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Device Development and Manufacturing Leader
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 Senior Director, Device Development and Manufacturing to lead our device development and manufacturing efforts in support of our product portfolio and programs. The successful candidate will provide leadership for device development and manufacturing activities, working closely with cross-functional peers and team members to influence and define product and clinical strategy.
Key Responsibilities- Leadership and Collaboration
- Provide leadership for device development and manufacturing activities in support of BRT product portfolio and programs.
- Work in close collaboration with cross-functional peers and team members to influence and define product and clinical strategy.
- Device Development and Manufacturing
- Identify and assess new product and manufacturing technologies for possible integration and development.
- Act as product development subject matter expert providing advice and diligence support for company leadership.
- Take a leadership role in medical and combination device product development efforts, including customer interactions and design controls.
- Regulatory Compliance
- Ensure all development complies with relevant regulatory standards and guidance, and company product development, manufacturing, and product quality requirements.
- Team Management
- Mentor and train engineers, technicians, and assemblers in medical device development, manufacturing, and testing methods.
- Education and Experience
- Bachelor's or Master's degree or equivalent, or PhD with 12+ years of experience with a minimum of ten years of medical product (preferably medical device or biologics) 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 leader with successful track record of delivering projects on time and within budget.
- Working knowledge of quality statistics, including Six Sigma, DoE, SPC, and process capability.
- Practical understanding of operational excellence programs, including QbD, 5S, and Kanban.
At BlueRock Therapeutics, we value diversity and inclusion, and we are proud to be an equal opportunity workplace. We offer a dynamic and collaborative work environment, with opportunities for professional growth and development.
We are committed to making a positive impact on the lives of patients and families affected by disease. If you are passionate about delivering innovative solutions and making a difference, we encourage you to apply for this exciting opportunity.
