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.
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
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.