Scientist - Pharmacokinetics and Drug Metabolism (PKDM)
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. Amgen Pharmacokinetics and Drug Metabolism (PKDM) is currently seeking a motivated scientist to work out of the Thousand Oaks location and who will contribute to developing, validating and implementing robust bioanalytical methods for detection of binding and neutralizing anti-drug antibodies to large molecule biotherapeutic modalities. These methods will be required to understand the immunogenic properties of these molecules in both nonclinical and clinical studies.
The department of PKDM within Amgen is dedicated to the discovery and development of novel effective, safe medicines. PKDM scientists work closely in partnership with disciplines such as protein therapeutics, medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences and clinical pharmacology and regulatory to design promising clinical therapeutic candidates, conduct preclinical development studies, support clinical evaluation and contribute to regulatory submissions.
The primary responsibilities of the Scientist will include:
- Design and execution of innovative scientific experiments for development, validation and implementation of robust bioanalytical methods capable of detecting anti-drug antibodies (ADA) in clinical and nonclinical study samples.
- Develop and implement new and novel protocols to address specific issues and/or troubleshoot and improve current existing assay platforms towards being more robust and transferable.
Basic Qualifications for Scientist
Master's degree and 4 years of pharmaceutical-biotechnology and/or CRO industry and/or Scientific experience
Bachelor's degree and 6 years of pharmaceutical-biotechnology and/or CRO industry and/or Scientific experience
- 0-2 years of laboratory experience.
- Experience in any of the following areas: immunology, immunochemistry, biochemistry, cell biology or equivalent.
- Analytical skills in utilizing broad range of technologies including ligand binding and/or cellular assays for detection of anti-drug antibodies or test analyte of interest in complex biological matrices.
- Working knowledge of the regulatory (GxP) requirements for bioanalysis in drug development.
- Demonstrated ability to drive scientific excellence and innovation.
- Demonstrated record of contributing as lead author on external peer review publications.
- Ability to work in a team environment with excellent verbal and written communication skills.
- Critical thinking skills with an ability to integrate data and information to solve complex problems to advance drug discovery and development programs.
- Effectively be able to communicate complex ideas to audiences with varying degrees of knowledge.