Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Overview:We are seeking an experienced SAP Business Analyst Lead to spearhead the Plan to Produce workstream, focusing on Manufacturing (In-house and Contract), Quality Control, and Quality Assurance within a GxP-regulated environment. The lead will drive the integration of processes across critical subsystems, including SAP, Laboratory Information Management Systems (LIMS), Warehouse Management Systems (WMS), Manufacturing Execution Systems (MES), and Quality Management Systems (QMS), to ensure seamless operations, compliance, and efficiency. Key Responsibilities: Process Leadership & Integration: Lead the design, configuration, and implementation of SAP modules (e.g., PP, QM, MM) to support end-to-end Plan to Produce processes, including production planning, shop floor execution, quality management, and material management. Facilitate integration between SAP and subsystems (LIMS, WMS, MES, QMS) to ensure data consistency, process alignment, and real-time visibility across manufacturing and quality operations. Collaborate with cross-functional teams to map and optimize business processes, ensuring compliance with GxP standards and regulatory requirements (e.g., FDA, EMA). Manufacturing Support: Support both in-house and contract manufacturing operations by configuring SAP solutions to manage production schedules, capacity planning, and material traceability. Ensure SAP configurations align with manufacturing workflows, including batch management, shop floor control, and contract manufacturing processes. Quality Control & Assurance: Oversee the implementation of SAP Quality Management (QM) module to support quality control and assurance processes in a GxP environment. Enable integration with QMS for non-conformance management, CAPA (Corrective and Preventive Actions), and audit trails. Ensure traceability and compliance for quality-related data across SAP, LIMS, and QMS systems. Stakeholder Collaboration: Act as the primary liaison between business units (Manufacturing, Quality, Supply Chain) and IT teams to translate business requirements into technical specifications. Lead workshops, Cross functional Collaboration, requirement-gathering sessions, and solution design reviews to align stakeholders on process improvements and system capabilities. Project Management & Delivery: Drive end-to-end project execution, including requirements analysis, solution design, testing, training, and go-live support for SAP and integrated subsystems. Develop and maintain project documentation, including business process flows, functional specifications, and test scripts. Ensure timely delivery of projects while adhering to budget, scope, and quality standards. Continuous Improvement: Identify opportunities for process optimization and system enhancements to improve operational efficiency and compliance. Stay updated on SAP advancements, industry best practices, and GxP regulations to recommend innovative solutions. Qualifications: Bachelor's degree in Business, Information Technology, Engineering, or a related field; advanced degree preferred. 7+ years of experience as an SAP Business Analyst, with at least 3 years in a lead role supporting Plan to Produce processes. Expertise in SAP modules such as PP (Production Planning), QM (Quality Management), and MM (Materials Management); experience with SAP S/4HANA is a plus. Proven experience integrating SAP with LIMS, WMS, MES, and QMS in a manufacturing or life sciences environment. Strong understanding of GxP regulations (e.g., 21 CFR Part 11, GMP) and their application to manufacturing and quality processes. Experience with in-house and contract manufacturing workflows, including batch management and material traceability. Excellent project management skills, with proficiency in tools like MS Project, Jira, or similar. Strong analytical, problem-solving, and communication skills to bridge business and technical teams. SAP certifications (e.g., SAP PP, QM, or S/4HANA) are highly desirable. Preferred Skills: Knowledge of Industry 4.0 technologies, such as IoT or automation, in manufacturing environments. Familiarity with data analytics and reporting tools (e.g., SAP Analytics Cloud, Data Sphere Power BI) for process insights. Experience with Agile or DevOps methodologies for system implementation. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. SAP Business Analyst Lead - Record to Report (R2R) Workstream Overview:We are seeking an experienced SAP Business Analyst Lead to spearhead the Record to Report (R2R) workstream, with a focus on Treasury and Banking, Finance and Controlling (FICO), Profitability and Performance Management (PaPM), and Financial Planning & Analysis (FP&A). The SAP Business Analyst Lead will play a critical role in designing, implementing, and optimizing SAP solutions to support end-to-end financial processes, ensuring alignment with business objectives and operational excellence. Key Responsibilities: Solution Design and Implementation: Lead the design, configuration, and deployment of SAP modules and functionalities within the R2R workstream, including SAP FICO, Treasury (TRM), SAP MBC, PaPM, and FP&A solutions. Collaborate with business stakeholders to gather and analyze requirements for financial processes, ensuring alignment with organizational goals. Develop and maintain functional specifications, process flows, and system configurations to support R2R processes. Process Optimization: Drive process improvements