Manufacturing Bioprocess Associate

Job Title:

Manufacturing Bioprocess Associate Drug Substance Process Operations (MRL)

Purpose of Role:

The facility in, Co. Meath is a state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.

The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change.

An amazing opportunity has arisen for a Manufacturing Bioprocess Associate to provide operational support for manufacturing operations of the Late Stage and Launch Pipeline products at our new state of the art single use biotechnology facility in Dunboyne, Ireland.    

Activities Within Role:

The Senior Manufacturing Bioprocess Associate will support end-to end production operations for both Fed Batch and Continuous Manufacturing.

Primary activities/responsibilities: 

• Operate equipment according to electronic batch records, sampling plans and standard operating procedures.
• Work as part of a dedicated process team where flexibility and teamwork are a key requirement.
• Ability to solve problems with a desire to continuously learn, improve and develop. 
• Support weekend or out of hours work on select time frames to support manufacturing activities.
• Conduct all work activities with a strict adherence to the safety and compliance culture on site
• Support the Authoring of electronic batch records, sampling plans, work instructions and standard operating procedures.

Required Education, Experience and Skills:

• Level 7 qualification in a science or engineering discipline desired.
• A level 6 with a minimum of 3+ years’ experience in a GMP Manufacturing requirement shall be deemed equivalent
• Competent in troubleshooting and show practical problem-solving capabilities.
• Ability to work independently and within a cross-functional team.
• Familiarity with contamination control and batch release requirements
• Familiarity with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing Process.  
• Proficiency in various SingleUse technologies in a manufacturing environment

Preferred Experience and Skills:

• Commissioning and Qualification experience 
• Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
• Understanding of both continuous and batch fed manufacturing processes

Reports to:

Drug Substance Process Operations Manager