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Details

API Third Party Manufacturing Manager


Reference:AHYH-865112 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

API Third Party Manufacturing Manager
Our client, a global pharmaceutical organisation are currently recruiting for an API Third Party Manufacturing Manager. As API Third Party Manufacturing Manager you will be the primary point of contact for technical oversight and support of third party manufacturers producing API, intermediates, and starting materials for the organisation. This is a permanent opportunity based in Dublin.

Responsibilities
• Manage the technical support (product and process expertise) of API manufacturing processes executed at the third party manufacturers. This includes a range of activities, from day-to-day manufacturing problem solving to continuous improvements to performance monitoring
• Manage the technical portion of product transfers into third party manufacturers including from PRD to TPM, TPM to TPM, and Operations to TPM
• Manage product investigations. Management and execution can include contributing to and reviewing of project reports and investigations. Make scientific recommendations as to the acceptability and quality of affected product lots and any remediation required
• Identify and implement process changes to improve product quality and/or reduce processing costs in the manufacturing of TPM produced products. Prepare and review scientific reports and validation/engineering protocols describing and supporting process changes and improvements
• Contribute and write potential submission documents for governmental regulatory agencies
• Provide product and process expertise in the execution of plant projects (for example, technical transfer, installation of new manufacturing equipment, process changes) including process validation and cleaning validation
• Communicate cross functionally to keep product teams and management updated on project status and drive resolution of technical issues

Requirements
• BS or equivalent education in chemistry or engineering and 10+ years of industry experience, MS or PhD or equivalent education with 6+ years of industry experience
• Industry experience to include technical experience in API process chemistry including laboratory and GMP/FDA/EMA regulated plant support experience
• Possesses knowledge and a skill set to operate within a cross-functional environment that requires a high degree of urgency, strong analytical and problem solving skills, and positive interpersonal skills
• Ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals with demonstrated success as a collaborative team player.
• Proficient in the analysis and preparation of complex scientific data, reports, and global regulatory submissions
• Must have excellent project management, presentation, oral and written Communication Skills
• Must have a good knowledge and understanding of global regulatory and compliance requirements relating to CMC related areas

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252