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Manager of Contract Manufacturing

3 months ago


Raleigh, United States Insight Global Full time

Must-Haves:

  • Bachelor's Degree in STEM or other related field
  • 10+ years of combined experience within the pharmaceutical industry in the areas of manufacturing, direct material sourcing, quality, logistics, alliance or external manufacturing management or similar technical functions.
  • 6+ years of demonstrated successful experience directly managing pharmaceutical contract manufacturing and packaging organizations.
  • Travel: Approx. 20% travel will be expected.

Pluses:

  • Professional certifications desired in Lean Sigma, Project Management, or related areas.

Day-to-Day:

The Senior Manager, Contract Manufacturing is responsible for the oversight of external manufacturing/packaging activities and day-to-day business management of assigned Contract Manufacturing Organization (CMO) relationships with accountability for ensuring supply of product to patients on-time and for driving continuous improvement in risk, performance, quality, and total cost.

Essential Functions:

  • Provide leadership and day to day management of the assigned Indivior external manufacturing and packaging CMOs.
  • Ensure on time and quality supply of all contracts manufactured and/or packaged finished product from Indivior CMOs.
  • Develop a right first-time culture with internal stakeholders and CMOs to avoid undesirable events in the future.
  • Lead coordination of resources across R&D, Quality, Regulatory, Finance, Supply Planning, Logistics and Technical Operations for the successful implementation and ongoing management of pharmaceutical finished product manufactured and packaged with CMOs.
  • Implement, monitor, and deliver against key performance metrics in support of improving team, CMO and company performance.
  • Negotiate contracts and supply agreements with our manufacturing and packaging CMOs to secure value, quality and delivery of objectives while developing supplier relationships that minimize business risk.
  • Ensure effective management of strategic CMOs with a view to building long term strategies.
  • Develop appropriate CMO relationships, including strategic alliances between key CMOs and internal stakeholders.
  • Conduct joint operations and business review meetings with each CMO at defined frequencies to monitor and improve performance.
  • In collaboration with R&D and the Supply organization, ensure that development projects are delivered on-time and are on an appropriate path for optimal commercialization. Take ownership for commercial aspects of new product development projects utilizing CMOs for manufacturing and packaging.
  • Financial – Set, monitor, and deliver cost improvement and containment targets to support business growth. Continually identifying new opportunities for cost reduction across their portfolio.
  • Business Continuity Planning – Create, maintain, and implement effective business continuity plans to ensure patient supply of product.
  • Ensure compliance to all company policies and government laws.