Manager - Cellular and Vector Production Facility

The MetroHealth System - Cleveland, OH

Full-time - Manager

Cleveland, OH

Ambulatory Health Care Services

About the position

The Manager of the Cellular and Vector Production Facility at MetroHealth Medical Center is responsible for overseeing the daily operations of the GMP laboratory facility. This role ensures the safety, functionality, and efficiency of the facility while managing operational and regulatory compliance. The manager collaborates with physicians and scientists to support preclinical strategies of cell therapy and facilitates the execution of clinical trials.

Responsibilities

• Oversee daily operations of the GMP laboratory facility.
• Ensure building and systems' safety and effective functionality.
• Manage the GMP Facility's operational and regulatory compliance plan.
• Collaborate with physicians and scientists for protocol/grant assistance and regulatory guidance.
• Support preclinical strategies of cell therapy and execution of 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.
• 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.

Nice-to-haves

• Doctorate degree in a health-related field.
• Experience in service line development and business development.