Hispanic Alliance for Career Enhancement
Director of Maintenance - Wilmington, Biotech
Hispanic Alliance for Career Enhancement, Wilmington, Delaware, us, 19894
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 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, 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, Lean Management, Lean Manufacturing, Maintenance Management, Operation Maintenance, Operations Management.
Preferred Skills Not specified.
Equal Employment Opportunity Policy 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 U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement.
Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a hybrid schedule consisting of three total days on‑site per week, Monday‑Thursday, with Friday designated as a remote‑working day, unless business critical tasks require an on‑site presence. This hybrid model does not apply to field‐based positions, facility‑based manufacturing positions, or positions covered by a collective bargaining agreement.
Compensation & Benefits Salary range: $169,700.00 – $267,200.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days. More information available at https://jobs.merck.com/us/en/compensation-and-benefits.
Application Information Apply through https://jobs.merck.com/us/en. Application deadline is stated on this posting. The job posting end date is 10/31/2025.
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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 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, 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, Lean Management, Lean Manufacturing, Maintenance Management, Operation Maintenance, Operations Management.
Preferred Skills Not specified.
Equal Employment Opportunity Policy 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 U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement.
Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a hybrid schedule consisting of three total days on‑site per week, Monday‑Thursday, with Friday designated as a remote‑working day, unless business critical tasks require an on‑site presence. This hybrid model does not apply to field‐based positions, facility‑based manufacturing positions, or positions covered by a collective bargaining agreement.
Compensation & Benefits Salary range: $169,700.00 – $267,200.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days. More information available at https://jobs.merck.com/us/en/compensation-and-benefits.
Application Information Apply through https://jobs.merck.com/us/en. Application deadline is stated on this posting. The job posting end date is 10/31/2025.
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