Senior Associate Manufacturing – Strategic Projects - Remote

Overview

The Senior Associate Manufacturing – Strategic Projects role involves collaboration across multiple functions at the Amgen Dun Laoghaire site, focusing on manufacturing operations and planning activities, with a strong emphasis on process improvements and project management.

In Short

• Collaborate with various departments including Quality Assurance and Engineering.
• Serve as primary production process owner for new product introductions and CAPEx projects.
• Drive process efficiencies in both vial and syringe facilities.
• Develop and review master batch records and operating procedures.
• Provide training on scientific or technical aspects of processes.
• Support scheduling and execution of manufacturing runs.
• Perform job hazard assessments and change control assessments.
• Consult with Quality Assurance to maintain GMP standards.
• Lead change controls and review bills of materials.
• Ensure compliance within a regulatory environment.

Requirements

• Bachelor’s degree in a science discipline.
• 5+ years of biopharmaceutical manufacturing experience.
• Experience with regulatory compliance in cGMP manufacturing.
• Strong project management and organizational skills.
• Excellent verbal and written communication skills.
• Critical thinking and decision-making skills.
• Ability to work independently and deliver results.
• Negotiation and influencing skills.
• Teamwork and coaching abilities.
• Initiative to identify and drive improvements.

Benefits

• Opportunity to work in a dynamic environment.
• Collaboration with cross-functional teams.
• Engagement in innovative projects.
• Potential for career growth within a leading biotechnology company.
• Access to training and development resources.