Head of External CMO Operations & Supply (EUR/US/ASIA)

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Company: Takeda Pharmaceuticals
Location: Cambridge, MA 02139 (Area IV area)

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Objective

  • Responsible to manage and develop a worldwide portfolio of CMOs for plasma, ensuring predictable product release, and product quality.
  • Act as a primary liaison between Takeda and CMOs to ensure the key business objectives are met and shape the strategic development of these relationship
  • Meeting delivery schedules, adjusting production to unanticipated demand or supply issues
  • Evaluate CMO opportunities from fractionation to packaging for the plasma OpU organization


Accountability

  • Primary contact for the specified contract manufacturing organisation which includes

    • Establishing and/or maintaining the appropriate level of relationship
    • Managing and solving potential disagreements, contract breaches, etc,
    • Assuring the interfaces between Takeda and CMO processes are functional and efficient
    • Proactively identify CMO activity-related risks that may impact Takeda’s program commitments: supply delivery dates, program milestones, or goals. Work with CMOs and cross-functional business partners to develop robust mitigation and contingency plans.
  • Overall external supply responsibility to ensure on-time and in full delivery of clinical and commercial products, resolution of operational issues (e.g. deviations, corrective and preventive actions, production delays), alignement of production planning, and follow-up of change control timely implementation.
  • Identify, elevate, and work with Takeda’s stakeholders and CMO’s to facilitate resolution of manufacturing, analytical, supply chain, quality, or issues that may arise.
  • Monitor and drive adherence to Takeda’s and CMO contractual commitments, obligations, and processes, including milestone dates, financial terms, and production schedules both internally and externally.
  • Partner with select among existing or develop new CMOs who can meet program requirements and augment Takeda’s internal or external manufacturing network capabilities.
  • Work with other functional leads to ensure that technology, operations, and quality expectations are accurately represented in requests for proposals, and then reflected in subsequent contracts and agreements with CMO’s.
  • Ensure adequate support during technology transfer, scale up and engineering runs.
  • Provide the financial oversight and lead/support overall business improvement opportunities with External Parties.
  • Establish, track, monitor, and report performance metrics related to operations, quality, cost, and customer service. Develop and distribute periodic reports on CMO performance, issues, risks, and schedules of key activities, events, or milestones.
  • Deliver business benefit through annually set savings targets
  • Supports implementation of Agile and Digital initiatives at suppliers/CMO’s


EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

  • Master’s Degree in Engineering, Biotechnology, Business or scientific field
  • Minimum of 7 years relevant clinical/commercial Pharmaceutical experience
  • Able to negotiate and manage contracts
  • Experienced in risk management processes
  • Previous leadership experience with matrix cross-functional experience.
  • Demonstrated experience leading high priority, business critical initiatives within a matrix organization.
  • Experience in managing cross-functional, global teams.
  • Strong networking and interpersonal skills. Ability to build positive working relationships across senior leadership teams.
  • Ability to effectively communicate and influence different levels of the organization.
  • Strong business acumen.


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 SR0039379