Jonathan Tung Email & Phone Number

South San Francisco, CA, US

Wedding and Portraits Photographer in California and now in the Greater Seattle Areawww.instagram.com/jont.photowww.jontphoto.com Weddings: Lead, Associate, and Second Shooter for weddings of over 200 guests. Successfully managed client expectations through consulting, contracts, invoicing, shoot execution, post-image processing and editing, and final.

New York, New York, US

Led cross-functional tech transfer sub-team for 270,000 ft2 manufacturing greenfield facility (Launchpad).Developed timelines and tech transfer workflow strategy for mAb clinical and commercial transfers.Developed Quality Risk Management strategy and led Risk Assessments for the upstream anddownstream process.Led upstream technical team for at-scale.

Gaithersburg, Maryland, US

• Led multiple cross-functional investigations as SME and project manager related to biological contaminations, process performance, and drug substance quality attributes.
• Provided 3 months technical person-in-plant (PIP) support to Novavax’s key flagship site in Czech Republic as U.S. MS&T representative. Managed relations between local site and U.S. site.
• Routinely provides upstream data trending and analysis of global GMP manufacturing data to tech transfer and commercial GMP forum.
• Lead team staff meetings and represents DS MS&T to executive leadership in global technical meetings
• Authored multiple change controls to drive process improvement opportunities for CDMOs while assessing risk and impact.
• Identified business process improvement opportunity and collaborated with business teams to kaizen and further improves business process, enabling quicker turnaround with sample requests.

Indianapolis, Indiana, US

• Executed Installation Verification Activities for HVAC Systems
• Performed Installation/Qualification Activities for Dehumidifiers and Bag Sealer

San Diego, California, US

• Planned, designed, and executed small scale cell culture experiments with adherent fish cells. Tech transfer of adherent cultures into 3L bioreactors via microcarriers
• Served as BlueNalu Technical SME in cross-functional capacity with external partners for process, utility, and equipment design for 200L pilot and 2kL production GMP facility
• Routinely presented team technical updates and strategy to R&D
• Collaborated with internal quality department to implement manufacturing cleanroom gowning and process room classification strategy
• Collaborated with numerous external vendors to introduce, test, and implement new technology
• Led implementation of data management system for R&D and Process Development

South San Francisco, California, US

• Phase 3 Clinical Team
• Internal tech transfer Technical SME for phase 3 clinical and PPQ campaigns as the Cell Culture Process Engineer in GMP manufacturing plant in accordance with cGMP practices and CFR-21
• Develop, justify, and execute process changes pre-campaign and mid-campaign to optimize process performance in accordance with quality regulations
• Developed and led new viral filtration process into cell culture manufacturing to mitigate batch failure risk
• Managed interns, trained/mentored new hires and rotational employeesFrontline Team
• Provided technical frontline equipment support on upstream equipment including 80-12,000L Bioreactors, Disc Stak Centrifuges, CIP skids, media tanks, etc.

San Ramon, California, US

• Authored Cell Culture Conformance Report.
• Authored, reviewed, approved, and assembled protocols, interim reports, and final summary reports
• Authored protocol deviation reports and corrective action investigations to develop corrective actions.
• Provided technical training to production staff regarding protocol execution and redlined SOPs changes
• Coordinated, managed, and scheduled Validation-QC activities and document approval process
• Led cleaning and process development/validation protocol executions at full production scale for small equipment pieces, various vessels (media, buffer, bioreactors, eluate collection), isolation chromatography.

South San Francisco, California, US

• Planned and executed a factorial DoE study on PFS Siliconization to observe silicone stability/migration over different operating parameters and storage conditions
• Evaluated the crimping process of a commercial prefilled cartridge product and correlated to container seal integrity
• Performed a fill accuracy assessment with different pump systems to understand process limitations and performance using mild to high viscosity formulations
• Supported pre-filled syringe pilot fill suite team and familiarized with clean room operations

Davis, California, US

Synthesized iron oxide cores and shell nanoparticles for potential use in drug deliveryApplied degasification, centrifugation, and ultrasonification techniques to core particle synthesisPerformed UV/VIS measurements to construct calibration curves for use in dye release tests Applied methods of lipid attachment to nanoparticles and observed its effects on.

Davis, California, US

Executed data analysis of various suspensions containing substrates and enzymes Performed MRI images to examine water content to analyze physical properties of suspensionsObserved diffusion-adsorption characteristics of various tracer molecules in biomass fibers

Master Of Business Administration - Mba

B.S, Chemical Engineering

Fermentation Technology (Summer-Program)

Education record