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Head, External Manufacturing

Head, External Manufacturing

Astellas PharmaNorthbrook, IL, US
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Astellas External Manufacturing Leadership Opportunity

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope :

This position will provide leadership to Astellas External Manufacturing (ExM) organization by delivering exceptional value through industry leading management of the Astellas late-stage development and Commercial external supply network (CDMOs) across all product modalities. The External Manufacturing organization purpose is to leverage capacity and capabilities of external manufacturing & supply partners to deliver reliable supply of quality products with a focus on speed, tech transfer, capacity access and benchmark costs. The Head of External Manufacturing will deliver exceptional service and value by driving external supplier CDMO business processes in partnership with other critical internal functions as per the operating model.

Responsibilities and Accountabilities :

Lead a dedicated team of External Manufacturing Supplier Relationship Managers (SRMs) and Manufacturing Science and Technology (MS&T) professionals.

Enable execution via the Virtual X Team (VxT) cross functional business processes model in partnership with critical internal functions and within the operating model.

Ensure the CDMO External Manufacturing organizational and operating models work seamlessly within the PDM operating model and with the PDM Functional Leadership teams (LTs).

The Astellas Vice President External Manufacturing leader will be accountable for the following :

Strategic Focus :

  • Development of external supplier strategic partnerships
  • Tiered governance and management of the CDMO network
  • Business continuity management across the external supply network
  • External supplier innovation exploration and development

Supplier Management and Operational Execution :

  • CDMO VxT operational execution and performance management
  • Supplier continuous improvement
  • CDMO network budgets and projections management
  • External supply issues and crisis management
  • Manufacturing Sciences and Technology Focused :

  • Coordinating with Product Development for the development and qualification of externally manufactured NPIs
  • Technical process execution (robustness, investigations management, continuous improvement programs)
  • External supplier technical transfers management for NPIs, new suppliers and commercial transfers
  • Quality Focused :

  • Quality operational execution for releases and QEs management
  • Execution of CDMO QMS, APQR, QRM and stability management programs
  • Development and negotiation of CDMO Quality Assurance Agreements (QAAs)
  • Supply Chain :

  • Inventory planning, forecasting and purchase order execution
  • Supply logistics and warehousing management
  • Serialization monitoring and administration
  • Sourcing and Procurement :

  • CDMO network category strategies
  • Supplier section processes (RFIs / RFPs)
  • CDMO Contract development and negotiations (pricing, amendments, new business)
  • CDMO Contract dispute management
  • In addition, this role will contribute to optimal commercial manufacturing site selection along with strategy and value proposition in close collaboration with CMC-PM and other relevant FUs
  • Coordinate activities on negotiating contractual terms & conditions, technology transfer, trouble shooting, change control and so on
  • Selection and development of external supplier strategic partnerships
  • Partner with internal manufacturing units & other relevant functions in optimal manufacturing site selection process
  • Business continuity management across external supply network and in partnership with other relevant internal functional units
  • Establish tiered governance and management of the CDMO network.
  • CDMO Contract development and negotiations (pricing, amendments, new business)
  • Drive external supplier technology transfers, development and qualification of externally manufactured products, technical process execution including process robustness, continuous improvement management
  • Lead external manufacturing operations, governance, budget and overall performance
  • Coordinate supply chain management with CDMOs to ensure efficient and reliable supply.
  • Gather insights in external manufacturing & supply across the geographies and translate into sourcing strategy
  • Partner with peer functional leaders to ensure efficient and reliable supply of externally manufactured products
  • Build and lead high performing teams and drive a culture of continuous learning and improvement
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    External • Northbrook, IL, US

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