Target Start Date: 10/1/2024 / ASAP
Position - DMPK Contractor
Full-time or part-time: Full time Contract
Remote, hybrid or onsite?: Onsite
Company Address: Cambridge, MA
End Date: 12/31/2024
Target Pay Rate: Market rate
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).
