QC Senior Microbiologist

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.

Reporting to the QC Lab Director, Salt Lake City, the QC Senior Scientist Microbiologist will play a key role as the lead technical subject matter expert for all aspects of microbiological testing including routine environmental monitoring to support the facility and utilities and bioburden and endotoxin testing to support product disposition.

Key Accountabilities/Core Job Responsibilities:

• Performs implementation and execution of microbiological testing such as bioburden, endotoxin, media qualifications and interpretation of identified microbes.

• Expert in microbial organisms and origin and impact to product safety and quality and compendial testing.

• Leads microbial method qualification design for new product introductions and technology transfer

• 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 and support quality events such as CAPA, Change Control, Deviations, and LIR/OOS as microbiologist subject matter expert

• Authors Facility environmental trend reports - quarterly and annually

• Provides disposition recommendations and supports product quality investigations as required

• Works with accuracy, urgency and a continuous improvement perspective

• Author and review method validations, qualifications, technical reports and CMC sections for IND and BLA filings, conduct data input, analysis and interpretation.

• Provide flexible support for on-call or outside normal business hours if required

Qualifications/Skills:

• BS in Biology or Microbiology
• 7 + years of experience in Pharmaceutical or Biotech Microbiology
• Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance
• 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
• 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
• Excellence in execution through accuracy, right first time and a proactive nature
• Familiar with Master Control and LabWare LIMS 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.