Manager, Bioanalytical

  1. Well-versed in cGXP regulations, managing bioanalytical (BA) and nonclinical formulation analysis projects internally and at CROs.
  2. Understand and interpret drug metabolism and pharmacokinetics (“DMPK”) and present in project meeting.
  3. Independently perform BA method development and sample analysis to support in vivo studies and perform maintenance and troubleshooting of LC-MS/MS systems.
  4. Incorporating emerging technologies and relevant applications in bioanalysis.
  5. Supervise and training junior scientists.
  6. Prepare and peer review of BA/PK/TK data and reports and regulatory documents.
  7. Other duties may be assigned as necessary.

Qualifications:

  1. College degree chemistry/biology or a related discipline with at least 15 years of experience (demonstrated relevant experience may be substituted for degree).
  2. Prior industrial experience in small molecule bioanalysis and CRO management is required; experience in large molecule bioanalysis is desirable.
  3. Prior experience in non-compartmental PK data analysis is desirable but not required (preferably using Phoenix WinNonlin software).
  4. Prior experience in Watson LIMS is desirable but not required.

 

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