Scientist II, Analytical Development

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Technical and GMP expert that will be responsible for supporting analytical method lifecycle activities at external AD/QC laboratories for late-phase antibody-drug conjugate (ADC) development. The candidate will support CMC activities to enable filing and commercialization of ADC programs. The candidate will manage antibody and ADC reference standard programs for all development phases.

Responsibilities:

• Support validations, re-validations, transfers, continued performance verification (trending), optimization, troubleshooting, etc. for antibody and ADC methods established at external laboratories for IPC, release, and stability testing
• Set strategy and oversee execution of phase-appropriate qualification and re-qualification of antibody and ADC reference standards (RS), track and manage RS inventory at external laboratories, determine forecasts and work with external organizations to fill and qualify new RS when needed
• Author or review all documentation (protocols, reports, test methods) related to the activities above; collaborate closely with QA to ensure applicable requirements are met (GMP, ICH, compendial, etc.)
• Plan and execute laboratory experiments to support method optimization or troubleshooting
• Author change controls for analytical-related changes and support deviation/excursion management
• Serve as analytical representative on CMC team; work closely with manufacturing sciences, quality assurance, regulatory CMC, and supply chain to support program objectives
• Perform statistical analysis of batch data to support specification setting and product comparability studies
• Support Regulatory CMC activities (filings, information requests, in-country registration testing)

Q