Process Development Specialist

4 days ago


Christchurch, Canterbury, New Zealand Eq Consultants Full time
Company Overview

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.

Salary

A competitive salary and benefits package is offered to successful candidates.

Job Description

We 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
  1. Process Technical Support: Provide technical support to design, develop, and optimize manufacturing processes for producing high-quality diagnostic control solutions.
  2. 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.
  3. Compliance with International IVD Standards: Ensure all processes comply with international IVD standards, including ISO 13485 and GMP.
Required Skills and Qualifications
  • 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.
Benefits
  • 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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