Head of Facility Operations from Joulé

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