Experience

Experimental Drug Development Centre (EDDC)

• Singapore
• Research
• 1 - 100 Employee

• Head of Biomarker Development

  • Apr 2022 - Present

• Senior Research Manager

  • Feb 2019 - Apr 2022

  1. Discover and validate biomarkers that can be developed into companion diagnostics or in vitro diagnostic kits in cancer and responsible to plan and implement the analytical validation of putative biomarkers so that they can be translated into the clinic.• Develop, validate and implement protein or nucleic acid based diagnostic tests for cancer to be readily use in clinical trial Phase 1A/B.• Perform process optimizations and analytical validations of biomarker assays, and write and implement SOPs (including all record sheets) for clinical trial samples processing and analysis.• Run assays to support pre-clinical and clinical studies.• Participate in team meetings and create assay development strategies based on project needs.• Generate reports summarizing study findings including Clinical Data Interchange Standards Consortium (CDISC) and supported in clinical trial biomarker manual review and writing.• Oversee assay translation into a CAP/CLIA laboratory or ISO 13485 compliant kit. • Manage and oversee preclinical/analytical validation/method development activities performed at CROs.• Ensure compliance to all applicable work instructions, SOPs and precise documentation e.g. validation plans/reports in accordance to industry’s standards (e.g. GCP, CAP/CLIA, FDA).2. Manage and lead own team/direct reports and provide training for student attachments.• Actively engage RA in project discussion e.g. experimental troubleshooting which require problem-solving skill.• Give comprehensive training in technical knowledge (pipetting skills, handling of reagents and samples, lab workflow, calculations) and documentation.3. Support procurement and tender processes.4. Write/review and maintain risk assessments for relevant project specific involving laboratory work. Establish and train RA the best practices in lab safety when working with biological samples. Take part in the Safety Committee and provide suggestions regarding lab safety issues to the committee. Show less



D3 (Drug Discovery & Development)

• Biopolis, Singapore

• Research Manager

  • Jul 2013 - Feb 2019

  1. Discover and validate biomarkers that can be developed into companion diagnostics or in vitro diagnostic kits in cancer and responsible to plan and implement the analytical validation of putative biomarkers so that they can be translated into the clinic. • Develop, validate and implement protein or nucleic acid based diagnostic tests for cancer to be readily use in clinical trial Phase 1A/B. • Perform process optimizations and analytical validations of biomarker assays, and write and implement SOPs (including all record sheets) for clinical trial samples processing and analysis. • Run assays to support pre-clinical and clinical studies. • Participate in team meetings and create assay development strategies based on project needs. • Generate reports summarizing study findings including Clinical Data Interchange Standards Consortium (CDISC) and supported in clinical trial biomarker manual review and writing. • Oversee assay translation into a CAP/CLIA laboratory or ISO 13485 compliant kit. • Ensure compliance to all applicable procedures, work instructions, SOPs and precise documentation e.g. validation plans and reports in accordance to industry’s standards (e.g. GCP, CAP/CLIA, FDA). 2. Manage own team/direct reports and provide training for student attachments. • Actively engage RA in project discussion e.g. experimental troubleshooting which require problem-solving skill. • Give comprehensive training in technical knowledge (pipetting skills, handling of reagents and samples, lab workflow, calculations) and documentation. 3. Maintain operations of designated laboratory and equipment. Support procurement and tender processes. 4. Write and maintain risk assessments for D3’s office and relevant project specific involving laboratory work. Establish and train RA the best practices in lab safety when working with biological samples. Take part in the Safety Committee and provide suggestions regarding lab safety issues to the committee. Show less



Dx assays Pte. Ltd.

