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.
Key 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 13485) 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
Basic Requirements of the Job
Education& Qualifications
MSc or PhD in Biochemistry, Molecular Biology, Molecular Genetics, or a related field
Experiences
- Minimum of 3 years of hands-on experiencein molecular assay development (e.g., qPCR)
- Demonstrated work experience in an ISO 13485-compliant environment
- Solid understanding of IVD product development processesand regulatory expectations
- Proven ability to troubleshoot and optimize molecular assays
- Excellent oral and written communication skills
- Skilled in bioinformatic analysis of genomes is an advantage
- Experience in regional technical support or customer training is a plus
- Willingness to travel when required
Language skills
Native or Fluent in English and Mandarin is required; Fluent in Malay or Bahasa will be a plus.