Lim Gaik Ling

Lim Gaik Ling

Senior Scientist

About

From concept to commercialisation, I have led the development, optimisation, and market launch of lateral flow immunoassays (LFIA), alongside advancing a molecular cancer prognosis panel, and scaling diagnostic manufacturing processes. My work spans full product lifecycles — from R&D innovation and design control to technology transfer, process validation, and ISO 13485-compliant manufacturing — ensuring both technical excellence and regulatory readiness. Positioned at the intersection of industry and academia, I thrive in transforming laboratory innovation into market-ready healthcare solutions. I have successfully delivered multidisciplinary projects by combining deep assay development expertise with practical manufacturing know-how, robust quality assurance leadership, and a results-driven approach to technology transfer and process improvement. I am always open to connecting with forward-thinking teams, investors, and recruiters seeking a proven partner to lead diagnostics or medical device projects. Whether for strategic advisory, hands-on project leadership, or cross-border technology transfer, I welcome opportunities to collaborate on impactful innovations that advance global healthcare.

Country

Malaysia

City

Penang

Industry

Consumer Goods

Skill

Quality Assurance, Technology Transfer, Process Validation, Quality Management, Project Management, Technology Leadership, Technology Management, Technology Commercialization, Technical Support, ISO 13485, Quality Control, Lateral Flow Asaay Development, Real-Time Polymerase Chain Reaction (qPCR), Microarray, Data Analysis, Microbiology, Molecular Biology, Polymerase Chain Reaction (PCR), Research and Development (R&D), Assay Development

Experience

Medical Innovation Ventures (Mediven)

Senior Scientist

Medical Innovation Ventures (Mediven)

2021-4 - Present · 5 yrs 6 mos

Penang, Malaysia

Promoted for exceeding KPIs and delivering strategic contributions Key accomplishment: Successfully incorporated lateral flow immunoassays into a lateral flow reader and achieved 95-100% of agreement in performance. Roles and responsibilities: -Lead the development of fluorescence POCT with reader integration -Expand and optimise manufacturing capabilities to include contract manufacturing services -Manage the full product lifecycle of lateral flow immunoassays, from R&D to commercial production -Drive the manufacturing scale up, increasing production throughput and efficiency -Facilitate seamless technology transfer between R&D and production teams -Oversee quality data analysis, driving continuous process improvements for product consistency and reliability -Design and execute validation protocols for equipment, reader systems, processes, and test methods -Author and review technical documentation, including SOPs, reports, protocols, ensuring alignment with regulatory requirements -Increased upstream production capacity, optimising workflow efficiency and scalability -Conducted gap analyses, identifying technical challenges, and implementing preventive actions for technical transfer and production scaling -Oversee project management, ensuring timely completion of milestones aligned with organisational objectives

Medical Innovation Ventures (Mediven)

R&D Scientist

Medical Innovation Ventures (Mediven)

2017-4 - 2021-4 · 4 yrs 1 mo

Key accomplishments: - Established lateral flow immunoassays development platform for the initiation of projects -Successfully converted two ELISA test kits into lateral flow immunoassays with more than 95% agreement in performance - Successfully completed the development of three lateral flow immunoassays - Up-scaled protein conjugation production to 20x Roles and responsibilities: - Properly grounded the research and development of new lateral flow immunoassays, with a primary emphasis on infectious diseases - Led the seamless transfer of prototypes/products from the lab bench to commercialisation - Continuously enhanced the R&D platform for lateral flow immunoassays - Established and refined manufacturing processes for lateral flow immunoassays, prioritising on scalability, efficiency, and quality control - Collaborated with cross-functional teams and external institutions, including manufacturing, quality assurance, and regulatory affairs, to facilitate the smooth transfer of products and align with organisational goals; and universities and organisations on collaborative R&D of IVD projects - Mentored and trained individuals in lateral flow immunoassays development and manufacturing

