Director, Maintenance & Facilities

About Forge

Our mission at Forge Biologics, is to enable access to life changing gene therapies and help bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most. 

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.

About The Role:

Forge Biologics is seeking a Director of Facilities & Maintenance to lead and develop a high-performing team responsible for maintaining GMP and non-GMP equipment, utilities, and facilities in a regulated CDMO environment. This role oversees approximately 15-20 technical professionals across mechanical, electrical, calibration, controls, CMMS management, and facility planning disciplines. The Director will drive maintenance compliance, implement best practices for predictive and planned maintenance, and foster a culture of operational excellence and continuous improvement. This role offers the opportunity to lead a critical function within a dynamic CDMO, ensuring reliability, compliance, and efficiency in support of life-changing gene therapies.

What You'll Do:

• • Leads, mentors and coaches the Maintenance & Facilities department, building a high-performance culture.
  • Creates and manages departmental KPIs that align with site and corporate objectives.
  • Promotes a world-class maintenance culture.
  • Oversee the CMMS system, ensuring compliant and timely maintenance of assets.
  • Develops robust training programs for the operation and maintenance of critical utility systems.
  • Promotes a continuous improvement mindset and fosters collaboration with Manufacturing, Operations, Development, and Quality teams.
  • Plans and manages the R&M (Repair and Maintenance) budget, ensuring cost-effective and efficient maintenance practices.
  • Implements best practices for predictive and preventive maintenance, in collaboration with Plant and Reliability Engineering.
  • Provides strategy on the overall site equipment and facility reliability program.
  • Drives improvements in facility and equipment reliability, integrating methodologies such as Total Productive Maintenance (TPM).
  • Maintains the site spare parts program and manages inventory for critical assets.
  • Provides strategic input on CapEx projects and reliability improvements for GMP facility infrastructure and equipment.
  • Collaborates with Plant and Reliability Engineering and provides input on improvements to critical and key assets.
  • Evaluates opportunities to streamline facility shutdowns and builds processes for effective shutdown management.
  • Ensures adherence to safe work permitting and Lockout/Tagout (LOTO) procedures during maintenance activities.
  • Fosters a culture of quick turnaround response time in troubleshooting and repair of critical assets.
  • Identifies opportunities to perform troubleshooting or maintenance work in-house.
  • Monitors the health of critical GMP manufacturing and utility assets and communicates opportunities to leadership.
  • Promotes the use of risk assessment methodologies (PHA, FMEA) to identify and implement appropriate engineering and procedural controls for compliant use of GMP equipment and utility systems.
  • Manages and evaluates vendor/contractor performance to ensure high-quality service and support.
  • Works with the Manager of Plant & Reliability Engineering by building a strategic vision for the site on overall asset reliability for critical GMP facility infrastructure and equipment.
  • Aligns with Plant & Reliability Engineering on health score cards for critical and key assets.
  • Maintains center of excellence and competencies on the BAS and identifies areas for continuous improvement.

What You'll Bring:

• Minimum Education and/or Experience:
• Director Maintenance and Facilities (min 12 years and an Associates or Bachelor's Degree in Engineering or equivalent or min 16 years in a technical field including hands on experience with maintenance of complex mechanical systems and applicable certifications).
• Experience working in a regulated environment (GMP, FDA, ISO).
• Must be a self-starter, detail oriented, able to perform complex tasks and work cross functionally with other departments with minimal supervision.
• Strong leadership, communication, and change management skills to influence and drive improvements.
• Proven ability to identify issues and implement robust technical solutions.
• Proficiency in MS Office Suite and experience with CMMS or similar maintenance systems.
• Understanding of process control systems, computerized systems, and BAS (building automated system).
• Ability to support after hours as needed (response to building management and building monitoring systems).
• Preferred: Experience in startup, maintenance, and troubleshooting of GMP equipment and facilities.

Physical Requirements:

• May be required to lift up to 50 pounds of materials or equipment.
• Requirement to gown into Classified Areas of the facility (ISO 7 and 8 sterile gowning)
• The ability to move safely over uneven terrain or in confined spaces
• The ability to safely climb ladders while carrying 40 pounds
• The ability to wear personal protective gear correctly as required

Work Environment and Physical Demands

This position works in both a warehouse and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The noise level in the work environment ranges from moderate to occasionally loud. Must be able to lift, carry, push, and/or pull objects weighing up to 35 lbs. Ability to frequently operate a computer, and communicate with others in person, over the phone, and via other devices. Must be able to move about the facility for moderate to extended periods of time. Ability to wear task dependent personal protective equipment as needed.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by. 

• HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.
• OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.
• PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.
• ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.

We've Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

• Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
• Competitive paid time off plan
• Annual bonus for all full-time employees
• 401(K) company match
• Fully-stocked kitchen with free food/drinks
• 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
• Employee Assistance Program
• Wellness benefits (financial planning services, mental health counseling, employer paid disability)
• Onsite fitness facility
• Professional & Personal development resources