Description

SUBFUNCTION DEFINITION: To conduct independent and directed scientific studies and research in support of a Principal Investigator's research

CCHMC SALARY GRADE:17

Scope: 2+ reports

REPRESENTATIVE RESPONSIBILITIES

???Program Management
Responsible for the overall operational management of production operation. Working in close collaboration with scientific leaders specific to production lines. The Director will oversee all day-to-day operations, including project and time line management, budget, personnel, facility management, and Quality Control. The Director is responsible for ensuring delivery of all products in a timely, compliant, and fiscally responsible fashion. The Director works with the production line to develop and enact strategic direction, including the determination of project priorities and time lines, and oversee all resources, including production, facilities, and quality control, meeting production goals.

???Laboratory Management - Direct processes of operations
cleanroom utilization for production. Direct scheduling, staffing, support operations & troubleshooting. Direct lab staff in the production including competency, training, technology transfer & process scale up when needed. Develop, approve & implement policies, SOPs, master production records, specifications, & certification plans for improved use, quality & operations. Proactively identify & implement areas for improvement. Develop & maintain productivity standards for all areas of the lab. Ensure lab is properly staffed, utilized, & work is scheduled & performed according to contractual obligations & regulatory requirements. Manage staff, training, business revenue & expenses associated with assigned laboratories. Develop & implement policies & procedures for improved use, quality & operations. Identify opportunities for improving cost & quality & offer recommendations to drive significant operational change. Ensure operations are efficient, cost effective & effective. Resolve issues concerning staffing, use of facilities & equipment. Manage facility & resource coordination with prioritization of work as required by academic & contract commitments.

???Compliance
Sustain a working understanding of regulatory requirements and accreditation standards. Evaluate area of responsibility for compliance with regulatory and accreditation standards. Identify best practices as well as deficiencies to share with peers and make recommendations for improvement. Participate in the development of corrective action plans to guide needed and sustainable improvements. Ensure that compliance and readiness plans are current. Enhance relationships to promote interdisciplinary involvement and knowledge of compliance standards, status, and actions. Track laws, regulations and standards that may affect practice and policies. Work with direct reports to insure that needed changes are made by the effective date of any change(s) in requirements.

???Lab Operations
Develop the strategic plan in support of new clinical, research and translational programs. Increase market share for external academic and industry contracts to enhance research and financial results while maintaining full compliance with regulatory agencies. Ensure the infrastructure is systemically sound and in alignment with Institutional mission, vision and values.

???Operational Management
Propose, research, and manage the development, implementation and assessment of long and short term operating goals and objectives. Operationalize, implement and monitor assigned strategic initiatives. Drive execution of the assigned strategic plan components.

Qualifications

EDUCATION/EXPERIENCE

Required:

???Bachelor's degree in a related field
???7+ years of work experience in a related job discipline