Scientist, PK/PD
4 weeks ago
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.
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