Chen-Wei Su Email & Phone Number

Houston, Tx, Us

Basel, Ch

Basel, Ch

Basel, Ch

1) Write SOPs, forms and bioanalytical assay qualification/validation protocols and reports. Responsible for assay development, optimization and evaluating methods received from clients for equipment and material gaps prior to starting transfer activities.2) Interact with clients in joint project team meetings regarding method development, optimization, qualification, validation and technical challenges.3) Serve as SME on specific assays and serve in consultation role on difficult laboratory investigation in QC.4) Train QC analysts on new methods during assay tech-transfer activities. Also interacts with QC on equipment platform alignment and assay qualification/validation strategies

Miami, Florida, Us

1) Develop SOPs , optimize and validate Analytical Methods (e.g., ELISA, Cell-Based Assays, HPLC) and Processes (e.g., Protein Purification, Lyophilization) for biological drug manufacture, characterization and safety/potency testing to support CMC of IND submissions to the FDA2) As a supervisor; lead, train and directly supervise lab analysts to execute research and analytical method development projects; responsible for reviewing, interpreting and approving data to report to the upper management 3) Identify gaps, conduct risk assessments and solve problems occurred for technology transfer to the manufacturing team, CMOs or GMP QC lab and establish product specification (QTPP) 4) As a project manager, worked with a cross-functional team to design a new formulation, conducted required testing (e.g., IRB approved clinical trial and product stability testing) and collaborated with a CMO for packaging design and scale-up manufacturing to launch a product named Cliradex Light in the US market• FY 2017, More than 100,000 units were sold• Scientific paper published in April 2018 as the 1st author5) Co-authored over 8+ scientific publications as a major contributor. Extensive research experiences in retinal detachment (PVR), Osteoarthritis, Ocular Diseases (Blepharitis) and Cancers 6) Versed in developing essential lab operating parameters, validating study procedures related to cell culture, isolation, induction, characterization and stability (i.e., mouse monocyte macrophage, human retinal pigment epithelium and mesenchymal stem cells); responsible for GLP lab investigation (OOS/OOT/CAPA) and convert successfully validated studies to develop cell-based potency assays utilized for biological products efficacy testing7) Develop SOPs for equipment procurement (DQ, URS) and performed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for 40+ lab equipment to establish and maintain GLP laboratory

Miami, Florida, Us

Miami, Florida, Us

桃園市, Tw

1. Designd and optimized culture condition by studying metabolic mechanisms for bacteria Ralstonia eutropha H16 to increase yield of Polyhydroxyalkanoates (PHA)2. Performd bacterial/cell/fungi culture, protein extraction, purification and quantification3. Operated HPLC, GC, GPC, qPCR and microplate photometer to gain and analyze the experiment results.4. Coordinated lab meeting and lab events

Master Of Science - Ms, Chemical Engineering

Bachelor Of Science - Bs, Chemical Engineering