Process Development and Transfer Expertise Opportunity

2 weeks ago

Dublin, Dublin City, Ireland beBeeTransferProcess Full time €72,000 - €96,000
Job Title: Transfer Process Specialist

The role involves facilitating effective cross-functional collaboration with external and internal partners including Technical Services, Manufacturing Science & Technology, Product Development and Clinical Supply, Supply Relationship Management, External Manufacturing and Operations, Quality and Regulatory teams.

You will be responsible for:

  • Developing and implementing transfer strategies including process validation and control strategy. This includes drug substance and drug product (biologic) and small molecule drug substance and drug product (eg oral solid dosage).
  • Leading technical gap assessment and ensuring implementation of any associated mitigation activities.
  • Authoring and reviewing project-related documentation. Reviewing and approving supporting protocols and reports.
  • Ensuring site-specific cleaning validation and media fill strategy is aligned with global requirements.
  • Providing SME input to technical aspects of IR response. Providing support to regulatory audits as needed.
  • Supporting the implementation of transfer and validation best practices across the network, working closely with other members of the TT and Validation team on improvement implementation.
Key Skills and Qualifications:
  • pharmaceutical
  • technology transfer
  • biologics
  • process validation
Benefits:No information available in the job description.Other Information:Dublin, Ireland. Contract position.

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