Principal Scientist

JOB SUMMARY:

Prollenium is a Canadian-based company focused exclusively on the research and manufacturing of medical devices. Our commitment to product development, innovative research and manufacturing means we will continue to revolutionize the medical aesthetics market while maintaining to be one of the leading manufacturers of HA fillers, worldwide. Prollenium provides competitive compensation, benefits and development opportunities.

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.

MAJOR RESPONSIBILITIES:

• 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

QUALIFICATIONS:

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
• 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

Behavioral

Demonstrated ability to apply the following behavioral competencies on the job:

• Leadership: Effectively managed the execution of product development activities to support organization’s regulatory submission and product approval
• Teamwork: Working effectively and productively with other departments within the organization.
• Written Communication: Writing clearly, succinctly with a deep scientific understanding.
• Problem Solving: Anticipating, analyzing, diagnosing and resolving problems in a timely fashion.
• Organization and Planning: Utilizing logical, systematic and orderly procedures to meet objectives.
• Flexibility: Agility in adapting to change