Mediven

Application Specialist

Mediven

2016-7 - 2017-4 · 10 mos

Key accomplishments: - Resolved complex and longstanding troubleshooting cases, resulting in successful of brand switching from competitors and customers retention - Spearheaded and initiated the establishment of SOPs for the applications team, streamlining processes and ensuring consistent and high-quality performance - Actively mentored and guided applications specialists and sales team, enhancing their expertise in troubleshooting, after-sales service, and customer support - Provided comprehensive training to healthcare professionals by conducting on- and off-site technical troubleshooting, empowering healthcare professionals to perform tests with accuracy and realibility - Engaged in collaborative efforts with professionals from various disciplines, seeking insights and feedback to enhance the performance and usability of marketed IVD test kits

GeneNews Diagnostics (Presently known as BioNexus Gene Lab Sdn. Bhd.)

Researcher/ Technical Manager

GeneNews Diagnostics (Presently known as BioNexus Gene Lab Sdn. Bhd.)

2015-6 - 2016-1 · 8 mos

Key accomplishments: - Assumed responsibility for the development of a non-invasive genomic signature panel for multi-disease prediction using microarray-based mRNA analysis, steering the project from its midway state to completion with improved performance to 90-95%, enabling the marketability of the panel Roles and responsibilities: - Oversaw and managed the diagnostic service for RT-qPCR tests used in the prediction of colorectal and prostate cancers. Ensured the seamless operation of the service, guaranteeing prompt and reliable test results for patients by adhering to SOPs and quality control standards set by the US counterpart - Played a proactive role in the accreditation process for ISO 15189, contributing to the development and implementation of required QMS. Collaborated with internal teams and external auditors to ensure successful accreditation

Centre for Drug Research, Universiti Sains Malaysia

Research Officer

Centre for Drug Research, Universiti Sains Malaysia

2013-4 - 2015-4 · 2 yrs 1 mo

Penang, Malaysia

Key Accomplishments - Completed four bioassay screening projects with two projects with a pharmaceutical company and two with universities • Published the biofilm study in a journal paper Roles and Responsibilities - Spearheaded the development and implementation of the microbial biofilm culture platform, enabling the execution of biofilm-related studies. Developed robust protocols and procedures to ensure consistency and reliability in the results obtained from the platform. Leveraging expertise in microbiology to optimise conditions for biofilm growth and evaluation - Established SOPs for bioassay screening, ensuring uniformity and reproducibility in evaluating the antimicrobial and antibiofilm activities and substances against hospital-acquired pathogens - Established and facilitated collaborative partnerships with pharmaceutical companies and universities to foster joint initiatives, shared resources, expertise, and data in bioassay screening projects

Winwa Medical Sdn. Bhd.

Quality Control Assistant Microbiologist

Winwa Medical Sdn. Bhd.

LinkedIn
2012-7 - 2012-8 · 2 mos

Roles and Responsibilities: - Successfully completed GMP (Good Manufacturing Practices) internal training and performed routine microbiological testing and analysis of various samples, including raw materials, in-process samples, finished products, and environmental monitoring. Ensured adherence to regulatory standards and comply specifications, verifying the safety and quality of products - Supported the identification of root causes and implementation of corrective actions to maintain product quality and regulatory compliance. Maintained accurate documentation and records of quality control activities - Reviewed and provided recommendations for improvements and updates to SOPs related to microbiological testing and quality control processes

Education

Universiti Sains Malaysia

Universiti Sains Malaysia

LinkedIn

Biotechnology

2009 - 2013 · 4 yrs

- Conducted independent research on the study of different PhaCCn variants generated through site-directed mutagenesis on the production of bioplastics (PHA) by a bacterial host with the usage of different plasmids - Presented research work at local and international conferences - Assisted numerous practical classes in USM related to Biochemistry, Genetics and Biotechnology

Universiti Sains Malaysia

Universiti Sains Malaysia

LinkedIn

Microbiology

2005 - 2008 · 3 yrs
Jit Sin High School l SMJK Jit Sin 日新國民型中學

Jit Sin High School l SMJK Jit Sin 日新國民型中學

LinkedIn

Lim Gaik Ling's Contact Information

Email

******@***.com

Phone

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