Molecular Assay Development Specialist
1 week ago
We are seeking a highly motivated and experienced molecular assay development specialist to join our team. 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 will have strong expertise in molecular diagnostics and IVD product development, with experience across the entire lifecycle, including assay 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
- BSc or MSc 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
- 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
- Native or Fluent in English is required; Fluent in Mandarin is desirable; Fluent in Malay or Bahasa will be an asset
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