Senior Manufacturing Sciences and Technology Engineer
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.
Reporting to the Associate Director of Manufacturing Sciences and Technology (MSAT), you will be a successful hands-on contributor to the build and start-up of Denali’s Utah manufacturing site. You will assist in the build, commissioning, execution and technical support of GMP manufacturing to enable the delivery of Denali’s rapidly expanding large molecule pipeline. The Sr. MSAT Engineer will foster an environment that encourages Denali’s Core Values, innovation, and continuous improvement.
- 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
- Bachelor's 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
- Clear technical 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
- Extensive experience with GXP system implementation, procedures, and documentation
- Exceptional influencing, partnership, and collaboration skills across all levels
- Excellent oral presentation and written communication skills
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.
Salary Range: $130,000.00 to $156,667.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. 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.