The Bioanalytical Sr. Scientist/Principal Investigator (DMPK) will be an essential contributor to the scientific and operational scope of both discovery and clinical programs. The successful candidate will develop and conduct immunoassays in support of preclinical pharmacokinetics, GLP toxicology studies, and clinical PK and ADA studies supporting the development of protein therapeutics. Working in collaboration with Discovery, Clinical Development, and Translational functional areas, the candidate will develop large molecule bioanalytical strategies for drug and ADA assays, as well as bioanalytical support for quantification of translational biomarkers.
Job Duties and Responsibilities
Responsibilities may include, but are not limited to:
- Develop and perform bioanalytical immunoassays to determine pharmacokinetic parameters of protein therapeutics in preclinical species.
- Develop and qualify PK and ADA bioanalytical methods appropriate for GLP preclinical and clinical studies, and facilitate method transfer to external CROs.
- Collaborate with translational scientists to develop quantitative methods for measurement of biomarkers and relevant PD endpoints.
- Manage, review, and evaluate bioanalytical immunoassay results supplied by external CRO, and review GLP and clinical bioanalytical assay validation protocols and reports.
- Prepare bioanalytical method summaries for study reports and relevant sections of regulatory filings.
- Analyze, summarize, and present large molecule PK data in project team meetings.
- Ph.D. in biochemistry, analytical chemistry, pharmacokinetics or related field with at least 3 years of experience at a CRO, biotechnology or pharmaceutical company, or BS/MS with extensive biopharmaceutical industry experience.
- Expertise in immunoassay/ligand binding assay techniques and experience with ADA assays.
- Knowledge of regulatory bioanalytical guidelines as applied to protein therapeutics.
- Demonstrated ability to analyze, interpret, and communicate complex bioanalytical data.
- Excellent oral and written communication skills.
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