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Director – Cellular Therapy Lab – Orlando in Orlando, FL at Adventist Health System

Date Posted: 12/4/2018

Job Snapshot

  • Job Schedule
  • Location:
    Orlando, FL
  • Date Posted:
  • Job ID:
  • Job Function
    Director / Executive
  • Travel
  • Shift
  • AHS Zone
    2-Legacy System
  • Organization
    Florida Hospital

Job Description

Director – Cellular Therapy Lab – Orlando

Florida Hospital Orlando Here seeks to hire Director – Cellular Therapy Lab who will embrace our mission to extend the healing ministry of Christ.

Facility Profile:

Located on a lush tropical campus, our flagship hospital, 1,107-bed Florida Hospital Orlando, serves as the major tertiary facility for much of the Southeast, the Caribbean and South America. Florida Hospital Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country. We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year.

Department Profile:

Established in March of 2011, the Florida Hospital Cancer Institute-Translational Research Core (FHCI-TRC) laboratory provides the infrastructure and scientific support to our physicians as an onsite laboratory facility for collaborative in-house and external innovative research studies aimed at improving patient care and outcomes. Our goals include fostering research at FHCI using our expertise in clinical oncology and access to clinical data and fresh/archived specimens to advance the treatment of our cancer patients. FHCI-TRC is deeply committed to the education of physician scientists in oncology research through joint projects with our residents/attending physicians through the Tumor Site Practice Groups of FHCI throughout the Florida Hospital system and with UCF medical students.

Work Hours/Shifts:

8a-5p; M-F

Job Summary:

The Director of the Florida Hospital Cellular Therapy Lab (CTL) is responsible for the accurate and efficient performance of all work assignments performed in the cellular lab in support of the Blood and Marrow Transplant and Cellular Therapy Programs (BMTCT). The Director is forward-thinking, anticipates and facilitates the adoption, development, and clinical implementation of new technologies (whether research driven or by evolving best practices), as well as the development of new procedures to support the advancement of standards of care as well as performance improvement initiated protocols. The Director will have a direct role in the evolution of novel cellular therapy research protocols working closely with the Medical Director of the Blood and Marrow Transplant Program. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

Knowledge, Skills, Education, & Experience Required:

  • Strong organization skills
  • Excellent analytical and problem-solving skills
  • Effective oral and written communication skills, with the ability to articulate complex information in understandable terms to all levels of staff
  • Effective computer skills, particularly Microsoft Office Outlook, Word, Excel
  • Ability to work in a matrix-management environment to achieve organizational goals
  • Expertise in the design, validation, and performance of flow cytometric analysis of cellular function and subset composition in a variety of human cell lineages and cell lines
  • Extensive knowledge of human hematopoietic stem cell processing
  • Extensive knowledge of compliance adherence to regulatory guidelines relevant to human hematopoietic cell processing and manipulation
  • Extensive Technical and biological knowledge of experience applicable to cell processing and cell culture
  • Strong knowledge of laboratory procedures and with specific knowledge and experience with human cell handling procedures
  • Demonstration of working familiarity of accreditation standards of the
  • Foundation for Accreditation of Cellular Therapy (FACT), as evidenced by past successful accreditations
  • Knowledge of other relevant accreditation standards such as AABB, CAP
  • Knowledge of and experience with the architectural design and development of cGMP-compliant Laboratory facility(ies) for human hematopoietic cell collection, processing, and manipulation
  • Doctor of Philosophy (PhD) in field related to cellular therapy
  • Minimum ten (10) years of experience in operating a certified cellular therapy lab
  • Minimum of seven (7) years of leadership experience
  • Experience with human hematopoietic stem cell processing and manipulation
  • Experience with the Foundation for the Accreditation of Cellular Therapy (FACT) accreditation process for cellular labs.
  • Budget development and management experience
  • Experience with application of FDA Good Tissue Practices (cGTP) and Good Manufacturing Practices (cGMP) regulations
  • Experience preparing Investigational New Drug (IND) and Investigational
  • Device Exemption (IDE) applications and working under IND and IDEs
  • Minimum of fifteen (15) years of experience beyond doctoral degree in cellular lab (Preferred)
  • Experience as a Cellular Therapy Lab Inspector for FACT (Preferred)

Licensure, Certification, or Registration Required:

  • N/A

Job Responsibilities:

Demonstrates through behavior Florida Hospital’s Core Values of Integrity, Compassion, Balance, Excellence, Stewardship and Teamwork as outlined in the organization’s Performance Excellence Program

