Associate Director, MSAT Late Stage

Role Summary

Associate Director, MSAT Late Stage responsible for leading and mentoring a team of MSAT engineers focused on late-stage molecules, providing hands-on technical support in manufacturing and process validation at the Salt Lake City site. Oversee preparation for process performance qualification campaigns, ensure complete technical documentation, support tech transfers and regulatory filings, and deviations management while identifying and developing team capabilities to meet evolving goals.

Responsibilities

• Lead a team of MSAT 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

• 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.
• 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 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.