Denali Therapeutics · 8 hours ago
Lead, Microbiologist (Thu-Sun)
Salt Lake City, UT
Full-time
Onsite
Senior Level
7+ years expDenali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases. This position involves supporting the Salt Lake City clinical manufacturing site with microbiological testing, implementing USP methods, and providing data analysis and recommendations.
BiotechnologyGeneticsHealth DiagnosticsTherapeutics
Responsibilities
Performs implementation and execution of Microbiological testing such as bioburden, endotoxin, media qualifications and microbial identification
Supports the qualification and implementation of USP methods for sample test and environmental monitoring processes throughout the facility
Executes ‘on-floor’ operations with environmental monitoring sampling for facilities and utilities and emergency or unplanned monitoring
Initiates environmental excursion workflows and coordinates with corresponding functional areas
Support quality events such as CAPA, Change Control, Deviations, and LIR/OOS as microbiologist subject matter expert
Generates, analyzes, and reports data and takes appropriate action
Authors Facility environmental trend reports - quarterly and annually
Reviews documentation for product disposition, generates CofA’s and batch summary reports
Provides disposition recommendations and supports investigations as required
Works with accuracy, urgency and a continuous improvement perspective
Provide flexible support for on-call or outside normal business hours if required
Qualification
Required
BS in Biology or Microbiology
7+ years of experience in Pharmaceutical or Biotech Microbiology
Familiarity with USP/EP test method qualifications and execution
Knowledge of Environmental Monitoring for GMP regulated facilities and utilities
Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance
Ability to work with independently
Build productive relationships with internal teams and external sources
Well-developed verbal and written communication skills
Ability to closely follow quality standards and have attention to detail
Excellence in execution through accuracy, right first time and a proactive nature
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
Ability to work with independently with guidance or in team environments under deadlines
Strong collaboration skills
Familiar with Master Control and Kneat applications
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
2026-01-11
Longevity.Technology
2026-01-03
Company data provided by crunchbase