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Director of Outsourced Manufacturing

Manufacturing / Production
Cork
Jill Madden
Permanent
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Job Reference: JO-2007-65284_1594145495

Summary:

Our client is a leading Biopharma M/ N, due to increasing business needs, they are looking to appoint a Director of Outsourced Manufacturing to effectively manage Supplier relationships, their delivery and performance, specifically in the Commercial Drug Product CMO space. Liaising with all internal stakeholders (Commercial Manufacturing, Analytical Operations, Quality, R & D etc) and external CMO partners, the successful candidate will ensure organisational strategy & supply plans are effectively delivered on.


This position will lead the respective CMO Management Teams for assigned CMOs and support implementation and execution of CMO initiatives as part of the larger orgnisational CMO governance model.


This person will also support Supply Chain Management in the development of supply mitigation plans with CMOs in response to critical supply issues. Assigned CMOs are expected to be primarily located in Europe.



Requirements:



  • Serve as the primary day to day contact to support the relationship between the organisation and assigned CMOs

  • Serve as the production champion/point of contact (POC) with assigned CMOs to manage and mitigate issues and drive robust supply of product through coordination across commercial functions.

  • Manage external manufacturing activities and relationships. Serve as the day to day internal representative for CMO management at assigned CMOs.

  • Execute strategies that drive effective operational performance and service levels at CMOs. Strong alignment with Supply Chain, Commercial Manufacturing, and Quality is required.

  • Lead initiatives that drive a collaborative and robust relationship and drive alignment between CMOs and the organisation including but not limited to: Business reviews, Performance Metrics, Continuous Improvement projects, and Risk Management.

  • Support and effectively execute CMO Management initiatives and cross functional efforts, processes and strategies to ensure supply performance is achieved, both at the CMO and within the organisation.

  • Utilize analytical tools to identify, quantify, and minimize risks at assigned CMOs

  • Negotiate and manage key CMO agreements (MSAs, SOWs, Supply Agreements, Pricing, etc.)

  • Implement and manage joint operating procedures between the organisation and the supplier/CMO to ensure effective execution.

  • Report metrics and lead supplier specific performance improvement initiatives

  • Understand the CMO market and capabilities that are consistent with manufacturing requirements. Develop relationships with potential CMOs that support future CMO needs

  • Coordinate interdepartmental activities with Quality Assurance, Manufacturing, Development and other functions that support commercial supply.

  • Work closely with department management to establish standards and policies that support key CMO/supplier partnerships.



Requirements:




  • Minimum Level 8 Degree Qualification & 8 years relevant experience managing CMO networks specifically in the commercial drug product environment.

  • Strong commercial acumen and the ability to build long lasting relationships with all stakeholders.

  • Ability to effectively manage & develop a team of CMO Managers






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Jill Madden
Jill Madden
Business Unit Lead
Supply Chain & Operations
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