Molecular Development Specialist

6 days ago

Singapore beBeeMolecular Full time $100,000 - $140,000
Senior Molecular Assay Developer

Our organization is seeking an experienced Molecular Assay Developer to lead the design, development, and validation of qPCR-based viral load quantification assays within a regulated environment.

The ideal candidate will be an innovative thinker with strong expertise in molecular diagnostics and IVD product development. They should have experience across the entire IVD product lifecycle, including assay design, verification/validation, technical transfer, and training.

This role plays a key part in expanding and optimizing our diagnostic product portfolio and supporting global deployment.

Key Responsibilities:

  • 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 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

Requirements:

A successful Molecular Assay Developer should have:

  • 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
  • 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 is required; additional languages may be beneficial.

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