IG CMC Lead
Job ID SR0025315 Date posted 01/24/2019 Location Los Angeles, California; Lessines, Wallonia; Vienna, Vienna; Santa Rufina, Latium
As a member of the Plasma Global Stewardship team and the IG TOPT, this individual will be responsible for providing technical leadership in cross-functional forums to support definition of the global strategy for IG products. He/ She will drive innovation and continuous improvement programs in coordination with key stakeholders. Additionally the IG CMC Lead will ensure Knowledge Management is captured and shared across the different facilities, and will evaluate areas of alignment within the manufacturing processes. Responsibilities Managing Product Lifecycle activities Member of IG TOPT, representing PDTS organization Ensure harmonization/ standardization between facilities and best practice sharing Accountable to guarantee proper yield tracking and to provide accurate yield status and forecast Accountable for CMC content of new submissions & post approval changes Drive Yield projects identification, scoping, prioritization, tracking and reporting Drive a culture of innovation and continuous improvement Owns and coordinates the Quality by Design (QbD) PFMEA deployment and drives the implementation of identified activities Key Skills, Abilities, and Competencies Demonstrated Takeda Leadership Behaviors Ability to manage activities in a matrix environment Deep knowledge of plasma proteins and plasma processing High level of customer orientation and organizational skills Six Sigma and Statistical knowledge Experience within the GMP environment, and regulatory affairs Flexible in mind / out of the box thinker Enthusiastic, decisive, self-motivating and convincing personality International background appreciated Excellent communication skills, verbal and written communication skills Fluent English Other Job Requirements Travel up to 20% of his/her time Education and experience Education: Master Degree or PhD in a scientific discipline preferably biochemistry, biotechnology or pharma. Experience: Minimum 7 years of relevant technical experience, preferably within the plasma business
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Job ID SR0025315