Senior Scientist, Bioanalytical Science

MS/PhD degree in analytical chemistry, bioanalytical chemistry, pharmaceutical analysis with 3+ years for PhD, or 8+ years for MS.

Track record of supporting the development and validation of bioanalytical LC-MS/MS methods designed at standards ranging from “fit-for-purpose” through GLP.

Analysis of prodrugs and associated species highly desirable

Hands-on familiarity running and maintaining industry-standard mass spectrometry instrumentation

Understanding of FDA and global regulatory requirements of study types assigned, as well as Testing Facility SOPs and Good Laboratory Practices (GLPs), as appropriate.

Experience with CROs and managing outsourced studies critical

Support the development and optimization of bioanalytical methods (e.g.

LC/MS) to evaluate concentration of API, metabolites, and related species across multiple small and large animal species

Manage execution of method development and sample analysis across multiple external CROs and collaborators

Assist in design and selection of methods of sample extraction and analysis across a range of matrices including lymph, plasma, and solid tissues

Perform pharmacokinetic analysis of data, communicate results, provide scientific interpretations and recommendations to cross-functional project teams and leadership

Contribute to the development or application of relevant pharmacokinetic models to add fundamental understanding where appropriate