David Chiu Email & Phone Number

Basel, Ch

• Directed the process development, optimization, and scale-up for the downstream purification process up to the 50 L scale. Experience includes Adenovirus (Ad5), Lentiviral, and AAV viral vectors for cell and gene therapies. Downstream lead for client projects involving Ad5 adenoviral and lentiviral vectors.• Client-orientated role. Ensured effective and responsive relationships was established and maintained with clients. Presented data and communicated the results of process development studies and experiments in a timely manner under tight timelines to clients. • New Product Introduction (NPI). Oversaw the initial technical transfer of protocols, reports, process block flow diagrams, raw material lists, manufacturing assessments, and training of the MSAT and viral vector cGMP manufacturing teams.• Utilized various downstream techniques such as chromatographic separation methods using FPLC (ÄKTA avant, pure, pilot, ready), TFF (Pendotech, SciLog), centrifugation, and filtration methods to carry out studies up to the 50L scale.• Thorough understanding of virus characterization methods including DLS, SDS-PAGE, infectious titer, and viral particle determination (HPLC and spectrophotometry).• Constructed, maintained, and oversaw the testing for an Ad5 viral vector stability study program in process development. • Cross-trained on the viral vector upstream process including HEK293 cell thawing, suspension, passaging, expansion, 3L and 10 L bioreactor batch process, harvesting, and clarification. Upstream lead for client project involving AAV.

Basel, Ch

Basel, Ch

• Performed analytical and wet chemistry assays (including HPLC analysis, A260/A280 spectrophotometry, Silver Staining, and SDS-PAGE) on stability, in-process, and final drug product samples in compliance with cGMP/GLP for the World's Largest Dedicated Cell and-Gene-Therapy Manufacturing Facility.• Prepared media and buffers, maintained cell lines (A549, HEK293, HeRC32), harvest, and conduct cell-mediated bioassays (Adenovirus Titer Immunoassay and Western Blot with Cellular-based aspects) while utilizing proper aseptic techniques.• As a Lonza qualified trainer, I trained and mentored more than ten employees since October 2016 on assays and analytical procedures used for the release testing of manufacturing buffers and viral IND (Phase I-III) products.• Actively supported viral vector technology transfer activities for analytical test methods including training on new methodology, setup of new equipment, review and providing feedback of standard operating procedures (SOPs), and the execution of qualification protocols.• Followed Lonza’s standard for visual inspection (meeting USP <1> , USP <790>, WHO 96.585, EP 2.9.20 and JP XIV 20 requirements) to inspect drug products to ensure that there are no visible defects to the product and/or packaging and no visible particulates are observed in the filled product containers• Wrote and completed Deviation Reports, CAPAs, and Change Controls with TrackWise to improve and/or update the quality control process used during the testing of raw materials, buffers, and viral vector-based drug products.• Authored/Updated/Revised technical documentation (e.g. Standard Operating Procedures, Forms, Test Records, and Learning Qualification Modules) using Lonza's Error Prevention System (EPS) guidelines.

Basel, Ch

• See above and below.

Basel, Ch

• Performed raw material and buffer release testing (pH, Osmolality, Conductivity, Density Determination, Bioburden, Physical Appearance) according to established Pharmacopeia methods (including USP, Ph. EUR) and according to Standard Operating Procedures, in compliance with cGMP.• Performed routine and specialized sampling of raw materials utilizing appropriate sampling techniques in a controlled environment.• Managed raw material sampling and sample shipping schedules in support of manufacturing operations.• Collaborated and worked closely with Quality Assurance, Materials Management/Warehouse, Manufacturing, External Testing Laboratories, and other cross-functional teams as required to meet raw material release timelines in a timely and effective manner.

Vacaville, California, Us

• Lead of team of three engineering graduates students on a project to determine the viability of transforming a naturally occurring biopolymer produced from waste biogas (methane) into a commercially viable product.• Investigated how to mitigate critical technical risks (product development cycle, economies of scale, commercialization requirements) and marketplace risks (customer interest in the product, competitors, and product differentiation) for this biopolymer technology to be adopted in these high-potential markets.• Presented to the CEO and to key personnel a report of key success factors and list of recommendations of the three most viable products and key markets to focus on.

• Formulated and prepared Accutase® (cell dissociation reagent) and other reagents in large-scale reagent vessels (up to 1000 L) for production runs and helped out with the fill-and-finish process.• Assisted with the production-scale downstream manufacturing process of purifying proteins using standard filtration and purification techniques.• Developed a protein standard mix as a means to specifically evaluate and benchmark a ShodexTM Size Exclusion HPLC Column (300 x 8 mm) used for the QC release testing of the purified lyophilized Accutase® product. • Updated and revised standard operating procedures and reports used for the manufacturing process.

La Jolla, Ca, Us

Advisor: Dr. Michael Berns• Investigate cell biomechanics by performing computer-aided laser cutting on cells.• Assist with troubleshooting LabView used for the computer-aided laser process.

Master'S Degree, Chemical Engineering

Bachelor'S Degree, Bioengineering (Biotechnology)