QC Chemist

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.This role supports GMP Quality Control testing for biologic drug substance and drug product, with a primary focus on plate-based potency and impurity assays (e.g., ELISA or similar ligand-binding assays). The QC Chemist will execute routine and stability testing, analyze and report data, and support investigations while maintaining strict compliance with GMP and data integrity expectations.Key Accountabilities/ Core Job Responsibilities:Performs implementation and execution of routine and ad hoc chemical and analytical testing for raw materials and large molecule drug substance and drug product.Supports the qualification and implementation of USP/EP methods and product specific methods as part of new product introduction and technology transfer.Supports stability testing of drug substance and drug product for all timepoints and conditions.Supports quality events such as CAPA, Change Control, Deviations, and LIR/OOS as subject matter expert for QC ChemistryGenerates, analyzes, and reports data and takes appropriate actionWorks within LabWare LIMS for execution of methods, data trending and report issuance.Reviews documentation for product disposition, generates COA/COC and batch summary reportsWorks with accuracy, urgency and a continuous improvement perspectiveProvides flexible support for on-call or outside normal business hours if requiredQualifications/Skills:BS in Chemistry or equivalent science4+ years of experience working in GMP regulated chemistry laboratoryLarge molecule experience preferredFamiliarity with GMP regulationsKnowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidanceAbility to work with independentlyBuild productive relationships with internal teams and external sourcesWell-developed verbal and written communication skillsExcellence in execution through accuracy, right first time and a proactive naturePhysical requirements– must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, stand for multiple hours at a timeStrong collaboration and project management skillsFamiliar with Master Control and LabWare LIMSCompensation 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 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 #J-18808-Ljbffr Denali-Therapeutics