Nicole O'Callaghan Email and Phone Number

Manage the small molecule process team.Manage DS, DP CMOs and Pack sites to ensure continuity of supply to the patient.Collaborate with a cross functional team to ensure uninterrupted supply of product.Manage and maintain with cross functional team a visual metric/dashboard to provide an oversight of the GEO business.Manage contracts and negotiations with CMO.Coordinate Business Reviews with CMOs.monitor production campaigns and develop an in-depth knowledge of the manufacturing process and systems at the CMO.Coordinate as required BioMarin activities in the evaluation of process changes, change requests and deviations to ensure timely resolution without impacting on supply.

Developed Category Strategies for Chemicals, Media, Excipients & ResinsPerformed market intelligence for key strategic suppliers to identify risk to the business and implement process improvements to mitigate such risk Executed key supplier strategies such as supplier rationalization, process efficiencies and risk managementAligned key strategic strategies with overall Global Procurement StrategiesDrove Innovation Programs with key suppliers on 2nd sourcing while driving cost optimizationDeveloped and led cross functional teams to support category strategiesPrepared a tangible list of projects and implemented Project Charters Coordinated and led global business review as well as quarterly business reviews for top tier suppliersCreated global supplier scorecards to drive processes for continuous improvements. Supply Chain lead for 3 New Product Introduction to Shanbally Facility.Support and negotiate global master supply agreements Partner with finance teams in defining rules around cost avoidance/cost saving Partner with Global Supplier Quality to ensure robust quality technical agreements are in place to protect the business.Collaborating with key stakeholders and coordinating voice of the customer to ensure site and global goals are metBuilding out the supplier relationship management framework for the businessWorking with the key stakeholders in our CMC teams to ensure custom raw material specification are defined Building tools to capture overall spend per commodity and applying to supplier dashboards

Responsible for the sourcing and supplier management strategy at BioMarin Maintaining Supplier Scorecards and ensuring robust quarterly business reviews for our preferred suppliersResponsible for strategic sourcing, Identifying, leveraging and harmonizing best sourcing practices for GMP Raw Materials Building out our contract framework on both Master Supply Agreements and quality technical agreement to ensure they are robust enough to safe guard the business.Building market intelligence to ensure proactivity for continuation of supplyRisk management of key suppliers and reviewing their supply capabilities Developing strategic goals and objectives from the high level site goals into category management

Lead in Supply Chain Operational readiness for the introduction of 3 New Products to the Shanbally facility.Project management of all supply chain activities end to end.Responsible for the management/implementation of the VWR/Distribution model for the on boarding of GMP process chemicals/excipients.Managed Custom portfolio for both Media and Resin Responsible for 2nd sourcing activities in process chemicalsResponsible for the governance of Tolling materialsResponsible for ensuring released raw materials for manufacturing.Coordinator for the LIMS Requalification for all chemicals on site.Responsible for the preparation of the Financial Budgets for 3 productsCoordination of all MSDS/Reach compliant records/All relevant assessments for the introduction of materials to site.Played a vital role in HPRA and FDA inspections from a supply chain aspect.Responsible for the extending/updating all raw materials specifications from a global level and ensuring all is captured in Trackwise from a traceability perspective.Responsible for ensuring all Master Supply Agreements and Quality Technical agreements are in place for raw materialsResponsible for review of Supplier Change Notifications and assignment of relevant task through TrackwiseCollaboration with global partners on supply chain best practices.Support function on Ready, Run ,Release Lean Boards and led the Ready Boards for manufacturing readiness which incl. collaboration of function such as warehouse, QC , QA , planning.

• Executing MRP in SAP for materials for the commercial products for small molecule and procuring of consumables for the large molecule• Reviewing the planning paramenters in order to set up traffic lights in SAP to review exception messages in SAP which highlights reschedule in/outs to reduce the risk of stock-outs• Responsible for procuring/planning Bulk Solvents deliveries for Small molecule, monitoring the non-bom materials• Creating source list, PIR records in SAP for the introduction of all new materials for the large molecule site• Weekly meeting with warehouse on incoming materials and capacity constraints.• Attending the weekly Site Scheduling meeting for the small molecule and planning according to the schedule• Attend a monthly ROP meeting to discuss any potential changes in the schedule due to customer demand/ levels of safety stock.• Full review of all master data in SAP to enable MRP review for large molecule• Close relationships with Global procurement on global supply agreements etc.• Working closely with shopping cart requisitions for non-mrp materials, manage the triage rules with appropriate GL code/mgc codes

• SME in SAP - owned/implemented Exception Based Planning in Janssen Leiden which later lead to global buying between three sites which in turn reduced inventories/safety stocks from a global level• Coordinating the buyer/planners in both Janssen Bio & Chem. Cork/Janssen Pharma Leiden to ensure alignment on exception based planning • Reviewing MPS with buyer/planner to ensure all new lines are been driven correctly for New products• Continuously looking at process improvement on the SAP system to ensure accurate MRP from the MPS (revised re-order points, lead-times, GRT settings and other MRP parameters)• Procedures updated with the new MRP parameters • Monthly Forecasts to Global & Local Key suppliers• Worked closely with suppliers on price negotiations and lead-times• Weekly meetings with suppliers on capacity constraints and ways in which to improve the overall logistics• Overall review of Excess & Obsolete materials• Delivered KPI’s to very tight deadlines

• Place all orders and dealing with sub-contractors• Expedite orders for urgent deliveries• Manage and maintain all bill of materials (bom’s) on the in-house system • Negotiations with Sub-contractors on competitive pricing.• Liaised with suppliers to achieve better lead-times • Arranging all data for transfer of products to China i.e. accurate bom’s, Gerber files etc.• Review & Audit all in-house ISO procedures to enable the company to receive ISO Certification.• Write up of ISO Procedures• Weekly meeting with Engineering on ECO (Engineering Change Orders) to ensure all E&O is reviewed and any major component changes are reviewed prior to final approval.Core Achievements• Implemented a Supplier Evaluation System to ensure the company received full visibility of the suppliers performance• Lead a team to implement ISO procedures to achieve ISO Certification

• Purchase & Schedule components and equipment to satisfy company & customer demands• Develop & Streamline appropriate Management Information Systems to ensure maximum cost effectiveness• Member of the Supply Chain turn around project• Implemented Vendor Management project.• Review Excess and Obsolete Report (E&O)• Part of the NPI team to implement New products under tight deadlines• Review of Material Review Board (MRB) • Initiating Change Orders for obsolete parts• Prepare Vendor Assessments• Maintain System Reports & Review Matrix on a weekly basis• Implemented a Kanban system for sub-contract suppliers thus reducing inventory levels...• Key member of a cost reduction team looking at key Direct and Indirect spend throughout the plant resulting in cost reductions.• Implemented an order integration system with our inter-company suppliers. This resulted in a huge reduction on time spent sending Purchase orders and in-transit details.

Accounts payable for all incoming direct materialsWages clerk - preparation of payroll for over 700 employeesIndirect materials buyer