Deskripsi Pekerjaan
Are you a visionary scientist ready to make a tangible impact on global healthcare? Join the **Agency for Science, Technology and Research (A*STAR)** as a Senior Scientist within the DxD Hub. In this pivotal role, you will lead cross-functional teams in the development of cutting-edge diagnostic products, bridging the gap between complex laboratory research and commercial reality.
You will be at the forefront of **ImmunoDx (Immunodiagnostics)** innovation, ensuring that our diagnostic solutions meet the highest standards of quality, accuracy, and regulatory compliance. We are looking for a leader who combines deep scientific expertise with exceptional project management skills to drive projects from concept to launch. If you are passionate about translating scientific breakthroughs into reliable diagnostic tools, this is your opportunity to shape the future of diagnostics.
Tanggung Jawab
- Lead and manage the end-to-end product development lifecycle for immunoassay-based diagnostic products.
- Ensure all R&D activities comply with strict regulatory guidelines (e.g., IMDA, ISO 13485) and Good Manufacturing Practices (GMP).
- Mentor and guide a multidisciplinary team of scientists, engineers, and technicians to foster professional growth.
- Identify, evaluate, and implement innovative technologies and methodologies in diagnostic development.
- Collaborate with internal stakeholders and external partners/vendors to ensure project milestones are met.
- Prepare comprehensive technical documentation, including protocols, reports, and regulatory submissions.
- Conduct rigorous data analysis and troubleshooting to optimize assay performance and sensitivity.
Kualifikasi
- PhD or Master’s degree in Immunology, Molecular Biology, Biochemistry, or a related Life Sciences field.
- Minimum of 5-7 years of experience in diagnostic product development, preferably within a biotechnology or pharmaceutical setting.
- Strong understanding of regulatory frameworks and quality management systems (QMS) for medical devices.
- Proven experience in leading cross-functional teams and managing complex projects with multiple timelines.
- Excellent written and verbal communication skills, with the ability to present technical data to diverse audiences.
- Strong problem-solving skills and a proactive approach to scientific challenges.
- Ability to work independently in a fast-paced, dynamic research environment.