QC, Microbiologist

Denali Therapeutics•Salt Lake City, UT

2d•Onsite

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. 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.

Requirements

Typically requires a BS in Biology or Microbiology and 7+ years of experience in Pharmaceutical or Biotech Microbiology (or an MS in Biology or Microbiology and 4+ 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

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