Experience supporting biologics programs is required, and experience with Antibody-Drug Conjugates (ADCs) is highly desirable.
Key Responsibilities:
- Lead analytical CMC activities for early-stage biologics and/or ADC programs, with oversight of analytical development and QC activities at CDMOs and external laboratories
- Serve as the primary analytical lead for CDMO interactions, managing technical execution, timelines, deliverables, and cross-functional coordination across CMC, quality, regulatory, manufacturing, and clinical supply teams
- Oversee analytical method development, qualification, transfer, and lifecycle management for drug substance and drug product programs
- Provide analytical oversight of QC activities including release and stability testing, characterization, reference standards, investigations, deviations, and change controls
- Develop phase-appropriate analytical control strategies, including specification setting and justification, to support clinical development and regulatory requirements
- Lead stability strategy and data review to support shelf-life and retest period assignments
- Review analytical data to support process development, comparability, process characterization, investigations, and regulatory submissions
- Author and review analytical CMC sections for INDs and other regulatory submissions, including specifications, analytical methods, qualification/validation summaries, comparability, and stability documentation
- Support regulatory interactions and ensure analytical activities comply with GMP, ICH, and global regulatory expectations
- Identify analytical and operational risks related to external execution and implement mitigation strategies to support program timelines and milestones