Senior Director, Technical Development Lead, Device

BlueRock Therapeutics a wholly-owned and independently operated subsidiary of Bayer AG is a leading engineered cell therapy company pioneering a new generation of cellular medicines. Utilizing our proprietary CELLGENE platform we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases.

Founded in 2016 BlueRock is at the forefront of the convergence of cell biology and genetic engineering. Our mission is to harness pluripotent stem cell technology and gene editing to deliver authentic functional cell therapies that address the root causes of disease and offer hope to millions of patients worldwide.

What Are We Doing

Our foundational science enables the generation and directed differentiation of universal pluripotent stem cells into authentic functional cells for allogeneic cellular therapies.

We are passionate about realizing the promise of cell and gene therapy shaping the future of regenerative medicine and delivering new therapies to patients with limited or no treatment options.

Who is BlueRock

BlueRock Therapeutics LP is a clinical stage cell therapy company harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies bemdaneprocel (BRT-DA01) for the treatment of Parkinsons disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge the urgency to transform medicine and deliver hope integrity guided by mission and community-mindedness with the understanding that we are all part of something bigger than ourselves.

What Are We Doing

Ourfoundational scienceharnesses 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.

Description of Position:

This role is responsible for providing strategic and technical leadership for the development and execution of potential delivery device systems supporting the companys combination cell therapy addition this role serves as the single point of accountability for program-level technical development ensuring alignment from early development through clinical stages and commercialization readiness. The individual will bring deep expertise in medical device development and commercialization integrated with biologics/cell therapy development to enable successful delivery of complex combination products.

This leader will work crossfunctionally with Device Development Clinical Development Regulatory Affairs Quality and External Manufacturing teams to ensure device solutions are robust scalable regulatorycompliant and aligned with patient clinician and business needs.

Responsibilities:

Strategy & Leadership

Define and lead the medical device development strategy aligned with the companys cell therapy pipeline and longterm platform vision.

Act as a core leader for combination product development ensuring strategic alignment across various technical areas.

Serve as the primary technical leader in governance forums.

Act as a thought leader in deviceenabled cell therapy delivery monitoring emerging technologies standards and competitive approaches.

Produce Development Oversight

Lead integration of device options into an overall program strategy

In partnership with functional leadership oversee device development activities including but not restricted to: user needs design inputs/outputs risk management verification & validation and design transfer

Ensure device designs are compatible with sterile GMP and scalable manufacturing environments while meeting international or region-specific standards.

Program Leadership

Drive integrated development plans and timelines ensuring execution across a matrixed organization

Partner with Regulatory Affairs to define and execute U.S. and global regulatory strategies for combination products (e.g. FDA CDRH/CBER interactions).

Support regulatory submissions including INDenabling device sections IDEs 510(k) PMA De Novo and combination product filings as applicable.

Partner with various stakeholders to ensure devices meet realworld clinical workflows and adoption requirements

Ensure compliance with ISO 13485 ISOCFR Part 820 and applicable combination product regulations.

Minimum Requirements:

• Advanced degree (MS Ph.D. or equivalent) in Biomedical Engineering Mechanical Engineering Materials Science or related discipline.
• 12 years of progressive experience in medical device development with senior leadership experience in biotech medtech or combination product environments.
• Demonstrated success leading complex device programs from concept through commercialization.
• Handson experience with combination products drugdevice or biologicdevice integrations strongly preferred.
• Deep knowledge of medical device regulatory frameworks and design control requirements.
• Track record of building and leading highimpact technical teams.
• Experience managing external development partners CDMOs and device vendors.
• Strategic thinker with strong execution discipline
• Collaborative strategic leader who thrives in crossfunctional matrix organizations
• Clear communicator with the ability to influence at executive and board levels

Equal Opportunity Workplace: At BlueRock we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

Equal Opportunity Workplace: At BlueRock we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.