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Scientist, PK/PD

3 months ago

Gaithersburg, United States Fladger Associates Full time

We are seeking a dynamic Scientist or Senior Scientist to join our Integrated Bioanalysis team in Gaithersburg, MD. This role focuses on supporting preclinical and clinical studies for our cutting-edge pipeline, with a focus on cell and gene therapy.


Key Responsibilities:

  • Lead the development, qualification, and execution of bioanalytical assays for Pharmacokinetics (PK), Pharmacodynamics (PD), biomarkers, and immunogenicity.
  • Analyze and interpret data to support preclinical and clinical drug development.
  • Collaborate with cross-functional teams to advance bioanalytical strategies and technologies.
  • Ensure accurate documentation in electronic laboratory notebooks and technical reports.
  • Contribute to regulatory submissions, tech transfers, and project milestone achievements.


Requirements:

  • PhD with 0-3 years of experience, or MS/BS with 3+ years of experience in immunology, molecular biology, or related fields.
  • Proven expertise in immunoassays and bioanalytical characterizations.
  • Strong problem-solving, communication, and organizational skills.
  • Ability to manage multiple tasks in a fast-paced environment.


Preferred Qualifications:

  • Hands-on experience with bioanalytical assay validation (qPCR, ddPCR, flow cytometry, mass spectrometry, cell-based assays).
  • Experience with GLP/GCP compliant studies and IND/BLA regulatory submissions.