NIBRT National Institute for Bioprocessing Research and Training

Fastnet are delighted to partner with NIBRT National Institute for Bioprocessing Research and Training to hire a Director of Technology and Data. This role will establish and lead the Director of Technology & Data function, shaping and refining its focus on operations, technology, data, and innovation—both internally and externally. As a key member of the Site Leadership team, you will play a crucial role in driving the organisation toward its strategic goals and objectives. Please reach out to Jill Madden for a confidential conversation - jill@fastnettalent.com

Advance Your Data Analytics Skills in Biopharma - Short Course 08 - 10 April 2025 Our Advanced Data Analytics course is a three-day onsite programme designed for those who have completed the Introduction to Data Analytics for Biopharma Manufacturing and want to develop their expertise further. Taking place from 8–10 April at NIBRT, this course provides advanced skills and knowledge essential for data analytics in biopharma manufacturing. Key topics include: -Reproducibility in Data Science – Infrastructure, documentation, and version control (Git) -Linear and Non-Linear Regression – Combining bioprocess knowledge with statistical modelling -Design of Experiments (DoE) – Benefits over one-factor-at-a-time (OFAT) experiments -Statistical Process Control (SPC) – Control charts and process capability -Ideal for those with a good foundation in statistics, including process and quality control scientists Enrol now https://hubs.la/Q03bsK_10

Starts Tomorrow – Register Now for the PQS & RBDM Webinar - 'Demonstrating the Effectiveness of the PQS and the Role of Risk-Based Decision Making' This is a reminder that our free webinar takes place tomorrow. Last chance to register! Date: 13 March 2025 Time: 3:00 PM Dublin/GMT Join NIBRT and PRST at TU Dublin for a valuable session on: Risk-Based Decision Making (RBDM) and PQS effectiveness Updates from ICH Q9(R1) Practical insights into Quality Risk Management (QRM) Speakers: Valerie Mulholland: Principal Consultant, GMP Services Michael Schousboe: Senior QMS Specialist in Quality Risk Management, Novo Nordisk Professor Kevin O’Donnell: Market Compliance Manager, Health Products Regulatory Authority (HPRA) Moderator: Alice Redmond: Chief Strategy Officer (CSO), CAI Register: https://hubs.la/Q0382n7q0

Prof. Mark Smales Secures Prestigious Taighde Éireann Award to Advance Biotherapeutics Manufacturing NIBRT is pleased to announce Prof. Mark Smales has been awarded over €3.5 million through the prestigious Taighde Éireann - Research Ireland Research Professorship Programme. Holding a joint appointment between NIBRT and the University of Kent, Prof. Smales will lead a five-year research programme focused on revolutionising the manufacturing of next generation biotherapeutics. The project will be based at NIBRT and will support a dedicated research team, including three PhD studentships. Biotherapeutics, such as monoclonal antibodies, gene therapies, and RNA-based medicines, have transformed the treatment of diseases worldwide. Manufacturing these advanced therapies, however, remains complex, inefficient, and costly, limiting their availability and impact. Prof. Smales’ research will take a pioneering approach to redefine how these medicines are produced, making manufacturing more efficient, predictable, and scalable. The project will focus on three key areas: Gene Therapy Production – Understanding the biology of the cells and genetic components that underpin gene therapy manufacturing and developing improved production systems. RNA Therapeutics – Investigating how RNA sequences, modifications, and control elements impact their effectiveness as vaccines and therapeutics. Bioprocess Engineering – Applying cutting-edge engineering biology techniques to create new cell factories capable of producing novel format, complex biotherapeutic proteins with improved quality and yield. Read full press release here https://hubs.la/Q03b2PjX0

NIBRT Careers in Biopharma 2025 is fast approaching, and we are delighted to share the list of top biopharma companies ready to meet YOU! Whether you're looking to kick-start your career or explore new opportunities in the industry, this is your chance to connect with leading employers. Exhibitors include: AbbVie, Amgen, APC Ltd & VLE Therapeutics, Arcadis, Astellas, ATU, BioMarin, BMS, Eurofins, Fastnet, Grifols, Johnson & Johnson Innovative Medicine, KPC International, LSC, MSD, NIBRT, Parker Hannifin Ltd, PDA Ireland, Pfizer, RCSI, Sanofi, TU Dublin, Veolia, WuXi Biologics. Exhibitor enquiries: Interested in exhibiting? Contact emer.norton@nibrt.ie In its 11th year, NIBRT Careers in Biopharma is Ireland’s largest biopharma careers fair, bringing together graduates and top employers in the biopharma industry. When: Saturday, 29th March 2025, 10:00 AM – 3:30 PM Where: O'Reilly Hall, University College Dublin, Belfield, Dublin 4 Cost: Free (registration required) Why attend? Meet top biopharma employers actively hiring Gain industry insights from expert talks Discover training programmes and upskilling opportunities Network with industry professionals Register now: Attendance is free, but advance registration is required (limited places). https://hubs.la/Q039V4sf0 #Biopharma #CareerFair #NIBRT

