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IG CMC Lead

Los Angeles, California, Lessines, Belgium, Vienna, Austria, Santa Rufina, Italy, Rieti, Italy

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Self-starter
  • Versatile
  • Team player

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Opportunity

  • Values-Led

    Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • People-First

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Corporate Social Responsibility

    Our vision is of a world with accessible healthcare for all, where prevention measures are exponentially advanced and billions are freed of disease. Our approach is rooted in our patient-centricity and the creation of outstanding treatments that change people's lives. Building upon a foundation of sustainability, we are committed to contributing to the long-term health of people through disease prevention.

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IG CMC Lead

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Job ID SR0025315 Date posted 01/24/2019 Location Los Angeles, California; Lessines, Belgium; Vienna, Austria; Santa Rufina, Italy; Rieti, Italy

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

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

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.

Job ID SR0025315

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