Job Information
University of Colorado Director of Operations in Aurora, Colorado
Director of Operations
Description
University of Colorado Anschutz Medical Campus
Department: Gates Institute
Job Title: Director of Operations
Position #:00832650 - Requisition #:36497
Job Summary:
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:
Why Join Us:
delivering to patients
Diversity and Equity:
Qualifications:
Minimum Qualifications:
A bachelor's degree in degree in biotechnology, life science, or a directly related field from an accredited institution
10+ years' experience in a GMP-regulated biomanufacturing environment.
5+ years of progressive leadership and strategy planning within a GMP-regulated biomanufacturing and development organization.
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 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, 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.
Demonstrated commitment and leadership ability to advance diversity and inclusion.
How to Apply:
Screening of Applications Begins:
April 11 th , 2025
Anticipated Pay Range:
$195,000 - $245,000.
ADA Statement:
Background Check Statement:
Vaccination Statement:
Job Category
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Schedule
Posting Date
Unposting Date
To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=36497&lang=en (https://apptrkr.com/6112572)
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Director of Operations - 36497 University Staff
The Director of Operations is responsible for leading and overseeing the operational strategy and management of the Gates Institute Biomanufacturing (GBF), ensuring alignment with research and clinical objectives. Reporting to the Executive Director, this role provides strategic leadership in manufacturing operations, facilities management, supply chain logistics, and compliance with regulatory standards. The 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 Director of 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.
This role is expected to work onsite and is located in Aurora, CO.
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!In addition to the benefits offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is .The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get_redirect.php?id=6112572&targetURL=https://www.cu.edu/employee-services/benefits-wellness) .
The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.
Applicants must meet minimum qualifications at the time of hire.
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 2. Curriculum vitae / Resume3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email addressQuestions should be directed to: Joleen Bohnen - joleen.bohnen@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=6112572&targetURL=joleen.bohnen@cuanschutz.edu)
Immediately and continues until position is filled. For best consideration, apply by .
The starting salary range (or hiring range) for this position has been established as 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 (https://apptrkr.com/get_redirect.php?id=6112572&targetURL=http://www.cu.edu/node/153125)
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 (https://apptrkr.com/get_redirect.php?id=6112572&targetURL=hr.adacoordinator@cuanschutz.edu) .
The University of Colorado Anschutz Medical Campus 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.
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get_redirect.php?id=6112572&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . 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 (https://apptrkr.com/get_redirect.php?id=6112572&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) . Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 22128 - ADM CHAN Gates Inst Operating : Full-time : Mar 28, 2025 : Ongoing Posting Contact Name: Joleen Bohnen Posting Contact Email: joleen.bohnen@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=6112572&targetURL=joleen.bohnen@cuanschutz.edu) Position Number: 00832650jeid-2fadab3b8b0ce54994504a78379b68fb
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.