Manager - Cellular and Vector Production FacilityLocation: METROHEALTH MEDICAL CENTERBiweekly Hours: 80.00Shift: 8-5The MetroHealth System is redefining health care by going beyond medical treatment to improve the foundations of community health and well-being: affordable housing, a cleaner environment, economic opportunity and access to fresh food, convenient transportation, legal help and other services. The system strives to become as good at preventing disease as it is at treating it. Founded in 1837, Cuyahoga County’s safety-net health system operates four hospitals, four emergency departments and more than 20 health centers.Summary:Oversees daily operations of the GMP laboratory facility. Ensures building and systems’ safety, effective functionality, and optimal efficiency through oversight of assigned departments and areas of responsibility. Oversee the execution and management of the GMP Facility's operational and regulatory compliance plan. Collaborates with physicians and scientists with protocol/grant assistance and regulatory guidance. Support physicians and scientists at MetroHealth and within Case Comprehensive Cancer Center partner institutions in the facilitation of preclinical strategies of cell therapy, including execution and regulatory compliance for manufacturing and experimental clinical trials.Qualifications:Required:
Medical, Doctorate, or equivalent degree/experience in a relevant science. (i.e., Medical Technologist with a graduate degree who has extensive cell processing experience).
Two years of experience with cGMP.
Four years of laboratory and cell therapy experience and prior experience working with biologics, the FDA, and other regulatory bodies.
Extensive knowledge of lab, service codes, FDA, 21 CFR, and other regulatory standards.
Knowledge of drug product manufacturing.
Functional knowledge of software used for cellular therapy manufacturing.
Extensive experience working with laboratory equipment.
Ability to prepare, review and execute GMP documents.
Experience in scale-up/process R & D and technical transfer.
Knowledge of general computer applications; MS Word, Excel, PowerPoint.
Strong leadership and communication skills.
Ability to collaborate with interdisciplinary teams.
Ability to interact effectively with a wide range of cultural, ethnic, racial, and socioeconomic backgroundsPreferred:
Doctorate degree in a health-related field.
Experience in Service line development, business development, hospital
