Contract Senior Pharmacovigilance Scientist
3 weeks ago
- 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 decisions 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 different market requirements (Canada, US, Europe, Rest of the World).
- Assisting the Global Chief Scientific Officer in the evaluation of 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 a minimum of 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 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.
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