Product Development Scientist (immunoassay)

PUB285489

About this role

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.

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.

Requirements

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.

Benefits

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.

Join the Brunel Family

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.

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)
  • Resume or up-to-date LinkedIn / Xing profile
Apply now

Any questions remaining?

Your consultant, Monnatha Grego is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB285489

Account manager

Monnatha Grego
Brunel Canada - Calgary
m.grego@brunel.net

All fresh vacancies in your mailbox?

Sing up for the Brunel job alert

Look at our privacy statement

Other people also looked at