Scientist, Bioanalytical Sciences

Amgen; United States; On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical/Dental/Vision

Life/Disability insurance

Flexible spending accounts

Job summary

Scorpion Therapeutics is seeking a Scientist, Bioanalytical Sciences to provide technical SME oversight of outsourced bioanalytical methods, ensuring method validation and optimal CRO performance in alignment with GLP/GCP and regulatory requirements.

You will oversee PK assay transfer/validation at CROs using LBA, ELISA, ECL, LC-MS/MS, and hybrid approaches; collaborate with internal SMEs; manage method lifecycle and review study documentation for GLP/GCP compliance.

Qualifications

• Doctorate required or equivalent post-doc experience.
• Master''s degree with 2+ years regulated commercial scientific lab experience or Bachelor''s with 4+ years regulated lab experience.
• Experience with GLP/GCP and regulatory guidance (FDA/ICH/EMEA/NMPA).
• Strong project/people management and planning/process skills.
• Excellent written and verbal communication; collaboration/negotiation; results-oriented mindset.

Responsibilities

• Oversee PK assay transfer/validation/execution at CROs per sponsor requirements and regulatory guidance.
• Lead transfer/validation of PK assays using ligand-binding, ELISA, ECL, LC-MS/MS, and hybrid methodologies.
• Collaborate with internal bioanalytical SMEs; monitor performance, troubleshoot, and drive continuous improvement.
• Manage method lifecycle: review validation plans, protocols, and reports; qualify/bridge reagents and materials.
• Review study documentation for scientific accuracy and GLP/GCP compliance; support issue resolution with CRO partners.
• Provide expertise for supplier evaluation/monitoring; contribute to guidance/SOPs; support regulatory activities.

Skills

PK assay development/validation/trTrou

Project management

Communication

Regulatory knowledge

Education

Doctorate

Master's + 2 years regulated lab experience

Bachelor's + 4 years regulated lab experience

Job description

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.