University of Colorado Anschutz

Department: Gates Institute Biomanufacturing Facility

Job Title: Senior Director of Biomanufacturing Operations

Position #: 00832650 – Requisition #: 40399

Job Summary:

The Senior Director of Biomanufacturing Operations is responsible for leading and overseeing the operational strategy and management of the Gates Institute Biomanufacturing Facility (GBF), ensuring alignment with research and clinical objectives. Reporting to the Executive Director, this role provides strategic leadership in manufacturing operations, facilities management,, and compliance with regulatory standards. This role will supervise a multidisciplinary team, including senior managers and directors, fostering a culture of innovation, accountability, and continuous improvement.

This role is instrumental in developing long-term operational strategies, optimizing resource utilization, and driving technology integration to enhance manufacturing efficiency. The Senior Director of Biomanufacturing Operations will ensure compliance with cGMP, FDA, FACT, and OSHA regulations while collaborating with Quality Assurance, clinical teams, and external partners to support investigational drug production and first-in-human clinical trials.

Key Responsibilities:

Strategic Leadership:

• Develop and execute operational strategies aligned with the Institute’s research and clinical objectives.

Operational Management:

• Oversee day-to-day operations at GBF, ensuring compliance with GMP, safety regulations, and institutional policies and procedures. Strong knowledge of planning, scheduling, and operational tools and systems (such as Smartsheet, MRP, Quality system software, document control, maintenance systems, etc.).

Team Leadership and Development:

• Lead, mentor, and develop a multidisciplinary operations team, develop Operational leaders, and foster a culture of accountability, innovation, and continuous improvement.

Regulatory Compliance and Quality Assurance:

• Ensure adherence to regulatory requirements (i.e., FDA, FACT, OSHA, etc.) for CGT and Biologics manufacturing, materials, and facility operations. Strong understanding of cGMP.

Collaboration and Stakeholder Engagement:

• Partner with academic researchers, clinical teams, and external collaborators to support development and tech transfer initiatives.

Financial and Resource Management Oversight:

• Partner with Finance to develop and manage the annual operating budget, project cost proposals (i.e., RFPs), statements of work, capital expenditures, milestone completion, and resource allocation.

Facility Infrastructure, Expansion and Innovation:

• Propose and lead facility infrastructure and technology upgrades and expansions to meet evolving research and clinical manufacturing demands.

Work Location:

This role is expected to work onsite and is located in Aurora, CO.

Why Join Us: