Scientist - LC-MS/MS Bioanalytical

About the role

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Responsibilities

• Develop and implement LC-MS/MS bioanalytical methods with quick turnaround times.
• Conduct small molecule bioanalysis of parent and metabolites in non-clinical and clinical samples from various matrices (plasma, urine, CSF, tissues).
• Perform biological sample extraction using protein precipitation, SPE, and LLE.
• Generate complete, accurate, and concise documentation using LIMS and electronic laboratory notebook systems.
• 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, scientific publications, 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 which include but are not limited to the completion of training on assigned tasks, maintenance of training records, laboratory documentation, and following detailed SOPs and other written procedures.
• Perform general laboratory housekeeping activities and operational support as needed.

Requirements

• Doctorate degree PhD
• OR PharmD
• OR MD [and relevant post-doc where applicable]
• OR Masters degree and 3 years of LC-MS/MS Bioanalytical experience
• OR Bachelors degree and 5 years of LC-MS/MS Bioanalytical experience

Qualifications

• Prior experience in pharma/biotech strongly desired.
• Strong technical expertise in quantitative mass spectrometry on triple quadrupole (QQQ) platforms.
• Demonstrated expertise in working with a variety of sample types (e.g., blood, plasma, tissues, urine, cerebrospinal fluid) employing diverse sample preparation techniques (e.g., SPE, LLE) to support analysis of small molecules and metabolites by LC-MS/MS.
• Experience with an array of analytical equipment and technologies that can accelerate bioanalysis including automation and/or micro-sampling.
• Prior GLP and GCP experience.
• Prior experience in bioanalytical (regulated) assay execution and method transfer to external contract laboratories.
• Understanding of pharmacokinetic and toxicokinetic principles and analysis.
• Must be willing to work in a fast-paced, multi-project environment with high workload demands, and consistently deliver high-quality results within established timelines.
• Demonstrated ability to efficiently resolve scientific challenges, prioritize and effectively manage multiple projects.
• Excellent scientific problem-solving skills.
• Excellent project and time management abilities.
• Ability to work collaboratively with internal and external stakeholders.
• Supervisory and mentoring experience in a lab-based setting.