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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

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here.

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.

Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4.439,- gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.

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