Senior Manufacturing Sciences and Technology Engineer
Posted on 4/6/2024
Denali Therapeutics

201-500 employees

Develops therapies for neurodegenerative diseases
Company Overview
Denali Therapeutics stands out as a leader in the field of neurodegenerative diseases, leveraging recent scientific insights into genetic causes and biological processes to develop effective treatments for conditions like Alzheimer's, Parkinson's, and ALS. The company's culture is characterized by a commitment to rigorous science, translational medicine, and collaboration, fostering an environment where diverse backgrounds and experiences unite behind the shared goal of defeating degeneration. Denali's competitive advantage lies in its deep expertise in neurodegenerative disease biology and the blood-brain barrier, which informs a robust portfolio of programs at various stages of clinical and preclinical development, all aimed at improving patient lives by addressing disease causes or risk factors.
Biotechnology

Company Stage

N/A

Total Funding

$1.1B

Founded

2015

Headquarters

South San Francisco, California

Growth & Insights
Headcount

6 month growth

-8%

1 year growth

-5%

2 year growth

7%
Locations
Salt Lake City, UT, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
QA & Testing
Performance Testing
Quality Assurance
Requirements
  • Minimum bachelor's degree or advanced degree in Chemical, Mechanical or Biomedical Engineering or related discipline
  • 10+ years of engineering related experience
  • 5+ years in BioPharma Industry experience related to protein therapeutics
  • Ability to travel up to 10% by air and road
  • Physical - must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, stand for multiple hours at a time
  • Experience in leading product/process support within a GMP manufacturing setting
  • Builds trustful and effective relationships with authenticity and humility
  • Confidence to lead through uncertainty in a rapidly changing environment
  • The ability to contribute to a team where employees have a shared purpose and vision; foster a “One Denali” environment
  • Strong self-awareness of the impact communication and working style has on others
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
  • Ability to work intermittent, on-call schedules as needed to support manufacturing
  • Partner with Quality to assess deviations, determine root cause and execute preventive and corrective actions