MSAT Engineer
Denali Therapeutics
August 07, 2026
On-site
Salt Lake City, UT
Operations
Key Accountabilities/Core Job Responsibilities
- Support recipe authoring and technical content development for GMP manufacturing processes, procedures and reports
- Assist in technical transfers to enable production of new clinical processes
- Function as a process and technology subject matter expert providing on-the-floor technical support
- Analyze data to monitor manufacturing in real time; support investigations, process monitoring, and optimization
- Serve as a subject matter expert during regulatory inspections
- Partner with Quality on deviations, product impact analysis, root cause, preventive/corrective actions
- Work intermittent, on-call schedules as needed to support manufacturing
- Draft, revise and maintain SOPs, protocols and reports reflecting process conditions, equipment configuration and regulatory compliance
- Execute validation and process improvement studies (execution, monitoring, sampling, in-process data collection)
- Coordinate sample preparation, chain of custody, labeling and timely transfer to QC/analytical labs
- Execute laboratory scale cell culture and purification operations
Qualifications/Skills
- Bachelor’s in Chemical, Mechanical or Biomedical Engineering (or related) + 5+ years engineering experience (or Master’s + 3+ years)
- Ability to travel up to 20%
- Physical: specialized gowning; lift/manipulate items over 25 lbs; climb ladders; stand multiple hours
- Experience supporting product/process within a GMP manufacturing setting
- Strong communication and relationship-building skills
- Ability to lead through uncertainty and foster a team environment
Preferred Qualifications
- BioPharma protein therapeutics experience
- Bio-processing technologies (cell culture/purification), including single-use technologies
- Scale-up and tech transfer experience
- Direct knowledge of FDA cGMP requirements for clinical biopharmaceutical manufacturing
- Experience with GXP system implementation and documentation
- Support recipe authoring and technical content development for GMP manufacturing processes, procedures and reports
- Assist in technical transfers to enable production of new clinical processes
- Function as a process and technology subject matter expert providing on-the-floor technical support
- Analyze data to monitor manufacturing in real time; support investigations, process monitoring, and optimization
- Serve as a subject matter expert during regulatory inspections
- Partner with Quality on deviations, product impact analysis, root cause, preventive/corrective actions
- Work intermittent, on-call schedules as needed to support manufacturing
- Draft, revise and maintain SOPs, protocols and reports reflecting process conditions, equipment configuration and regulatory compliance
- Execute validation and process improvement studies (execution, monitoring, sampling, in-process data collection)
- Coordinate sample preparation, chain of custody, labeling and timely transfer to QC/analytical labs
- Execute laboratory scale cell culture and purification operations
Qualifications/Skills
- Bachelor’s in Chemical, Mechanical or Biomedical Engineering (or related) + 5+ years engineering experience (or Master’s + 3+ years)
- Ability to travel up to 20%
- Physical: specialized gowning; lift/manipulate items over 25 lbs; climb ladders; stand multiple hours
- Experience supporting product/process within a GMP manufacturing setting
- Strong communication and relationship-building skills
- Ability to lead through uncertainty and foster a team environment
Preferred Qualifications
- BioPharma protein therapeutics experience
- Bio-processing technologies (cell culture/purification), including single-use technologies
- Scale-up and tech transfer experience
- Direct knowledge of FDA cGMP requirements for clinical biopharmaceutical manufacturing
- Experience with GXP system implementation and documentation