Our client is a Biopharmaceutical organisation with global operations in Ireland, Europe, The US, and the Middle East. As a result of continued growth, this organisation is currently looking to recruit an External Manufacturing Manager to oversee the ongoing manufacture, implementation, and maintenance of commercial processes.

The Role

This exciting permanent role will see the successful candidate oversee commercial manufacturing activities for their contract manufacturers.

Key Responsibilities would include:

• Maintain effective coordination and on-time execution of complex activities at multiple locations in support of product supply or activities on the critical path to regulatory submissions and launch.
• Act independently to determine best methods on new assignments and may provide guidance and oversee the activities of other support personnel.
• Contribute to effective specification development of starting materials, chemical intermediates, and drug substance/product.
• Provide commercial oversight of CMO activities, CMC support & deviation review.
• Actively participate in Project Teams, New Regulatory filings, and updates. Analytical, Development, Formulation Development, Chemical Development, Communicate with Quality Control/Quality Assurance, and Regulatory Affairs to facilitate the maintenance of commercial compounds and the commercialization of candidate compounds and products.
• Author and review of GMP- and ICH-compliant technical reports and Chemistry Manufacturing and Controls (CMC) documentation required for regulatory submissions.
• Author and review regulatory CMC submissions including method validations, batch analyses, product characterization, stability, and specification sections.
• Ensure Compliance with appropriate Safety, Quality and Regulatory requirements

The Person

In order to be considered for this role, specific requirements for the successful candidate would include:

• Minimum Level 8 Degree in Chemistry / Biochemistry or similar discipline
• Experience candidate within Pharma or Biopharma industry
• Experience in drug substance / drug product / Bulk API would be preferable
• Systems experience is beneficial such as Vault and Trackwise

What's on offer:

• Competitive base salary
• Pension
• Private Healthcare
• Hybrid role
• Career progression with the organisation

To discover more about this opportunity, apply now or contact Déanna Healy at HRM on +353 87 636 9263 for a confidential discussion.