About this role
We’re hiring a Product Development Scientist for one of our clients. This is a permanent full-time position. Reporting to the Manager of Product Development, the successful candidate will play a key role for new product development, new product transfer to manufacturing and trouble-shooting existing products.
We’re looking for a professional with extensive experience in chromatographic immunoassay (e.g. lateral flow immunoassay) development and manufacturing.
- Plan design and development of novel IVD including searching literature, preparing design development proposal and monitoring project progress.
- Participate in new project execution with related experimental techniques
- Play a key role in the continuous improvement of the existing products
- Lead the transfer of products and processes from Product Development to Manufacturing
- Plan and perform equipment, process and product validation and stability studies
- Prepare and review manufacturing instructions and SOPs while complying with organizational quality system requirements.
- Participate in bench studies and clinical studies for regulatory submission of novel IVD devices
- Work in a Bio-Containment Level 2 (CL2) laboratory and ensure all work in a safe manner by following CL2 requirements
- Perform other job-related duties as required
- Assist in the organization and conduct of investigator meetings.
- Close-out of study sites.
- Assist with audits and audit reports.
- BSc or MSc or PhD in immunology, microbiology, molecular biology, or other appropriate discipline is required.
- Minimum 5 years’ experience working in R&D and/or Production in IVD industry.
- Sound knowledge in immunoassay, molecular biology and cell biology especially recombinant protein expression and purification, antibody development and characterization
- Good communication skills, computer skills and problem-solving skills
- Working experience in an ISO and GMP compliant environment, and knowledge in ISO13485.
- Experience in development of chromatographic immunoassay devices, including device design, device optimization, and trouble shooting.
- Experience in manufacturing of chromatographic immunoassay devices, including raw material identification, product transfer, process validation, equipment validation and quality criteria establishment.
- Ideally, a chromatographic immunoassay device of which a candidate is involved in development and manufacturing has been cleared or approved by FDA or Health Canada.
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Start applying immediately
Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Certifications (optional)
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Monnatha Grego is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Calgary
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