Process Science Lead
Job ID SR0056550 Date posted 11/12/2020 Location Social Circle, Georgia; Lessines, Belgium; Vienna, Austria; Los Angeles, California; Santa Rufina, Italy; Rieti, Italy
- 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
- 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
- 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
- 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
- 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
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Job ID SR0056550