Scientist, Bioanalysis

Denali Therapeutics•South San Francisco, CA

4d•$110,000 - $143,000

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. 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.

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.
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.

Nice To Haves

Hands-on experience with ligand binding assays (e.g., ELISA, MSD) is preferred.

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.