Director- Cell Therapy Core
The Director is responsible for oversight of the Cell and Tissue Manufacturing Core that supports translational and clinical research programs focused on cell-based therapies, tissue-engineered cardiovascular constructs, and pancreatic islet cell isolation. The Director plans, directs and monitors all aspects of the Cell and Tissue Manufacturing Core. The Director must be sufficiently knowledgeable in all technical procedures and quality processes and systems of cGMP cell and tissue manufacturing to provide oversight and leadership to the core staff. This position provides leadership to the core personnel, manufacturing, facilities, Quality Control, regulatory support, customer audits and Quality Assurance for the manufacture of cell-based and tissue engineered therapeutic products for human use. The position is responsible for financial management, human resource management and training, quality, and process development & improvement, accreditation, safety, and compliance of the core. The Director ensures adequate space, capital and human resources are available to meet the research and manufacturing needs of the supported clinical programs. The Director supports the strategic planning and resource management of the core with guidance of the Cell Therapy Program Faculty Advisor and the Directors of the supported clinical programs.
Schedule: (Full time, Benefits Eligible)
Research I I I700 Children's DrColumbus, Ohio 43205
Why Nationwide Children's Hospital?
Why Nationwide Children's Hospital
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Directs the development, implementation and monitoring of the Cell and Tissue Manufacturing Core, including the manufacturing and analytical processes ensuring compliance to ISO & FDA regulations of multiple programs within the CMF facility (e.g., Cell Therapy and Cancer Immunotherapy, Tissue-engineered Vascular Grafts, Pancreatic Islet Cell Isolation, and Immune Monitoring programs)
Interprets policies and procedures and directs implementation while maintaining compliance. Reviews all policies and procedures periodically to ensure they are current and adequate.
Ensures products and services align with the institutional strategic priorities.
Implements and evaluates programs designed to achieve program goals and objectives.
Communicates program goals and objectives to staff and senior leadership.
Ensures all core staff maintain appropriate training and documentation required to operate compliantly
Performs evaluations of direct reports. Initiates or assists with development and performance activities where appropriate.
Ensures compliance with requirements of all regulatory and accrediting bodies (i.e., FDA, ODH, TJC, CMS, FACT, ISO, BoP).
Participates on external scientific and professional committees in cellular and tissue therapeutics to advance the reputation of the supported programs. Prepares data for presentation at scientific meetings and publication in scientific journals related to manufactured products.
Serves as a subject matter expert on aseptic techniques, cell therapy practices and procedures, current Good Tissue Practices (cGTPs), current Good Manufacturing Practices (cGMPs) and current Good Laboratory Practices (GLPs) as appropriate.
Provides technical direction for the development and implementation of existing and new technologies/services as needed.
Identifies opportunities for operational process improvements to achieve improved efficiency, consistency, or quality and initiates and implements improvements.
Compiles and analyzes data related to cell collection, processing, and storage, including appropriate outcome measures. Provides data as required and appropriate.
Works with faculty, external sponsors, and process development teams to further technology transfer from pre-clinical research and process development studies to clinical manufacturing procedures.
Identifies opportunities for operational improvement to new and existing processes resulting in improved customer satisfaction; develops, initiates, and implements improvements.
Assists in the development and approval of validation protocols for new processes, oversees performance, prepares records, and reviews and summarizes results.
Assists with preparation and review of regulatory submissions such as initial IND applications and annual updates of the CMC. Prepares IND submissions to the FDA and works with investigators and study teams on IRB or IBC submissions and follow-up.
Ensures products comply with all regulatory requirements as appropriate.
Ensures staff compliance with clinical protocols, FDA, and sponsor reporting.
Collaborates with investigators and sponsors to determine appropriate activities to complete pre-clinical research, IND-enabling studies, pharm-tox studies, clinical scale-up, materials upgrade and compliance with current Good Manufacturing Practices (cGMPs).
Functions as PI for sponsor-initiated projects within the Immune Monitoring Core, writes and submits study reports as required.
Serves as signatory for Immune Monitoring and Manufacturing Core service agreements.
Ensures facility requirements and condition are monitored and maintained as appropriate for manufacturing (e.g. VMP, ISO, FDA). Works directly with Facilities Engineering to diagnose and troubleshoot corrective actions to mitigate any risk to products or patients.
Oversees the development, implementation, and monitoring of all CBT processes, policies, and procedures of the Quality Management Team.
Ensures compliance with all regulatory and accrediting agency standards and regulations (i.e. CAP, FACT, FDA).
Performs technical reviews of quality control data, batch records, procedures, change controls, deviations, CAPAs, CMC documents and provides corrective action for any deficiencies, discrepancies, or aberrant findings prior to product disposition or implementation.
Approves protocol and qualification plans for new equipment, oversees and reviews results of equipment performance, maintenance, and continued qualification.
Assists in preparation of scheduled quality assessment reports including quality audits, supplier audits and makes corrective actions based on findings.
Oversees all aspects of manufacturing and release to ensure maximum efficiency and facility utilization to ensure each program maintains appropriate capacity to ensure clinical timelines.
Establishes staffing needs of the Manufacturing Core, evaluates and approves staff orientation, training and competency processes, including manuals, procedures, checklists, requirements for mock procedures or observations and other training tools.
Evaluates staff productivity. Assures that workloads are distributed for maximum efficiency and effectiveness.
Oversees selection and hiring of new staff.
Communicates hospital and departmental goals and objectives to staff.
Oversees the selection and implementation of all technology solutions.
Ensures appropriate training to maximize the flexibility of staff and reduce risk to program delays.
Works with Manufacturing Core business manager and team for the development of capital and operating budgets, long term budget projections, capital planning and monitoring budget performance.
Works with Manufacturing Core business manager and other program resources to identify strategic opportunities for cost savings, additional revenue generation, and efficiency gains.
Assists in development of technical writing, project scope of work and budgets for industry sponsorship, government or private grants or cooperative agreements with other programs to support research protocols.
KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
Minimum of 3-5 years of leadership experience with an appropriate scientific or manufacturing background.
Knowledge in aseptic manufacturing technique, cell culture, liquid separation techniques and/or fluid handling.
Must be computer literate with experience in Microsoft Office products and Quality Management Systems.
Minimum Physical Requirement:
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