Process Development Specialist
4 days ago
Canterbury Scientific is a prominent figure in the global medical diagnostic sector. We take pride in being a leading OEM supplier, specialising in high-quality, stable IVD controls for diabetes and hemoglobinopathy assays.
SalaryA competitive salary and benefits package is offered to successful candidates.
Job DescriptionWe are seeking a Senior Process & Development Scientist to join our dynamic team and contribute to the product and process development for existing and new products.
Key Responsibilities- Process Technical Support: Provide technical support to design, develop, and optimize manufacturing processes for producing high-quality diagnostic control solutions.
- Development and Amendment of SOPs, WIs, and BMRs: Develop and amend standard operating procedures (SOPs), work instructions (WIs), and batch manufacturing records (BMRs) related to manufacturing processes.
- Compliance with International IVD Standards: Ensure all processes comply with international IVD standards, including ISO 13485 and GMP.
- Postgraduate degree in Bioengineering, Biomedical Science, or related discipline.
- 5+ years of experience in process development or manufacturing, ideally within the IVD or medical diagnostics industry.
- Core understanding of protein chemistry and related bioprocessing technologies for purification and production.
- Advanced project management skills.
- Strong understanding of regulatory frameworks (ISO 13485, FDA regulations, CE marking) and practical haematology experience.
- An exciting and innovative working environment within a world-class scientific team.
- Opportunities for professional growth and development.
- The chance to make a meaningful impact in the medical diagnostics field, contributing to global healthcare advancements.
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