Senior Director of Biomanufacturing Operations

University of Colorado•Aurora, CO

9d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in engineering, biotechnology, life science, or a related field from an accredited institution.
A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
10+ years’ experience working in a GMP-regulated biomanufacturing environment.
5+ years’ progressive leadership and strategy planning within a GMP-regulated biomanufacturing and development organization.
Strong knowledge of planning, scheduling, and operational tools and systems (such as Smartsheet, MRP, Quality system software, document control, maintenance systems, etc.).
Detailed knowledge of manufacturing technology, industry trends and requirements associated with the introduction of new equipment, systems, and processes into a manufacturing setting.
Proven success in leading cross-functional teams and managing complex projects.
In-depth understanding of regulatory requirements (i.e., FDA, FACT, OHSA, etc.), and quality systems.
Strong financial acumen, business process and skills, with experience developing and managing operational budgets.
Excellent communication, human resource management leadership, and problem-solving skills.
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.

Nice To Haves

Master’s degree in engineering, biotechnology, life science, or a related field; PhD and/or MBA preferred.
Minimum 10 years’ experience in cell and gene therapy in a multi-product clinical or commercial manufacturing environment.
Experience working in an academic or nonprofit environment.
Experience and familiarity with Lean Six Sigma and continuous improvement methodologies.
Demonstrated experience in creating and executing Request for Proposal in CDMO environment.
Demonstrated experience and expertise in operational strategy and execution, facility management, project execution, and compliance within a regulated manufacturing setting.

Responsibilities

Develop and execute operational strategies aligned with the Institute’s research and clinical objectives.
Oversee day-to-day operations at GBF, ensuring compliance with GMP, safety regulations, and institutional policies and procedures.
Lead, mentor, and develop a multidisciplinary operations team, develop Operational leaders, and foster a culture of accountability, innovation, and continuous improvement.
Ensure adherence to regulatory requirements (i.e., FDA, FACT, OSHA, etc.) for CGT and Biologics manufacturing, materials, and facility operations.
Partner with academic researchers, clinical teams, and external collaborators to support development and tech transfer initiatives.
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.
Propose and lead facility infrastructure and technology upgrades and expansions to meet evolving research and clinical manufacturing demands.