Shire IG CMC Lead in Los Angeles, California
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.
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 Shire 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
Other Job Requirements
Travel up to 20% of his/her time
Education and experience
Master Degree or PhD in a scientific discipline preferably biochemistry, biotechnology or pharma.
Minimum 7 years of relevant technical experience, preferably within the plasma business
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.