Specialist, Quality Control Lab
Denali Therapeutics
Summary
This position will play a key role in managing, improving and streamlining the QC Laboratory operations for both microbiology and chemistry departments.
Job description
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.
Requirements
- BBS in Chemistry or equivalent science experience
- 2+ years of experience working in GMP regulated analytical and chemistry laboratories is preferred
- Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance
- 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
Benefits
- 401(k)
- Healthcare coverage
- ESPP
Company overview
Denali Therapeutics is a pioneering biotechnology company focused on developing innovative therapeutics for neurodegenerative and lysosomal storage diseases. Founded in 2015 and headquartered in South San Francisco, California, the company has developed a proprietary TransportVehicle™ (TV) platform designed to enable biotherapeutics to cross the blood-brain barrier, addressing one of the most significant challenges in treating central nervous system disorders. Denali's pipeline includes promising candidates for conditions such as Hunter syndrome (MPS II), Parkinson's disease, frontotemporal dementia, Sanfilippo syndrome (MPS IIIA), and MPS I, with several programs in advanced clinical development stages. The company collaborates with major pharmaceutical partners including Biogen and Sanofi, leveraging its platform technology to create a new class of barrier-crossing therapeutics. With approximately 500-1,000 employees and operations spanning multiple locations including Salt Lake City, Denali Therapeutics represents a leading force in neuroscience drug development, combining deep scientific expertise with a patient-centric approach to transform treatment paradigms for serious neurological conditions.