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

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About Us

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