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Scientist - LC-MS Bioanalytical

Amgen
2023 years ago
On-site
Thousand Oaks, CA
Clinical Research and Development

Role Summary

The Scientist โ€“ LC-MS Bioanalytical designs, develops, validates, and implements LC-MS/MS bioanalytical methods for small molecules, oligonucleotides, proteins, and other complex modalities to support GLP preclinical and regulated clinical studies. The role is lab-based with emphasis on data integrity, documentation, and timely collaboration across research and development teams.

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 which include but is 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, including QC of reports.

Qualifications

  • Required: Doctorate degree
  • Required: Masterโ€™s degree and 2 years of relevant industrial/technical experience
  • Required: Bachelorโ€™s degree and 4 years of relevant industrial/technical experience
  • Preferred: Prior experience in CRO or pharma/biotech strongly desired
  • Preferred: Strong technical expertise in quantitative mass spectrometry on triple quadrupole (QQQ) platforms as well as HRMS
  • Preferred: Experience with an array of analytical technologies that can accelerate bioanalysis including automation and/or micro-sampling
  • Preferred: Prior GLP and GCP experience
  • Preferred: Demonstrated expertise working with a variety of sample types (e.g., blood, plasma, serum, tissues, cerebrospinal fluid) and employing diverse sample preparation techniques (e.g., SPE, LLE, immunocapture) to support analysis of different therapeutic modalities, including small and large molecules by LC-MS
  • Preferred: Prior experience in bioanalytical (regulated) assay execution and transfer to CROs
  • Preferred: 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
  • Preferred: Demonstrated ability to resolve scientific challenges efficiently and prioritize effectively
  • Preferred: Excellent scientific problem-solving skills
  • Preferred: Excellent project and time management abilities
  • Preferred: Ability to work collaboratively with internal and external stakeholders
  • Preferred: Supervisory and mentoring experience in a lab-based setting