CMC Lead Plasma


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Objective/ Purpose:

  • Accountable for CMC LCM of one or more plasma products
  • Represents the CMC team on the Technical Operations Product Team
  • Leads a cross-functional CMC team to drive effective product LCM

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 GMS Product team on CMC LMC 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 SME 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

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:

  • Provides effective CMC leadership for product management
  • Ability to influence across the organization to drive decisions, alignment, and conflict resolution for complex cross-functional CMC
  • Provides vision and passion for driving technology and innovation within the plasma portfolio
  • Able to operate effectively through ambiguity
  • Displays and drives Takeda culture of Takeda-ism, PTRB, safety, and quality into the organization

Decision-making and Autonomy:

  • Has the ability to operate autonomously for most aspects of the role; aligns with supervisor where necessary
  • Has overall decision authority for activities managed by the CMC subteam

Interaction:

  • Works across GMSci Plasma for business metrics and to align CMC LCM procedures & activities
  • Works across GMSci Plasma, PDT BU R&D, and Site Manufacturing Sciences groups to align on vision and priorities for Plasma products LCM
  • Works with the PDT BU R&D group on coordination of hand-off of late-stage products to the commercial team

Innovation:

  • Uses an innovative approach to solving complex CMC LCM issues
  • Draws in others focused on innovation to drive better outcomes from the product

Complexity:

  • Manages with a matrix of reporting lines and across functional areas
  • Provides leadership to drive highly complex projects involving cutting across multiple sites and products
  • Manages multiple products

Education, Behavioral Competencies, and Skills:

Education/ Experience:

  • Degree in engineering or life sciences
  • Experience operating globally in a matrixed organization highly preferred
  • Minimum 7 years of relevant technical experience, preferably within the plasma business
  • Experience defining the strategy and roadmap for complex, cross-functional CMC initiatives

Skills:

  • Must be self-motivated, have good interpersonal and communication skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools

Behaviors:

  • Strategic enterprise thinking, finding innovative ways to serve patients to build reputation and trust
  • Creating an environment that inspires and enables people
  • Focusing on the few priorities and provide superior results
  • Elevating capabilities for now and the future

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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