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A multinational biopharmaceutical company, are looking for a Contract Manufacturing Specialist to join their team on a permanent basis. This position is a manager level position and an experienced professional within a manufacturing environment is required.

The company who operate internationally, manage a diverse portfolio of multi-site CMO's, and are looking for the right individual to provide information insight and data analysis, while driving execution of transactional/tactical tasks to ensure the CMO work cell success for the organisation.

The Role

Reporting into the Director of Drug Product for Contract Manufacturing Global sites.

Responsibilities will include:

• Ensuring accuracy and completion of data entries

• Working on Quality records and contractual needs for the company

• Owning of NC.Class records, CAPA, CAPA EV, and more complex change control records

• Successfully managing relations with multi-site CMO representatives

• Reporting on contract site performance metrics to site lead

• Identifying opportunities to continuously improve site performance

• Managing timeline of Technical Transfer

• Coordinating risk management activities as part of each transfer

The Person:

• Bachelor's in Business Administration, Engineering or Science-related field

• 5+ years of experience in protein, API, DS, DP or packaging manufacturing environment

• 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles

• 2+ years of project management experience leading multi-functional and/or multi-location team

• 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products

To learn more, apply online or contact Ellen Walsh with your CV at to arrange a confidential discussion.