Principal Project Manager, CMC - Temporary

6 days ago

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We are harnessing the immune system to treat neurodegeneration and cancer.

Biotechnology • Neurodegenerative disease • Neurodegeneration • Immuno-neurology

51 - 200

💰 $133M Series E on 2018-07

Description

• Provides CMC and Quality project management support for the Research and Development Portfolio. • Ensure the CMC team meets key landmarks, goals and timelines as defined in the program strategy. • Develop and track timelines, integrating CMC timelines into overall program timelines. • Document meeting minutes, actions and decisions, ensuring timely completion of activities/CAPAs. • Manage risk registers and other operational activities as needed.

Requirements

• Strong scientific background, minimum of a bachelor’s degree in the Sciences (advanced degree preferred; PMP Certification is a plus). • 10-15+ years biopharma industry experience, including experience with biologics and virtual manufacturing, with a minimum of 5-8 years of experience in CMC project management; experience working in Process Sciences and with filing BLAs is preferred. • Knowledge of the cross-functional CMC & Quality activities required to take a research program from development to commercial launch. • Working knowledge of GLP, GMP and commercial material requirements. • Thorough understanding of QA/QC and CMC activities and their integration into overall program plans and timelines. • Proven success in ensuring collaboration and alignment cross-functionally. • Excellent communication, decision-making and analytical skills. • Ability to operate independently within a matrix organization