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Howard K. is listed as A collaborative and passionate Process Development Scientist/Engineer/MSAT/ Process Transfer Scientist at Gilead Sciences, a company with 11861 employees, based in Oceanside, California, United States. AeroLeads shows a matched LinkedIn profile for Howard K..
Howard K. previously worked as Associate Scientist, Process Development at Gilead Sciences and MSAT Scientist at Lonza. Howard K. holds Master'S Degree Of Science (M. S.), Molecular Biology And Immunology from Usc.
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Self-driven and enthusiastic on manufacturing process development.The bridge to work with engineers, process development, regulation, and manufacturing.• SME and trainer in upstream GMP biologics manufacturing cell culture process development and scale-up.•Proven CMC team project management core member.•SME of AVEVA Pi, DeltaV and Sartorius BioPAT automation system, led operation, URS, qualification, innovation and troubleshooting.•Work with quality and engineering to develop, review and execute GMP manufacturing process equipment user requirement specification (URS), design (CD/BD/DD) and qualification (DQ/IQ/OQ/PQ): Bioreactor, UF/DF, Disc Stack Centrifuge, Microfluidizer, CIP, AKTA Process, and TFF.•Process transfer (new product introduction): process model, gap analysis, author of manufacturing batch records and SOPs.•Benchling ELN, Apprentice EBR (MES), SAP DMS, IBM Maximo/ Blue Mountain CMMS.• Proven ability to coordinate engineering and process development, resulting in reduced construction costs and increased flexibility on the manufacturing.• Known for leadership, managerial and organizational skills to increase operational excellenceSpecialties: Cell culture process development from benchtop to GMP manufacturing.Project management on facility design, equipment engineering, qualification, process development, and validation.
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A career timeline built from the work history available for this profile.
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.
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.
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.
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.
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.
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).
Other employees you can reach at gilead.com. View company contacts for 11861 employees →
Robert J.E. Tarney
Colleague at Gilead Sciences
San Francisco, California, United States, United States
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Amanda Whelan
Colleague at Gilead Sciences
New York City Metropolitan Area, United States, United States
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Preena Mathew
Colleague at Gilead Sciences
Union City, California, United States, United States
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Nora Prescot
Colleague at Gilead Sciences
Pomona, California, United States, United States
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HR
Himanshu Roy
Colleague at Gilead Sciences
Raleigh, North Carolina, United States, United States
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David Brito
Colleague at Gilead Sciences
Tustin, California, United States, United States
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Luis Eduardo Guerra
Colleague at Gilead Sciences
London, England, United Kingdom, United Kingdom
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Sarah Ng
Colleague at Gilead Sciences
Milpitas, California, United States, United States
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Bris K
Colleague at Gilead Sciences
Greater Melbourne Area, Australia
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KZ
Kathryn Zemlachenko
Colleague at Gilead Sciences
New York City Metropolitan Area, United States
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Therapeutic mammalian antibody development and testing.
Quick answers generated from the profile data available on this page.
Howard K. works for Gilead Sciences.
Howard K. is listed as A collaborative and passionate Process Development Scientist/Engineer/MSAT/ Process Transfer Scientist at Gilead Sciences.
Howard K. is based in Oceanside, California, United States while working with Gilead Sciences.
Howard K. has worked for Gilead Sciences, Lonza, Polaris Pharmaceuticals Inc.- Vacaville, Polaris Pharmaceuticals Inc., and Tanvex Biologics Corp.
Howard K.'s colleagues at Gilead Sciences include Robert J.E. Tarney, Amanda Whelan, Preena Mathew, Nora Prescot, and Himanshu Roy.
You can use AeroLeads to view verified contact signals for Howard K. at Gilead Sciences, including work email, phone, and LinkedIn data when available.
Howard K. holds Master'S Degree Of Science (M. S.), Molecular Biology And Immunology from Usc.
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