Posted 30 June, 2026
Quality Control Bioassay Specialist
Next Generation
Dundalk
Full Time
Reference: 481_660562_14416
Job Description Help Build the Future of Biopharmaceutical Quality Quality Control Bioassay Specialist Imagine being the scientific expert who helps ensure life-changing medicines consistently meet the highest quality standards before they reach patients. Every assay you optimise, every investigation you support, and every improvement you drive strengthens the reliability of advanced biopharmaceutical manufacturing and contributes to safer, more effective therapies. This opportunity places you at the heart of a growing Quality Control organisation during an exciting period of laboratory expansion. Working within a highly regulated GMP environment, you'll combine technical expertise with scientific leadership to help establish advanced bioassay capabilities, solve complex analytical challenges, and build laboratory excellence from the ground up. What you'll achieve (and why it matters) Bring your expertise into a specialist Quality Control function where your scientific knowledge will directly influence laboratory capability, compliance, and operational excellence. Provide technical leadership for complex bioassay methods, including method establishment, optimisation and troubleshooting. Support advanced cell biology, biochemistry and analytical testing to ensure robust, reliable laboratory performance. Review, interpret and approve analytical data, ensuring the highest standards of quality, accuracy and data integrity. Lead scientific input into laboratory investigations, identifying root causes and implementing effective corrective actions. Support analytical method transfer, verification and validation activities as new capabilities are introduced. Partner with cross-functional teams across Quality, Manufacturing and Technical Operations to solve technical challenges and improve laboratory performance. Help establish laboratory best practices by preparing and improving SOPs, technical documentation and standard work. Coach and support colleagues, helping to strengthen scientific capability across the laboratory. Drive continuous improvement initiatives using Lean principles, 5S and process simplification to improve efficiency and quality. Contribute to laboratory start-up activities, equipment qualification and inspection readiness. Support regulatory inspections and audits while ensuring ongoing compliance with GMP, ICH, USP and global regulatory requirements. Champion a culture of safety, innovation and continuous improvement while helping the laboratory deliver right-first-time performance. Your edge (desired, not required) Degree in Biochemistry, Biotechnology, Biology, Pharmaceutical Science or another relevant scientific discipline. 5 or more years' experience within biotechnology and/or pharmaceutical manufacturing. Strong technical expertise in cell-based assays, cell biology techniques, qPCR and analytical laboratory methodologies. Excellent understanding of GMP, analytical method lifecycle management and Good Documentation Practices. Experience supporting analytical method transfer, verification or validation. Strong troubleshooting and scientific problem-solving abilities. Experience participating in investigations, deviations, CAPAs and quality improvement activities. Familiarity with Laboratory Information Management Systems (LIMS). Exposure to Lean, DMAIC, 5S or Lean Six Sigma methodologies would be advantageous. Excellent communication skills with the ability to collaborate across multidisciplinary technical teams. Why this role matters Quality Control is far more than testing; it's about building confidence in every product that reaches patients. In this role, you'll help establish specialist laboratory capability while providing the technical expertise that supports compliant, reliable and efficient biologics manufacturing. Your work will influence analytical excellence, strengthen laboratory performance, and help maintain the rigorous quality standards expected within a world-class biopharmaceutical environment. If you're someone who enjoys solving complex scientific problems, mentoring others, driving continuous improvement, and working where quality truly matters, this role offers an outstanding opportunity to make a lasting impact. The next step for you If this opportunity is of interest, please send your CV to [email protected] or apply on our website to discuss the role in more detail. All applications are treated in the strictest confidence. Next Generation Recruitment specialises in Supply Chain, Procurement, Engineering, Quality, Scientific, Manufacturing, Technical and Operations recruitment across permanent, contract and temporary positions. Your data will never be shared outside our organisation without your prior written consent.