  • Oversees the effort to design and construct a state of the art cell processing physical plant that can support future cutting edge clinical research efforts at Florida Hospital. This facility will be designed to provide the optimal footprint to deliver outstanding quality care in the collection, processing, manipulation, storage, and infusion of human hematopoietic cells
  • Collaborates with the Medical Director of the Blood and Marrow Transplant Program and CTL Assistant Director with establishing and defining goals, objectives, and an operational plans that support the scientific and clinical goals and objectives of the Blood and Marrow Transplant Program and Florida Hospital as they relate to advancing Cellular Therapy at the institution for the treatment of malignant and non-malignant disease
  • Anticipates and facilitates the adoption, development, and clinical implementation of new technologies (eg., chimeric antigen receptor T-cell therapy; [CAR T-cell therapy]) to advance our mission of treating and eradication malignant and non-malignant life threatening disease in adults and children
  • Establish and maintain an ‘in-house’ Hematopoietic and Immune Cellular Function Laboratory (eg., flow cytometry, elisa) to support the clinical and investigational components of the Blood and Marrow Transplant Program
  • Develops and implements a robust Quality Management Program, driven by a validation master (VMP) plan and supported by a robust electronic records system.
  • Oversees the annual update to the Transplant Program Clinical Quality Management Report as provided by the Laboratory Assistant Director.
  • Establishment of collaborative arrangements with basic science laboratories at outside institutions to facilitate maximum potential for clinical research program Serves as liaison with other Florida Hospital departments to ensure the quality of CTL products and services, as well as to advance the scientific mission of expanding the clinical research program involving Cell Therapy at Florida Hospital across malignant and non-malignant platforms (eg., potential applications in pediatric brain injury, cardiac, and neurologic disease).
  • Interacts with Medical Director & Faculty of the Blood and Marrow Transplant and Cellular Therapy Program on the development of new processes and procedures for clinical protocols.
  • Maintains scientific and technological expertise appropriate for the mission of the cell lab.
  • Oversees the day-to-day activities of the laboratory and is actively involved in reviewing and improving operational procedures in the laboratory. Analyzes workflow and recommends methods for effective and efficient operation.
  • Troubleshoots barriers to identify variations or failures and improve processes.
  • Oversees appropriate completion of all components of laboratory operation including: standard operating procedures, validation procedures, document control and record keeping, reports of adverse reactions, accidents, deviations/variances and corrective action plans.
  • Determines need for new or updated methodology, and directs development and validation of new methods of production, associated quality control assays, and all associated standard operating procedures (SOP), master process records and staff training programs
  • Pursues publishable research opportunities when made available.
  • Attends and presents at national and international meetings, when requested.
  • Performs other related duties as assigned in order to meet the goals of the department and institution.
  • Works closely with the Program Director of Bone Marrow Transplant (BMT) to ensure regulatory compliance with FACT standards.
  • Prepares reports and materials for submission to regulatory agencies.
  • Evaluates and recommends purchases of new equipment/instruments as necessary.
  • Oversees process for procedure charges to ensure accurate billing.
  • Provides stewardship and oversight to resources.
  • Oversees annual operating budget and capital budget.
  • Ensures, through oversight of the CTL budgetary process, that adequate resources are in place in anticipation of emerging technologies
  • Works with clinical leadership to gauge emerging cellular therapeutic technologies and to incorporate them into the strategic planning process
  • Development, implementation, and maintenance of an electronic batch process record system (eBPR) which provides a robust process for the tracking and tracing of cellular products through the production cycle, and for the evaluation of products and clinical outcomes associated with them on both an individual and aggregate basis.
  • Works to initiate continuous improvement plans to optimize efficiency, improve batch records and Standard Operating Procedure (SOP), and advance technical expertise of the staff.
  • Assures that preventative maintenance is performed.
  • Oversees accurate records to assure performance of all quality control procedures.
  • Participates in the Bone Marrow Transplantation Quality Assurance/Quality Improvement Committee.
  • Implementation of a Validation Master Plan (VMP) that will cover all aspects of the operation of the cell processing facility and will include a program for risk assessment as an integral part of all changes, additions, and/or deletions from the existing facility
  • Oversees overall staffing for assigned area. Ensures staffing is effective and efficient, and promotes core values. Assures that staff is representative of the population diversity through oversight of recruitment, selection and retention of personnel. Ensures that staff are actively engaged in decisions within their scope of practice.
  • Ensures appropriate orientation for new staff and appropriate methodologies for ongoing competency assessment of staff. Monitors and ensures timely completion of performance evaluations, sets goals, and provides feedback and counseling to employees.
  • Rounds with employees on regular basis, engaging staff and leading on maintaining environment of safety.
  • Plans and develops a complete succession plan for rollup up to and including own position. Identifies high performing staff and works with Leadership Development and Talent Management to groom staff to meet succession plan timelines and curriculum.
  • Actively mentors others into the leadership roles throughout the timeline. Reviews succession plan at least annually and during performance review period.
  • Establishment of a Staff Development Program that will facilitate the transition from a standard of care transplant program to a cutting-edge research program
  • Ensures that all employees are knowledgeable in current applicable technologies and skills

If you want to be a part of a team that is dedicated to delivering the highest quality in patient care, we invite you to explore the Director – Cellular Therapy Lab opportunity with Orlando and apply online today.

Job Keywords:

Director, Cellular Therapy Lab, Laboratory, Lab, Leadership, Orlando

Position Location:  Orlando
Job:  Director / Executive
Organization:  Florida Hospital
Primary Location:  US-FL-Orlando
Schedule:  Full-time
Shift:  Day
Job Level:  Director
Education Level:  Doctorate Degree
Travel:  No
Job Posting:  Feb 4, 2018, 3:31:56 PM

Location | Organization | Category | Job Function