Responsible for: - The management of compounding operations - Meeting business KPI’s in strict accordance with GMP, GDP and Quality standards. - Resource planning - Performance management - Warehousing and Dispatch

• Led team of 18 staff responsible for manufacture, in-process testing and filling and packing of 5 Product lines, 31 products• Achieved 100% product availability of all products manufactured on site i.e. zero backorders• Ensured all regulatory and compliance issues related to Production were maintained to a high level, resulting in zero major non conformances in FDA, ISO 13485 and HPRA audits.• Core member of CAPA investigation team and managed all Production non conformances (NCRs)• Minimised scrap due to Production errors to < 0.3% of process orders.• Achieved average schedule adherence of 95%• Ensured safe work environment through compliance to Health and Safety procedures – zero HSA reportable accidents• Supported Supply Chain in material management i.e. key member of Material Review Board• Ensured all equipment under Production’s responsibility was cleaned, maintained and calibrated on time• Team member of a lean six sigma project that resulted in a 100% increase in throughput for a critical manufacturing line and an annual saving of circa €170k• Represented Production on the site Molecular Preparations Team i.e. involved in the design, validation and commissioning of a new manufacturing facility for Molecular and EIA products• Managed the transfer of the manufacture of Parvovirus EIA Product range from the old facility to the new facility and represented Production in the 180 PMA supplement and the FDA site approval audit• New Product Introduction: Achieved validation timelines for 12 new molecular products transferred from R&D• Technical Transfer - Successfully integrated new molecular nucleic acid extraction business into Production (14 products) and key member of team that transferred two FDA approved EIA products, 5 molecular products and 14 molecular extraction products to global manufacturing sites

• Led team of 18 responsible for the production, in-process testing and filling and packing of diagnostic products (EIA and IFA, 22 products)• Managed multiple Production labs including Tissue Culture lab• Ensured regulatory compliance resulting in zero major citations in FDA and ISO 13485 audits.• Controlled stocks of raw materials, work-in-progress and finished goods to ensure adequate stock levels.• Production planning and scheduling.• Led continuous improvement initiatives• Successfully integrated new and re-developed products from R&D into Production.• Planned for increases in Production volume and efficiencies. Increased batch sizes by 100%

In addition to responsibilities listed for Production Supervisor role, also took on responsibility for Supervising the Filling and Packing Department (i.e. additional 8 staff)

• Led a team of 8 Production Scientists responsible for the manufacture and in-process testing of diagnostic products (EIA and IFA, 15 products) and also responsible for the running of the Tissue Culture lab• Represented Production in successfully achieving FDA Pre-market approval of two flagship EIA products• Reviewed batch history records• Controlled raw material stocks

• Manufacture and testing of EIA products for infectious diseases and biomarkers• Manufacture of immunofluorescence (IFA) products which involved tissue culture techniques to generate recombinant proteins. • Protein purification and conjugation of enzymes to antibodies.

Responsible for development and validation of Immunoassays