Daniel Yokoshima Email & Phone Number

United States

United States

Hercules, California

PCR Process Development (LSG)

South San Francisco, Ca

• Responsible for coordinating and/or performing all in house manufacturing activities, including formulations, filling, capping, labeling and final assembly•Practice GMP protocol in an ISO 13485 regulated medical device facility• Reviews Batch records from contract manufactures for accuracy, correctness of calculations and completeness• Ensures the preparation and completion of internal manufacturing documents• Works directly with members of the Development team to assist in the transfer of new products to manufacturing• Participates in CAPA subsystem teams to support quality system process• Responsible for performing sampling of inventory materials (e.g. antibodies, antigen, bulks, etc.)• Assist in the creation of manufacturing SOPs, deviation reports, rework procedures, manufacturing process documents and process guidelines• Writes and executes validation protocol for manufacturing equipment/process as required.• Oversee/Ensure the manufacturing equipment maintenance and calibration• Coordinated and Performed environmental monitoring sampling of the DI water system and air.• Served as a backup QC Analyst (e.g. perform ELISA based qualification testing, data review, etc.)• Served as a backup for the Materials Manager (e.g. shipping, receiving, cycle counts, etc.)

United States

•Perform raw material, in-process component and final QC testing: Nucleic Acid-based Rapid Test, SDS-PAGE, Isotyping, ELISAs, Western Blot, etc.•Practice GMP/GLP protocol in an ISO 13485 regulated medical device facility•Revision/authoring of Standard Operating Procedures•Test stability of current inventory and past lots of various products•Work between Sunnyvale, CA (US) and Cambridge, England (UK) sites for QC and trouble shooting testing

Santa Clara, Ca / Athens, Oh

•Reagent Chemist I and II responsibilities•Lead responsibilities of organizing schedules, overseeing production and final documentation review•Voluntarily supported operational transfer of procedures and set up of new manufacturing facility in Athens, OH

Santa Clara, Ca

•Reagent Chemist I responsibilities•Trained new employees on all aspects of laboratory procedure, production and documentation•Reviewed documents and products for final release•Coordinated and performed tasks for development/validation various ELISA assays, PCR assays and equipment•Assisted R&D in the development of protocols leading to the launch of Quidel's lateral flow C. difficile molecular assay

Santa Clara, Ca

•Reagent Chemistry Processes: Buffer preparation, plate coating, antibody/conjugate titration, standards and controls formulation, lyophilization, final kit qualification•Performed and analyzed data from testing of various ELISA and PCR Assays•Practiced GMP protocol in an QSR and ISO 13485 regulated medical device facility•Used effective communication and flexibility to work effectively with other departments: QC, Packaging, R&D, etc.•Tested stability of current inventory and past lots of various products•Trouble shooting and product improvement of kits and components•Revision/authoring of Standard Operating Procedures•Review documents for content and adherence to the applicable GDP guidelines•Created and maintained Excel databases•Performed various preventive maintenance and calibrations on various laboratory equipment•Experience with various lab equipment; Smart-Cyclers, 7500 Fast System, SpectraMax Plus Plate Reader, etc.

Campbell, Ca

• Downstream purification of various bacterial toxins and proteins with the use of column chromatography, HPLC and various other procedures• Performed cell extraction to produce purified lipopolysaccharide (LPS)• Cultivation/Fermentation of bacteria• Responsible for filling, lyophilizaton, crimping and labeling of final products.• Researched and developed processes to improve protein purification techniques• Practiced GLP and GMP protocol• Authored Standard Operating Procedures for equipment, processes, techniques and QC• Preformed in-process, stability and final QC testing: HA assays, Quantitative Bradford Assays, LAL testing, ELISAs, etc.• Performed sampling of RO/DI water system and environmental monitoring of sterile work areas• Worked under BSL1 to BSL3 conditions• Trained new employees on all aspects of production, purification and documentation• Documented and maintained hazardous material inventory• Provided technical support to customers

Bs, Geology

Activities and Societies: Geology Club: Secretary San Jose, CA 2004-2005 - Scheduling seminar speakers, advertising/marketing.

Bachelor'S Degree, Geology/Earth Science, General