Director, Cmc Lead

**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.

BlueRock is seeking a collaborative and self-driven CMC Lead to join our Technical Operations team sitting in our
**Toronto (Hybrid)** location is preferred and open to our
**Cambridge**
**(Hybrid) **location. The Director, CMC Lead will be leading one or more cross functional CMC development teams. The goal of this group is to establish and lead comprehensive CMC development strategies and tactics, aligned with the Program Team objectives, and incorporating all elements across process development, analytical, quality, regulatory, supply chain, manufacturing operations and clinical supplies. This includes acceleration, deceleration, risk/issue identification and mitigation, as well as project level sourcing recommendations.

**Responsibilities**:

- Lead a cross functional CMC team that drives all activities across process development, analytical, quality, regulatory, supply chain, manufacturing operations and clinical supplies.
- Accountable for successful advancement of programs from a CMC perspective incl. meeting quantitative and qualitative program objectives and milestones
- Provide guidance and mentorship to the members of the CMC team. Maximize alignment, cooperation, input, decision making, commitment and synergy of CMC team members to ensure their technical contributions meet/exceed program objectives. Builds and motivates teams to become high performing, as well as works with functional leaders to identify and on-board team members as needed
- Ensures appropriate level of scientific and technical rigor, scale-up, and production strategies and timelines are in place to deliver successful clinical outcomes, meet clinical supply, and registration needs
- Represent the CMC function at the Core team level and act as the single point of contact to present high level CMC plans and strategies. Communicates effectively and transparently with functional representatives and stakeholders within Technical Operations, and other relevant stakeholders
- Ensure high quality and compliance of team deliverables and product supply through CMC deliverables.
- Align/collaborate with other relevant functions as e.g. formulation and device development teams to drive CMC strategy.
- Escalates/Informs functional leadership when additional assistance is needed
- Presents at governance committees and effectively communicate program-related updates to ensure alignment on proposed strategies to senior management and stakeholders.
- Provide committed and inspiring CMC leadership, stewardship, and advocacy, striving for knowledge development, continuous improvement, acceleration, risk assessment and mitigation, resource allocation and support, as appropriate.
- Collaborate with other CMC Leads and team members to enable alignment of key project strategies and tactics, establish best practices on CMC development and project leadership, and continuous learning
- Contribute to the management of overall program portfolio, including supporting capability build efforts across Technical Operations

**Minimum Requirements**:

- BS/MS or PhD in a scientific field with 10+ years of experience in product development; previous experience leading a cell therapy CMC team and interfacing regularly with CMC functionsis preferred
- Demonstrated ability for critical thinking and innovation; highly motivated, willingness to acquire new