Scientist, Bioanalysis

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.

About the role

The Scientist in Bioanalytical Sciences contributes to development, qualification/validation, and implementation of bioanalytical methods to support drug discovery and development. The incumbent ensures accurate analysis of biological samples and collaborates cross-functionally to ensure regulatory compliance and timely delivery of project goals.

Responsibilities

• Develop and qualify bioanalytical methods supporting discovery and development of novel therapeutics, including measurement of biomarker, drug concentration, and anti-drug antibodies.
• Conduct bioanalytical experiments to support advancement of drug development portfolio.
• Work with novel biotherapeutic analyses and contribute to the development of mass spectrometry methods and analyses for oligonucleotides & proteins.
• Engage bioanalytical CROs for method optimization, assay transfer, qualification/validation, sample testing, and delivery of results within project timelines.
• Write, review, and finalize bioanalytical study reports that adhere to global regulatory guidelines for IND/CTA/BLA/NDA filings.
• Analyze, interpret, and present data to project teams.

Requirements

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related scientific discipline (or MS with 3+ years or BS with 5+ years of biotechnology or pharmaceutical discovery and development experience).
• Hands-on experience in conduct of bioanalytical method development, qualification/validation, and sample testing for drug discovery and development.
• Hands-on experience with various sample preparation techniques (protein precipitation, liquid-liquid extraction, and solid-phase extraction), chromatographic separation, and operation of triple-quadrupole mass spectrometers.
• Hands-on experience with ligand binding assays (e.g., ELISA, MSD) is preferred.
• Practical knowledge of regulatory guidance (FDA, EMA, and ICH) related to regulated bioanalysis.
• Experience in relevant bioanalytical tools and instrumentation.
• Excellent critical thinking, communication, and collaboration skills, with experience working cross-functionally or with CROs.

Pay

Salary range: $110,000 to $143,000. Compensation for the role will depend on a candidate’s qualifications, skills, competencies, and experience.

Benefits

• Competitive total rewards package, including a 401k, healthcare coverage, and Employee Stock Purchase Plan (ESPP).
• Broad range of other benefits.

Learn more at Denali Therapeutics Careers.