Director, Biomaterials - GORG

This position will be responsible for the marketing of the Biomaterials product line to achieve the established company objectives.

Duties:

• Evaluate and source or develop new, novel technologies for Dental Surgery applications.
• Manage the biologics products strategy including new products, process development and manufacture which includes development and analysis, process scale up and transfer to manufacturing department
• Liaise with BHCL and SIN to serve as a biomaterials R & D resource for each organization
• Be a member of the Global Biomaterials Steering Committee 
• Optimize company resources related to the biologic’s product line.
• Responsible for our peri-implantitis initiatives (internal development and/or technology partner) and other future tissue regeneration innovations 
• Work closely with product marketing and research on biomaterials related projects and studies
• Routinely interface with other departments, such as Marketing, Sales, Operations, Supply Chain, Regulatory, Quality Assurance and Finance
• Develop and implement comprehensive development activities reports
• Review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
• Develop and participate in efforts to ensure consistency in procedures, best practices and policies
• Develop department goals, objectives, and metrics.
• Implement and evaluate continuous improvement opportunities.

Qualifications:

• Experienced in early development as well as late stage/commercial Biologics projects with a strong track record of successful 510k, CE Mark and Health Canada filings.
• Significant experience working in an outsourcing environment as well as building internal manufacturing capabilities.
• Strong leadership skills with a proven record of leading international teams.
• Ability to interpret and communicate information both internally and to external suppliers.
• Ability to interpret and apply regulatory requirements and industry best practices.
• Self-organizing, self-directing highly motivated with critical thinking and analysis skills
• Ability to initiate and manage external collaborations and engage key opinion leaders
• Excellent project management skills
• Excellent writing and language skills
• Computer literacy including fluency with Microsoft Word, Excel and PowerPoint
• Valid driver’s license, acceptable driving record, and current automobile insurance are required for regional travel.
• Must be able to travel overnight, including weekends

Education:

•MS in biology or related sciences is required, PhD is preferred

•MBA preferred

•Minimum of 7 years in the relevant Medical Device industry