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.
Key Accountabilities/Core Job 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.
Qualifications/Skills:- 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.
Salary Range: $110,000.00 to $143,000.00 . 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.
