Senior Director, Device Development and Manufacturing

5 days ago


Toronto, Ontario, Canada BlueRock Therapeutics Full time
Job Title: Senior Director, Device Development and Manufacturing

BlueRock Therapeutics is seeking a highly experienced Senior Director to lead our Device Development and Manufacturing team. As a key member of our organization, you will be responsible for ensuring the development and manufacturing of our medical devices and combination products meet the highest standards of quality and regulatory compliance.

Responsibilities:
  • Provide leadership and direction to the Device Development and Manufacturing team to ensure timely and successful delivery of projects.
  • Collaborate with cross-functional teams, including Process Development, Program Management, Clinical Development, and Regulatory Affairs, to influence and define product and clinical strategy.
  • Identify and assess new product and manufacturing technologies for possible integration and development.
  • Take a leadership role in medical and combination device product development efforts, including customer interactions and design controls.
  • Ensure all development complies with relevant regulatory standards and guidance, and company product development, manufacturing, and product quality requirements.
Requirements:
  • Bachelor's or Master's degree or equivalent, or PhD with 12+ years of experience in medical product development and manufacturing.
  • Experience with biologic product delivery and significant experience in development and validation of medical device manufacturing processes and technologies.
  • Thorough understanding of Design Controls and cGMP requirements compliant with ISO 13485 and the QSR (21 CFR Part 820).
  • Demonstrated cross-functional leader with successful track record of delivering projects on time and within budget.
  • Working knowledge of quality statistics and practical understanding of operational excellence programs.
About BlueRock Therapeutics:

BlueRock Therapeutics is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are an equal opportunity workplace and welcome and support differences and diversity. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process.



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