Ashwathi Asha Madhavan

Head of R&D and Quality Manager

Experience

Head of R&D & Quality Manager

Oxford MEStar Ltd, UK
  • 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.

Molecular Diagnostic Scientist & Laboratory Manager

Oxsed, UK
  • 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

Specialisation: Nanotechnology, Biosensors, Electrochemical Diagnostics, Glycation Biology

MSc in Molecular Medicine (Distinction)

University of Essex, UK

MSc in Biotechnology

Amrita School of Biotechnology, India

CGPA: 9.2/10

Publications

Gold Nanoparticle Based-Detection of Low Molecular Weight AGEs from In Vitro Glycated Hemoglobin A0 Samples

Ashwathi Asha Madhavan et al. (2018) · Nanoscale Research Letters, 13:390

Synthesis of Graphenized Au/ZnO Plasmonic Nanocomposites for Simultaneous Sunlight-Mediated Photo-Catalysis and Anti-Microbial Activity

Subhavna Juneja, Ashwathi Asha Madhavan, Anujit Ghosal, Ranjita Ghosh Moulick, Jaydeep Bhattacharya (2018) · Journal of Hazardous Materials, 347: 378–389

Growth Kinetics of Gold Nanoparticle Formation from Glycated Hemoglobin

Ashwathi Asha Madhavan et al. (2020) · ACS Omega, 5(8): 3820–3827

Natural Occurrence of Carbon Dots during In Vitro Non-Enzymatic Glycosylation of Hemoglobin A0

Ashwathi Asha Madhavan et al. (2020) · ACS Omega, 7(5): 3881–3888

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

Jaydeep Bhattacharya, Ranjita Ghosh Moulick, Ashwathi Asha Madhavan, Subhavna Juneja · Patent Application No. 201811014098, filed 12 Apr 2018

A Low-Cost Point-of-Care Microfluidic Device for DNA/RNA Isolation, Purification and Amplification Using Chip-Based PCR/RT-PCR

Jaydeep Bhattacharya, Ranjita Ghosh Moulick, Raj Kamal, Ashwathi Asha Madhavan · Provisional Patent Application No. 201811004666, filed 07 Feb 2018

Conferences & Awards

6th NanoToday Conference

Poster presentation · Organised by Nano Today journal, the NanoBio Lab and Elsevier · Lisbon, Portugal, 16–20 June 2019

Ashwathi Asha Madhavan

Head of R&D and Quality Manager