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Manager, Manufacturing Operations

Denali Therapeutics
Salt Lake, UT Full Time
POSTED ON 2/22/2025
AVAILABLE BEFORE 5/23/2025

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.

This position's responsibilities span from cell culture to purification; including but is not limited to, media and buffer preparation, set-up and take-down of equipment and single-use assemblies, and both testing and actual operations.

Key Accountabilities / Core Job Responsibilities :

  • Collaborate with cross-functional teams to optimize manufacturing processes, improve efficiency, and assist in technical transfers to enable production of new clinical processes
  • Support recipe creation and technical content development for manufacturing processes and procedures
  • Document all non-conformance issues and partner with Quality to assess deviations, determine root cause and execute preventive and corrective actions
  • Conduct all activities in accordance with company policies & Standard Operating Procedures, global regulatory guidelines, environmental guidelines, as appropriate, etc.
  • Responsible to lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement
  • Responsible for oversight on weekends for staff from other departments, including warehouse, facilities and engineering. Ensure maintenance and calibration work is coordinated, material requests are fulfilled, prioritize work as issues arise, escalate urgent matters to appropriate area leader for resolution and containment, coach and provide feedback on growth, development and areas of improvement

Qualifications / Skills :

  • Bachelor's degree and 4 years of experience in a regulated industry OR associate degree with 5 total years of relevant experience
  • 2 years of managing a team
  • BioPharma Industry experience related to protein therapeutics, particularly operation of bio-processing technologies (cell culture and purification) preferred
  • Builds trustful and effective relationships with authenticity and humility in a rapidly changing environment
  • 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
  • Physical requirements- 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
  • Experience with single use technologies preferred
  • 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

    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.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.

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