Cellular and Vector Production Facility Manager

1 week ago


Cleveland, Ohio, United States MetroHealth Full time
Job Title: Manager - Cellular and Vector Production FacilityJob Summary:

As a key member of the MetroHealth team, we are seeking a highly skilled and experienced Manager to oversee the daily operations of our GMP laboratory facility. The successful candidate will be responsible for ensuring the safety, functionality, and efficiency of the facility, as well as overseeing the execution and management of our operational and regulatory compliance plan.

Key Responsibilities:
  • Oversee daily operations of the GMP laboratory facility, ensuring safety, functionality, and efficiency.
  • Manage the execution and management of the GMP Facility's operational and regulatory compliance plan.
  • Collaborate with physicians and scientists to provide protocol and grant assistance, as well as regulatory guidance.
  • Support physicians and scientists in the facilitation of preclinical strategies of cell therapy, including execution and regulatory compliance for manufacturing and experimental clinical trials.
Requirements:
  • Medical, Doctorate, or equivalent degree/experience in a relevant science.
  • Two years of experience with cGMP.
  • Four years of laboratory and cell therapy experience, with 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 backgrounds.
Preferred Qualifications:
  • Doctorate degree in a health-related field.
  • Experience in Service line development, business development, hospital operations.

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