Research and Development Director

1 week ago

Richmond Hill, Ontario, Canada Prollenium Medical Technologies Inc. Full time
Senior Scientist Job Description

Prollenium Medical Technologies Inc. is a renowned company specializing in the research and manufacturing of innovative medical devices. Our commitment to product development, cutting-edge research, and quality manufacturing enables us to revolutionize the medical aesthetics market while maintaining our position as a leading manufacturer of HA fillers worldwide.

This key role reports directly to the Global Chief Scientific Officer and is responsible for technical leadership of research activities through project conception, study design, and monitoring, resource management, scientific data review and reporting, and intellectual property management.

The Principal Scientist, R&D will drive the execution of technical development plans spanning preclinical animal studies through process validation to support IDE and PMA submission by leveraging expertise from Prollenium's Technical Subject Matter Experts (SMEs) and external Contract Manufacturing Organizations (CMOs).

A new projects initiator for the R&D team to sustain Prollenium's product pipeline, this position involves supervising project-related scientific/technical activities and contributing to strategic decisions through reviewing and evaluating data, interpreting results, and drawing relevant conclusions.

This role ensures technical readiness by designing, reviewing, and approving animal study protocols for commencing preclinical studies in support of IDE submissions. Additionally, it involves providing technical expertise in 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.

The successful candidate will partner with Quality/Regulatory and Analytical Technical experts to prepare Technical Files and Design Dossiers in line with various market requirements. They will also assist the Global Chief Scientific Officer in evaluating key technologies of biotech companies and analyzing their technological capabilities for M&A activities, as well as assisting in evaluating budgetary proposals from Contract Manufacturing Organizations to determine the optimum budget for product characterization and biocompatibility studies.

This role requires strong communication skills, enabling the Principal Scientist, R&D to effectively communicate current scientific findings to the Global Chief Scientific Officer through peer-review journals, ISO standards, and clinical trials, thereby supporting Prollenium's product development pipeline.

Key Responsibilities:
  • ">
  • Technical leadership of research activities through project conception, study design, and monitoring.">
  • Driving technical development plans spanning preclinical animal studies through process validation.">
  • Serving as a new projects initiator for the R&D team to sustain Prollenium's product pipeline.">
  • Supervising project-related scientific/technical activities and contributing to strategic decisions.">
  • Ensuring technical readiness by designing, reviewing, and approving animal study protocols.">
  • Providing technical expertise in authoring drug and medical device IDE and PMA modular components.">
  • Partnering with Quality/Regulatory and Analytical Technical experts to prepare Technical Files and Design Dossiers.">
  • Assisting the Global Chief Scientific Officer in evaluating key technologies of biotech companies and analyzing their technological capabilities.">
  • Assisting in evaluating budgetary proposals from Contract Manufacturing Organizations.">
  • Communicating current scientific findings to the Global Chief Scientific Officer through peer-review journals, ISO standards, and clinical trials.

Requirements:
  • ">
  • Ph.D. in Chemistry, Materials Science, or Polymer Science with a minimum 10-12 years of 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.">
  • Familiarity with safe chemical/biological techniques and aseptic techniques.

Benefits:
  • ">
  • Competitive salary: $180,000 - $200,000 per annum.">
  • Opportunities for career growth and professional development.">
  • Collaborative and dynamic work environment.">
  • Benefits package including health insurance, retirement savings plan, and paid time off.

Location:
Prollenium Medical Technologies Inc. is located in [insert location].

$180,000 - $200,000 per annum

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