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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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Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


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