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CMC Lead Plasma

Vienna, Austria, Lessines, Belgium, Pisa, Italy, Ospedaletto, Italy, Santa Rufina, Italy, Rieti, Italy

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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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.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

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

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

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

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CMC Lead Plasma

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Job ID R0023775 Date posted 10/19/2020 Location Vienna, Austria; Lessines, Belgium; Pisa, Italy; Ospedaletto, Italy; Santa Rufina, Italy; Rieti, Italy

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Job Description

Objective/ Purpose:

  • Accountable for CMC Lifecycle Management of one or more plasma products
  • Represents the CMC team on the Global Manufacturing & Supply Product team
  • Leads a cross-functional CMC team to drive effective product Lifecycle Management

Accountabilities:

  • Responsible for CMC strategy to enable effective lifecycle initiatives for supply continuity, risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product/process knowledge, capability & improvement, tech transfer, and process validation
  • Aligns with Global Manufacturing & Supply (GMS) Product team  on CMC Lifecycle Management strategy
  • Drives the link between CMC strategy on the GMS Product team and CMC execution on the CMC subteam
  • Ensure harmonization/ standardization between facilities and best practice sharing
  • Accountable to guarantee proper yield tracking and to provide accurate yield status and forecast
  • Drive Yield projects identification, scoping, prioritization, tracking, and reporting
  • Is the overall product/process expert for the product; provides bridges across expertise represented on the CMC team
  • Accountable for CMC sections of product dossiers
  • Provide Subject Matter Expertise of major process and methods investigations
  • Assess and provide feedback to cross-functional technical proposals and recommendations
  • Manage multiple workstreams and projects
  • Make sound and timely decisions based on project priorities.
  • Discern paths forward within ambiguous environments

Skills and Qualifications:

  • Higher Degree in engineering or life sciences
  • Experience operating globally in a matrix organization highly preferred
  • Profound and relevant technical experience, preferably within the plasma business
  • Experience defining the strategy and roadmap for complex, cross-functional CMC initiatives
  • Ideally deep and broad understanding of plasma manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial acumen
  • Self-motivated with good interpersonal and communication skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools
  • Strategic enterprise thinking, finding innovative ways to serve patients to build reputation and trust
  • Creating an environment that inspires and enables people
  • Excellent command of the English language is essential, any other language is an asset

Locations

ITA - Rieti

BEL - Lessines, ITA - Pisa, Vienna, Austria

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0023775

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