DMPK Scientist

4 days ago

Cambridge, Massachusetts, United States Beacon Hill Full time
Job Title: DMPK Contractor

Beacon Hill is seeking a skilled DMPK Scientist to support drug metabolism and pharmacokinetics activities in research and development.

Key Responsibilities:
  • Document Preparation and Review: Prepare, review, and quality control (QC) of GLP and non-GLP documents (SOPs, protocols, amendments, reports) related to DMPK, toxicology, and formulation activities.
  • Data Management and Analysis: Create and manage master DMPK data files, performing multi-angle PK data analysis, and enter DMPK data into internal databases, ensuring accuracy and compliance with regulatory requirements.
  • Collaboration and Support: Assist the DMPK department head in developing and optimizing research and development systems, and collaborate with internal teams to ensure data integrity and adherence to industry standards and guidelines.
Qualifications:
  • Education and Experience: Ph.D. or MS in DMPK, Pharmacology, Biochemistry, or a related field with 3+ years of relevant experience.
  • Regulatory Knowledge: Strong understanding of GLP regulations and relevant FDA guidelines.
  • Technical Skills: Proficiency with analytical methods, particularly LC/MS/MS (e.g., HRMS), with the ability to interpret data and troubleshoot bioanalytical equipment and method development, and experience with PK analysis software such as WinNonlin/Phoenix and simulation software (e.g., Simulation Plus or SymCyp).
  • Communication and Interpersonal Skills: Excellent communication and interpersonal skills for effective collaboration across teams.
Preferred Skills:
  • Method Development and Validation: Experience with bioanalytical method development and validation.
  • Organizational Skills: Strong organizational skills and attention to detail.
  • Toxicology and Formulation Support: Experience supporting toxicology and formulation-related tasks.

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