Science, Pharmaceutical & Food

CMO Manager

  • Full Time
  • Remote
  • Cork
  • 41830892

PE Global are currently recruiting for a CMO Manager on behalf of a leading biopharmaceutical company. This is a 6 month contract role based in Cork.

The role requires strong influencing, leadership and communication skills to drive business outcomes. The role may require time at the manufacturing sites of responsibility to ensure ongoing success, and partners with an organization spanning Western Europe and the US.

 

Primary Responsibilities

  • Supporting the ExM Virtual Plant Manager (VPM), overseeing our company’s relationship with the contract manufacturer. The VPM serves as the air traffic controller of all information/interactions between the Manufacturing Division and the contract manufacturer and establishes boundaries and ground rules of engagement. 
  • As required engage with the cross functional team (Supply Chain, Quality, Technical Operations, Planning) responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s).
  • Responsible for operational related activities as delegated by the VPM:
    • Compliance (Quality Risk management, Deviation Management, Product Release, Change Control)
    • Meeting Demand
    • Production Planning
    • Materials Management (MRP entries)
    • Logistics including shipping of product to the downstream location
    • Technology issues
    • Oversight of shop floor production
    • Linking end to end (upstream and downstream) and with Supply Chain Management to ensure optimal flow of materials
    • Represent the VPM in forums as delegated by the VPM
  • Routine presence at external partners site on the production floor. Building a strong relationship with the site team and able to assess & diagnose with appropriate tools and resource the true current condition & risks at a partners site. Formulate in partnership with the external partner and the cross-functional team action orientated and time bound improvement plans
  • He/She works with the team and external partner to understand capacity and future capacity based on agreed improvements
  • Responsible for maintaining the integrity of the MSA (Master Supply Agreement) ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms agreed upon are executed, including purchase orders, forecasts, deliveries, and approving invoice payments. 
  • Responsible for inventory control. Depending on the location of goods, He/She ensures adequate documentation of material disposition. 
  • Supports periodic Business and Operations Review Meetings.
  • Supporting the VPM, plans strategically, understands broad CMO business environment, specific opportunities & potential partners in their operations area
  • Responsible to ensure fulfillment of operations activities related to commercialization, new product introduction and commercial supply of pediatric and spray dried intermediate products.
  • Ensure commercial item code creation
  • Ensure shipping lane set up and qualification of product in the shipping lane
  • BOMs
  • Ensure Product standard cost set up
  • Cold chain management system setup at external partner
  • Understand product importation and exportation requirements
  • Operations support for Product PPQs
  • Operations support for packaging and artwork
  • Is a delegate for the VPM as required

 

Experience and Skills:

Education/Experience

  • Bachelor’s degree minimum, with a degree in Engineering or Science and Business is preferred
  • No less than seven (7) years’ experience in pharmaceutical manufacturing (operations, quality, technology, supply chain) roles with a significant portion in management/leadership positions
  • Supply chain excellence knowledge and experience preferred
  • Compliance – Deep understanding of GMP and EHS compliance and compliance risk
  • World Class Supplier Mindset – proven Lean Six Sigma skills
  • Business & Financial Acumen
  • Depth of Manufacturing Knowledge
  • Knowledge of SAP

 

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