Senior Director, Device Development

Who is BlueRock? BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, 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.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. What Are We Doing? Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. 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 seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.As part of BlueRock Therapeutics vision to change the future of medicine by enabling ground-breaking cell therapies, the candidate will be a leader in the combination device development and manufacturing team responsible for ensuring that the company’s leading cell product candidates have an appropriately designed, tested and implemented combination device. Key elements include procedures to prepare and administer cell products compatible with current clinical technologies and practice of medicine, and medical device systems that safely, and accurately deliver these products to meet the unmet needs of patients with intractable diseases. The Device Development team works with leading physicians and other experts to develop clinical product procedures, delivery systems and other technologies in close partnership with our cell product development colleagues. The successful candidate is a proven team leader in the development and manufacturing of cutting-edge medical product technologies including combination medical devices and ancillary products. The ideal candidate has a deep understanding of medical device development processes and regulations, is comfortable working directly with world-renowned physicians, is highly familiar with design and manufacturing technologies and has a demonstrated track record of leading product development teams that have taken concepts and advanced them into clinical evaluation and commercial launch utilizing internal and external capabilities. Collaboration with a highly motivated, world-class team of engineers and scientists promises an exciting and engaging work environment for motivated, self-starting candidates. Strong knowledge of medical and combination device regulations (development and manufacturing) is required.

Responsibilities:

Provides leadership for device development and manufacturing activities in support of BRT product portfolio and programs. Liaises with QA, RA and program team to ensure device development decisions consider cross-functional inputs such as technical (device design and development), project level business processes (project management, quality mgmt. sys, governance and decision making), and influencing project stakeholders for technical decisions. Works in close collaboration with cross-functional peers and team members including Process Development (cell product team), Program Management, Clinical Development, New Product Planning, Regulatory Affairs and Quality to influence and define product and clinical strategy including user needs and design requirements for delivery systems and formulation devices. Identifies and assesses new product and manufacturing technologies for possible integration and development. Acts as product development subject matter expert providing advice and diligence support for company leadership. Takes a leadership role in medical and combination device product development efforts including customer interactions and design controls (design inputs, design requirements and specifications, detailed design process, risk management, verification and validation), manufacturing process and equipment, management of external development and manufacturing partners and complex technical investigations. Collaborates with engineers and cross-functional product development teams developing leading-edge integrated cell therapy products (including medical devices, tools, delivery systems, formulation devices and packaging) to meet clinical needs. Ensures all development complies with relevant regulatory standards and guidance, and company product development, manufacturing, and product quality requirements. Ensures appropriate external manufacturing partners are selected and perform as needed. In partnership with Quality, Regulatory Affairs and Program Management establishes processes and capabilities for effective and phase-appropriate development and manufacturing of delivery systems and formulation devices, verification & validation activities, and associated documentation. Ensures compliance with BlueRock’s Quality Management System implementation of the design control process for medical devices and combination products. Responsible for Design Control documentation such as DHF’s, DMR’s and their contents and providing technical documentation in support of regulatory filings. Writes, amends, and reviews plan documents, SOP’s, batch records, raw material specifications, drawings and other documentation as required to support product development, manufacturing, and quality control testing. Mentors and trains engineers, technicians and assemblers in medical device development, manufacturing, and testing methods.

Minimum 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 (preferably medical device or biologics) development and manufacturing experience. An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above may be considered. Experience with biologic product delivery (delivery media, bio-polymers, delivery technologies, micro-fluidic control, anatomy) 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 Working knowledge of quality statistics is desired, Six Sigma, DoE, SPC, process capability. Practical understanding of operational excellence programs is a strong plus, QbD, 5S, Kanban Experience in managing external development and manufacturing or other such business partnerships A solid understanding of aseptic techniques and technologies and operating room procedures is desired Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint, Project) Experience leader in delivering products through IND #LI-AL1

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