Department:

Stem Cell Therapy Center

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Stem Cell Therapy Center

Position Title:

Associate Director - Midwest Stem Cell Therapy Center

Job Family Group:

Professional Staff

Job Description Summary:

The Associate Director, Midwest Stem Cell Therapy Center (MSCTC) is responsible for the expansion and oversight of the cGMP operations within the current and future manufacturing facilities utilized to manufacture autologous and allogeneic cell therapy products at the University of Kansas Medical Center (KUMC). The Associate Director will partner with other functions within and outside the University to produce cell therapy products through safe and compliant manufacturing operations according to cGMP requirements. This position will require proven leadership to drive effective communication, coordination, and collaboration across relevant cross functional groups to ensure robust production, testing, and release of life-saving cell therapies to patients. The Associate Director will ensure timely delivery of cell therapies to patients by focusing on team leadership, process execution, compliance, and quality through the management of production schedules, troubleshooting issues, developing SOPs, and coordination with quality assurance, research and development teams, suppliers, engineering/facilities, environmental health and services, and School of Medicine finance functions. This position reports directly into the Director of the MSCTC.

Job Description:

Key Roles and Responsibilities:

• Lead, direct, coach and develop manufacturing teams responsible for manufacturing of autologous and allogeneic cell therapy products fostering a culture of safety, compliance and continuous improvement

• Oversee all aspects of clinical and commercial manufacturing, ensuring adherence to SOPs, batch records, and regulatory guidelines

• Drive technical execution, troubleshoot deviations, support investigations (CAPAs), and implement process improvements

• Provide technical and managerial leadership by collaborating with key stakeholders and functions across the University (e.g., Quality Assurance, Quality Control, Process Development, Engineering/Facilities, Supply Chain, and other

• Monitor and improve production metrics related to safety, quality, compliance, cost, delivery and people

• Oversee the hiring, development, and performance management of CGMP manufacturing staff

• Establish a cGMP quality assurance function within the MSCTC independent of the cGMP manufacturing operation

• Lead and participate in health authority, sponsor, and internal audits of the MSCTC facility

• Ensure the MSCTC closely with University centers and institutes to develop and execute against strategic plans for the MSCTC

• Ensure area employees conduct activities in a professional and ethical manner, and in accordance with KUMC Policies and applicable local, state and federal laws and regulations.

• Ensure all work performed by employees in the area is done in a safe and secure manner.

• Direct coordination of area work with other areas of KUMC to ensure integration and support of KUMC goals and objectives.

• Maintain personal level of subject matter expertise necessary to ensure the area activities are carried out on a best practices basis.

• Participate in and/or lead appropriate committees, task force, or other similar activities assuring optimal resource utilization.

• Ensure that necessary electronic data collection, storage and retrieval systems are implemented and used by area personnel in an appropriate fashion.

• Ensure that the area maintains any certifications desired by KUMC to further promote quality education and research.

• Ensure the confidentiality of medical center, employee, and patient information. Handle sensitive data with discretion and in accordance with KUMC policies and legal requirements.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.

Required Qualifications

Education: PhD in pharmaceutical sciences or related field.

This position requires a formal degree in the cited discipline area(s) to ensure that candidates have the foundational knowledge and skill set required to perform the duties of the position.  The level of degree is based on accreditation requirements, institutional standards of academic and professional excellence, alignment with peer institution benchmarks, and contributes to the credibility and effectiveness of the role within the university community.

Work Experience:

• 20 years of direct experience in regulated biological and pharmaceutical manufacturing (cGMP) including technology transfer, process validation, project management, and change management, with specific experience in cell and gene therapy product development.

• 10 years of experience as a manager of employees.

• Understanding of GMPs, including change control, validation, and quality systems

• Experience interacting directly with the FDA and other regulatory agencies with mastery knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standards

Preferred Qualifications

Work Experience:

• Experience interacting directly with the FDA and other regulatory agencies with mastery knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standards.

Skills

• Project management

• Problem-solving

• Communication

• Interpersonal relationships

• Leadership

• Mentorship

• Analytical thinking

• Problem solving

• Critical thinking

• Workplace organization

Required Documents

Resume

Cover Letter

If selected as a final candidate for this position, you may be required to complete the Association of American of Universities Representations and Warranties document and sign a release of records that will allow the University of Kansas Medical Center to conduct a further background check with former employers.  A copy of the Representations and Warranties document can be found here.

Comprehensive Benefits Package:

Employee Type:

Regular

Time Type:

Full time

Rate Type:

Salary

Compensation Statement:

The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above. 

Pay Range:

$184,600.00 - $313,140.00

Minimum

$184,600.00

Midpoint

$248,880.00

Maximum

$313,140.00