Job Title: Head of Facility Operations
Location: Philadelphia, PA
Hours/Schedule: Monday - Friday (8AM-5PM)
Compensation: Very competitive !
Type: Direct-Hire

Overview:
Our client is a CDMO start-up company whose focus is in the Cell and Gene Therapy field. They have unmatched experience in pioneering the early viral vectors of two FDA-approved AAV gene therapy products seeking a Head of Facility Operations to manage cGMP for the facility (drive cGMP and own SOPs around design, control, documentation, investigations, training, e.g. access, calibration schedule , if interested in learning more please apply !

Responsibilities

• Manage cGMP for the facility (drive cGMP and own SOPs around design, control, documentation, investigations, training, e.g. access, calibration schedule, etc.)
• Drive maintenance, cleaning and environmental monitoring programs
• Manage contractors and suppliers (cleaners, HVAC monitoring, etc.) 
• Provide leadership and vision in developing GMP facility management strategies and best practices
• Work with outside contractors to ensure that the GMP facility adheres to industry standards.
• Oversee preventive maintenance program for GMP equipment, as well as GMP building management systems
• Coordinate work assignments among building technicians, vendors, and contractors to ensure assignments are completed on time and within budget.
• Develop and report on key maintenance metrics that drive continuous improvement within the GMP facilities organization.
• Investigate, troubleshoot, and resolve problems that occur during routine operations related to facilities, engineering, and manufacturing.
• Project manage cGMP facility shutdowns aligning key stakeholders and ensuring successful return to production.
• Oversee utility and building management systems that support the GMP manufacturing area.
• Author procedures, policies and regulatory audit responses.

• BS in engineering or life sciences
• 15 years of facilities engineering, building maintenance, establishing maintenance (cleaning, EM), and calibration programs for a start up GMP compliant biological manufacturing, QC/analytical testing facility (ideally gene therapy)
• Prior experience providing facilities support for a BSL-2 laboratory and manufacturing space
• Executive leadership presence
• Strong project management skills
• Experience building out, qualifying, and implementing GMP facilities operations for biologic manufacturing operations
• Prior experience managing 3^rd party vendors to support equipment and facility lifecycle management
• Safety mindset and a demonstrated focus on EHS (environmental health and safety)
• Working knowledge of facilities vendor management, and supply chain experience