in financial close, general ledger, accounts payable/receivable, asset accounting, cost center accounting, and profitability analysis. Optimize treasury and banking processes, including cash management, liquidity forecasting, payment processing, and bank communication (e.g., SWIFT, SEPA). Enhance FP&A capabilities through SAP SAC solutions, enabling robust budgeting, forecasting, and performance reporting. Leverage SAP PaPM to support Transfer Pricing, profitability analysis, cost allocation, and performance management initiatives. Leadership and Collaboration: Lead a team of business analysts and coordinate with cross-functional teams (e.g., SAP technical consultants, integration specialists, and business users) to deliver R2R solutions. Act as the primary point of contact for R2R-related inquiries, providing guidance to stakeholders and resolving complex issues. Facilitate workshops, Cross Functional Collaboration, training sessions, and change management activities to ensure user adoption and process alignment. System Integration and Data Management: Ensure seamless integration of SAP R2R modules with other SAP and non-SAP systems (e.g., SAP S/4HANA,or third-party banking platforms). Oversee data migration, master data management, and data quality initiatives for financial and treasury processes. Compliance and Reporting: Ensure compliance with financial regulations (e.g., IFRS, GAAP) and internal controls (e.g., SOX) within SAP configurations. Support the development of financial reports, dashboards, and analytics to meet stakeholder needs in FP&A and PaPM. Project Management: Manage R2R workstream deliverables, timelines, and budgets within SAP implementation or enhancement projects. Collaborate with project managers to align R2R activities with overall program objectives. Qualifications: Education:Bachelor's degree in Finance, Accounting, Information Technology, or a related field. MBA or relevant certifications (e.g., SAP Certified Application Associate, CPA, CMA) are a plus. Experience: 7+ years of experience as an SAP Business Analyst, with at least 3 years in a lead or senior role focused on R2R processes. Proven expertise in SAP FICO, Treasury, PaPM, and FP&A modules, preferably within SAP S/4HANA environments. Hands-on experience with treasury processes (e.g., cash management, bank reconciliation, liquidity forecasting) and banking interfaces. Strong knowledge of financial close, general ledger, cost accounting, and profitability analysis. Technical Skills: In-depth understanding of SAP modules (FICO, TRM, PaPM, SAC for FP&A) and their integration with other SAP components. Familiarity with SAP configuration, master data setup, and reporting tools (e.g., SAP Fiori, SAP Analytics Cloud). Knowledge of financial regulatory requirements and compliance standards (e.g., IFRS, GAAP, SOX). Soft Skills: Exceptional leadership, communication, and stakeholder management skills. Strong analytical and problem-solving abilities, with a focus on process optimization. Ability to work in a fast-paced, collaborative environment and manage multiple priorities. Preferred: Experience with SAP S/4HANA implementations or upgrades. Familiarity with Agile or hybrid project methodologies. Knowledge of advanced analytics or AI-driven financial tools is a plus. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Senior Business Operations Manager - Shanbally, Ringaskiddy, Cork Hybrid Role - 4 days per week onsite Closing date: 1st Aug 2025 BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. BioMarin's Technical Operations group (TOPS) is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients' lives. OVERALL PURPOSE OF THE ROLE Reporting into the Director of Business Operations at Shanbally, the Business Operations Senior Manager will be expected to relentlessly drive the business forward while simultaneously increasing their own technical capability through training and experience as well as the capability of others. They will lead the achievement and sustainment of performance excellence, primarily through the use of lean and six sigma methodologies. This role adds value by 1) supporting the business to accelerate the strategic improvement journey and 2) building Operational Excellence capability across the organisation and 3) implementing robust OE infrastructure to sustain the improvement journey. RESPONSIBILITIES Support Leaders across the business to have confidence and control in their performance by: Ownership for the deployment of the DMS system at Shanbally. Prepare an annual DMS improvement plan in collaboration with the business aligned to the site strategy. Challenge the status quo in terms of current performance. Partner with Flow Team Leaders to get the balance right to robustly challenging and support the team to drive the performance improvement agenda. Partner with the leads to implement lean solutions aligned with delivering better control and improved performance across all teams. Key elements for deployment will include visual metrics, performance management, 5S, standard work, LSW and gemba to support the business. Work with the business to optimise the existing governance structure and implement changes to lean, standardise and strengthen the system - evolving with the business changes. Host the annual Site DMS Maturity Assessment to measure progress and identify our next improvement opportunity / focus area. Support Leaders across the business to fix problems by: Own and manage the BioMarin Root Cause (RCAR) program ensuing that the programme is supporting thorough best in class problem solving. Providing regular training to build a community of RCAR expertise across the business. Identify gaps and implement plans to close capability gaps across the site. Identify continuous improvements our overall RCAR process and capture business benefit For complex RCAR (or significant business impact), lead the RCAR team using standardised and specialist tools to identify the correct root cause, fit for purpose effective CAPAs and accelerated implementation plan Lead Value Realisation initiative for the business to embed value and robust COST management across the SQDEC by: Co-lead the Value Realisation program year on year to ensure we have steady stream of projects to achieve savings targets. In collaboration with Finance partner, coach peer across the Flow Team to build their capability on overall management of financial metrics in SQDEC to ensure a balanced scorecard in their Tier structure. Partner with the business lead to tackle waste opportunities and drive efficiencies using structured DMAIC approach Support the business to accelerate the site strategic improvement journey by: Deploy solutions to key business processes on site, aligned with the site strategic improvement plan. Improvement will be delivered in partnership with the business typically through lean, reengineering or Six Sigma. Impact will be measured via improvement in agreed business KPIs. Coach Lean, Reengineering and/or Six Sigma projects as required by the business. Support the Greenbelt programme owner within the BusOps team. Participate actively in Flow Teams on their CI journey to agree improvement priorities. Proactively work with GEO and sister sites NVT and GEO to maintain alignment and share best practices. General maintenance of alignment in methodology, procedure and governance within global organisation (TOPs). Competencies: Cognitive capability - Ability to learn quickly and to be able to share those learnings to wider colleagues in a way that is understandable. Ownership and Accountability - Takes accountability for actions, drives results, and able to learn from mistakes. Delivers on promises, goals, and expectations. Makes quality decisions and resolves problems with minimal delay as appropriate. Asks "what can I do to help?" Collaborative Leadership - Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment. High tolerance for ambiguity and able to create order from chaos. Builds credibility through solid relationships and solid track record of results. Communication - Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity. Ability to draft and deliver clear and concise procedures or business process documents. Planning/Organization - Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amounts of information. Able to deliver results despite shifting environment. Analytical Problem Solving - Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigation, and execution. Manages expectations. EDUCATION Science, Engineering or Business background preferred but not essential. Formal Lean, Reengineering and/or Six Sigma training preferred but not essential. EXPERIENCE Must have a demonstrated track record in driving performance through self and others by inventively harnessing surrounding (albeit often) constrained resources. A demonstrated track record in working with people, understanding customer/client dynamics and driving positive change. Minimum 10 years of experience in industry. Sound knowledge of cGMPs and equivalent industry regulations. Experience in systems thinking. Knowledge and previous work experience with process mapping, Lean Six Sigma and Business Process Reengineering would be preferable. Knowledge of performance measurement tools and metrics. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Supply Chain Operations Shift Lead - Shanbally, Ringaskiddy, Cork Closing Date - 11th August Role The Shift Lead will serve as an integral member of the Supply Chain Operations Group based in a biologics facility which incorporates drug substance manufacturing, labelling & packaging of finished product, Fill Finish operations along with global supply co-ordination and product launch. The Supply Chain Operations Shift Lead will fulfil a key role by coordinating the Receiving, Warehouse, Weigh and Dispense/Sampling team in support of the plant's material operations requirements for steady - state manufacturing, packaging, fill finish and new product introductions (NPI). In addition, the Material Operations Shift lead will have oversight of receiving activities executed at BioMarin third party logistics (3PL) partners, and will act as liaison between the 3PL and BioMarin stakeholders with regards to any raw material issues and support requirements. This varied role includes the coordination of 3PL inventory replenishment, maximizing on site storage and capacity utilization, resource planning for standard work, and team coordination to ensure all tasks are completed and targets are achieved and updated/tracked on the area Daily Management Standard Workboard. The role calls for strong time management and prioritization skills. Ideally, the successful candidate will have experience and understanding of Materials Management in a Biotechnology or Pharma environment with particular focus on maintaining GMP standards. The successful candidate will be an enthusiastic and energetic person with an ability to prioritize & co-ordinate multiple tasks across