Scientist DMPK

Description:

Duration: 6 months, extension possible. Contract to hire based on business needs and performance.

Location: Gaithersburg, MD, 100% onsite

Title: Scientist / Senior Scientist, Integrated Bioanalysis

We are seeking a highly motivated scientist with excellent scientific and technology skills to join our group within Integrated Bioanalysis at Gaithersburg, Maryland. The successful candidate will lead the development and execution of the Pharmacokinetics (PK), Pharmacodynamics (PD), biomarker and immunogenicity assays to support the preclinical and clinical studies for client's pipeline products across diverse therapeutic areas, with a specific focus on the cell and gene therapy therapeutic areas.

The position is in our Integrated Bioanalysis global team which is part of the Clinical Pharmacology and Safety Sciences, and is responsible for providing broad discovery, preclinical, and clinical support including life cycle management across all therapeutic areas enabling pipeline delivery, decision making, innovation and advancement to improve the lives of patients through life-changing medicines.

What you'll do:

• 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. Review data and reports including troubleshooting as SME.
• Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports. Support regulatory submissions.
• Participate and present in group meetings, project update meetings or technical and scientific discussions.

Required for the role:

• 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 for the role:

• Deep understanding 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.