MSAT Engineer

Denali Therapeutics•Salt Lake City, UT

1d•Onsite

About The Position

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 MSAT Engineer will be an integral part of Denali’s growing GMP manufacturing site in Salt Lake City, Utah. You will support currently manufactured products and technology transfers of future products in Denali’s rapidly expanding large molecule pipeline. The MSAT Engineer will foster an environment that encourages Denali’s Core Values, innovation, and continuous improvement.

Requirements

Typically requires a Bachelor's degree in Chemical, Mechanical or Biomedical Engineering or a related discipline and 5+ years of engineering-related experience (or a Master's Degree and 3+ years of experience)
Ability to travel up to 20% 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 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
Proficient oral presentation and written communication skills

Nice To Haves

BioPharma Industry experience related to protein therapeutics
Experience in design and operation of bio-processing technologies (cell culture and purification), with experience with single use technologies
Experience in scale-up and tech transfer of bio-processes
Direct knowledge of FDA cGMP regulations/requirements for manufacturing clinical biopharmaceuticals
Experience with GXP system implementation, procedures, and documentation

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, translating process requirements into the ability to successfully execute manufacturing.
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, perform process monitoring, and optimization
Serve as a subject matter expert on process and technology related topics during regulatory inspections
Partner with Quality to assess deviations, perform product impact analysis, determine root cause and execute preventive and corrective actions
Ability to work intermittent, on-call schedules as needed to support manufacturing
Draft, revise and maintain SOPs, protocols and reports that accurately reflect process conditions, equipment configurations and regulatory compliance
Execute validation and process improvement studies coordinating execution, process monitoring, sampling, and in-process data collection
Coordinate and perform sample preparation, chain of custody, labeling and timely transfer to QC or analytical laboratories
Execution of laboratory scale cell culture and purification operations