Quality Control (QC) Analyst

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 role executes analytical/chemistry test methods for in process, drug substance, and drug product supporting large molecule clinical and commercial products, working under the general supervision of senior QC Chemistry staff.

Key Accountabilities/ Core Job Responsibilities:

• Executes routine and ad hoc analytical testing of raw materials, drug substance, and drug product using chromatographic and electrophoretic methods in accordance with approved test methods and procedures.
• Performs chromatography-based assays including SEC, Reverse Phase HPLC (titer), icIEF, CE-SDS, and glycan/sialic acid analyses for large molecule programs.
• Participates in the validation, transfer, and implementation of USP/EP and product-specific analytical methods by executing protocol testing under the direction of senior QC staff.
• Performs stability testing of drug substance and drug product at required timepoints and storage conditions.
• Generates, processes, and reports analytical data with accuracy and in compliance with data integrity requirements; escalates atypical or unexpected results promptly.
• Supports QC-Chemistry investigations and quality events, including deviations, LIR/OOS, CAPA, and change controls, by providing accurate laboratory documentation, data, and observations; initiates LIR/OOS records when required.
• Works within LabWare LIMS for sample login, method execution, and result entry.
• Assists with review of analytical documentation for product disposition.
• Helps to draft risk assessments, protocols, methods, and any other QC documentation as needed
• Collaborates with Analytical Development, Manufacturing, and Quality teams during method validation/transfer and assay troubleshooting.
• Prepares reagents, buffers, mobile phases, and reference standard solutions; performs routine instrument checks, preventive maintenance, and calibration verification; maintains laboratory supplies and sample inventory.
• Completes required training and maintains training records current in accordance with site procedures.
• Works with accuracy, urgency, and a continuous improvement mindset and provides flexible support 

Qualifications/Skills:

• Typically requires a BS in Chemistry, Biology, Biochemistry, or a related scientific discipline with 4+ years of experience in a GMP-regulated laboratory, including hands-on chromatography (HPLC/UPLC) experience; large molecule/biologics experience preferred.
• Working knowledge of GMP regulations and familiarity with current USP/Ph. Eur., FDA, and ISO standards and guidance.
• Ability to follow established procedures with attention to detail and a right-first-time approach; developing ability to work independently with general supervision.
• Effective written and verbal communication skills and the ability to build productive working relationships with internal teams.
• Experience with LIMS and electronic quality management systems required; LabWare LIMS, MasterControl, and Waters empower experience preferred.
• Ability to meet laboratory physical requirements, including specialized gowning, lifting and manipulating items greater than 25 lbs, climbing ladders, and standing for extended periods.

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.

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.

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