The Bioanalytical Manager is responsible for overseeing the development and implementation of both internal and external bioanalytical methods in support of discovery, GLP toxicokinetic (TK) and clinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This individual will work with internal and external resources to ensure adequately qualified/validated assays are available to support development of Neurocrine’s preclinical candidate and clinical-stage compounds and that PK and PD study samples are optimally collected, analyzed and analytical results reported.
Responsibilities include, but are not limited to:
- Consistent with industry standards and regulatory requirements, acting as scientific lead and project manager for the external assays development and validation and sample analysis of Neurocrine’s development compounds, metabolites, concomitant medications, and/or pharmacodynamic markers.
- Work with Neurocrine colleagues across multiple programs to determine assay needs and manage assay development, TK/PK/PD sample analysis and reporting of results in a timeframe consistent with project goals.
- Supervise internal bioanalytical team.
- Troubleshooting and maintaining laboratory instrumentations, evaluating and introducing relevant new technologies to laboratory.
- Hand-on bioanalytical work as needed.
- D. in Pharmaceutical Sciences, Analytical Chemistry or related discipline with 5+ years pharmaceutical industry experience or BS/MSc. with 10+ years relevant experience.
- Highly knowledgeable on domestic and international regulatory requirements for bioanalytical assay validation and sample analysis.
- Extensive hands-on experiences in bioanalytical method development and validation, sample analysis, and LC-MS/MS system maintenance and troubleshooting.
- Extensive expertise overseeing work conducted at CROs.
- Experience with writing and review reports and technical regulatory documents.
- Experience with high resolution mass spec (HRMS) is highly desirable.
- Experience developing biological assays for PD markers is a plus.
- Strong communication skills and ability to work effectively in a multidisciplinary team environment.