Senior Process Development Specialist

6 days ago

Dublin, Dublin City, Ireland beBeeProcess Full time €111,555 - €142,424

**Job Summary:**

We are seeking a skilled Process Development Manager to lead our team in the technical delivery of new products and life cycle management. This role requires a strong background in process development, with experience in leading tech transfers and process validation activities.

Key Responsibilities:

  • Manage a team of tech transfer engineers/scientists supporting new product introductions and lifecycle changes.
  • Lead tech transfers of NPIs and LCMs to ADL, providing technical support to large molecule and small molecule drug product manufacturing.
  • Develop and characterize drug product processes, transferring technology to commercial drug product sites.
  • Identify and implement operational opportunities for current and new sterile operations.
  • Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer, and validation.

Requirements:

  • A third-level Bachelor's degree in Science, Engineering, or a relevant Quality discipline, with 5 years' experience in a similar role.
  • Knowledge of cGMPs and other worldwide regulatory requirements.
  • Problem-solving ability and excellent oral and written communication skills.
  • Strong skills in applying fundamental engineering and scientific principles to design, implementation, and process validation.
  • Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.

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