Director Manufacturing

Director Manufacturing

Amicus Therapeutics

Ireland

Position Summary

The Director of Manufacturing will lead an external manufacturing team to ensure uninterrupted supply of Amicus commercial products through oversight and management of our global external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. The preferred candidate will have experience of leading teams both within and external to the Amicus organization. This role requires strong collaboration with the Quality, Supply Chain, CMC, Manufacturing Technical Operations and GRA teams.

Roles and Responsibilities:

  • Accountable for ensuring compliant continuity of supply from Amicus external manufacturing network;
  • Leads the manufacturing teams within External Manufacturing to execute the external manufacturing network strategy;
  • Responsible for overall tactical manufacturing strategy and execution of manufacturing activities within the external manufacturing network;
  • Provide leadership and oversight of the external manufacturing network performance;
  • Provides leadership to Amicus External Supply Operating Teams (ESOT) and supports management of escalations and key decision making;
  • Leads cross functional teams to enable timely resolution of complex issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, material review board associated investigations, finished product trending and change controls;
  • Develop near and long-term goals for the department in accordance with the overall technical operations objectives;
  • Create, measure, trend, and report manufacturing related KPIs as a basis to drive continuous improvement;
  • Proactively and effectively leads collaboration with functions within and external to manufacturing to achieve corporate, cross functional, and departmental goals;
  • Fosters and facilitates continuous improvement of production and business processes to improve quality, increase efficiency, ensure sustainability, and manage cost;
  • Build clear communication structure between the external manufacturing team, technical operations leadership and the key business stakeholders.

Requirements

Educational Requirements

  • Bachelor's or Master’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related field.

Professional Work Experience Requirements

  • 8-10 year’s experience in pharmaceutical and/or biopharmaceutical manufacturing with a strong understanding of GMP and regulatory compliance;
  • Experience of leading an external manufacturing team and working with CDMOs;
  • Excellent communication and interpersonal skills, with the ability to build relationships and work effectively with stakeholders at all levels of the organization.

Experience and Skills

  • Strong understanding of the contract manufacturing organization (CMO) landscape knowledge of CMO capabilities and limitations for worldwide drug product manufacturing;
  • Strong understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP). Strong knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance;
  • Strong communication skills and the ability to perform effectively in a fast paced, multi-faceted environment;
  • Independent decision-making abilities with strong results orientation;
  • Demonstrated job history of managing external manufacturing networks;
  • Possess a professional attitude and a strong attention to detail and organizational skills;
  • Organizational and operational agility, able to operate at all levels of the organization and able to shift priorities successfully;
  • Ability to manage projects involving multiple functional groups without direct reporting authority;
  • Strong interpersonal skills and good communicator.

Other skills/Attributes

  • Demonstrated alignment with Amicus Mission Focus Behaviors;
  • Passion for rare disease and patient focused;
  • Strong team player.

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