Leads the strategic direction, execution, and delivery of R&D programmes focused on molecular diagnostics, biosensor development, and rapid diagnostic solutions.
Drives biosensor development targeting antimicrobial resistance (AMR), rapid diagnostics for emerging pandemic-potential pathogens, and sexually transmitted diseases (STDs).
Leads rapid diagnostic development programmes for high-risk and emerging pathogens, supporting pandemic preparedness and global health security initiatives.
Oversees end-to-end assay design, development, verification, validation, and clinical evaluation, translating research into deployable diagnostic products.
Owns and continuously improves the company's Quality Management Systems (ISO 13485:2016, ISO 9001:2015, ISO 15189:2012), ensuring regulatory compliance and audit readiness.
Leads internal audits, external assessments, supplier qualification, risk management, and CAPA; represents R&D and Quality at management reviews and regulatory discussions.
Scientist & Quality Manager – R&D
Oxford MEStar Ltd, UK
Led assay development, optimisation, verification and validation for molecular diagnostic and biosensor-based platforms, designing R&D workflows, SOPs, and validation protocols.
Built and managed laboratory operations, including staff recruitment, training, competency frameworks, equipment qualification, and supplier management.
Played a central role in establishing and maintaining ISO 13485 and ISO 15189 compliant QMS, supporting regulatory submissions and audit readiness.
Played a key technical role in developing, verifying, and clinically validating MPOX (Monkeypox) molecular diagnostic assays, contributing to a WHO Emergency Use Authorization (EUA) submission.
Led end-to-end assay design, development, verification and validation for molecular diagnostic products, contributing directly to commercial product pipelines.
Played a key technical role in validating fit-to-fly COVID-19 tests (LAMP and qPCR) at UK airports.
Designed and implemented R&D workflows and SOPs; managed laboratory operations including staff training, equipment qualification, supplier management, and regulatory documentation.
Key contributor to establishing and maintaining ISO 13485 and ISO 15189 compliant quality management systems, working closely with Quality & Regulatory Affairs on IVD submissions.
Education
PhD in Biotechnology
Jawaharlal Nehru University (JNU), New Delhi, India
Evaluation and Clinical Validation of Pan-Specific and Clade-Specific Diagnostic Real-Time PCR Assays for Monkeypox Virus
Hong Chang, Tin Hang Gung, Binbin Li, Bobby Lim Ho Kong, Ashwathi Asha Madhavan, Yue Wang, Ming-shan Tsai, Dan Deng, Zhangfeng Cui · Submitted to Journal of Medical Virology (JMV-25-25372.R1)
Patents
A Gold Nanoparticle-Based Colorimetric Biosensor for the Detection of Advanced Glycation End Products