Product Development Scientist (immunoassay)

Richmond Hill - Ontario - Canada - Life Sciences & Health Care - Medical devices - Medical - Academic Master +

Introduction

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.

Feel free to contact

Monnatha Grego, Account manager

Apply now

About this role

Responsibilities

  • 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.

About you

Requirements

  • 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.

Special Requirements:

  • 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.

What we offer

What We Offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

About Us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Publication: PUB285489
  • Location: Richmond Hill
  • Market: Life Sciences & Health Care
  • Hours per week: 40
  • Branche: Medical devices
  • Education level: Academic Master +
  • Area of expertise: Medical
  • Closing date: Monday, December 21, 2020
Apply now

Feel free to contact

MG

Monnatha Grego

Account manager Brunel Canada - Calgary

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