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.