Facilities Manager

The Facilities Manager is responsible for the overall operation and administration of the facility infrastructure and maintenance controls to support a CDMO specializing in Cell Therapy (CT) products, manufacturing and research operations. This position reports to the Sr. Director of Finance and manages the development, implementation, and the continuous improvement of a safe, compliant, and reliable facilities in support of multiproduct commercial GMP cell and gene therapy manufacturing operations.

The scope of the role covers site equipment and facilities maintenance and calibration programs, facility master planning, capital planning & execution and management of the facilities operating budget. This position will develop and lead the facilities team that is responsible for delivering reliable and uninterrupted manufacturing operations, manage critical equipment and facility projects, that will have a direct impact on the growth and success of the organization. This role requires close partnerships with Cell Therapy Manufacturing, Quality, Engineering, Primary Cell & Product Services, Process Development team leaders to ensure reliable and smooth operations.

RESPONSIBILITIES

• Ensures that production facilities are maintained at a high standard, equipment maintenance and

calibrations are performed, and validation protocols and reports are reviewed and approved where

facilities and utilities are deployed.

• Management of facilities and equipment related vendors including security personnel, grounds, pest control, GMP Facility Cleaning Programs, HVAC maintenance, instrumentation, and janitorial services.

• Perform procurement activities including pre-qualification, negotiating supplier agreements, for equipment and facility related services and requirements.

• Advising business on measures to improve the efficiency and cost-effectiveness of the facility.

• Works closely with the leadership team to coordinate activities concerning operational decisions and business requirements, including plans to increase capacity and throughput of operations.

• Compiles data for monthly reports and departmental key indicators.

• Works in partnership with Quality and Regulatory personnel both internally and externally to assure compliance of all regulatory requirements.

• Manages the relationships with external network of contractors, consultants, service providers, and external stakeholders.

• Identifies and mitigates risks in facility operations that could negatively impact safety, quality, delivery, cost, or personnel.

• Establishes and manages operating budgets for all facility initiatives.

• Works collaboratively with the project leads from CT, Manufacturing, Quality, Process Engineering, and Research on all aspects of facility design, construction, qualification, lab equipment maintenance and repair.

• Management of construction activities and ensures engineering documentation is prepared in accordance with all applicable codes and regulations.

• Oversight, Environmental Monitoring System (EMS) and Temperature Monitoring System.

• Provides leadership to site in the development and execution of site safety activity and partners with Safety to maintain up to date records.

• Responsible for developing, training, and providing growth opportunities for the Facilities and team members.

• Perform other duties as assigned.

WORKING ENVIRONMENT

• ISO 7 and ISO 8 clean room facilities, including sterile gowning garments. Will be required to work in controlled or clean room environments.

• Normal laboratory environment with biohazard precautions.

• May be exposed to blood or bodily fluids that may be capable of transmitting diseases.

• Frequent exposure to outdoor environment and non-company facilities.

• Will be working with liquid nitrogen and subzero freezers.

• Must wear PPE due to safety requirements in designated lab areas.

• May be called on to workdays or hours other than routinely scheduled hours, work overtime hours, or potentially work through breaks, if necessary.

PHYSICAL REQUIREMENTS

• Must be able to stand long hours.

• Must be able to communicate clearly.

• May be required to lift up to 40 pounds.

EQUIPMENT USED

• General Laboratory equipment (examples include but are not limited to: centrifuges, heat sealer, sterile docking device, refrigerators/freezers, sterile hood, cell counter)

• Normal office equipment e.g., telephone, computer, cell phone, copier, fax.

QUALIFICATIONS

Education:

• Bachelor or Master of Engineering or related field or equivalent combination of education, training and/or experience.

Experience:

• 8+ years previous work in biotech and cell therapy, preferable in an ISO 7 GMP cleanroom and

manufacturing facility.

• 3+ years in a management role.

• Biotech or cell therapy manufacturing experience preferred.

Skills:

• Demonstrate an understanding of organizational structure, operating culture, effective work styles, and achieving results in an innovative environment.

• Strong knowledge of GMP & environmentally compliant facility and engineering operations.

• Strong knowledge of bio technologies and infrastructure (HVAC, EMS operations, process equipment, automation, maintenance systems).

• Solid knowledge in the validation of equipment, utilities, and systems.

• Strong experience in the capital planning & project management.

• Experience in building and developing engineering competency, talent, and performance to support successful manufacturing operations.

• Interpersonal skills to establish and maintain professional relationships and manage support staff and customers.

• Critical thinking, creativity, and innovation.

• Decision-making skills. Uses authority appropriately in making sound judgments in a timely manner.

• Accepts accountability.

• Professional communication both written and oral, which is clear and precise.

• Organizational skills - time management, priorities, deadlines, goals.

• Flexibility - ability to effectively manage change and positively influence others.

• Attention to detail and cGMP compliance.

• Integrity and discretion - ability to maintain confidentiality.

• Ability to perform under pressure and work under stressful situations.

• Team orientation and ability to work with a diverse group.