Senior Manufacturing Biotech Associate

Job Description

A fantastic and exciting opportunity has arisen for a Senior Manufacturing Biotech Associate at Dunboyne Biologics, our new state of the Art single use Multiproduct Biotech facility.

The Senior Manufacturing Biotech Associate will work in a manufacturing self-directed shift team to deliver batch operations successfully, identify and resolve issues in order to allow the site to deliver for our patients in a culture that supports Quality, EHS, Learning and Continuous improvement.

What you will do:

Bring your energy, knowledge, and innovation to:

• The production of biologic drug substance on their designated shift team and will be responsible for the preparation, operation and monitoring of equipment, use of business systems and carrying out tasks including but not limited to the cleaning, validation, in-process testing.
• The progression of an automated recipe using paperless technology in order to generate the drug substance through inoculation and cell culturing activities directing to filtration and purification of the product.
• Setting up the single use equipment between runs, carrying out the production process according to world class GMP and EHS standards and driving to optimise and improve the processing activities through use of standard work and lean processing techniques. 
• Focusing on delivery to the patient through living the Dunboyne culture including a commitment to safety, focusing on right first time in everything we do and concentrating on the engagement and development of self and peers.
• Participate in internal audit programs and risk assessment compliance activity.
• Ensure incident investigations and audits are fully supported with improvement actions implemented.
• Coach shift teams related to RFT documentation.
• Lead by example through coaching and mentoring on our company'sProduction systems (MPSs) skill transfer.
• Coach CAPAs, Change actions/ SOP updates, training module development/revision related to cell area
• Utilise real-time data analytics for making decisions on the value stream improvement intiatives.
• Troubleshoot and resolved issues and delays
• Leads and participates in investigations arising from manufacturing documentation aspects when required.
• Promote EHS leadership behaviours and engages employees at all levels on EHS issues.
• Promote an environment where everyone speaks up for our culture of safety and looks out for one another.
• Confirms that all activities have been correctly completed by the end of shift such as Real-time batch record/ SAP Comet review and elogs review.
• Be a visible leader of safety initiatives and stay actively involved in safety forums.
• Act as a Cell Lead and be responsible for a unit operation.
• Any other duties as and when assigned by the Manager
   

What skills you will need:

• A science qualification in a technical, engineering or science-based discipline or equivalent.
• 4 years’ experience in the biotechnology and/or pharmaceutical industry or equivalent.
• Experience in a highly regulated pharmaceutical manufacturing environment
• Good understanding in the production of biologic drug substance and experience an advantage.  
• Ability to work as part of a shift team and on own initiative in a constructive manner.
• Ability to think logically and be proactive under pressure.
• Flexible and self-motivated
• Maintain a high level of expertise and working knowledge of the process equipment.
• Can lead and deliver cross-functional Operational Excellence projects/ Initiatives.
• A proven ability to work with automated systems such as Manufacturing Execution System (MES), Systems Applications and Products (SAP), Delta V etc.

As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. 

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of