Research Officer, Precision Medicine (GIS)

Job Summary

We are seeking a dedicated and detail-oriented Research Officer to join our Centre for Genome Diagnostics (CGD). The successful candidate will play a key role in the development, optimization, verification and validation of molecular diagnostic assays, with a particular focus on isothermal amplification-based assays, while ensuring full compliance with ISO 13485 standards. This position combines hands-on molecular biology work with quality-focused documentation to support assay and technology development.

Key Responsibilities

• Lead the development, optimization, verification, and validation of molecular diagnostic assays, with a strong emphasis on isothermal amplification-based technologies.
• Design and execute hands-on laboratory experiments for assay development and performance improvement.
• Ensure all assay development activities comply with ISO 13485 quality management system requirements.
• Prepare and maintain comprehensive quality-focused documentation, including protocols, reports, and records to support regulatory and quality standards.
• Perform verification and validation studies to meet regulatory and performance requirements.
• Collaborate with internal teams to support the overall technology and assay development pipeline.
• Troubleshoot technical issues and implement solutions to optimize assay performance and robustness.

Qualifications and Requirements:

• Bachelor’s degree in Molecular Biology, Biotechnology, Biochemistry, Biomedical Science, or a related field.
• At least 0.5-2 years of relevant hands-on experience in molecular diagnostic assay development, preferably in isothermal amplification technologies (e.g., LAMP or similar).
• Strong practical experience in assay optimization, verification, and validation processes.
• In-depth knowledge and working experience with ISO 13485 quality management systems for medical devices or in vitro diagnostics is highly preferred.
• Proficient in molecular biology techniques including nucleic acid extraction, amplification, and detection methods.
• Demonstrated ability to prepare high-quality technical documentation, protocols, and reports in a regulated environment.
• Detail-oriented with excellent organizational and record-keeping skills.
• Strong problem-solving abilities and the capacity to troubleshoot technical issues independently.
• Good communication and teamwork skills, with the ability to work effectively in a multidisciplinary setting.
• Ability to manage multiple tasks and meet project timelines in a fast-paced environment.
• Excellent attention to detail and commitment to data integrity and traceability.

Desirable:

• Hands-on experience in developing isothermal amplification assays (e.g., LAMP).
• Prior working experience in an ISO 13485-certified.
• Experience in product development of molecular diagnostic assays.
• Familiarity with design control processes and risk management according to ISO 13485.
• Experience with Next-Generation Sequencing (NGS) and NGS data analysis.
• Knowledge of regulatory requirements for in vitro diagnostic (IVD) products (e.g., Singapore HSA, FDA, or CE marking).

Skills and Competencies

• Proficient in the development and optimization of isothermal amplification assays (e.g., LAMP or similar technologies).
• Strong technical expertise in molecular biology techniques, including nucleic acid extraction, primer/probe design, amplification, and detection methods.
• Solid experience in assay verification, validation, and performance characterization under regulated standards.
• Thorough understanding of ISO 13485 quality management system requirements and their application in diagnostic assay development.
• Excellent documentation skills with the ability to prepare clear, accurate, and audit-ready protocols, reports, and records.
• Strong analytical and problem-solving abilities with a systematic approach to troubleshooting technical issues.
• High attention to detail and strong organizational skills to maintain accurate laboratory records and data.
• Ability to work independently as well as collaboratively in a multidisciplinary team environment.
• Good time management and project-handling skills to meet deadlines in a dynamic research setting.
• Effective verbal and written communication skills for presenting technical information and collaborating with internal stakeholders.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.