multiple activities in an everchanging environment. Attention to detail is critical in this operating environment. Strong and effective communication skills will be necessary, as well as the ability to positively influence without authority. This role will report to the Material Operations Lead. Key Responsibilities Develop and demonstrate a proactive approach to safety, industrial hygiene, environmental and regulatory compliance Co-ordinate the Receiving, Warehouse, Weigh and Dispense and Sampling teams within Material Operations by maintaining Daily Management Standard work boards and giving clear direction to the Ensure adherence to the Receiving, Warehouse, Weigh and Dispense and Sampling schedules Collaborate with Material Operations colleagues, QA, QC, Manufacturing, Packaging and Engineering to ensure all KPI's, SLA's and departmental targets are achieved Responsible for material management and storage, 3PL Inventory management and fulfilment of inventory requirements at BioMarin Shanbally Responsible for ensuring adherence to schedules for Manufacturing, Fill Finish and Packaging operations Co-ordinate both local and offsite facilities to ensure inventory supply is efficiently maintained for Shanbally, and replenishment signals are reviewed regularly to ensure they are in line with activity Maximize capacity efficiency of warehouse and cold-rooms/Freezers. Oversee all cycle counting activities at the Shanbally and satellite warehouse facilities Area lead for regulatory inspections Perform updates to standard operating procedures, training modules and compliance requirements Maximise efficiency through continuous improvement and progressive thinking Ensure temperature - controlled areas within Material Operations are maintained within compliance Ensure all weekly tasks are completed on time and in full Ensure housekeeping and 5S practice standards are maintained to the highest levels. Timely escalations of any issues or concerns to Material Operations Leadership Team Act as a role model for the values and behaviours of BioMarin Shanbally in a dynamic and fast paced working environment The execution of the above activities will often be to very exacting timelines and will require interaction with key collaboration partners in different time zones Other duties as assigned. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Senior Equipment Engineer/Equipment EngineerShanbally, Ringaskiddy, CorkOnsite RoleClosing Date: 15th August 2025Biologics Centre of Excellence(CoE), Technical Development Services (TDS) is hiring ahighly skilled and experiencedSenior Equipment Engineer/Equipment Engineerto oversee the management and maintenance of laboratory equipment. The ideal candidate will have a strong background in engineering, exceptional problem-solving skills, and a passion for ensuring the accuracy and reliability of lab instruments. Strategic thinking and the ability to align equipment management with the broader goals of the organization are essential. Key Responsibilities:This person will be responsible for the delivery and operational management of the lab asset management processes & systems. Design and implement the laboratory equipment asset system, along with their supporting lifecycle management processes. Manage and maintain all laboratory equipment, ensuring optimal performance and adherence to safety standards. Provide clear visibility of all laboratory equipment and their associated asset lifecycle costs. Diagnose and troubleshoot equipment/instrument technical issues, collaborating closely with vendors and service providers for repairs and replacements. Using Asset management principles to guide specification of KPI's for Lab Operations program. Deliver dashboard(s) that provide clear performance reporting for each type of lab asset Will be a prominent change leader for new processes interacting with both internal & external vendors, global procurement, and scientific functions. Partner with Automation and IT to align data consistency & reporting relating to lab equipment assets. Apply standard data analysis practices and techniques to establish root cause for product and process failures or to support the justification for improvements to products and processes. Contribute to the strategic planning of laboratory operations, aligning equipment management with the organization's long-term objectives. Review procedures and CAPEX equipment plans prior to implementation as well as existing ones for failure analysis and potential improvements. Oversee equipment asset lifecycle management, ensuring timely preventive maintenance and accurate repair documentation in the Computerized Maintenance Management System. Strong fault-finding expertise to identify faults or issues with lab equipment to ensure quick turnaround of equipment for maximum uptime. Coordinate and/or conduct training sessions for laboratory personnel on the proper use and care of equipment. Stay informed about the latest advancements in laboratory technology and recommend upgrades as necessary. Work in partnership with Engineering Reliability Team to develop and maintain reliability program for lab equipment Develop FMEA's or similar for existing and new lab equipment to identify key objectives or priorities for asset life management Adhere to all safety, environmental, security and quality requirements including, but not limited to: Safety & Environmental Management Systems, Quality Management Systems (QMS) regulations, company policies and