Canada, Richmond Hill
Parttime: 0 hrs a week
Experience: 5 years
Closing: March 10, 2025

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Introduction

The Principal Scientist, R&D is responsible for technical leadership of research activities through project conception, study design and monitoring, resource management, scientific data review and reporting and management of company intellectual property. This position reports to Global Chief Scientific Officer.

What are you going to do 

  • Drives the execution of technical development plans spanning preclinical animal studies through process validation to support IDE and PMA submission by leveraging expertise of Prollenium's Technical Subject Matter Experts (SME) and external Contract Manufacturing Organization (CMOs)
  • Initiator of new projects for the R&D team for the purposes of commercialization to consistently sustain Prollenium's product pipeline
  • Supervise project related scientific/technical activities and contribute to strategic decision by reviewing and evaluating data, interpreting results and drawing relevant conclusions
  • Ensures technical readiness by designing, reviewing, and approving the animal study protocols for commencing preclinical studies in support of IDE submission
  • Providing technical expertise by authoring drug and medical device IDE and PMA modular components covering product background, device description, preclinical testing, product biocompatibility, manufacturing process and product testing and characterization
  • Partnering with Quality/Regulatory and Analytical Technical experts to prepare Technical Files and Design Dossiers in line with the different market requirements (Canada, US, Europe, Rest of the World)
  • Assisting the Global Chief Scientific Officer in the evaluation key technologies of biotech companies and analyzing their technological capabilities for the purposes of Merger & Acquisition (M&A) activities
  • Assisting the Global Chief Scientific Officer in evaluating budgetary proposals from Contract Manufacturing Organizations (CMOs) to determine the optimum budget for product characterization and biocompatibility studies
  • Being a key member of the R&D, Regulatory and Clinical bi-weekly team meeting in the preparation of IDE and PMA submissions
  • Communicating current scientific findings to the Global Chief Scientific Officer through peer-review journals, ISO standards and clinical trials in order to assist in Prollenium's product development pipeline
  • Other duties as assigned

Essential skills and knowledge 

  • PhD in Chemistry, Materials Science, Polymer Science with minimum 10-12 years related industrial experience
  • Strong knowledge of the development and approval of medical devices (Class I, II, III) and Biologics
  • Experience with combination devices or drug delivery applications
  • Deep understand of design, development, optimization and technology transfer of medical devices and biologic manufacturing processes
  • Late-phase development experience including process validation, authoring of IDE, PMA sections, technical files and design dossiers
  • Experience with the development of biomaterial-based medical devices in the Ophthalmic, Orthopedic, or surgical areas
  • Experience with the development of cosmetic dermal fillers based on Hyaluronan and other biomaterials
  • Strong knowledge of Regulatory Standards (ISO) and Regulatory Audits (Health Canada, FDA, EU)
  • Project Management Experience for developing a product through pre-clinical, clinical phase and to commercialization
  • Familiar with safe chemical/biological techniques and aseptic techniques

What we offer 

What We Offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We'll get you going while you get on with the job.

About Us

Brunel has a reputation for working with some of the best in the business. That's what we continually strive for. Over 45 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.

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Sarah Beaton

+1 403 539 5009