QC Microbiologist, Clinical Manufacturing

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.

Responsibilities (include but are not limited to the following)

• Support implementation and execution of Microbiological testing
• Support the qualification and implementation of USP methods for sample test and environmental monitoring processes throughout the facility
• Support ‘on-floor’ operations such as sampling
• Generate, review and report data
• Support Facility environmental trend reporting
• Review documentation for product disposition generate CofA’s and batch summary reports
• Provide disposition recommendations and support investigations as required
• Work with accuracy, urgency and a continuous improvement perspective
  
  

Requirements

• BS in Biology or Microbiology
• 3+ years of experience in Pharmaceutical or Biotech Microbiology
• Familiarity with USP test method qualifications and execution
• Knowledge of 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
• 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
  
  

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.