Bioanalytical Scientist - PK/LC-MS & ELISA, CRO Expert

Scorpion Therapeutics; 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

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.