Howard K. Email & Phone Number

Oceanside, Ca, Us

Oceanside, California, United States

CMC project team member. SME of pilot plant upstream single-use bioreactor systems, SUB bag/tubing assembly design. Successfully led and completed automation system transition life cycle from DeltaV Operate to DeltaV live. Successfully introduced, standardized, led, and trained upstream single-use manufacturing from vial to 500L bioreactor with EBR induction and implementation. Worked with reliability engineers to troubleshoot and to perform instrument review with re-assessing calibration and PM. Built calibration and operation SOPs for bioreactor systems and probes. Tested new single-use technology and supported new single-use 2KL system design.

Hayward, California, United States

Conducted CDMO mammalian upstream new product introduction and process transfer from lab scale to pilot, and cGMP single-use 1K/2K manufacturing. Perform process monitoring and provide on-plant/ remote technical support as a process expert. Cross-functionally communicates and coaches departments toward successful manufacturing. Explore, test, and introduce new equipment with the engineer department to improve productivity, quality, and robustness.

Vacaville, California, United States

SME of commercial upstream equipment- 5-200L SS Fermentor, Alfa Laval Disc Stack Centrifuge, and Microfluidizer. Designed/performed/summarized engineering runs. Designed and improved 200L upstream process including CIP, and drafted equipment SOPs, process SOPs and batch records. Key person to investigate the deviation root cause. Managed GMP production activities and process development in coordination with Facilities, QA, and QC departments. Performed GMP industrial-scale 200L manufacturing to produce E.coli-based antitumor protein drug products for global clinical trials. Participated in autoclave validation and aseptic filling suite design/ construction. Participated in facility changeover development process from single-product to CDMO multi-product GMP manufacturing. Led CDMO upstream process development team.

Vacaville, California, United States

Conducted installation/operation/process qualification (IQ/OQ/PQ) and calibration assessment on the process equipment including 200L SS Fermentor and Disc stack Centrifuge. Performed process and cleaning development of the GMP commercial-scale upstream process. Performed clinical protein drug production activities on the pilot plant scale upstream (100L SS Fermentor), downstream, and aseptic filling. Drafted SOPs for upstream equipment and process, and manufacturing batch records.

Chengdu, Sichuan, China

Managed conceptual design and basic design of DesigneRx Chengdu new antitumor protein drug manufacturing facility (2X 2000L SS fermentors)and infrastructure construction with project management. Responsible for technique transfer from pilot plant to commercial-scale production. Supported DesigneRx USA commercial manufacturing equipment and system FAT, SAT, installation and qualification, construction management, and documentation review. Worked under international leadership, participated in multi-cultural and geographical spread teams.

Taipei, Taiwan

Coordinated pre-clinical CRO projects as a client on non-GMP protein production, toxicity, and assay development. Developed bio-similar of therapeutic monoclonal antibodies and cell line expression platform (96-well to 5L Bioreactor). Designed and built the new lab for bio-similar cell line development.

New Taipei City, Taiwan

Custom antibody development with rabbit and mouse hybridoma platform, gene cloning, E. coli protein expression, and RNA purification kit production.

Taipei, Taiwan

Potential drug screening with human cancer cell platform. Characterized candidate antitumor drug pathways and dosage on cancer cells.

Taipei City, Taiwan

Using molecular biology techniques to characterize and test the interaction, function, characterization of a novel splicing regulator, RBM4 (RNA binding motif protein 4).

Master'S Degree Of Science (M. S.), Molecular Biology And Immunology

Therapeutic mammalian antibody development and testing.

Bachelor Of Science (B.S.), Biology/Biological Sciences, General