Design, develop, optimize, and validate ligand binding assays for PK, ADA, and other biomarker applications in accordance with applicable SOPs, regulatory guidelines, and industry best practices.
Lead scientific troubleshooting and implement appropriate assay improvements to address technical challenges.
Perform method transfer, qualification, and validation activities to support study requirements.
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Organizes, conducts and evaluates analytical results and testing.
Maintains study documentation and laboratory records.
Independently sets-up, maintains, operates and performs routine and non-routine maintenance on general equipment, including problem identification and resolution.
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Analyzes biological or chemical samples and/or develops/validates methodologies for various compounds and components in compliance with appropriate standard operating procedures (SOPs) and regulatory agency guidelines.
Documents work and maintains study documentation and laboratory records.
Independently sets up, maintains, operates and performs routine and non-routine maintenance on general equipment, including problem identification and resolution.
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Responsible for coordinating the receipt, tracking, processing, shipment, and documentation of clinical trial samples to ensure they are handled according to study protocols, regulatory requirements, and quality standards.
Receive, accession, track, label, store, ship, and dispose of clinical samples.
Verify sample inventory accuracy and resolve or escalate discrepancies.
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