Key Responsibilities:
- Lead and guide lab team members on technical tasks and projects
- Develop, validate, and improve lab test methods (like bioassays and mycoplasma testing)
- Review and approve test results for both accredited and non-accredited tests
- Analyze lab data and provide scientific conclusions
- Act as a subject matter expert (SME) and ensure compliance with all regulatory standards
- Communicate directly with customers about technical matters and attend site visits if needed
- Write and update lab documents (methods, SOPs, protocols, reports, etc.)
- Ensure lab procedures meet all regulatory and quality requirements
- Troubleshoot technical problems and support investigations
- Report any compliance issues to Quality Assurance and Senior Management
- Monitor and manage lab performance testing and ensure ongoing compliance
- Take part in audits (internal, external, regulatory) and regular management reviews
- Lead improvements in processes, quality, and safety within the lab
Requirements:
- Min. Bachelor's degree in Science or a related field
- Min. 2 years of hands-on experience in microbiology testing in an ISO17025/GMP lab
- Experience in method development, validation, transfer, and qualification
- Strong knowledge of ISO 17025, cGMP, and other relevant regulations
- Understanding of project management and measurement uncertainty is a plus
- Good technical judgment and problem-solving skills
- Strong communication skills, especially across different cultures
- Able to work well both independently and as part of a team
If interested, please email me at [Confidential Information] or telegram @kellynlytan
Kellyn Fullviana
(CEI.No: R25157445 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599).
