Associate Director, Analytical Development and QC
- Lead and manage, in partnership with internal cross-functional teams, QC quality events, such as change controls, deviations, adverse stability trends, OOS/OOT/OOE investigations, root cause analysis, and CAPAs.
- Partner with internal and external teams to meet timelines and company objectives, including, Non-clinical Development, Quality Assurance, Regulatory, and CRO/CDMOs.
- Proactively manage QC gap analyses and QC SOP authoring and revisions for continuous improvement.
- Oversee CDMO for analytical method transfer, phase-appropriate qualification/full validation, reference standard generation and qualification, stability program management and quality control related events.
- Support CDMO as a technical SME for drug intermediates, DS and DP QC testing activities, ensuring all activities are completed according to established timelines and quality standards.
- Support CDMO with management and communication of stability pulls and ensure stability testing occurs within specified testing windows to establish/extend DS and DP shelf life based on stability data.
- Coordinate with internal stakeholders to ensure uninterrupted clinical and commercial supplies.
- Oversee CDMO to manage reference standard and critical reagent programs, including qualification/requalification, inventory, and bridging activities.
- Partner with CMC technical SMEs, QA and Regulatory to prepare and review QC related sections of IND, IMPD, NDA/MAA and global regulatory submissions.
- Provide necessary support information for addressing information requests from regulatory agencies.
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