MSAT Engineer
Denali Therapeutics
June 24, 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.
- Serve as a process and technology subject matter expert providing on-the-floor technical support.
- Analyze data to monitor manufacturing in real time; support investigations; perform process monitoring and optimization.
- Serve as a subject matter expert during regulatory inspections.
- Partner with Quality to assess deviations, perform product impact analysis, determine root cause, and execute preventive and corrective actions.
- Work intermittent, on-call schedules as needed.
- Draft, revise, and maintain SOPs, protocols, and reports reflecting process conditions, equipment configurations, and regulatory compliance.
- Execute validation and process improvement studies (coordination, monitoring, sampling, in-process data collection).
- Coordinate and perform sample preparation, chain of custody, labeling, and 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) with 5+ years engineering experience, or Master’s with 3+ years.
- Ability to travel up to 20%.
- Physical: gowning; lift/manipulate items >25 lbs; climb ladders; stand for multiple hours.
- Experience in product/process support within a GMP manufacturing setting.
- Strong communication skills (oral and written) and relationship-building; confidence leading through uncertainty.
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 for clinical biopharmaceutical manufacturing.
- GXP system implementation, procedures, 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.
- Serve as a process and technology subject matter expert providing on-the-floor technical support.
- Analyze data to monitor manufacturing in real time; support investigations; perform process monitoring and optimization.
- Serve as a subject matter expert during regulatory inspections.
- Partner with Quality to assess deviations, perform product impact analysis, determine root cause, and execute preventive and corrective actions.
- Work intermittent, on-call schedules as needed.
- Draft, revise, and maintain SOPs, protocols, and reports reflecting process conditions, equipment configurations, and regulatory compliance.
- Execute validation and process improvement studies (coordination, monitoring, sampling, in-process data collection).
- Coordinate and perform sample preparation, chain of custody, labeling, and 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) with 5+ years engineering experience, or Master’s with 3+ years.
- Ability to travel up to 20%.
- Physical: gowning; lift/manipulate items >25 lbs; climb ladders; stand for multiple hours.
- Experience in product/process support within a GMP manufacturing setting.
- Strong communication skills (oral and written) and relationship-building; confidence leading through uncertainty.
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 for clinical biopharmaceutical manufacturing.
- GXP system implementation, procedures, and documentation.