Senior QC Microbiologist

Denali Therapeutics•Salt Lake City, UT

About The Position

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. The Senior QC Microbiologist will lead microbiological testing and environmental monitoring processes, support method implementation, and serve as a subject matter expert on microbiology at the facility. This role ensures compliance with GMP and USP standards through data review, investigations, and collaboration across quality operations to drive continuous improvement and product quality.

Requirements

Typically requires a BS in Biology or Microbiology and 8+ years of experience in Pharmaceutical or Biotech Microbiology
Familiarity with USP test method qualifications and execution
Familiarity with Environmental Monitoring
Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance
Ability to work with independently
Well developed verbal and written communication skills
Ability to closely follow quality standards and have attention to detail
Strong collaboration skills
Excellence in execution through accuracy, right first time and a proactive nature
Ability to learn quickly, driven by high curiosity
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

Responsibilities

Implement and execute Microbiological testing
Support the development and implementation of USP methods for sample test and environmental monitoring processes throughout the facility
Support ‘on-floor’ operations such as investigations
Generate, review data and report / approve as required
Undertake Facility environmental trend reporting
Review documentation for product disposition generate CofA’s and batch summary reports
Provide disposition recommendations and support investigations as required
Serve as a Microbiology subject matter expert
Work with accuracy, urgency and a continuous improvement perspective