Only one week to go until our free webinar on the effectiveness of the Pharmaceutical Quality System and the role of Risk-Based Decision Making. Upcoming Webinar: Demonstrating the Effectiveness of the PQS and the Role of Risk-Based Decision Making Date: 13 March 2025 Time: 3:00 PM Dublin/GMT Join NIBRT and the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin to explore how Risk-Based Decision Making (RBDM) enhances Pharmaceutical Quality Systems (PQS) and strengthens Quality Risk Management (QRM). Speakers: Valerie Mulholland: Principal Consultant, GMP Services Michael Schousboe: Senior QMS Specialist in Quality Risk Management, Novo Nordisk Professor Kevin O’Donnell: Market Compliance Manager, Health Products Regulatory Authority (HPRA) Moderator: Alice Redmond: Chief Strategy Officer (CSO), CAI Key Topics: The Pharmaceutical Quality System Risk-Based Decision Making ICH Q9(R1) Updates Quality Risk Management Best Practices Do not miss this opportunity to hear from industry experts and gain valuable insights. Register: https://hubs.la/Q0381_r90

New Course - Operator Inspection Readiness: A Practical Perspective. Prepare yourself or your team for the regulatory inspection process! When: 27th May 2025 Delivery: One day onsite at NIBRT facility This one-day, in person course at NIBRT Dublin is designed to equip manufacturing operators in the biopharmaceutical industry with the knowledge and practical skills necessary to prepare for regulatory inspections. Participants will gain a comprehensive understanding of the inspection process, the critical role of operators during inspections, and best practices for inspection preparation. Key topics covered -Introduction to Regulatory Inspections and Regulatory bodies (EMA, FDA, HPRA) -Regulatory Inspection processes and guidelines -Role of Manufacturing Operators -Inspection Readiness Strategies -Practical Exercises for Operator Readiness Enrol and more information: https://hubs.la/Q039tghQ0

It was wonderful to be in the audience at this week's IPHA Conference. The personal highlight for me was being there for the evening panel session featuring homegrown advanced therapy innovators in discussion with Matt Cooper. Nicki Panoskaltsis (TCD/St James's/NIBRT), Jane Farrar (TCD) and Mark O’Neill FCA (Haon Life Sciences) did a great job telling their very different stories working at the research, development and innovation coal-face. It was also tremendously gratifying that each of these world-leading innovators are either NIBRT research partners or members of Ireland's CGT Forum community. Each of them in their own unique way is representative of the green shoots emerging in Ireland's indigenous life science ecosystem, sitting alongside Ireland's long established excellence in biophama manufacturing. #CGTForum #advancedtherapeuticsireland #NIBRT

At NIBRT, our people are what make us great. Ambitious, motivated and with a desire to make a difference, our team thrives in an environment of collaboration, respect, and innovation. With a strong sense of belonging, where everyone is valued, unique, and empowered to push boundaries. Watch the video to see what makes #lifeatnibrt so special. #OurPeople #Innovation #Diversity #Belonging #Teamwork

2 Weeks to Go – Register for Our Free PQS & RBDM Webinar Upcoming Webinar: Demonstrating the Effectiveness of the PQS and the Role of Risk-Based Decision Making Join us in just two weeks for a free webinar, hosted by NIBRT in collaboration with the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin. Date: 13 March 2025 Time: 3:00 PM Dublin/GMT This session will explore how Risk-Based Decision Making (RBDM) enhances the Pharmaceutical Quality System (PQS) and strengthens Quality Risk Management (QRM) practices. Learn from expert speakers as they discuss key updates from ICH Q9(R1) and provide practical insights to improve regulatory compliance and operational efficiency. Speakers: Valerie Mulholland: Principal Consultant, GMP Services Michael Schousboe: Senior QMS Specialist in Quality Risk Management, Novo Nordisk Professor Kevin O’Donnell: Market Compliance Manager, Health Products Regulatory Authority (HPRA) Moderator: Alice Redmond: Chief Strategy Officer (CSO), CAI Key Topics: The Pharmaceutical Quality System Risk-Based Decision Making ICH Q9(R1) Updates Quality Risk Management Best Practices Register: https://hubs.la/Q0382nF-0