Specialist, Quality Control Lab

Denali Therapeutics; Salt Lake City (UT); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics seeks a QC Lab Analyst to manage microbiology and chemistry QC operations in Salt Lake City. You will ensure supplies, maintain Labware LIMS records, and coordinate stability testing and audits with cross-functional teams.

The role requires GMP-regulated lab experience, B.S. in Chemistry, and strong communication. Expect on-site work with potential on-call hours, contributing to an inspection-ready environment.

Qualifications

• B.S./B.B.S. in Chemistry or equivalent science experience.
• 2+ years of GMP-regulated analytical lab experience.
• Knowledge of USP/Ph. Eur./FDA/ISO/GMP standards and quality systems.
• Ability to work independently and build productive relationships.
• Strong verbal and written communication skills.
• Physical ability to gown, lift items over 25 lbs, and stand for extended periods.

Responsibilities

• Ensure laboratory supplies, consumables, reagents, and solutions are purchased and available for test methods.
• Record and maintain reagents, lots, and validation samples in Labware LIMS.
• Coordinate with stability coordinator for routine and stability testing.
• Support systems/equipment needs for QC labs with Administrator.
• Oversee organization of the QC lab and activities.
• Assist with logging tasks, assign owners, and take meeting notes.
• Prepare for audits/inspections and track quality actions.
• Clean glassware for analysts and maintain inspection readiness.
• Provide on-call support outside normal business hours if required.

Skills

GMP experience

Analytical chemistry

LIMS

Documentation

Communication

Independence

Project management

Education

B.S. in Chemistry

Tools

Labware LIMS

USP/Ph. Eur./FDA standards

Job description

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.This position will play a key role in managing, improving and streamlining the QC Laboratory operations for both microbiology and chemistry departments.Key Accountabilities/Core Job Responsibilities:Ensure laboratory supplies, consumables, reagents, and solutions are purchased and available for execution of test methods by analysts.Record and maintain all reagents, lots, and validation samples in Labware LIMSWork with stability coordinator to schedule, manage and report status on routine and stability testing for drug substance and drug product for both Microbiology and Analytical Departments.Coordinate with the Systems and Equipment Administrator as needed to support system or equipment needs for the QC laboratories.Oversee general organization of the QC lab and lab activities.Help with the administrative process of logging tasks, assigning owners, and driving accountability after meetings along with taking meeting notes.Help prepare for audits and inspections, track assigned quality actions, and support adherence to SOPs.Clean glassware for analystsMaintain the laboratories in an inspection readiness state.Works with accuracy, urgency and a continuous improvement perspective.Flexible to provide on-call support outside of normal business hours if required.Qualifications/SkillsTypically requires a BBS in Chemistry or equivalent science experience.2+ years of experience working in GMP regulated analytical and chemistry laboratories is preferred, including knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance and familiarity with quality systems.Ability to work independently and to build productive relationships with internal teams and external sources.Well-developed verbal and written communication skills.Excellence in execution through accuracy, right first time and a proactive nature.Strong collaboration and project management skills.Physical requirements: must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, and stand for multiple hours at a time.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/careersThis 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.Salt Lake City Drug Testing Policy