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rAssociate Director - Midwest Stem Cell Therapy Center
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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 p rsonnel 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.
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University of Kansas Medical Center