Head, External Manufacturing

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. For more information on Astellas, please visit our website at www.astellas.com .

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
• 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
  
  

Required Qualifications

• Master’s degree in Engineering, Sciences or Business (w/Supply Chain or Production Operations focus) with 15 years in Pharma/Biopharma operations (BS/BA with 20 years), supply chain and/or sourcing and procurement roles.
• A demonstrated history of driving performance, operating model change and transformation across a matrixed, global organization
• Experience in CDMO management for more than 7 years with proven track record in establishing executive relationships and/or working directly at a mid-to-large CDMO organizations.
• Experience of large scale project/program management (e.g., PMI, M&A, Cross functional project at enterprise level, and new product launch at global basis etc) for more than 5 years
• Ability to build cross-functional relationships and work openly & collaboratively
• Strong communication and negotiation skills with fluency in English language (read, write, speak)
  
  

Salary Range

$180K – $240K (NOTE: Final salary could be more or less, based on experience)

Working Environment

Choose one of the first two statements below to describe onsite work expectations for the role. Additional points may include travel requirements, office or laboratory working environment, highly collaborative environment, description of equipment used, etc.

At Astellas, we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for this position to succeed and deliver. Hybrid work based in Americas region may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Category Chief Manufacturing Officer

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans