Director, Facilities and Engineering

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

The Opportunity:

Reporting to the VP of Clinical Manufacturing, the Director, Facilities and Engineering will be a member of the site leadership team, and a successful hands-on contributor to the build and start-up of Denali’s SLC manufacturing facility. This individual will build and lead a technical and execution team to deliver Denali’s rapidly expanding large molecule pipeline. The Director, Facilities and Engineering will foster an environment that encourages Denali’s Core Values, innovation and continuous improvement.  This role is in-person, based in Salt Lake City, Utah.

Responsibilities:

• Develop and maintain a staffing strategy to deliver facilities and engineering services to the SLC site. Source, hire, build, mentor and lead a team of internal and external resources responsible for safety and environmental culture and compliance, equipment maintenance, troubleshooting, and upgrades, Automation and IT support, Site security administration, Site cleaning and tenant/landlord relationship management
• Safety and environmental program execution, collaboration with internal and external stakeholders, compliance with applicable OSHA and local authority EH&S codes
• Development of maintenance, spare parts, calibration, and metrology strategies, staffing, and procedures. Performance of preventive and repair maintenance and calibration, ownership of external maintenance supplier relationships and performance
• Ownership of lifecycle asset planning and execution for utilities, facility, equipment and automation including new technology introduction, continuous improvement, capacity upgrades, ownership and assessment of technical change management in conjunction with Quality, and project management of associated activities
• Partner with Denali IT, Quality and Denali SLC leadership to complete an assessment of the digital landscape for internal manufacturing, selection of solutions, development of system requirements, and portfolio management of digital solutions selected 
• Ownership of automation and IT systems, troubleshooting and continuous improvement of automation and IT systems, ownership and assessment of technical change management in conjunction with Quality
• Execution and management of site facility services including security and management of access, cleaning of GMP regulated areas, and ongoing coordination with site landlord management team
• Thought partner and collaborator to colleagues on the Denali SLC site Leadership team in the development of SLC site operational strategies, culture & business processes

Requirements:

• Education: Bachelor’s Degree required with at least 10 years of experience in biotech, pharma or med device
• Ability to travel up to 10%
• Significant experience in the engineering and maintenance of manufacturing facilities for GMP regulated production and previous experience in life cycle asset strategies
• Demonstrated experience sourcing, selecting, mentoring, building and leading technical teams and developing people

Desired Knowledge/Skills/Competencies:

• Experience in the engineering and maintenance of manufacturing facilities for large molecule pharmaceuticals
• Understanding and familiarity with CMC development of protein therapeutics
• Direct knowledge of FDA cGMP regulations/requirements for facilities and utilities within manufacturing
• Extensive experience with digital solutions for manufacturing encompassing business system solutions, control systems and data historians
• Experience having primary responsibility for EH&S, including collaboration with internal stakeholders and external agencies to comply with all relevant codes, and interfacing with various team members to maintain safe working conditions in manufacturing, warehouse, labs and common spaces
• Extensive experience with GXP system strategies, implementation, staffing, procedures and documentation
• Extensive experience managing a complex portfolio of technical deployments, including ability to engage leaders in value based tradeoff discussions in or