Scientist, Bioanalytical Sciences
Amgen
August 25, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Scientist, Bioanalytical Sciences
What You Will Do
- Serve as technical subject matter expert for outsourced bioanalytical methods; ensure adequate method validation and optimal performance at CROs.
- Provide scientific/technical oversight of outsourced bioanalytical phases governed by GLP/GCP, including PK/TK analyses.
- Ensure adherence to validated methods, data integrity, and alignment with study protocols and regulatory requirements.
Key Responsibilities
- Oversee transfer, validation, and execution of pharmacokinetic (PK) assays per sponsor requirements and regulatory guidance (e.g., FDA, ICH, EMEA, NMPA).
- Lead transfer/validation of PK assays at CROs using ligand-binding, ELISA, ECL, LC-MS/MS, and hybrid methodologies.
- Collaborate with internal bioanalytical SMEs; monitor performance, troubleshooting, and continuous improvement.
- Manage method lifecycle (review validation plans/protocols/reports; qualify/bridge reagents/reference materials).
- Review study documentation for scientific accuracy and GLP/GCP compliance; support issue resolution/escalation with CRO partners.
- Provide expertise for supplier evaluation/monitoring; follow and contribute to guidance/SOPs; support regulatory activities.
Basic Qualifications
- Doctorate (and relevant post-doc where applicable)
OR Master’s + 2 years regulated commercial scientific lab experience
OR Bachelor’s + 4 years regulated commercial scientific lab experience
Preferred Qualifications
- PK assay development/validation/troubleshooting for LBA, LC-MS, or hybrid assays; CRO experience
- Knowledge of regulatory guidance (FDA/ICH/EMEA/NMPA)
- Project/people management; planning/process and project/issue management
- Excellent written/verbal communication; collaboration/negotiation; drives for results.
Benefits (if eligible)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; bonus; stock-based long-term incentives; time-off; flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com; no application deadline—applications continue until sufficient candidates are received or a candidate is selected.
What You Will Do
- Serve as technical subject matter expert for outsourced bioanalytical methods; ensure adequate method validation and optimal performance at CROs.
- Provide scientific/technical oversight of outsourced bioanalytical phases governed by GLP/GCP, including PK/TK analyses.
- Ensure adherence to validated methods, data integrity, and alignment with study protocols and regulatory requirements.
Key Responsibilities
- Oversee transfer, validation, and execution of pharmacokinetic (PK) assays per sponsor requirements and regulatory guidance (e.g., FDA, ICH, EMEA, NMPA).
- Lead transfer/validation of PK assays at CROs using ligand-binding, ELISA, ECL, LC-MS/MS, and hybrid methodologies.
- Collaborate with internal bioanalytical SMEs; monitor performance, troubleshooting, and continuous improvement.
- Manage method lifecycle (review validation plans/protocols/reports; qualify/bridge reagents/reference materials).
- Review study documentation for scientific accuracy and GLP/GCP compliance; support issue resolution/escalation with CRO partners.
- Provide expertise for supplier evaluation/monitoring; follow and contribute to guidance/SOPs; support regulatory activities.
Basic Qualifications
- Doctorate (and relevant post-doc where applicable)
OR Master’s + 2 years regulated commercial scientific lab experience
OR Bachelor’s + 4 years regulated commercial scientific lab experience
Preferred Qualifications
- PK assay development/validation/troubleshooting for LBA, LC-MS, or hybrid assays; CRO experience
- Knowledge of regulatory guidance (FDA/ICH/EMEA/NMPA)
- Project/people management; planning/process and project/issue management
- Excellent written/verbal communication; collaboration/negotiation; drives for results.
Benefits (if eligible)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; bonus; stock-based long-term incentives; time-off; flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com; no application deadline—applications continue until sufficient candidates are received or a candidate is selected.