QC Chemist, Biologics Potency & Impurities (Term-to-Hire)
About The Position
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This role will play a key role in executing and reports analytical/chemistry test methods for raw materials, drug substance and drug product for large molecule clinical and commercial products.
Requirements
- BS in Chemistry or equivalent science
- 4+ years of experience working in GMP regulated chemistry laboratory
- Familiarity with GMP regulations
- Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance
- Ability to work with independently
- 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
- Physical requirements– must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, stand for multiple hours at a time
- Strong collaboration and project management skills
Nice To Haves
- Large molecule experience preferred
- Familiar with Master Control and LabWare LIMS
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 Chemistry
- Generates, analyzes, and reports data and takes appropriate action
- Works within LabWare LIMS for execution of methods, data trending and report issuance.
- Reviews documentation for product disposition, generates COA/COC and batch summary reports
- Works with accuracy, urgency and a continuous improvement perspective
- Provides flexible support for on-call or outside normal business hours if required
Benefits
- Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
