Demo

Infrastructure Delivery & Enablement, MfgX

Astellas
Sanford, NC Full Time
POSTED ON 1/25/2025
AVAILABLE BEFORE 4/23/2025

Infrastructure, Delivery & Enablement, MfgX

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 .

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities : gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website : www.astellasgenetherapies.com.

The Role :

The Infrastructure Delivery & Enablement Manager working in the Infrastructure Delivery Enablement POD (IDE) is responsible for :

Representing IDE and managing the business relationship in US Manufacturing. This will include, but not limited to :

  • Gain a good understanding of the local business operations, departments, and technologies.
  • Ensure Infrastructure systems are aligned with the business and IDE strategies.
  • Gathering requirements, review designs for renewal and / or expanding the infrastructure to meet technical and business requirements.
  • Contributes to creation & implementation of MFGX policies, Governance, and strategy.
  • Organization management - Foster organizational readiness by understanding the boundaries, dependencies, and interdependencies between each of the services / Vendors.
  • Liaising on a Strategic, Tactical and Operational level to ensure good quality end-to-end service delivery, integration, and interoperability.
  • Agreeing where information needs to be exchanged between vendors, between vendors and the Astellas IDE organization, and between vendors and users.
  • Manage E2E Performance, Relationship Co-ordination, Service Delivery Co-ordination, and Multi-vendor Delivery.
  • Coordinate with leaders in US Manufacturing relating to incoming technology projects from IDE and local site initiatives with technology requirements and impacts.
  • Ensure that business and IDE needs are clearly articulated for effective delivery.
  • Act as the point of contact and interface between IDE delivery teams and local business stakeholders.
  • Promote and adhere to the current Agile delivery model and delivering demonstrating tangible value and benefits.
  • Work with the local Service Delivery Manager, Business Stakeholders and Support organizations to reduce impact to local operations because of project and or business as usual (BAU) activity.
  • Support or take part where required in any audit activities.
  • Liaise with 3rd party vendors where required relating to Project and BAU Initiatives.
  • Ensure that all IDE infrastructure services are robust and fit for purpose in line with the agreed expectations of Astellas manufacturing facilities and are fully supported as per Astellas standards.
  • The Infrastructure Delivery & Enablement Manager operates on a tacticalStrategic level liaises between in US Manufacturing, IDE & suppliers.

Responsibilities :

  • Liaise with Infrastructure Delivery & Enable Lead to ensure :
  • Implementation of standard global solutions, governance & processes as per IDE Strategies
  • Support & input to communication & discussions between business stakeholders, service providers & IDE POD  Leadership
  • Oversight and governance of outsourced infrastructure related operations.
  • Plan, organize, lead, and maintain the US Manufacturing’s IT Infrastructure services.
  • Champion’s Operational Excellence, jointly developing strategies and incentives to enhance IDE performance & delivery capability.
  • Development and maintenance of a strong relationship with internal customers within US Manufacturing & IDE to optimize MFGX business processes, governance, and delivery.
  • Coordinate with Local Facilities leaders in US Manufacturing to support common global business processes via a consistent set of operating models, approaches, and toolsets where appropriate.
  • Manage US Manufacturing Plants Infrastructure teams to be the “trusted advisor’ and thus enable the business to execute business strategy successfully.
  • Ensure the US Manufacturing’s Divisions business functions understand, and support initiatives as appropriate and that the MFGX function is responsive to feed from internal customers.
  • Ensure Infrastructure demand generated by the US Manufacturing’s business are in line with IDE approach and utilize appropriate tools.
  • Participate with IDE in the appropriate selection of solutions and third parties required to support changes identified & delivery of services.
  • Responsible to start up new IDE / local demand projects and bring these into delivery phase for handover to IDE delivery team.
  • Drive for continuous Improvements resulting in better business outcomes, added value to Astellas, and reduction in overall costs with positive impacts on Quality. Focusing on but not restricted to processes, applications, or methodologies.
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