operating procedures, and other regulatory requirements. Facilitate or contribute to corrective and preventive actions while supporting the achievement of Biologics CoE SQDEC standards as well as 5S principles. Qualifications & Skills: Bachelor or Master's degree in engineering, preferably in Mechanical, Electrical, Chemical or Biomedical Engineering. Minimum of 5 years of experience in lab equipment management or a related field. Experience of Reliability programs and management Proven expertise in the maintenance and repair of laboratory instruments. Strong strategic thinking abilities and experience in integrating equipment management with organizational goals. Proficient in the use of Excel, Power Point and Visio software. Familiar with basic Data analytics and statistical methods. Proficiency with CMMS & Power BI would be an advantage. Demonstrated results through Lean practices and principles. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. SUMMARY DESCRIPTION The Director of Launch Excellence is a new role in the Product Supply Chain Management organization. Director, Launch Excellence will ensure enterprise governance and frameworks for new product launches and artwork and labelling are implemented with quality and timeliness to elevate BioMarin's launch discipline. Reporting to the Executive Director, Product Supply Chain Management, the Director, Launch Excellence will partner closely with Product Teams and cross-functional launch teams to develop launch disciplines and establish consistent tools, processes, and KPI dashboards, ensuring launch excellence against specific business deliverables. The ideal candidate will have strong leadership and team development skills, a deep understanding of Product Launch (New Product Introduction), Project Management and Artwork & Labelling with demonstrated ability to drive continuous improvement initiatives. Note that individual responsibilities may include all or part of responsibilities defined below depending on individual experience and abilities and may change to best support on-going business needs. RESPONSIBILITIESMange team to drive launch processes, disciplines, and toolkits including blueprints, frameworks, archetypes, playbooks, governance models that are standardized and utilizes across all products and launch teams. Create communities of practice across for upcoming launches to be able to gather, aggregate and share best practices and cross-functional perspectives across teams, ensuring that teams are building on launch and artwork and labelling learnings across the organization Manage a consistent and robust product launch process and governance as a 'control tower' structure to provide oversight and to ensure consistency of tracking and incorporating disciplines across launches Work with internal launch stakeholders to ensure launch process management and successful completion of launch readiness tasks (standardized approach across business units - including Blueprint / Playbook, Governance, and Dashboards /KPIs. Work with cross-functional team to understand the impact of changing regulations, product requirements and new market entry regarding artwork and labelling. Coordinate Launch Readiness Review Assessments across launch brands to ensure strategic and tactical plans are reviewed and aligned with CtF (commit to file) and CtL (commit to launch) dates with BU and TOPs leadership Establish reporting dashboards to manage reporting of key metrics and KPIs including leading and lagging indicators to ensure launch success, providing mechanism for teams to share critical updates. Leading overall business planning working with the Product Teams, Commercial / Country leaders, Planning & Logistics as well as cross-functionally to ensure that strategic planning & financial-planning deliverables are created at a high-level and in a timely manner Designs and establishes new processes, as required, for new modalities and emerging technologies that warrant deviation / modification of standard processes. Create and manage change control packages in product life cycle management system, ensure documentation is accurate and appropriate. Team Leadership: Lead, mentor, and develop a matrix team of TOPS professionals, fostering a culture of excellence and continuous improvement. Compliance: Ensure compliance with all relevant TOPS and Regulatory policies and processes. Stakeholder Collaboration: Collaborate and consistently communicate with key stakeholders, including BU leadership, TOPS product teams and leadership. Technology Utilization: Leverage appropriate technology and systems to streamline processes and improve data accuracy to support Product Launch Dashboards. Change Leadership:As a member of the Product Supply Chain Team(s) support and drive the change management requirements through communication internally and externally, developing the vision for Launch Excellence and broader PSCM and GSC organization and empowering team members to make effective decisions. SCOPEThis role is responsible for supporting the on-time Launch and availability of products and artwork and labelling in marketin compliance with applicable regulations. Decisions made in this role are of critical nature in mitigating risks for the business while ensuring BioMarin's commercial products are delivered to patients in a timely and compliant manner. The candidate should demonstrate the following attributes: A firm commitment to BioMarin's cultural beliefs and values Consistent track record of