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API Development Manager

2 weeks ago

Nenagh, County Tipperary, Ireland Merck Gruppe - Msd Sharp & Dohme Full time

About This Role:

This Senior Process Engineer position has arisen in our growing Commercialisation, Development and Supply (CDS) team. The successful candidate will have a strong background in process engineering and API development, with experience of leading cross-functional teams.

Key Responsibilities:

  • Lead engineer on new product introductions and/or technical transfers to and from the site, including new technologies
  • Co-develop new SM API products with Research and Development partners globally
  • Direct day-to-day project development plans
  • Provide knowledge and subject matter expertise on API processing unit operations and scale up to colleagues in Quality, Supply Chain and Manufacturing Operations
  • Evaluation of raw materials, development of process fits, safety and environmental reviews, batch sheet reviews, regulatory and validation compliance, process monitoring and cycle-time studies, deviation investigations and resolution, and development of filing strategies