Contract Senior Pharmacovigilance Scientist

3 hours ago

Richmond Hill, Canada Brunel Full time
p>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 the 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).Initiates new projects for the R&D team for the purposes of commercialization to consistently sustain the company's product pipeline.Supervises project-related scientific/technical activities and contributes to strategic decision making 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.Provides 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.Partners 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).Assists the Global Chief Scientific Officer in evaluating key technologies of biotech companies and analyzing their technological capabilities for the purposes of Merger & Acquisition (M&A) activities.Assists 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.Is a key member of the R&D, Regulatory and Clinical bi-weekly team meeting in the preparation of IDE and PMA submissions.Communicates 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 understanding 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.

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