Johnathan Khumnark Email & Phone Number

San Carlos, California, United States

South San Francisco, California, United States

Led the tech transfer of a highly automated cell manufacturing process for T-cells and ensured adherence to GMP processes, producing cell therapy products for cancer treatment in controlled clean rooms. I maintained strict compliance with FDA regulations for production and product release, demonstrating expertise in pharmaceutical quality assurance. • Facility Setup and Process Transition: Spearheaded the successful tech transfer into a new facility, preparing it for GMP pilot runs within a remarkable three-month timeframe. Implemented seamless transitions and ensured readiness for manufacturing operations. Effectively implemented automated manufacturing processes under MSAT oversight, enhancing efficiency and quality. • Cell Manufacturing Expertise and Process Optimization: Played a key role in manufacturing T-Cell Antigen Coupler (TAC) cells for both Autologous and Allogenic Programs. Developed electronic batch records utilizing the Apprentice platform. Demonstrated agility in problem-solving by addressing challenges and determining a path forward. • Equipment Management and Collaboration Excellence: Demonstrated proficiency in equipment onboarding, leading the drafting and execution of IQ/OQ/PQ protocols. Additionally, served as the Materials Management Lead, drafting master Bill of Materials and acting as the site subject matter expert for the Lonza Cocoon Cell Manufacturing Instrument. Collaborated extensively with clinical research organization (CRO) partners, ensuring GMP readiness, and provided valuable training to operators while facilitating productive team meetings.

South San Francisco, California, United States

Quickly transitioned from a contract to a full-time role, manufacturing personalized plasmid vectors within tight clinical deadlines and performing a range of tasks including aseptic techniques, chromatography processes, and product finishing. • Versatile Manufacturing and Process Expertise: Manufactured personalized plasmid vectors meeting clinical patient demand within stringent deadlines. Aseptically performed a range of critical tasks, including culture initiation, bioreactor inoculation, chromatography processes, microfiltration, and product finishing, ensuring precision and compliance. • Quality Assurance and Documentation Proficiency: Attained certification as a Lean Six Sigma Yellow Belt, highlighting a commitment to process improvement and efficiency. Played a pivotal role in quality assurance by writing and reviewing technical documents such as SOPs, DEVs, and MBRs, ensuring meticulous attention to detail and adherence to industry standards. • Innovative Process Enhancement and Chromatography Expertise: Contributed significantly to process enhancement through the validation and integration of automated skids for chromatography processes in GMP manufacturing. Actively participated in PD chromatography studies, creating robust test methods and conducting procedures using the AKTA Pure HPLC system, showcasing technical proficiency and innovation in chromatography techniques. Implemented a 5S system within the manufacturing suite, demonstrating initiative to establish an organized and efficient work environment.

Dayton, Ohio, United States

• Achieved antibody functionalization of the particles• Perform anerobic surface chemistry reactions working in a glovebox• Mediated project details between Biology, Chemistry, and Physics Labs• Performed characterization tests such as dynamic light scattering (DLS), FT-IR, and UV/Vis• Analyzed conjugation efficiency and imaging through use of electron microscopy

Kettering, Ohio, United States

• Interfaced with clients, and provided customer assistance• Create paper sketches of prototype designs, and model on CAD software• Designed, constructed, and tested an assistive design according to customer specifications

Master'S Degree, Bioengineering

Bachelor'S Degree, Chemical Engineering