Immunome, Inc.
Associate Director, Quality Control, Biologics
Bothell, Washington, United States · Director
Sponsorship not specifiedDetected 20 days ago
CadenceGMPFDA RegulatoryLeadershipCommunicationCollaboration
About the role
- Leadership and Collaboration <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbo
Responsibilities
- Develop and implement phase-appropriate QC strategies for biologics and ADC programs across drug substance and drug product development, release, and stability.
- Lead review and interpretation of QC data, trends, OOS/OOT results, deviations, investigations, CAPAs, change controls, and technical reports.
- External Laboratory and Partner Management
- Manage external contract testing laboratories and CDMO QC functions to ensure timely, compliant, and high-quality study execution.
- Establish expectations for documentation quality, sample management, stability pulls, and communication cadence with external partners.
- Regulatory and Documentation Support
Benefits
- Contribute to the long-term vision for Immunome's QC capabilities, including evaluation of technologies, systems, and external partnerships to support portfolio growth.
- Support preparation of IND, BLA, CTD, and other global regulatory submissions, including responses to health authority questions related to QC and analytical controls.
Apply directly at Immunome, Inc. →Create a free account for alerts like thisView Immunome, Inc. immigration profile
This listing is sourced directly from Immunome, Inc.'s careers page and normalized into a canonical job model.