Specialist, Quality Control Lab

Denali Therapeutics Inc; Salt Lake City (UT); Presencial; USD 55.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k

Healthcare coverage

ESPP

Descripción de la vacante

Denali Therapeutics Inc. seeks a QC/Analytical Laboratory Associate in Salt Lake City to ensure test method readiness. You will manage reagents, lots, and validation samples in Labware LIMS and coordinate stability testing across Microbiology and Analytical labs.

Growing responsibilities include supporting audits, driving quality actions, and maintaining a compliant, inspection-ready QC environment with a focus on accuracy and teamwork.

Formación

• Typically requires a BBS in Chemistry or equivalent science experience.
• 2+ years of GMP-regulated analytical/chemistry lab experience preferred.
• Strong communication and relationship-building skills.
• Proactive, accurate execution and right-first-time mindset.

Responsabilidades

• Ensure laboratory supplies, consumables, reagents, and solutions are purchased and available for test method execution.
• Record and maintain reagents, lots, and validation samples in Labware LIMS.
• Coordinate with stability coordinator for routine and stability testing for drug substance/product in Microbiology and Analytical labs.
• Team with Systems and Equipment Administrator to support QC lab needs.
• Oversee general organization of the QC lab and lab activities.
• Assist in audits/inspections, track quality actions, and support SOP adherence.
• Maintain lab cleanliness and readiness for inspections.
• Provide on-call support outside normal hours if required.

Conocimientos

GMP knowledge

Communication

Project management

Collaboration

Accuracy

Educación

BBS in Chemistry

Herramientas

Labware LIMS

Descripción del empleo

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.

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 LIMS.
• Work 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 analysts.
• Maintain 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/Skills:

• Typically 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. 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.

Salt Lake City Drug Testing Policy “Life at Denali” is a living reflection of our values: trust, unity, grit and growth. These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.