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.

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 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

  • 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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Reasonable Accommodations

Shire 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.

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.