What are the responsibilities and job description for the Associate Director, Facilities position at Replimune, Inc.?
Overview
Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease.
At Replimune, we live by our values:
United: We Collaborate for a Common Goal.
Audacious: We Are Bold and Innovative.
Dedicated: We Give Our Full Commitment.
Candid: We Are Honest With Each Other.
People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.
Join us, as we reshape the future.
Job Summary:
The Associate Director Facilities is responsible for routine management of the Facilities Department at the Framingham, MA manufacturing facility. The Facilities Department is responsible for ensuring all facility equipment and utilities are operating as required to support cGMP manufacturing, laboratory operations and administrative functions. The Associate Director Facilities is responsible for ensuring all facilities related activities are executed per the required site SOPs, safe work practices and cGMP regulations. The Associate Director Facilities is also responsible for ensuring that the facility is operating per required environmental, health, safety and government regulations.
This position is based in our Framingham location and typically has a 5-day on-site expectation.
Responsibilities
Key responsibilities:
- Responsible for management and organization of the Facilities Department
- Responsible for overall operation and maintenance of all facility utilities, systems and equipment required for support of cGMP manufacturing operation (HVAC, PW, PS, WFI, IT, etc.) and support functions (base building systems, laboratories, warehousing, etc.).
- Provide technical support and troubleshooting of cGMP utility systems
- Management of equipment maintenance scheduling and planning function for routine and non-routine maintenance of all facility equipment, utilities and systems, including manufacturing and laboratory equipment
- Business owner of Computerized Maintenance Management System (CMMS) for documentation and on-time execution of maintenance and calibration programs for all equipment and system assets
- Overall responsibility for ensuring all facilities related activities (maintenance, calibration, etc.) are documented by staff contemporaneously and per cGMP requirements
- Management responsibility for all work performed by outside contractors and for all service contracts
- Serve as Replimune’s liaison / contact with landlord, local authorities, etc.
- Responsible for management and operation of facility wastewater treatment and boiler operations per required licensing
- Support EH&S / management to ensure proper disposal of all facility wastes, including both chemical and biological wastes, per all governmental regulations
- Serve as Facility Emergency Coordinator (or back-up) and Safety Contact. Responsible for ensuring facilities are maintained in a safe manner and as key contact with employees and landlords regarding safety related items.
- Responsible for facility management of Woburn corporate office and serve as company liaison with both Framingham and Woburn facility landlords
Other responsibilities:
- Maintain equipment and facility to meet needs of support groups (Quality Control, Process Development, etc.)
- Manage facility construction / renovation projects or utility projects performed with external companies with review and approval of any project documentation and reports
- Assist Engineering and contractors with design, installation and modification of equipment / utilities
- Represent Facilities at inter-departmental meetings and interact with external vendors, as necessary
- Provide On-boarding/Off-boarding support to HR as needed
- Other tasks as assigned
Qualifications
Educational requirements:
- BA or BSc in Engineering, Science or a related discipline desired (Master’s degree preferred)
Experience and skill requirement:
- Minimum 8 years’ relevant experience managing daily facilities operations in a cGMP environment
- Minimum 3 years’ experience directly managing a team
- Extensive experience with biopharmaceutical utility systems (HVAC, PW, PS, WFI) and strong technical ability is required
- Training and/or field experience in building management systems, HVAC, refrigeration, plumbing and Health and Safety
- cGMP training and documentation experience
- Experience with biological and chemical waste management and Lockout/Tagout procedures
- Computer literacy (MS Word, MS Excel, Outlook, etc.)
- Ability to work well with others
- Excellent communication, organization and supervisory skills