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Process Scientist Manager

応募後で応募 求人ID R0027310 掲載日 06/15/2021 Location:Lexington, Massachusetts; Zurich, Switzerland

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Job Description

OBJECTIVES/PURPOSE

  • Member of the global team of process science experts responsible for the manufacturing process for Takeda’s large and diverse commercial biologics portfolio
  • Acts as a senior subject matter expert across the biologics portfolio
  • Provides technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products
  • Independent Contributor Manager: overseeing projects and function

ACCOUNTABILITIES

  • Provide upstream and downstream technical expertise and leadership for various projects across the biologics portfolio, including: lifecycle initiatives to enable supply continuity, risk management, line extensions & discontinuation, process tech transfers, global expansion/contraction, regulatory activities, and capability & improvement.
  • Ensure technical continuity of manufacturing processes across sites and time
  • Provide technical expertise for initiatives and investigations which are complex or span across multiple products
  • Lead process improvement projects that span sites or products
  • Ensure alignment of CMC content for multi-site products
  • Provide technical expertise required to maintain control strategy documents

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Has a good understanding of biologics manufacturing, the regulatory environment, life cycle management, and trends in innovation

Leadership

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

Decision-making and Autonomy

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

Interaction

  • Provides feedback within Bio 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 with Biologics Process Development on process improvements and other LCM projects

Innovation

  • Provides technical input to Biologics Process Development for process improvement and other LCM projects
  • Ensures process knowledge sharing across sites to ensure technical continuity for multi-site products

Complexity

  • Provides leadership on cross-functional teams
  • Provides leadership to drive highly complex projects including ones that span multiple sites and products

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education / experience

  • BS in engineering, life sciences, or related field with a Minimum 10 years experience, MS with a minimum of 8 years experience, or PhD with 0-5 years experience in pharmaceutical development and manufacturing
  • Experience operating globally in a matrixed organization highly preferred

Skills

  • Must have technical knowledge and experience in upstream or downstream process development
  • Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.

Behaviors

  • Focusing on the few priorities and provide superior results
  • Elevating capabilities for now and the future
  • Provide leadership on cross-functional teams

This job posting excludes CO applicants.

Locations

Lexington, MA

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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