Senior Director, Device Development and Manufacturing Lead

4 weeks ago


Toronto, Ontario, Canada BlueRock Therapeutics Full time

About the Role

We are seeking a highly experienced Senior Director to lead our Device Development and Manufacturing team at BlueRock Therapeutics. As a key member of our organization, you will be responsible for ensuring the development and manufacturing of our leading cell product candidates have appropriately designed, tested, and implemented combination devices.

Key Responsibilities

  • Provide leadership for device development and manufacturing activities in support of BRT product portfolio and programs.
  • Work closely with cross-functional peers and team members to influence and define product and clinical strategy, including user needs and design requirements for delivery systems and formulation devices.
  • 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.
  • Collaborate with engineers and cross-functional product development teams to develop leading-edge integrated cell therapy products.
  • 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 with a minimum of ten years of medical product development and manufacturing experience.
  • Experience with biologic product delivery is a strong plus.
  • Thorough understanding of Design Controls and cGMP requirements compliant with ISO 13485 and the QSR (21 CFR Part 820).
  • Significant experience in development and validation of medical device manufacturing processes and technologies is required.
  • Demonstrated cross-functional leader with successful track record of delivering projects on time and within budget.

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 that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.



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