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Scientist / Senior Scientist, Integrated Bioanalysis
2 months ago
We are seeking a highly skilled scientist to join our team within Integrated Bioanalysis at Gaithersburg, Maryland. The successful candidate will lead the development and execution of bioanalytical assays to support preclinical and clinical studies for our pipeline products across diverse therapeutic areas.
Key Responsibilities:
- Lead the development, qualification, and execution of bioanalytical assays.
- Perform data analysis and interpretation to support pre-clinical and clinical studies of drug development.
- Interact with cross-functional project teams and contribute to the development of bioanalysis strategy and advancing bioanalytical technologies.
- Ensure timely delivery of high-quality bioanalysis results to enable project milestone achievement.
- Conduct effective tech transfer and collaboration with internal teams or external contractors.
Requirements:
- PhD 0-3yr experience, MS or BS with 3+years experience in immunology, molecular biology, or related studies with relevant experience.
- Proven expertise in immunoassays for bioanalytical characterizations.
- Strong scientific, data analysis, and problem-solving skills.
- Demonstrated strong accountability, organizational, and communication skills.
- Ability to handle multiple projects and/or tasks concurrently in a fast-paced environment.
Desired Qualifications:
- Deep understanding of the bioanalysis requirement in development of biotherapeutics and hands-on experience in qualifying and validating bioanalytical assays.
- Experience across a range of therapeutic modalities.
- Broad knowledge and hands-on analytical skills, e.g., Molecular (qPCR/ddPCR) assays, Flow cytometry, Mass Spectrometry, Cell-based assays.
- Experience in GLP/GCP compliant studies and IND/BLA regulatory submissions.
