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Process Science Lead

OBJECTIVES/PURPOSE
Provide technical expertise for global initiatives/projects and investigations which are complex and/or span across multiple products and sites
Leverage process knowledge across products and sites, maintain and update QbD documents for multisite plasma commercial products

ACCOUNTABILITIES
Provide technical expertise and leadership for various global initiatives/projects across the plasma portfolio, including: lifecycle initiatives, risk management, process tech transfers, global expansion, improvement of process predictability and efficiency.
Provide technical expertise for investigations which are complex and/or span across multiple products and sites
Interface with pilot & control labs across the network and the company
Leverage process knowledge across products and sites. Maintain and update QbD documents for multisite plasma commercial products.
Data mining/analysis
Scientific due diligence and advisory
Co-own PV Strategy to globally harmonize and manage approaches and process control strategy accross the Plasma Network
Provide capability to properly document and/or communicate complex and technical information, including authoring CMC content for multi-site products
Responsible to identify best process practices and to promote harmonization between the sites

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise
Has a deep and broad understanding of plasma manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial acumen

Leadership

Ability to influence within teams to drive decisions, alignment, and conflict resolution for complex cross-functional issues
Displays and drives Takeda culture of Takeda-ism, PTRB, safety, and quality into the organization

Decision-making and Autonomy

Represents Process Sciences on various teams and is empowered to work within the team to align on decisions

Interaction

Provides feedback within Process Sciences to ensure LCM alignment across products
Works with site MS teams on process improvement projects and other LCM projects
Works within product governance teams to align on effective product LCM
Works on process improvements and other LCM projects

Innovation
Provides inputs for defining the innovation roadmap for GMSci Plasma
Ensures process knowledge sharing across sites and functions for effective management of products

Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
Provides leadership on cross-funtional teams
Provides leadership to drive highly complex projects including ones that span multiple sites and products

Education, Behavioural Competencies And Skills
BS in engineering, life sciences, or related field
Experience operating globally in a matrixed organization

 

Degrees of interest: BS in engineering, life sciences, or related field.

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