Support DMPK activity in research and development projects in Drug Metabolism and Pharmacokinetics (DMPK) team. The position reports to the Sr. director of DMPK.
Responsibilities: • Prepare, review, and data QC of GLP/non-GLP-related documents (SOPs, protocol, amendment, report, etc.) generated internally or externally in DMPK, toxicology and/or formulation • Create master DMPK data file and initiate multiangle PK related data analysis • DMPK Data entry to internal database • Assist the DMPK department head in establishing solid research and development system
Qualifications: • Ph.D. or MS 3+ years of experience in DMPK/ pharmacology/biochemistry, and ideally GLP regulations and relevant FDA guidelines • Analytical skills with LC/MS/MS (e.g. HRMS), data interpretation, and troubleshooting skills for bioanalytical equipment and method development. • Strong communication and interpersonal skills. • Hands-on experience with WinNonlin/Phoenix and simulation software (e.g. Simulation Plus or SymCyp).