About The Role
- Scientist or Senior Scientist (Bioanalysis) supporting early-stage biologics drug development programs.
- Develop ligand binding assays (LBA) and perform bioanalysis for preclinical pharmacokinetic (PK) studies in rodents and non-human primates, primarily under non-regulated conditions.
- May support regulated GLP toxicology studies and work with external CRO partners for method transfer and study execution.
- ADA assay development is desirable (screening/confirmatory/titer) as an add-on to primary PK responsibilities.
Your Contributions (include, but are not limited to)
- Develop, optimize, and qualify ligand binding assays (e.g., ELISA, MSD/ECL, Gyrolab) for preclinical non-regulated PK studies of antibodies, bispecifics, and fusion proteins.
- Perform hands-on bioanalysis of preclinical samples; ensure data quality, integrity, and scientific rigor.
- Author/review bioanalytical protocols, assay qualification/validation reports, and preclinical study reports.
- Analyze, interpret, and communicate PK bioanalytical data to project and DMPK teams.
- Collaborate with DMPK, toxicology, and pharmacology teams to support study design and data interpretation.
- Interact with external CROs: method transfer support, technical oversight, CRO data/document review, assay troubleshooting and workflow improvement.
- Senior Scientist: provide technical leadership, mentor junior scientists, and contribute to preclinical bioanalytical and outsourcing strategy.
Requirements
Scientist
- BS/BA with 2+ years of industry bioanalysis OR MS/MA with some relevant experience OR PhD/equivalent with some relevant experience.
- Hands-on LBA development for PK bioanalysis.
- Experience supporting preclinical non-regulated studies, preferably in rodents and/or non-human primates.
- Basic understanding of GLP principles and bioanalytical best practices.
- Strong experimental, data analysis, and documentation skills.
Senior Scientist
- BS/BA with 5+ years of industry bioanalysis OR MS/MA with 3+ years relevant experience OR PhD/equivalent with some relevant experience.
- Demonstrated expertise in preclinical PK LBA strategy and execution.
- Experience supporting GLP toxicology studies and working with quality/compliance functions.
- Proven experience interacting with and overseeing external CROs.
- Ability to work independently, lead bioanalytical efforts, and mentor junior scientists.
Benefits
- Annual base salary: $110,800–$151,000.
- Annual bonus (target 20% of earned base salary); eligibility for equity-based long-term incentive.
- Retirement savings plan (company match); paid vacation/holidays/personal days; paid caregiver/parental and medical leave.
- Health benefits including medical, prescription drug, dental, and vision (per plan terms).