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
Ensure all 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&S regulations and expectations
Act as a cross‑functional liaison with manufacturing, regulatory and external partners
Contribute to departmental strategy, budgeting and technology planning
Liaise with Global TBCT sites to advise on analytical related issues.
Own QC laboratory throughput and testing prioritisation processes to ensure analytical activities are aligned with production schedules, customer commitments and inventory requirements
Provide strategic leadership for batch release testing, ensuring timely generation, review and approval of analytical results to support on‑time product disposition and release.
Partner closely with Manufacturing, Quality Assurance, Supply Chain and R&D teams to balance analytical turnaround times, compliance requirements and operational priorities, minimising production delays while maintaining data integrity and quality standards.
Establish and monitor laboratory performance metrics relating to testing cycle times, sample backlog, testing right‑first‑time, and release performance, driving continuous improvement to improve responsiveness and efficiency.
Lead the analytical support for in‑process manufacturing testing, ensuring rapid, scientifically sound interpretation of results to enable timely operational decision making and process control.
Ensure appropriate laboratory resource planning, staffing and capability to meet fluctuating manufacturing demands, critical release timelines and business continuity requirements.
Act as the primary escalation point for critical production‑related analytical issues, providing risk‑based recommendations and expediting investigations to minimise manufacturing disruption.
Drive continuous improvement initiatives focused on reducing analytical turnaround times, optimising workflow efficiency and increasing laboratory capacity without compromising compliance or data quality.
Implementation and maintenance of LIMS (laboratory information management system) across laboratories.
Education
A degree in Chemistry or closely related subject
Experience
Extensive hands‑on experience in laboratory operations, demonstrating a high level of technical competence and scientific understanding
Experience in the Management of staff
Knowledge of current EP/USP methods
Experience in use of laboratory equipment – AA, HPLC, GC IC, ICP
Skills
Ability to manage multiple priorities and work collaboratively across departments
Excellent organisational, communication, and problem‑solving skills
Analytical Group Manager in Larne employer: Hira Ni
The Health Innovation Research Alliance Northern Ireland (HIRANI) is an exceptional employer, offering a dynamic hybrid work environment in the heart of Belfast that fosters collaboration and innovation in the health and life sciences sector. With a strong commitment to employee growth, HIRANI provides opportunities for professional development through engaging projects and partnerships with universities, healthcare providers, and industry leaders. Our inclusive work culture prioritises communication and teamwork, ensuring that every team member can contribute meaningfully to our mission of promoting health and prosperity across Northern Ireland.
