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Material Qualification Specialist

Lexington, Massachusetts

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Material Qualification Specialist

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Job ID SR0044282 Date posted 01/16/2020 Location Lexington, Massachusetts

Objectives:

  • Support global material qualification procedures and program
  • Oversight for global material qualification strategy and related documents to ensure consistent approach is taken across the portfolio
  • Support the Global Supplier Notification of Change, Material Change Management and Excipient Risk Assessment Programs
  • Drive organic extractables/leachables and container closure integrity programs

Accountabilities:

  • Develop and lead cross-functional initiatives to enable optimization of working capital within the commercial portfolio.
  • Develop project budget assumptions and resourcing needs; monitor, report and escalate unresolved issue and deviations in a time appropriate manner to appropriate functions and/or senior management.
  • Lead analysis (such a SWOT) of publicly available business intelligence (10-Ks, journals, etc) to identify business trends and opportunities in material selection, implementation and qualification.  Communicate results to senior leadership on a routine basis.
  • Collaborate with other GMS leadership functions such as Strategy & Business Excellence on developing an end to end product manufacturing network strategy.
  • Lead and coordinate manufacturing lifecycle management activities for Takeda’s commercial portfolio (from launch to divesture)
  • Deliver patient-focused lifecycle management priorities

Aspects:

Technical/Functional (Line) Expertise

  • Analyze unstructured problems, identify root causes and align team objectives to drive divisional goals
  • Use agile principles to reduce process complexity and increase organizational capacity
  • Deep knowledge of Project Management and Process Improvement methodologies (Agile, Lean, DMAIC, Waterfall, and/or PMBOK)
  • Extensive knowledge of essential CMC activities
  • Develop and apply custom strategies for processing and visualizing multidimensional data
  • Experience capturing and translating business requirements into technical solutions

Leadership

  • Experience managing projects in a matrix environment
  • Ability to inspire others to share their vision and support them to reach a common goal
  • A firm grasp of organizational development and cross-functional group alignment
  • Aptitude in building a patient-centered best in class organization
  • Develop diverse talent and elevate organizational performance

Decision-making and Autonomy

  • Make complex decisions regarding project resources and priorities on a regular basis. 
  • Work in a dynamic environment, be able to set, balance and communicate priorities, and serve as a change agent.
  • Create functional strategies and goals that are closely aligned with Takeda’s objectives and develops metrics to track and assess performance.
  • Develops concise, strategic plans based on a clear understanding of the organization’s strengths, weaknesses, opportunities and threats.

Interaction

  • Creates a clear and unifying vision that inspires the team to excel.
  • Exerts influence on the overall objectives and long-range goals of the organization.
  • Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations.
  • Strong interpersonal and active problem-solving skills
  • Engage partners to deliver agile and predictive results within a complex and evolving business landscape
  • Interface with each Operating Unit and Region supporting lifecycle management of development and commercially approved products

Innovation

  • Leverage business analytics (such as SWOT) to identify emerging opportunities and capability needs for GMSci.
  • Ability to apply first principles in chemistry, physics, and engineering to manufacturing problems and create new solution paths to manufacturing challenges.
  • Translate prior knowledge into new understanding of the development pipeline and expand the working knowledge of the essential activities for all key functional areas
  • Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.

Complexity

  • Understands differences in practices across organizations or countries, and balances local demands and perspectives with global strategies.
  • Creates an environment that promotes information exchange and the open and honest expression of opinions, thoughts and beliefs.

Education, Behavior and Skills:

Education / Experience

  • Minimum requirement of
    • Bachelor’s degree in Science or Engineering related field and 7+ years working within commercial bio/pharmaceutical manufacturing or related field
    • Bachelor’s degree in Science or Engineering, Master’s in Business Administration, and 3+ years working within bio/pharmaceutical manufacturing or related field
    • Ph.D. in Science or Engineering related field
  • Strong knowledge of pharmaceutical development, manufacturing operations, and product quality
  • Experience leading cross-functional project teams to solution implementation

Skills

  • Expert knowledge of Microsoft tools (Excel, SharePoint, etc.)
  • Strong interpersonal skills with the ability to motivate and influence others, negotiate during situational conflict, and establish the best forward path in the face of competing points of view.
  • Ability to articulate complex issues and ideas with clarity to enable understanding and timely decision making.


Behaviors

  • Create an environment that fosters a patient-focused entrepreneurial mindset
  • Strategic enterprise thinking to deliver innovative patient-focused solutions that build patient trust and Takeda’s reputation
  • Self-directed, accomplishment-driven individual with a strong sense of passion and urgency who can work both independently and in a cross-functional team environment

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.

Job ID SR0044282

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