Full Job Description
This position is part of a broader Large Molecule CMC Analytical and Formulation team. This is an opportunity to collaborate on formulation, process and analytical development activities across a broad range of large molecules, that cross the blood-brain barrier, for treating challenging diseases.
Key Accountabilities/Core Job Responsibilities:
- Assist in the development of chromatography, electrophoresis, spectroscopy and mass spectrometry-based analytical methods to be used for product release, stability, and characterization testing.
- Contribute to the design and execution of experiments for demonstrating method robustness and performance.
- Prioritize and perform timely testing that enables bioprocess and formulation development teams to meet project timelines.
- Critically evaluate analytical data to support method development decisions and product quality comparisons.
- Maintain accurate and timely experiment records in electronic laboratory notebook (ELN).
- Summarize and present data in a clear and meaningful way.
- Author and review analytical test methods and development reports.
Qualifications/Skills:
- B.S. or M.S. in Analytical Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences or related scientific discipline with 2+ years of CMC analytical development experience in biotech/pharma.
- Hands-on experience with various analytical methods for measuring the purity of biologics and residual process impurities (i.e. chromatography, capillary electrophoresis, spectroscopy, LC-MS, etc.).
- Experience with chromatography and mass spectrometry acquisition and data analysis software.
- Excellent laboratory, critical thinking, scientific problem-solving, and organizational skills.
- Familiarity with good documentation requirements and industry guidance.
- Knowledge of statistical approaches for data interpretation and analytical method development.
- Motivated, detail-oriented, naturally curious individual with a creative approach to scientific problem solving.
- Excellent spoken and written communication skills.
Salary Range: $106,000.00 to $138,000.00 . 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.
