Denali Therapeutics · 1 day ago
Associate Director, MSAT Late Stage
Salt Lake City, UT
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
7+ years expDenali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases. The Associate Director, MSAT Late Stage will lead and mentor a team of engineers, providing technical support in manufacturing and process validation, while overseeing the preparation for process performance qualification campaigns and ensuring compliance with regulatory requirements.
BiotechnologyGeneticsHealth DiagnosticsTherapeutics
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
Qualification
Required
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
Benefits
401k
Healthcare coverage
ESPP
A broad range of other benefits
Company
Denali Therapeutics
Denali Therapeutics is dedicated to defeating neurodegenerative diseases to deliver safe and effective medicines to patients and families.
501-1000 employees
H1B Sponsorship
Denali Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (14)
2023 (7)
2022 (6)
2021 (5)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.32BKey Investors
Royalty PharmaBaillie Gifford
2025-12-04Post Ipo Debt· $200M
2024-02-27Post Ipo Equity· $500M
2022-10-19Post Ipo Equity· $275M
Leadership Team
Ryan Watts
CEO
Peter Chin
Sr. Vice President & Head of Late-Stage Clinical Development and Medical Affairs
Recent News
Longevity.Technology
2026-01-03
Company data provided by crunchbase