Associate Director, Manufacturing, Science, & Technology (Late Stage)

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.

Lead and mentor a team of MSAT engineers focused on late-stage molecules, particularly DNL126, providing hands-on technical support in manufacturing and process validation at the Salt Lake City site. Oversee preparation for PPQ campaigns, ensure all technical documentation is complete, support tech transfers, regulatory filings, and deviation management, while identifying and developing team capabilities to meet evolving goals.

Key Accountabilities/ Core Job Responsibilities:

• Lead a team of Manufacturing, Science, and Technology engineers and senior engineers focused on late stage molecules, with particular focus on DNL126 in 2026 and 2027.

• Identify required skills within the team as goals change and develop/execute strategy for developing or acquiring those skills.

• Provide technical guidance and ensure resources appropriately allocated and managed in preparation for process performance qualification campaigns at the Salt Lake City (SLC) site, including process validation activities.

• Provide hands-on, technical leadership on the manufacturing floor and lab, while providing mentorship and coaching to engineers and operators.

• Ensure required technical content is in place for late stage manufacturing processes and procedures, including change controls, batch records, automation recipes, detailed process flow diagrams, sampling plans, etc.

• Monitor manufacturing in real time, support investigations, perform process monitoring, and process optimization

• Drive outbound tech transfers for products previously made at the SLC site moving to another production location.

• Ability to work intermittent, on-call schedules as needed to support manufacturing

• Support authoring and review of CMC sections of regulatory filings relevant to GMP manufacturing (e.g., BLA or IND amendments)

• Ensure MSAT team, in partnership with Quality, can effectively and efficiently assess deviations, determine root cause and execute preventive and corrective actions in a timely manner.

• 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.

Qualifications/Skills:

• PhD in Chemical, Mechanical or Biomedical Engineering or related scientific discipline plus a minimum of 7 years of engineering related experience; or BS/MS with a minimum of 12+ years of similarly applicable experience.

• 7+ years in BioPharma Industry experience, preferably in protein therapeutics

• 5+ years managing teams

• Previous experience working in GMP environment and with CMC activities for protein therapeutics

• Builds trustful and effective relationships with humility and authenticity

• The ability to contribute to a team where employees have a shared purpose and vision; foster a "One Denali" environment

• Physical - must be able to don put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, stand for multiple hours at a time

• Site based role, requires on site presence

• Ability to travel up to 10% by air and road

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.

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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