Analytical Group Manager (26_36) Terumo BCT is a Global leader in blood management, blood safety, therapeutic apheresis, cell therapy and cell collections. We have an exciting opportunity for an Analytical Group Manager to join Terumo BCT- Larne. Come join us today! The Analytical Group Manager will provide management, leadership and coaching to multiple operational analytical teams, serving as the technical leader and subject matter expert for chemistry and ensuring that analytical testing, method development and regulatory compliance meet the highest scientific and quality standards. In addition, the post holder will have responsibility for strategic oversight to ensure safe, efficient and compliant lab operations. General Duties Mentor analysts, senior analysts and department managers; uphold a culture of scientific rigor and good documentation practices Ensureall analytical and laboratory work is conducted in conformance with approved methods and systems to ensure adherence to the site QMS Ensure accuracy, traceability, and regulatory compliance of all analytical results and reports Provide technical review and approval of laboratory data and investigations (e.g., NC, OOS, OOT). Lead the development, validation / verification and optimization of analytical methods per ICH and pharmacopeial guidelines. Support product development and lifecycle management with stability-indicating methods and formulation analysis Manage feasibility testing of new methods Manage method transfers between departments (AD/QC) or sites (CMOs), ensuring readiness and robustness Maintain and enforce compliance with cGMP, GLP and internal quality standards Own and oversee SOPs, analytical method protocols, laboratory documentation, training records and instrument calibration and qualification programs. Implement CAPAs and ensure closure in alignment with regulatory and internal expectations Act as a key participant or host during internal audits, customer audits, regulatory inspections and quality reviews Define, track, and report KPIs (e.g., on time release, first-pass yield, training compliance, NC/CAPA closure rates) Use data-driven insights to improve lab efficiency, reduce errors and drive continuous improvement initiatives Collaborate with site leadership to align laboratory performance with broader organizational goals Champion laboratory safety practices in compliance with EH
Analytical Group Manager employer: Terumo BCT Ltd
Terumo BCT Ltd is an exceptional employer located in Larne, offering a dynamic work environment where employees can thrive while contributing to meaningful healthcare solutions. With a strong focus on employee growth, the company provides comprehensive training and development opportunities, alongside a supportive culture that promotes safety and compliance. Employees enjoy attractive benefits such as private health care, performance bonuses, and a robust pension plan, making it a rewarding place to build a career in the pharmaceutical industry.
