Summary

Reporting to the New Horizon (NH) site Head, the Facility Director will be a member of the site leadership team, and a successful hands-on contributor to the build and start-up of Cartesian's Frederick, MD, manufacturing facility. This individual will build and lead a technical and execution team to deliver Cartesian's rapidly expanding pipeline.

Principal Duties/Responsibilities:

• Develop and maintain a staffing strategy to deliver facilities and engineering services to the NH site. Source, hire, build, mentor and lead a team of internal and external resources responsible for safety and environmental culture and compliance, equipment maintenance, troubleshooting, and upgrades, Automation and IT support, Site security administration, Site cleaning and tenant/landlord relationship management
• Safety and environmental program execution, collaboration with internal and external stakeholders, compliance with applicable OSHA and local authority EH&S codes
• Development of maintenance, spare parts, calibration, and metrology strategies, staffing, and procedures. Performance of preventive and repair maintenance and calibration, ownership of external maintenance supplier relationships and performance
• Ownership of lifecycle asset planning and execution for utilities, facility, equipment and automation including new technology introduction, continuous improvement, capacity upgrades, ownership and assessment of technical change management in conjunction with Quality, and project management of associated activities
• Oversight of the validation program for facilities, equipment, and utilities in collaboration with Quality.
• Ownership of automation and IT systems, troubleshooting and continuous improvement of automation and IT systems, ownership and assessment of technical change management in conjunction with Quality
• Execution and management of site facility services including security and management of access, cleaning of GMP regulated areas, and ongoing coordination with site landlord management team
• Thought partner and collaborator to colleagues on the site Leadership team in the development of site operational strategies, culture & business processes

Qualifications:

• Education: Bachelor's Degree required with at least 10 years of experience in biotech, pharma or med device
• Ability to travel up to 10%
• Significant experience in the engineering and maintenance of manufacturing facilities for GMP regulated production and previous experience in life cycle asset strategies
• Demonstrated experience sourcing, selecting, mentoring, building and leading technical teams and developing people

Work Environment:

The position requires hands-on work setting up and operating equipment in an R&D laboratory. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.