Research Officer, Precision Medicine (GIS)

About This Role

Seeking a Research Officer to lead the development, optimization, and validation of isothermal amplification-based molecular diagnostic assays under ISO 13485 standards.

Responsibilities

• Lead the development, optimization, verification, and validation of molecular diagnostic assays.
• Design and execute hands-on laboratory experiments for assay development and performance improvement.
• Ensure all activity complies with ISO 13485 quality management system requirements.
• Prepare and maintain comprehensive documentation including protocols, reports, and records.
• Perform verification and validation studies to meet regulatory requirements.
• Collaborate with internal teams to support the technology and assay development pipeline.

Requirements

• Bachelor's degree in Molecular Biology, Biotechnology, Biochemistry, or related field.
• At least 0.5-2 years of hands-on experience in molecular diagnostic assay development, preferably isothermal amplification.
• Strong practical experience in assay optimization and validation processes.
• In-depth knowledge of ISO 13485 quality management systems for medical devices or IVDs.
• Proficient in molecular biology techniques including nucleic acid extraction, amplification, and detection.
• Demonstrated ability to prepare high-quality technical documentation in a regulated environment.
• Detail-oriented with excellent organizational and record-keeping skills.
• Strong problem-solving abilities to troubleshoot technical issues independently.