Senior Engineer, Manufacturing Sciences and Technology

Denali Therapeutics • Salt Lake City, UT

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About The Position

At Denali Therapeutics, Inc. Salt Lake City, UT Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degenerative biology and the principles of translational medicine. The Opportunity Denali Therapeutics, Inc. seeks a Senior Engineer, Manufacturing Sciences and Technology for its Salt Lake City, Utah location.

Requirements

• Must have a minimum of a Bachelor’s degree or foreign equivalent in Biology, Biotechnology, Chemical, Mechanical or Biomedical Engineering or related discipline and 5 years of experience as a Process Engineer, Manufacturing Manager, Manufacturing Ops Specialist, or related position in the BioPharma Industry working with biologics/protein therapeutics.
• Must have at least 5 years of experience with: Capital project life cycle: basic design, detailed design, construction, commissioning, process validation, and manufacturing
• Applying chromatography, UF/DF, formulation for biologics bulk drug substance
• Cytiva Flex Factory equipment (Akta Ready, Akta Flux) including method creation and editing in Unicorn
• Biologics technical transfer
• Process characterization and process validation (strategy and execution)

Responsibilities

• Provide process engineering expertise to engineering firms, equipment vendors, and construction resources throughout all project phases (design through construction and startup).
• Support vendor acceptance testing and startup validation activities for new equipment.
• Compile and maintain process requirements and ensure matching equipment capabilities.
• Lead technical transfers to enable production of new clinical processes.
• Support recipe authoring and technical content development for manufacturing processes and procedures.
• Function as a process and technology subject matter expert providing on-the-floor technical support.
• Serve as a subject matter expert on process and technology related topics during regulatory inspections.
• Apply process engineering knowledge throughout the capital project life cycle: basic design, detailed design, construction, commissioning, process validation, and manufacturing.
• Analyze data to monitor manufacturing in real time, support investigations, perform process monitoring, and optimization

Benefits

• Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level