Senior Director of Biomanufacturing Operations

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:

The opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ highly dedicated people, operating on a top tier research campus - the University of Colorado - Anschutz Medical Campus.

The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. We are only limited by our resources and need you to make our journey a success!

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options
• Dental: Multiple plan options
• Additional Insurance: Disability, Life, Vision
• Retirement 401(a) Plan: Employer contributes 10% of your gross pay
• Paid Time Off: Accruals over the year
  • Vacation Days: 22/year (maximum accrual 352 hours)
  • Sick Days: 15/year (unlimited maximum accrual)
  • Holiday Days: 15/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications:

• Bachelor's degree in engineering, biotechnology, life science, or a related field from an accredited institution. Substitution: 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.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• 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.

Competencies: Knowledge, Skills, and Abilities (KSA's):

• 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.

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: vanessa.mcwhirt@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration, apply by July 17, 2026.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $270,000 - $285,000.

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator: http://www.cu.edu/node/153125

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.

Background Check Statement:

The University of Colorado Anschutz is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.