Associate Director, External Quality Control

How You Will Make An ImpactProvide a full range of External Quality Control (QC) activities supporting Halozyme's ENHANZE programs across commercial, clinical, and development products and programs.Oversee Drug Substance (DS) and Drug Product (DP) Contract Manufacturing Organizations (CMOs) producing and testing Halozyme products, including supervision of staff.In This Role, You'll Have The Opportunity ToDirect, lead, and develop a team of QC associates; mentor and provide growth opportunities.Direct and manage technical external QC activities during GMP analyses (e.G., technical data review for in-process, release, and stability; support method transfers, qualifications, validations, and QA technical interactions).
Support CMOs with QC-related investigations and analytical method issues.Lead external QC activities, meet delivery dates, and lead technical areas across all programs while ensuring adherence to cGMP requirements at CMOs.Manage change controls for CMO analytical met...

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