Quality Control, 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.

This position involves supporting our Salt Lake City clinical manufacturing site with microbiological testing, qualifying and implementing USP methods, assisting with on-floor operations and environmental monitoring, generating and analyzing data, reporting environmental trends, reviewing documentation and providing disposition recommendations.

Key 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

Qualifications/Skills:

• BS in Biology or Microbiology
• 5 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
• 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
• Familiar with Master Control and Kneat applications

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

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.