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 MSAT Manager to contribute to the technical oversight of an increasing commercial portfolio.

The Role

This exciting permanent role will see the successful candidate work as part of a diverse and multi-disciplinary team on the development, manufacture, and lifecycle management of biologics, small molecules, botanical and gene therapies for the treatment of rare diseases.

Key Responsibilities would include:

• Technical support and oversight for a portfolio of Active Pharmaceutical Ingredients (APIs), Drug Substances, Intermediates, and/or Drug Products, including Device technology, ensuring compliance and security of supply.
• Manage new product introduction activities, contribute to technical assessments, and provide input to product strategy.
• Providing technical guidance in the understanding of root causes and corrective and preventive action (CAPA) identification for out-of-trend or out-of-specification results or deviations for candidate processes.
• Involvement in CMO / vendor selection - prepare technical information packages, participation in due diligence and site assessments, technical evaluation of requests for information (RFIs) and requests for proposal (RFPs).

The Person

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

• Minimum Level 8 Degree in Science
• 3+ years' experience in Biopharma, Pharma, or Device technology
• Experience with statistical process analysis and control methods
• Ability to document complex study plans and scientific reports as well as the ability to translate technical issues into relevant business solutions

What's on offer:

• Competitive base salary
• Pension
• Private Healthcare & Dentalcare
• Remote role with international travel opportunities
• 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.