About the Role
This position is part of a broader Large Molecule CMC Analytical and Formulation team, offering an opportunity to collaborate on formulation, process, and analytical development activities for large molecules targeting challenging diseases.
Responsibilities
- Assist in the development of chromatography, electrophoresis, spectroscopy, and mass spectrometry-based analytical methods for product release, stability, and characterization testing.
- Contribute to the design and execution of experiments to demonstrate method robustness and performance.
- Prioritize and perform timely testing to enable 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 an electronic laboratory notebook (ELN).
- Summarize and present data clearly and meaningfully.
- Author and review analytical test methods and development reports.
Requirements
- B.S. or M.S. in Analytical Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
- 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 (e.g., chromatography, capillary electrophoresis, spectroscopy, LC-MS).
- Experience with chromatography and mass spectrometry acquisition and data analysis software.
- Familiarity with good documentation requirements and industry guidance.
- Knowledge of statistical approaches for data interpretation and analytical method development.
Skills
- Analytical Chemistry
- Biochemistry
- Chemical Engineering
- Pharmaceutical Sciences
- CMC analytical development
- Chromatography
- Electrophoresis
- Spectroscopy
- Mass Spectrometry
- Method robustness and performance demonstration
- Data evaluation
- Electronic laboratory notebook (ELN)
- Data summarization and presentation
- Method authoring and review
- Critical thinking
- Scientific problem-solving
- Organizational skills
- Good documentation practices
- Statistical approaches
- Detail-oriented
- Creative approach to scientific problem solving
- Spoken and written communication skills
Location
- Remote
Work Type
- Full-time
Experience Level
- 2+ years
Education Level
- B.S.
- M.S.
Salary/Compensations
- $106,000.00 to $138,000.00
Benefits
- 401k
- Healthcare coverage
- ESPP
About the Company
- Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through a deep commitment to degeneration biology and principles of translational medicine.
- 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.
Equal Opportunity
- 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.
