Bioprocess Specialist
About Us:
Based in the vibrant city of Christchurch, 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. Our goal is to tailor our offerings precisely to our customers' specifications and regulatory requirements under ISO 13485, EU IVDR and US FDA 21 CFR 820.
As we continue to grow, we are seeking a Bioprocess Specialist to join our dynamic team and contribute to the product and process development for existing and new products.
The Role:
As the Bioprocess Specialist, you will play a crucial role in the production team, manufacturing our diagnostic control solutions. Pivotal to this work will be your background in protein purification and characterisation so that you are able to resolve issues related to protein degradation, aggregation, overall product consistency and yield.You will collaborate closely other teams to ensure the highest standards of quality and efficiency. Your work will directly impact the reliability and consistency of products used in critical diagnostic testing worldwide.
Key Responsibilities:
- Manufacture products in alignment with established work instructions, manufacturing processes and QMS.
- Work closely with cross-functional teams to manage processes in existing manufacturing lines and trouble-shoot any protein issues.
- Lead process improvement, root cause analysis and quality-focused decision-making, ensuring that all processes comply with international IVD standards, including ISO 13485 and GMP.
- Identify opportunities for process and product development and implement solutions to enhance productivity, reduce waste, and optimize resource utilization.
- Conduct product support studies, assisting in ensuring that products and processes meet manufacturing requirements.
- Post graduate degree in Biochemistry or Biotechnology with strong knowledge of protein structure and function.
- 5+ years of relevant experience in protein bioprocess development or biomanufacturing is a plus.
- Proactive approach to ensure high-quality and consistent product manufacturing.
- Strong understanding of regulatory frameworks is an advantage.
- Ability to train, mentor and lead by example, collaborating with cross-functional teams in a fast-paced, innovative environment.
- An exciting and innovative working environment within a world-class scientific team.
- Opportunities for professional growth and development.
- Competitive salary and benefits.
- The chance to make a meaningful impact in the medical diagnostics field, contributing to global healthcare advancements.
To be successful in this role, you need to be a New Zealand Citizen or Resident.
For a confidential discussion please contact Jenny Barr, EQ Consultants, on 021 223 5118.