Sheree W. Email & Phone Number

Singapore

Singapore

• Work on development and optimization of clinical diagnostic tests based on molecular technology (qPCR, dPCR, ddPCR, RT-PCR and NGS). • Involved in development of molecular technology to detection of miRNA, DNA methylation, as well as pathogens of interest, HPV. • Explore new technologies to meet/exceed current clinical requirements on diagnostics tests and improve existing methods.• Design and conduct scientific experiments for product development, performance troubleshooting, and protocol optimization.• Analyze and interpret data to obtain insights for project progressing.• Collaborate with other R&D team members to further multifaceted projects, including tech transfer.

Singapore

• Execute kit production operations according to defined procedures and ensure the integrity and quality Research Use Only (RUO) and Diagnostic Kits under ISO 13485 and other relevant regulatory requirements.• Perform formulation and dispensing of reagents in Research Use Only (RUO) and Diagnostic Kits, including simple calibration and maintenance of all equipment used to ensure proper working conditions according to ISO 13485 requirements.• Monitor, update and maintain on both RUO and Diagnostic Kits manufacturing inventory and material transfer. • Support in obtaining provisional authorisation from Singapore’s Health Sciences Authority (HSA), Food and Drug Administration (FDA) and CE-IVD marking for COVID-19 RT-qPCR Kit.• Execute QC testing on finished products (Consumables, Assay Kits, COVID-19 RT-qPCR Kits) and System Validation Test on Digital PCR instrument to ensure the products meet the specifications. • Draft and release technical file (Process Flowcharts, Work Instructions, Bill of Materials (BOM), Work Orders, Device Master Records, Risk Management Plan) for manufacturing operations under ISO 13485 and other relevant regulatory requirements.• Provide technical support, training to team members and approvals to manufacturing operations to ensure product/process quality and efficiency.• Provide insight on product development, manufacturing and quality control process improvements. • Perform process validation and support R&D from project initiation through manufacturing transfer for development of new products. • Support out-of-specifications manufacturing troubleshooting, engaging in root-cause investigations for non-conformance and CAPA activities.• Project management for external and internal projects.• Performed biological experiments (qPCR, dPCR, extraction, etc).• Responsible in purchasing of lab consumables and raw materials used in production.• Conduct internal audit as Lead Internal Auditor under ISO 13485 requirements.

Singapore

• Performed biological experiments (PCR, qPCR, dPCR, DNA isolation etc).• Worked together with scientists and engineers in setting up, executing and data collection for product testing.• Provided direct support to troubleshooting and improvement for production.• Provided feedback and assisted engineer in monitoring of any process or testing issues.• Assisted in prototyping and validating the prototypes.• Performed QC testing on finished products and instruments.

Singapore

• Presented research findings in both oral and poster presentation formats in two conferences; 10th BioEngineering Society Scientific Meeting (10BESSM) and Young Scientists’ Symposium 2016 (YSS2016).• Investigated the effects of micropatterned platform on the matrix alignment and later differentiation of mesenchymal stem cell-based cell sheets for tissue regenerative medicine via gene expression quantification, immunohistochemical analysis and interpretation. • Earned Grade A for Final Year Project.

Singapore

• Investigated the effects of polydopamine-coated polydimethylsiloxane (PDMS) surfaces on enhancement of multi-lineage differentiation of mesenchymal stem cell.• Performed related assays and experiments including cell proliferation assay, PCR, fluorescence staining and histological staining.• Performed photolithography and soft lithography.• Earned Distinction for internship.

Bachelor Of Biomedical Sciences

Diploma In Biotechnology