Scientist - LC-MS Bioanalytical

Role Summary

Scientist - LC-MS Bioanalytical: Design, develop, validate, and implement robust LC-MS/MS bioanalytical methods for a wide range of therapeutic modalities to enable GLP preclinical and regulated clinical studies. The role is lab-based with emphasis on data management, report generation, time management, communication, and data presentation, and involves multidisciplinary collaboration across research and development at Amgen.

Responsibilities

• Perform quantitative bioanalytical experiments and organize data and results, including planning and running LC-MS/MS bioanalysis and preparing and analyzing biological samples
• Develop and implement LC-MS/MS bioanalytical methods with quick turnaround times
• Conduct small and large molecule bioanalysis in non-clinical and clinical samples from various matrices (plasma, urine, CSF, tissues)
• Perform biological sample extraction using protein crash (PPT), SPE, LLE, and/or affinity capture methodologies
• Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook
• Ensure bioanalytical data meets regulatory expectations for global submissions by maintaining accurate records and staying current with industry guidelines
• Author study reports, standard operating procedures, analytical methods, memos, and other regulatory-compliant documents
• Communicate bioanalytical data to key discovery and development teams, contribute to scientific publications, and present at professional meetings
• Comply with safety guidelines and site-specific procedures including training, maintenance of training records, laboratory documentation, and following detailed SOPs
• Perform general laboratory housekeeping activities and operational support as needed, including QC of reports

Qualifications

• Required: Doctorate degree (PhD or PharmD or MD) and 1‚Äì3 years of relevant industrial or postdoctoral experience, or Master‚Äôs degree with 5 years of relevant industrial/technical experience, or Bachelor‚Äôs degree with 7 years of relevant industrial/technical experience
• Preferred: Prior experience in CRO or pharma/biotech; strong technical expertise in quantitative mass spectrometry on triple quadrupole (QQQ) platforms as well as HRMS; experience with automation and/or micro-sampling; prior GLP and GCP experience; experience with diverse sample types and preparation techniques (SPE, LLE, immunocapture) for small and large molecules by LC-MS; prior experience in bioanalytical (regulated) assay execution and transfer to CROs; ability to work in a fast-paced, multi-project environment; strong problem-solving, project/time management, collaboration, and supervisory/mentoring experience in a lab setting