Associate Director - Midwest Stem Cell Therapy Center

University of Kansas Medical Center • Kansas City, MO

1d

About The Position

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.

Requirements

• 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.
• 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

Nice To Haves

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

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.

Benefits

• Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan.
• Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available.
• Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays.
• One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment.
• A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree