Director of Maintenance - Wilmington, Biotech at Merck · Wilmington

Director of Maintenance - Wilmington, Biotech Location: USA - Delaware - 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 maintenance performance, reliability metrics, and improvement initiatives to senior management. Minimum Education and Experience: Bachelor’s degree in Engineering, Facilities Management, or a related field with ten (10) years of experience in maintenance management within a pharmaceutical or biotech environment Required Skills and Experience: At least five (5) years in a leadership role. Proven experience in managing maintenance for sterile manufacturing processes and equipment. Experience demonstrating leadership and technical skills in high-pressure environments. Experience or training in Lean manufacturing methodologies, with a track record of implementing Lean principles to improve maintenance processes and operational efficiency. Strong knowledge of maintenance management systems (CMMS) and reliability-centered maintenance practices. Excellent leadership, communication, and interpersonal skills. Ability to analyze complex problems and develop effective solutions. Familiarity with regulatory requirements and industry standards related to sterile manufacturing. Demonstrated success with talent management and creating an engaged workforce using inclusion as a core principle. Required Skills: Accountability, Accountability, Antibody Drug Conjugates (ADC), Change Agility, Collaborative Communications, Consulting, Continuous Improvement, Cross-Cultural Awareness, Engineering Design, Equipment Maintenance, Facility Management, GMP Compliance, Good Manufacturing Practices (GMP), GxP Compliance, Innovation, Leadership, Leadership Assessments, Lean Management, Lean Manufacturing, Lean Process Improvements, Lean Six Sigma Continuous Improvement, Maintenance Management, Maintenance Strategy, Operation Maintenance, Operations Management {+ 9 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $169,700.00 - $267,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/4/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.