Tyler Hawkes

Senior Quality Control Associate @Abzena

San Diego, CA, US

Perform timely and accurate analytical testing of raw materials, in-process materials, APIs, intermediates, finished products, release and stability samples• Execute qualification/validation protocols and analytical test methods• In-depth knowledge of the theoretical and practical aspects of analytical methods utilized to characterize large molecule therapeutics: U/HPLC (ex. SE-HPLC, RP-HPLC, Pro A Titer HPLC), CE-SDS, cIEF, ELISA, SDS-PAGE, IEF, Western Blot, UV-Vis Spectroscopy, Endotoxin, and all compendial testing (ex. pH, Conductivity, Appearance, Osmolality)• Operation and maintenance of laboratory equipment including: U/HPLC, ELISA Spectramax and Bio-Tek Reader, Capillary Electrophoresis, UV-Vis Spectrometer, pH meter, Conductivity meter, Osmometer, Densitometer• Work with AMD Scientists and leadership to perform additional method development work when needed• Lead trainer for new analysts on test methods and all other GMP lab operations• Provide comprehensive review of all QC data and associated documentation; provide feedback for continuous method improvement• Maintain stability program schedule, trend test results and investigate out of specification results• Work closely with project management to coordinate QC testing timelines and deliverables• Supported multiple IND submissions in the role of QC lead on various projects• Report and investigate deviations and OOS results to determine root cause; author and implement corrective actions as appropriate• Issue CoAs/CoTs for completed testing, including technical and quality data review• Strong working understanding of USP, EP, FDA and ICH guidelines • Author and revise SOPs, stability reports, qualification/validation protocols, and qualification/validation reports• Strong initiative, positive attitude, and ability to function effectively in a fast-paced CMO/CRO environment • Strong written and oral communication skills; proficient with Microsoft Office

California State University, Fullerton

Bachelor of Science - BS, Biochemistry