Manager, Cellular Therapy

1 week ago

Hackensack, United States Hackensack Meridian Health Full time

Overview:
Our team members are the heart of what makes us better. At Hackensack Meridian _Health_ we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

The Mgr, Cellular Therapy is responsible for the oversite of all clinical and investigational duties at the Cell Therapies Manufacturing Facility (CTMF), including supervising of all laboratory personnel assigned to CTMF and handling daily operation. This role will help develops and implements new procedures and testing, and will plan, coordinate, implement and evaluate all aspects of departmental quality control (QC) as applicable. They will also work in collaboration with the department quality and administrative management to ensure overall compliance with regulatory and accreditation requirements. This position performs both administrative and technical duties.

**Responsibilities**:
A day in the life of a Manager, Cell Therapy at Hackensack Meridian _Health_ includes:

- Responsible for all aspects of laboratory operations to ensure maximum efficiency and customer satisfaction.
- Oversees all clinical and investigational duties including supervision of laboratory personnel.
- Oversees the analyses and testing associated with QC and development of clinical and investigational procedures.
- Ensures laboratory activities are compliant with internal and external regulations.
- Maintains and improves standardized systems to support accurate, timely and reliable services to patients and healthcare providers.
- Prepares, revises and maintains policies specific to the department.
- Ensures rapid and appropriate issue resolution through effectively managed follow up and response of all occurrences and deviations. Works closely with quality and administrative management to investigate and report occurrences and deviations as applicable.
- Work with department leadership to incorporate investigational protocols. Reviews and monitors clinical trial data and ensures protocol adherence, data integrity and regulatory compliance.
- Manages, in collaboration of department leadership, the purchase and maintenance of laboratory equipment and supplies.
- Coordinates and supervises the operation of all laboratory instrumentation and oversees QC of all instrumentation. Ensures that all appropriate laboratory staff are properly trained in the performance of that instrumentation in accordance with applicable standards.
- Coordinates the accurate and complete department documentation, training, accreditation, and inspection process for regulatory agencies.
- Participates in preparing the department operating budget, and is responsible for operating within the budget by controlling departmental costs.
- Ensures that billing, reporting and revenue are at appropriate levels.
- Responsible for the administrative duties with regard to all employees within the CTMF. This includes time and attendance, evaluations, demographic updates and information.
- Educates and mentors laboratory technologists to improve overall job performance and to guide employees toward the attainment of their performance goals.
- Screens and interviews prospective applicants for the Section.
- Develops and implements appropriate training and education programs as applicable.
- Oversees supply and reagents inventory management.
- Develops and maintains reports and statistics that provide information needed by CTMF leadership, as appropriate, to continually assess the effectiveness of department programs.
- Requisitions proficiency testing programs and supplies as related to laboratory accreditation.
- Oversees all proficiency testing materials and quality control information and handles routine correspondence.
- Represents the department at meetings that relate to procedures and testing.
- Performs all computer system functions necessary for performance of specialist duties.
- Lifts a minimum of 30 lbs., pushes and pulls a minimum of 50 lbs. and stands a minimum of 4 hours a day.
- Adheres to the standards identified in the Medical Center's Organizational Competencies.

Qualifications:
Education, Knowledge, Skills and Abilities Required:

- Baccalaureate in laboratory science or equivalent combination of education and experience.
- Minimum 7 years of clinical laboratory experience with at least 1 years in management or supervisory role.
- Comprehensive knowledge of the field's concepts and principles.
- High degree of analytical ability and complex tasks performance.
- Excellent organization and time management, multitasking, attention to detail, and strong problem solving skills.
- Excellent interpersonal communication and listening s

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