MSAT Engineer

Key Accountabilities/Core Job Responsibilities

• Support recipe authoring and technical content development for GMP manufacturing processes, procedures and reports
• Aid 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
• 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
• Execute laboratory scale cell culture and purification operations

Qualifications/Skills

• 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

Preferred Qualifications

• 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

Compensation and Benefits

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

Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.