Senior Manufacturing Bioprocess Associate

Job Description

An amazing opportunity has arisen for a Senior Manufacturing Bioprocess Associate, in Dunboyne.

In this shift role (12/7), you will provide operational support and subject matter expertise for shop floor operations of the Late Stage and Launch Pipeline, at our new state of the art single use biotechnology facility.

At our company, we aspire to be the premier research intensive biopharmaceutical company. Our Biologics facility in Dunboyne is a state of the art facility that integrates leading edge technology with a dynamic workspace to support seamless connection and collaboration. BioNX provides Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch, operating in a multi product mode to adapt to changing demands.

Responsibilities

• Support production operations in Cell Expansion and Cell Banking
• Operate equipment according to electronic batch records, sampling plans, and standard operating procedures.
• Solve problems with a desire to continuously learn, improve, and develop.
• Support weekend or out of hours work on select 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.
• Work as part of a dedicated process team where flexibility and teamwork are key requirements.

Qualifications Required

• Level 6 qualification with a minimum of 3+ years' experience in a GMP manufacturing environment.
• Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.
• Experience with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing process.
• Experience with single use technology and aseptic operations.
• Proven ability to coach and mentor others.
• Knowledge in cell expansion and/or cell banking operations.
• Competent in troubleshooting and practical problem solving capabilities.
• Ability to work independently and within a cross functional team.
• Familiarity with contamination control and batch release requirements.

Preferred

• Level 7 qualification in a science or engineering discipline.
• Commissioning and Qualification experience.

Required Skills

Adaptability, Adaptability, Applied Engineering, Biopharmaceutical Manufacturing, CNC Operations, Cognitive Flexibility, Computer Literacy, Contamination Control, Data Analysis, FDA Regulations, GMP Compliance, Good Manufacturing Practices (GMP), Laboratory Techniques, Manufacturing Processes, Manufacturing Quality Control, Manufacturing Support, Master Batch Records, Material Selection, Operations Support, Pharmaceutical Process Development, Process Manufacturing, Production Planning, Production Support, Regulatory Compliance, Shift Work