Director of Operations
Director of Operations
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Job Description
University of Colorado Anschutz Medical Campus
Department:Gates Institute
Job Title: Director of Operations
Position #:Requisition #:36497
Job Summary:
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 longterm 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 firstinhuman clinical trials.
Key Responsibilities:
Strategic Leadership:
- Develop and execute operational strategies aligned with the Institutes research and clinical objectives.
Operational Management:
- Oversee daytoday 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 40000 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 isdelivering to patients.
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: Employment Opportunity Statement:
The University of Colorado (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 workplacewhere all individuals are treated with respect and dignity andwe encourage individuals from all backgrounds to apply.
Qualifications:
Minimum Qualifications:
- A bachelors degree in degree in biotechnology life science or a directly related field from an accredited institution
- 10 years experience in a GMPregulated biomanufacturing environment.
- 5 years of progressive leadership and strategy planning within a GMPregulated biomanufacturing and development organization.
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications:
- Masters 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 multiproduct 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 facility management project and compliance within a regulated manufacturing setting.
Competencies: Knowledge Skills and Abilities (KSAs):
- 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 crossfunctional teams and managing complex projects.
- Indepth 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 problemsolving 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:
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 / Resume
3. Three to five professional references including name address phone number (mobile number if appropriate) and email address
Screening of Applications Begins:
Immediately and continues until position is filled. For best consideration apply by April 11th 2025.
The starting salary range or hiring range for this position has been established as $195000 $245000.
The above salary range or hiring range represents the Universitys 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: 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 .
Background Check Statement:
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.
Vaccination Statement:
CU Anschutz strongly encourages vaccination against the COVID19 virus and othervaccine 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 theoccupational health medical surveillance program.
Required Experience:
Director
Employment Type
Full-Time
