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Toronto, Ontario, Canada BlueRock Therapeutics Full timeAbout the RoleWe 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...
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Senior Director, Device Development and Manufacturing
2 months ago
We are seeking a highly experienced and skilled 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 medical devices and combination products meet the highest standards of quality and regulatory compliance.
Key Responsibilities- Leadership and Team Management: Provide strategic leadership and direction to the Device Development and Manufacturing team, ensuring the successful development and launch of our medical devices and combination products.
- Device Development and Manufacturing: Oversee the development and manufacturing of medical devices and combination products, ensuring compliance with regulatory requirements and industry standards.
- Collaboration and Communication: Work closely with cross-functional teams, including Process Development, Program Management, Clinical Development, and Regulatory Affairs, to ensure seamless collaboration and effective communication.
- Regulatory Compliance: Ensure that all device development and manufacturing activities are in compliance with relevant regulatory standards and guidelines, including ISO 13485 and the QSR (21 CFR Part 820).
- Process Improvement: Identify opportunities for process improvement and implement changes to enhance efficiency, quality, and productivity.
- Technical Expertise: Provide technical expertise and guidance to the team on device development and manufacturing processes, including design controls, manufacturing process and equipment, and quality management systems.
- Education: Bachelor's or Master's degree or equivalent in a relevant field, such as engineering, biology, or chemistry.
- Experience: Minimum of 10 years of experience in medical device development and manufacturing, with a strong background in design controls, manufacturing process and equipment, and quality management systems.
- Skills: Strong leadership and team management skills, excellent communication and collaboration skills, and a thorough understanding of regulatory requirements and industry standards.
- Certifications: Relevant certifications, such as Six Sigma or Design for Six Sigma, are a plus.
BlueRock Therapeutics is a leading engineered cell therapy company that is dedicated to developing innovative treatments for patients with serious diseases. We are committed to creating a diverse and inclusive work environment that fosters collaboration, innovation, and excellence. If you are a motivated and experienced professional who is passionate about medical device development and manufacturing, we encourage you to apply for this exciting opportunity.
