Director, Facilities and Engineering - Salt Lake City, UT, United States - Denali Therapeutics
Description
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.
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 managementSafety and environmental program execution, collaboration with internal and external stakeholders, compliance with applicable OSHA and local authority EH&S codesDevelopment 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 performanceOwnership 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 activitiesPartner 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 QualityExecution and management of site facility services including security and management of access, cleaning of GMP regulated areas, and ongoing coordination with site landlord management teamThought partner and collaborator to colleagues on the Denali SLC site Leadership team in the development of SLC site operational strategies, culture & business processesRequirements:Education:
Bachelor's Degree required with at least 10 years of experience in biotech, pharma or med deviceAbility 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 strategiesDemonstrated experience sourcing, selecting, mentoring, building and leading technical teams and developing peopleDesired Knowledge/Skills/Competencies:Experience in the engineering and maintenance of manufacturing facilities for large molecule pharmaceuticalsUnderstanding and familiarity with CMC development of protein therapeuticsDirect knowledge of FDA cGMP regulations/requirements for facilities and utilities within manufacturingExtensive experience with digital solutions for manufacturing encompassing business system solutions, control systems and data historiansExperience 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 spacesExtensive experience with GXP system strategies, implementation, staffing, procedures and documentationExtensive 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.
Demonstrated ability to build trustful and effective relationshipsAbility to lead through uncertainty in a rapidly changing environment.The ability to build teams where employees have a shared purpose and vision; demonstrated experience building unity between sites and/or functionsExceptional influencing, partnership, and collaboration skills across all levelsExcellent oral presentation and written communication skillsDenali 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.
Salary Range:
$171,465.00 to $212, 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 *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. Applicant Privacy Policy