Director, Supply Chain

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 a wholly owned and independently operated subsidiary of Bayer AG is a leading engineered cell therapy company using its unique cellgene 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 cellgene platform to develop manufacture and deliver an entirely new generation of authentic and engineered cell therapies across two therapeutic areas: neurology 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.

Description of Position:
The Director Supply Chain is responsible for leading BlueRock Therapeutics end-to-end supply chain strategy and operations in support of research process development clinical manufacturing and clinical trial execution. As a key member of the Cell Therapy Product Supply Operations organization this role ensures the reliable compliant and scalable supply of critical materials products and services required to advance BlueRocks clinical-stage cell therapy portfolio.
The Director will establish and lead integrated planning strategic sourcing procurement materials management inventory control and distribution capabilities across the organization. This individual will partner closely with Manufacturing Technical Operations MSAT Process Development Quality Regulatory Clinical Operations and external suppliers to mitigate supply risk improve operational performance and enable successful delivery of clinical programs.
This leader will oversee teams responsible for procurement planning and materials management while building the processes systems and organizational capabilities necessary to support the business.

Responsibilities:
Develop and lead an integrated supply planning process that aligns demand manufacturing capacity inventory and sourcing strategies with CMC development plans and clinical program requirements.
Implement supply chain standards metrics and governance to improve forecasting accuracy inventory performance and operational execution.
Lead capacity planning and scenario modeling activities to support program prioritization resource allocation and business decision-making.
Develop sourcing strategies for critical raw materials consumables testing services and outsourced manufacturing activities to ensure continuity of supply and quality.
Build and maintain strategic partnerships with key suppliers to support clinical development timelines and long-term business objectives.
Lead cross-functional efforts to identify assess and mitigate supply and quality risks associated with critical materials and services.
Support supplier qualification performance management quality agreements audits and inspection readiness activities in partnership with Quality.
Ensure compliant and reliable movement of clinical materials drug product patient-specific therapies and development samples across the network.
Oversee logistics import/export activities permits chain-of-identity and chain-of-custody requirements and supporting documentation required for clinical execution.
Support the development and execution of cold chain and controlled-temperature distribution strategies that will service clinical programs.
Partner with Clinical Operations and Quality to ensure appropriate labeling packaging and distribution controls for clinical investigational products.
Lead GMP materials management operations including inventory control warehousing replenishment strategies master data governance and transactional compliance.
Serve as the business lead for supply chain-related systems processes and digital transformation initiatives including ERP inventory management sourcing and logistics platforms.
Establish procedures controls and quality systems to ensure accurate inventory records material traceability and regulatory compliance.
Lead and develop a high-performing team of supply chain planners buyers and materials management professionals.
Establish the materials management and supply chain infrastructure processes and organizational capabilities required for BlueRocks new Greater Toronto Area operations that is currently under design and construction.
Foster a culture of operational excellence collaboration accountability and continuous improvement across the supply chain organization.
Ensure all supply chain activities are conducted in accordance with GMP regulations BlueRock policies and applicable global regulatory requirements.
Maintain inspection-ready operations and support internal audits regulatory inspections and quality investigations as required.
Monitor and report key performance indicators to drive transparency operational effectiveness and continuous improvement.

Minimum Requirements:
BS/MS or PhD in a business or scientific field with 12 years of experience of related or equivalent work experience in operation procurement or supply chain role is required
Minimum of 5 years of relevant supply chain management and/or project leadership experience is required
Direct experience with shipments requiring critical/ultra-cold chain constraints materials inventory control and warehousing & distribution is required.
General understanding of pharmaceutical supply chain including serialization is preferred.
Experience working in GxP pharmaceutical and/or biotechnology regulated environment is required.
Experience in representing the function as Subject Matter Expert (SME) and defending GxP systems in audit setting is required.
Highly functional in a fast-paced dynamic company with ability to adapt to changing timelines and priorities required.
Excellent written and verbal communication skills are a must.
Experience with relevant legal standards and compliance systems is required
Working knowledge of Quality Assurance (QA) and Environmental Health & Safety (EHS) standards are required.
Demonstrated application of quality and efficiency improvement methods such as LEAN Six Sigma is preferred.
Experience working with contract service providers such as offsite warehouse and logistics is required.
Experience in working with electronic systems such as ERP LIMS CMMS WMS is required.
Ability to analyze and resolve problems independently.

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.