Scientist, Bioanalysis

Key Accountabilities/Core Job Responsibilities

• Develop and qualify bioanalytical methods supporting discovery and development of novel therapeutics, including measurement of biomarkers, drug concentration, and anti-drug antibodies.
• Conduct bioanalytical experiments to support advancement of the drug development portfolio.
• Work with novel biotherapeutic analyses and contribute to the development of mass spectrometry methods 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 adhering to global regulatory guidelines for IND/CTA/BLA/NDA filings.
• Analyze, interpret, and present data to project teams.

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

• Salary range: $110,000–$143,000; includes 401k, healthcare coverage, and ESPP.