Bioanalytical Scientist — PK/LBA Methods & CRO Oversight

Amgen SA; United States; Remote; USD 130,000 - 180,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Health, Dental, Vision Insurance

Stock-based incentives

Flexible work plans

Paid time off

Job summary

Amgen seeks a Scientist, Bioanalytical Sciences to serve as the technical SME for outsourced methods and ensure validated, high‑quality bioanalytical data. You will oversee PK assays at CROs, using ELISA, ECL, LC‑MS/MS and hybrid approaches, ensuring data integrity and regulatory alignment.

The role requires a PhD (or equivalent) with relevant post‑doctoral or industry experience in PK/LBA/LC‑MS bioanalysis, and strong communication skills to collaborate across teams.

Qualifications

• Experience in PK assay development, validation and troubleshooting for LBA or LC‑MS bioanalysis.
• Scientific oversight of outsourced bioanalytical activities with CROs.
• Familiarity with GLP/GCP principles and data integrity standards.
• Strong communication and cross‑functional collaboration abilities.

Responsibilities

• Provide scientific oversight for transfer, validation, and execution of PK assays at CROs.
• Lead transfer/validation of PK assays using ligand-binding, ELISA, ECL, LC-MS/MS and hybrids.
• Collaborate with internal SME to understand PK method attributes for successful transfer.
• Monitor assay performance and drive troubleshooting and continuous improvement.

Skills

PK assay development

LC-MS bioanalysis

Bioanalytical methods

Communication skills

Education

Doctorate degree

Master’s degree + 2 years

Bachelor’s degree + 4 years

Tools

ELISA

ECL

LC-MS/MS

Job description

Amgen seeks a Scientist, Bioanalytical Sciences to serve as the technical SME for outsourced methods and ensure validated, high‑quality bioanalytical data. You will oversee PK assays at CROs, using ELISA, ECL, LC‑MS/MS and hybrid approaches, ensuring data integrity and regulatory alignment.

The role requires a PhD (or equivalent) with relevant post‑doctoral or industry experience in PK/LBA/LC‑MS bioanalysis, and strong communication skills to collaborate across teams.