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.

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 success of Denali’s SLC manufacturing facility. This leader will play a key role in shaping the long-term vision and operational excellence of the SLC site, translating business goals into infrastructure and capability growth, while fostering a high-performance culture. This leader is accountable for the facilities, engineering and validation teams and ensures compliance with all cGMP and FDA regulations within the scope of their responsibility.

Key Accountabilities/ Core Job Responsibilities

• Provide strategic direction to the leaders of the facilities and engineering functions to evolve the staffing strategies for delivery of facilities, engineering and validation services to the SLC site. Source, hire, build, mentor and lead a team of internal and external resources as needed to deliver the scope of responsibilities for engineering, facilities and validation.

• Thought partner and collaborator to colleagues on the Denali SLC site Leadership team in the development of SLC site operational strategies, culture & business processes. Driver of the site strategic plan including expansion of site capabilities and capacity, space planning, capital forecasting and feasibility assessments.

• Lead site safety culture and ensure safety and environmental program execution, collaborate with internal and external stakeholders, ensure compliance with applicable OSHA and local authority EH&S codes

• Provide strategic direction to the leader of the facilities organization on maintenance, spare parts, calibration, and metrology policies, strategies, computerized maintenance management system, security, management of access, cleaning, coordination with site landlord, staffing, and procedures. Ensure excellence in performance of preventive and repair maintenance and calibration, ownership of external maintenance supplier relationships and performance.

• Provide strategic direction to the leader of the engineering function on lifecycle asset planning and execution for utilities, facility, and equipment including new technology introduction, continuous improvement, capacity upgrades as well as automation and IT systems, authoring and delivery of automation recipes in support of tech transfer of new products, troubleshooting and continuous improvement of automation and IT systems.

• Partner with Denali IT, Quality and Denali SLC leadership to deliver and support the IOT digital solutions supporting internal manufacturing and quality including selection of solutions, development of system requirements, evolution of systems in place, management of delivery of new solutions, and system ownership of deployed systems

• Leadership of the validation function including ownership of Validation and commissioning policies, strategies, computerized validation management system, staffing, and procedures for GMP equipment, instruments, utilities, and facilities, Development of validation strategies and ensuring compliance with cGMP and FDA regulations.

• Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.

Qualification/Skills

• 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

• Experience in the engineering, maintenance, and validation 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 order to drive scope decisions and prioritization.

• Ability to work in a rapidly changing environment

• Ability to contribute to a team where employees have a shared purpose and vision; foster a “One Denali” environment

• Ability to collaborate and build trustful and effective relationships

• Proficient oral presentation and written communication skills

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.