Scientist Molecular

We are seeking a highly motivated Scientist with strong expertise in molecular diagnostics and In Vitro Diagnostic (IVD) product development. This role offers the opportunity to lead the design, development and validation of qPCR-based viral load quantification assays within a regulated environment.

The ideal candidate is an innovative thinker with experience across the entire IVD product lifecycle, including assay design, design verification/validation, technical transfer, and training. This position plays a key role in expanding and optimizing our diagnostic product portfolio and supporting global deployment.

Responsibilities:

• Design, develop, and optimize qPCR-based IVD assays for viral load quantification
• Conduct design verification and validation studies to ensure performance, accuracy, and robustness
• Perform data analysis, troubleshooting, and optimization to ensure consistent assay reliability
• Ensure all products meet regulatory requirements (e.g., ISO and adhere to CLSI guidelines
• Lead the technical transfer of assays to overseas production or external partners
• Collaborate with Regulatory Affairs, QA, and Manufacturing teams to support product development and launch
• Maintain clear, complete, and compliant technical documentation and validation reports
• Support innovation by collaborating with cross-functional R&D teams to improve assay platforms and technologies
• Develop and deliver technical training to internal staff, customers, and end-users as needed

Qualifications:

• MSc or PhD in Biochemistry, Molecular Biology, Molecular Genetics, or a related field
• Minimum of 3 years of hands-on experience in molecular assay development (e.g., qPCR,)
• Demonstrated work experience in an ISO 13485-compliant environment
• Solid understanding of IVD product development processes and regulatory expectations
• Proven ability to troubleshoot and optimize molecular assays
• Excellent oral and written communication skills
• Experience in regional technical support or customer training is a plus
• Willingness to travel when required
• Native or Fluent in English and Mandarin is required; Fluent in Malay or Bahasa will be a plus