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  Support multiple antibody programs through various stages of downstream/purification process development, including process design, optimization, and characterization, at Arcus’ CMO(s).
• Provide technical and scientific support to CMO(s) during clinical and/or commercial drug substance manufacturing including tech transfer, batch record review/approval, technical data analysis, and technical report review/approval.
• Partner with other functional areas (e.g., Quality, Manufacturing, Clinical, Regulatory, etc.) to ensure our antibody development and manufacturing activities are always aligned with the highest quality standards (including cGMP compliance) and overall corporate objectives.
• Support authoring of CMC related documents required for global regulatory submissions.
• Enable successful licensure for commercial drug substance manufacture by preparing for and providing technical support for pre-approval inspections.

Qualifications

• Ph.D. in Chemical or Biochemical Engineering or relevant discipline with 3+ years of pharmaceutical industry experience or M.S. with 5+ years of experience or B.S. with 7+ years of experience
• Subject matter expertise in in one or more antibody drug substance downstream/purification process operations (including chromatography, viral clearance/filtration, and ultrafiltration/diafiltration)
• Experience planning and executing antibody commercialization enabling activities (e.g., PC, PPQ, CPV, CV)
• Strong aptitude to think strategically, with excellent analytical, communication, presentation and writing skills, including extensive experience authoring technical reports.
• Ability to work collaboratively with internal and external partners in a matrix structure to ensure that timelines and deliverables are met.
• Knowledge of GMP requirements and regulations for clinical and commercial CMC drug development
• Experience in managing development and manufacturing activities at CMOs is a plus
• Experience with data analysis software such as JMP, Spotfire, or Skyland PIMS