- Well-versed in cGXP regulations, managing bioanalytical (BA) and nonclinical formulation analysis projects internally and at CROs.
- Understand and interpret drug metabolism and pharmacokinetics (“DMPK”) and present in project meeting.
- Independently perform BA method development and sample analysis to support in vivo studies and perform maintenance and troubleshooting of LC-MS/MS systems.
- Incorporating emerging technologies and relevant applications in bioanalysis.
- Supervise and training junior scientists.
- Prepare and peer review of BA/PK/TK data and reports and regulatory documents.
- Other duties may be assigned as necessary.
- College degree chemistry/biology or a related discipline with at least 15 years of experience (demonstrated relevant experience may be substituted for degree).
- Prior industrial experience in small molecule bioanalysis and CRO management is required; experience in large molecule bioanalysis is desirable.
- Prior experience in non-compartmental PK data analysis is desirable but not required (preferably using Phoenix WinNonlin software).
- Prior experience in Watson LIMS is desirable but not required.