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Senior Director, Device Development and Manufacturing
2 months ago
BlueRock Therapeutics is a leading engineered cell therapy company that utilizes 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.
The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.
Job SummaryWe are seeking a highly experienced Senior Director to lead our Device Development and Manufacturing team. The successful candidate will be responsible for ensuring that our leading cell product candidates have an appropriately designed, tested, and implemented combination device.
Key Responsibilities- Leadership and Collaboration
- Provide leadership for device development and manufacturing activities in support of BRT product portfolio and programs.
- Liaise with QA, RA, and program team to ensure device development decisions consider cross-functional inputs.
- Device Development and Manufacturing
- Work in close collaboration with cross-functional peers and team members 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.
- Regulatory Compliance and Quality Assurance
- Ensure all development complies with relevant regulatory standards and guidance.
- Establish processes and capabilities for effective and phase-appropriate development and manufacturing of delivery systems and formulation devices.
- Team Management and Development
- Mentor and train engineers, technicians, and assemblers in medical device development, manufacturing, and testing methods.
- Collaborate with a highly motivated, world-class team of engineers and scientists.
- Education and Experience
- Bachelor's or Master's degree or equivalent, or PhD with 12+ years of experience.
- Minimum of ten years of medical product development and manufacturing experience.
- Skills and Qualifications
- 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.
- Demonstrated cross-functional leadership with successful track record of delivering projects on time and within budget.
At BlueRock Therapeutics, we value diversity and inclusion. We are proud to be an equal opportunity workplace and welcome candidates from diverse backgrounds.
We offer a comprehensive benefits package, including health and wellness benefits, paid time off, and financial benefits.
Our company culture is built on a foundation of collaboration, innovation, and excellence. We are committed to making a positive impact on the lives of patients and communities around the world.
