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Process Science Lead


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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

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law - Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


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