Singapore
• Executed successful PPQ runs and ensure that production is kept on schedule. • Subject matter expert to cleaning validation program for manufacturing and worked with the Process Engineer in charge to plan and execute the project. • Part of the team in commissioning of Chromatography Skids and Column packing equipment. • Author to several SOP such as "Equipment Release for Use", "Issuance and use of Equipment Use Records", "Resin and Membrane Tracking" and "Elution Profile Analysis". • Set up a system and worked with QA and several system owners to create FORMs for Equipment Use Records for Manufacturing use across all equipment. • Trained in the use and review of Electronic batch records. • Trained in downstream analytical instruments such as "Solo VPE, TOC analyzer, pH and conductivity meter". • Worked with Process Engineer in establishing cleaning validation samples and requirements for equipment release criteria.
-Trained to audit various GMP assays conducted by lab scientists for pre clinical drugs. -Experienced in auditing reports for stability testing of pre clinical drugs. -Proficient in auditing protocols for the conduct of GMP laboratory work. -Qualified to auditing various assays in electronic workbook. -Trained in 'White Belt'. -Experienced in coordinating and conducting laboratory audits to ensure GMP compliance.
• In charge of getting downstream suites GMP qualified. • Experienced in validating equipments and processes. • Perform duties to run and prepare for product processes • In charge of the KANBAN effort for downstream. • Acting shift lead for team which includes planning daily activities and attending production meetings. • Experienced in packing and unpacking of columns. • Experienced in Delta V system usage. • Qualified trainer for several operations such as cleaning of equipments and preparation of buffers. • Lead and organized change over for downstream. • Write Standard Operation Procedures for several operations.
• Trained on basic documentation for cGMP procedures. • Worked in Buffer Hold and Buffer Preparation in 101B for gained experience in most procedures needed to operate in either suites. • Transferred to Purification (P6) and was trained to work in different suites to work on processing product and process equipments such as chromatography, UF/DF and filter skids. • Involved in daily and weekly tasks such as water sampling, calibration of pH and conductivity probes and spectrophotometer. • Participate in project, ‘Batch Records Kaizen’ to make positive changes and corrections to batch records. • Worked in small scale Purification (P4) and was trained in basic procedures such as CIP and SIP of portable tanks. • Assisted in change over in both P4 and P6. • Participated in shift exchange report. • Attained 1st level review qualification. • Attended safety training sessions.
• Analysis of sequencing results using ‘Polyphred’ and ‘Phredphrap’ software. • Designed primers for sequencing of genes. • Performed sample preparations such as reading of DNA concentration and running of DNA on agarose gels for DNA sequencing. • Ran iPLEX Genotyping on ‘Sequenom’. • Maintained and cultured MCF7 cells. • Performed transfection and transformation of DNA sequences to MCF7 cells. • Carried out ‘Dual Luciferase Reporter Assay’ on transient transfected cells.
Assisted a research scientist , Dr Susan Lee in project • Conducted research on the generation of recombinant antibody library using samples of patients diagnosed with 'Grave's Disease' • Gained experience in ScFv engineering and Phage display • Performed panning of antibody library and screening for positive clones against thyrotropin receptor (TSHR). • Maintained and cultured mammalian cells. • Responsible for housekeeping and maintenance of laboratory equipment. • Planned and analyzed results of experiments.