Director of Maintenance - Wilmington, Biotech

Job Description

Welcome to the Future of Precision Oncology – Join Us in Wilmington, DE! 

We’re thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware—a bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. 

ADCs represent one of the most exciting frontiers in biopharmaceuticals today. By combining the targeting power of monoclonal antibodies with the potency of cytotoxic drugs, ADCs deliver cancer-killing agents directly to tumor cells, minimizing damage to healthy tissue. This precision has revolutionized treatment for hematologic malignancies and is rapidly expanding into other cancers.  The global ADC market is booming, projected to surpass $16 billion in 2025 and grow steadily through 2035. Innovations in linker technology, payload design, and AI-driven antibody optimization are accelerating breakthroughs and expanding therapeutic possibilities. 

Our Wilmington facility is designed to meet the growing demand for high-potency manufacturing, ensure supply chain resilience, and support the next wave of ADC launches.  Importantly, this site will support both drug substance conjugation and drug product. 

 As a member of the Wilmington Biotech site leadership team, the Director of Maintenance will lead and oversee all maintenance operations for our sterile product manufacturing facility. This role is critical in ensuring the reliability, safety, and efficiency of all equipment and systems while adhering to strict regulatory standards and best practices in the pharmaceutical industry. The ideal candidate will possess extensive experience in engineering and facilities management, particularly in sterile environments, and will demonstrate strong leadership capabilities to drive continuous improvement initiatives. This position will also have oversight and accountability for integrated facilities management (IFM) for the site.  

Key Responsibilities: 

Leadership & Strategy: 

• Develop and implement a comprehensive maintenance strategy aligned with the facility's operational goals. 

• Lead and manage the maintenance staff, fostering a culture of safety, compliance, and continuous improvement. 

• Oversee talent management processes, including recruitment, training, performance evaluations, and career development for maintenance personnel. 

• Collaborate with cross-functional teams to ensure maintenance activities support production schedules and compliance requirements. 

Facilities Maintenance Operations: 

• Design and implement a comprehensive predictive and preventive maintenance program to improve asset reliability and manufacturing capacity. 

• Design and implement an integrated facilities management (IFM) program for the site. 

• Oversee all maintenance activities, including preventive, predictive, and corrective maintenance for all equipment and systems. 

• Ensure compliance with Good Manufacturing Practices (GMP), safety regulations, and environmental standards. 

• Manage maintenance budgets, forecasts, and resource allocation to optimize operational efficiency. 

Continuous Improvement: 

• Drive initiatives to enhance equipment reliability and reduce downtime through root cause analysis and implementation of best practices. 

• Introduce and integrate reliability engineering principles into maintenance practices, including RCM, FMEA, and Criticality Analysis. 

• Utilize predictive maintenance tools (e.g., vibration analysis, ultrasound, infrared thermography) to assess asset condition and optimize maintenance activities. 

• Lead projects related to equipment upgrades, installations, and process improvements, employing Lean manufacturing principles to streamline operations. 

Regulatory Compliance: 

• Ensure all maintenance practices comply with FDA regulations, ISO standards, and internal policies. 

• Prepare for and participate in regulatory inspections and audits, providing necessary documentation and evidence of compliance. 

• Promote a culture of safety within the maintenance team, ensuring adherence to safety protocols and practices during maintenance operations. 

Collaboration & Communication: 

• Serve as the primary point of contact for maintenance-related issues, collaborating with production, quality assurance, and engineering teams. 

• Communicate maintenance strategies, goals, and performance metrics to senior management and stakeholders. 

• Prepare and present regular reports on maint