Senior Scientist

6 days ago

Richmond Hill ON, Canada Brunel Full time

We are hiring for a Senior Scientist position to join a GTA based Medical Aesthetics company. They are committed to product development, innovative research and manufacturing as one of the leading manufacturers of HA fillers, worldwide.
The Senior Scientist, R&D is responsible for the 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.

Drives the execution of technical development plans spanning preclinical animal studies through process validation to support IDE and PMA submission by leveraging expertise of the company'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 the company'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 the company's product development pipeline
Technical Knowledge/Experience
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
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

Leadership: Effectively managed the execution of product development activities to support organization’s regulatory submission and product approval
Writing clearly, succinctly with a deep scientific understanding.
Organization and Planning: Finding the next step in your career can be a fulltime job in itself. 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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