Director, Facilities and Engineering

Role Summary

Director, Facilities and Engineering at Denali Therapeutics. Lead the facilities, engineering and validation teams at the SLC manufacturing site, shaping long-term vision and operational excellence while ensuring compliance with cGMP and FDA regulations. Report to the VP of Clinical Manufacturing and contribute as a member of the site leadership team.

Responsibilities

• Provide strategic direction to facilities and engineering leaders; build, mentor, and lead internal and external teams to deliver engineering, facilities, and validation responsibilities for the SLC site.
• Partner with site leadership to develop operational strategies, culture, and business processes; drive site strategic plan, expansion of capabilities, space planning, capital forecasting, and feasibility assessments.
• Lead site safety culture; ensure safety and environmental program execution and compliance with OSHA and local EH&S codes.
• Direct maintenance, spare parts, calibration, metrology policies, CMMS, security, access management, cleaning, landlord coordination, staffing, and procedures; ensure excellence in preventive and repair maintenance and calibration; manage external maintenance supplier relationships.
• Direct lifecycle asset planning and execution for utilities, facilities, and equipment; oversee new technology introduction, continuous improvement, capacity upgrades, automation and IT systems; author automation recipes in support of tech transfer.
• Partner with IT, Quality, and site leadership to deliver IoT digital solutions for manufacturing and quality; oversee system requirements, evolution of systems, and deployment ownership.
• Lead validation function, including policies, strategies, validation management system, staffing, and procedures for GMP equipment, instruments, utilities, and facilities; ensure compliance with cGMP and FDA regulations.
• Manage performance of direct reports through goal setting, growth planning, training compliance, and ongoing feedback.

Qualifications

• Education: Bachelor‚Äôs Degree; 10+ years of experience in biotech, pharma, or medical device.
• Ability to travel up to 10%.
• Extensive experience in engineering and maintenance of GMP manufacturing facilities and life cycle asset strategies.
• Track record of sourcing, selecting, mentoring, building, and leading technical teams.
• Experience in engineering, maintenance, and validation of manufacturing facilities for large molecule therapeutics; familiarity with CMC development of protein therapeutics.
• Direct knowledge of FDA cGMP regulations for facilities and utilities; experience with digital manufacturing solutions, control systems, and data historians.
• Experience with EH&S, regulatory compliance, and collaboration with internal and external stakeholders.
• GXP system strategies, implementation, staffing, procedures, and documentation experience.
• Experience managing a complex portfolio of technical deployments; ability to drive scope decisions and prioritization.
• Ability to work in a rapidly changing environment; collaborative, trust-building, and able to foster a "One Denali" culture.
• Strong communication and presentation skills.