animal health and diagnostics. I worked in the formulations department doing bulk formulations of buffers, controls, and other kit components for more than 50+product lines all under GLP guidelines as we were regulated by the USDA. Purification's and conjugations utilizing an AKTA and FPLC. Testing of all purification's, conjugates, and raw materials. The ordering of all lab equipment and supplies using SAP inventory control system.

I was responsible for the managing, organizing, and quality of our clients commercial and clinical trial material. This includes pharmaceutical API, product, and medical devices.Responsible for the hazardous waste program, this included collection, storage, and disposal through a qualified vendor. I was IATA trained in the shipping of dangerous goods and DOT trained on the handling of hazardous material. I was forklift certified.I was responsible for the managing and organizing of a warehouse and its inventory, which includes a dispensing room, 2 large walk-in cold rooms with walk-in freezers, and a CRT room. The dispensing of API using a glovebox along with the proper handling, issuance, distribution, status labeling, inventory control, and the packaging and shipping of pharmaceutical API, product, and devices for all our long-term storage clients. All work performed in a GMP / ISO environment. To maintain accurate records and logs for all product, devices, and equipment. This includes all documentation and communication with the customers and management to ensure the scheduling of personnel, equipment and space is properly provided for any job. Ensure compliance with all regulations (i.e.: GMP’s, CFR’s, QSR’s, SOP’s) and that all written procedures are followed. Yearly training on GMP and ISO regulations.

San Diego, Ca

I was the lead chemist in the Assay and Supply group. I oversaw the manufacturing and testing of all reagents under GMP / ISO regulations. I was supported by 3 laboratory technicians.The transferring of new products from R&D to manufacturing. This involves making sure that the product is makable for manufacturing and reproducible on a large scale, that all documents are in the proper manufacturing format, and the training of each department that will be responsible for making and testing of the product.To develop and implement validations on new methods and equipment.Perform protein purification’s utilizing many types of gels on large and small-scale columns, latex bead couplings, and conjugations.

Santa Ysabel, Ca

Protein purification’s (including mice, rabbit, goat, and IgY from chicken eggs) and peptide conjugations.Testing of antibody purity and specificity performed by SDS-PAGE, Western Blot, ELISA’s, and other biochemical and immunological techniques.

Carlsbad, Ca

Quality Control in electrophoresis and raw material lab in an ISO environment.In the electrophoresis lab many biochemical and immunological techniques (including HPLC, capillary zone electrophoresis, and spectrophotometers) were used in evaluating gels, antiserum, controls, stains, buffers, and other products associated with electrophoresis. In the raw material lab many biochemical and analytical techniques (including HPLC and spectrophotometers) were used to evaluate enzymes, biochemicals, and other incoming and in house materials.

Education record

Associate Of Science (As), General Science