• Biotechnology Research
• 1 - 100 Employee

• Scientist

  • Apr 2012 - Jun 2013

  - Leads a team of Research Associates to conduct nucleic acid based cancer diagnostic (RUO and IVD) assay development and validation for client or with collaborator• Plan project and experimental designs to develop, optimize and modify diagnostic assay systems as defined by client and work closely with team members.• Analyze experimental results, present data to client, and contribute to technical discussions. • Work on budget and efficient use of resources by communicating closely with Project Managers and Director. • Keep track on the project plans and consistently communicate with client to provide update of project’s progress.• Ensure compliance to all applicable procedures, work instructions, SOPs and precise documentation e.g. development/verification plans and reports in accordance to client’s requirements and ISO 13485/90001. • Share knowledge and technical skills among team members for best practices to achieve robust, reliable, and reproducible research. • Proactively reacts to problems in a timely manner and troubleshoot with logical, practical, and acceptable solutions.- Actively support company’s goal in innovation and growth in getting research agreement for exploitation of new biomarker and potential diagnostic products.- Support the company’s processes to get up to FDA standards and that the ISO certification is renewed.• Assist the top management to ensure the implemented Quality Management System is effective and meeting the regulatory and customer requirement.• Maintain 100% compliance with SOPs, ISO standards, and company’s policies. Ensure compliance of subordinates.• Engaged as an internal auditor for ISO13485 to check conformance and effectiveness of the systems as well as highlight problems and identify areas for improvement.- Maintain operations of designated laboratory and equipments e.g. monthly lab cleaning, preventive maintenance of equipments, etc. Show less

• Senior Research Associate

  • Feb 2011 - Apr 2012

  - Project leader in developing RUO qPCR cancer diagnostic assays including analytical validation of developed assays for client. - Involved in Institutional Biosafety Committee (IBC) ensuring lab biosafety. - Engaged in internal quality audit ISO13485 to check conformance and effectiveness of the systems as well as highlight problems and identify areas for improvement. - Maintain operations of designated laboratory and equipments e.g. monthly lab cleaning, preventive maintenance of equipments, etc. Show less



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Scientist

  • Jun 2008 - Dec 2010

  - Developed/validated biomarker and patient tailoring solutions (in-vitro/cell-based assays) for portfolio targets. - Promoted learning and growth of the organization through improved communication, knowledge sharing, and training. - Shared responsibilities in maintaining the lab for full operation. - Achieved full compliance with policies and procedure, including safety and ergonomics, GRP, individual training, and SOPs. - Developed/validated biomarker and patient tailoring solutions (in-vitro/cell-based assays) for portfolio targets. - Promoted learning and growth of the organization through improved communication, knowledge sharing, and training. - Shared responsibilities in maintaining the lab for full operation. - Achieved full compliance with policies and procedure, including safety and ergonomics, GRP, individual training, and SOPs.



Innogene Kalbiotech (Kalbe Indonesia)

• Research Officer

  • Mar 2007 - Jun 2008

  - Laboratory set up including permit/license registrations - Manage the laboratory (daily operations) and logistics - Develop diagnostic kits for early cancer detection which involves design and packaging - Carry out clinical validations of diagnostic kit to determine the sensitivity and specificity of the kit - Laboratory set up including permit/license registrations - Manage the laboratory (daily operations) and logistics - Develop diagnostic kits for early cancer detection which involves design and packaging - Carry out clinical validations of diagnostic kit to determine the sensitivity and specificity of the kit



SingHealth

• Singapore
• Hospitals and Health Care
• 700 & Above Employee

• Research Scientist

  • Jun 2005 - Mar 2007

  Conduct cellular and molecular biology research on characterization of novel gene (LRRK2) in Parkinson’s disease. Conduct cellular and molecular biology research on characterization of novel gene (LRRK2) in Parkinson’s disease.



Singapore National Eye Centre

• Singapore
• Hospitals and Health Care
• 300 - 400 Employee

• Research Assistant

  • Aug 2001 - Sep 2002

  Established clinical diagnosis using PCR on vitreous sample of patients’ eyes suspected suffering from Endophthalmitis (caused by micro-organisms) via designing specific primers to detect pathogens. Project includes bacteria culturing, DNA extraction, Identification of Bacteria using API Kits. Established clinical diagnosis using PCR on vitreous sample of patients’ eyes suspected suffering from Endophthalmitis (caused by micro-organisms) via designing specific primers to detect pathogens. Project includes bacteria culturing, DNA extraction, Identification of Bacteria using API Kits.