exceeding objectives within area of influence Ability to multitask effectively within a highly dynamic environment Ability to achieve results through others without direct reporting lines Strong problem-solving skills with a global focus both internally and externally Possess a high level of accountability and demonstrate an ability to be a change agent in a highly regulated industry Flexibility and ability to deal with changing priorities without losing sight of the overall business, product and market needs Strong interpersonal, communication and influencing skills working with all levels and within an environment of constant change Proactive and energetic outlook with an unwillingness to accept the status quo Interaction and collaboration with team members, peers and senior management Ability to work independently with strong time management skills Ability to operate globally, across different time-zones, work with global and regional functions. EDUCATIONBachelor's degree in Life Science, Engineering, Supply Chain Management, Business Administration, or a related field. Preferred: MBA in supply chain management, finance or business operations EXPERIENCEMinimum 10 years of experience in Supply Chain Product Launch or related discipline. Experience developing and operationalizing processes, systems and plans for New Product Launches inclusive of Artwork and Labelling. Strong leadership and management skills, excellent communication and interpersonal skills. Lean-DMAIC expertise, preferably Green Belt Certified or higher Project management certification, PMP or equivalent (preferred). Strong regulatory and GMP acumen Detail-oriented, analytical thinker, problem-solver, and able to work in a fast-paced environment. Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk Ability to effectively work autonomously and independently Proficiency in Microsoft applications and understanding of Office Timeline, MS Project / Project Online, MS Teams, MS PowerBI, SAP, or like technologies CONTACTSTOPS and PSCT product teams, GSC Planning, Site SC and Operations, Regulatory (CMC, Labeling & International / EU), Commercial Ops., Master Data team, Logistics, Artwork / Packaging Operations, Quality SUPERVISOR RESPONSIBILITYManage a direct team of 3 - 5 professionals responsible for Product Launches and Artwork & Labelling across BioMarin portfolio of products. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Senior Engineer, Drug Product - Cork/Dublin Closing Date: 30th July Technical Development are hiring a Sr Engineer with the following duties: Duties Technical SME for drug product (DP) supporting filling operations, working in a matrix team environment with process development, QA, QC, analytical sciences, packaging, supply chain, and regulatory teams to achieve project objectives. Supporting both Global External Operations (GEO) and Shanbally teams. Develop process comparisons, risk assessments, manage DP technical and manufacturing risks and identify appropriate mitigations. Author technical reports to support DP process and product characterisation. Manage change control, deviations, and CAPAs through the quality management system until closure. Facilitate investigations, root cause analysis for deviation resolution, data gathering/analysis, and provide technical assessments for deviations. Initiate and lead process improvement projects, involving cross-functional teams. Support the technical delivery of new product introductions and tech transfer projects by closely collaborating with cross-functional project teams, ensuring compliance with specifications, regulatory guidelines, and right-first-time delivery. Assist with PPQ campaign readiness and provide in-person, on-the-floor execution support for technical runs and PPQ campaigns as required. Support on-site implementation of changes and DP launch activities. Support aseptic filling operations (vials and pre-filled syringes) for technology transfers and life cycle management, overseeing new product introductions from development batches to approval and commercialization. Assist with regulatory inspections and present technical topics related to process aspects of assigned products when necessary. Ensure a thorough understanding of all quality policies and BioMarin system items as outlined in the training curriculum. Other duties as assigned. Skills Strong understanding and hands on experience in MSAT or process development or technology transfer, background in large scale processing of biologic drug products. Possess a strong understanding and hands-on experience in MSAT, process development, or technology transfer, with a background in large-scale processing of biologic drug products. Have a solid understanding of regulatory requirements and guidelines. Proficient in technical writing. Demonstrated ability to build strong partnerships and work effectively with diverse team members in a dynamic environment. Excellent organizational, interpersonal communication, and problem-solving skills. Capable of identifying, communicating, and implementing continuous process improvements. Ability to multi-task and manage tight timelines in a fast-paced environment. Able to work on the manufacturing floor for extended periods during the execution of technical protocols. Excellent written, verbal, and presentation communication skills. Strong analytical skills and sound judgment. Effective decision-making skills, with the ability to negotiate and balance decisions and priorities across multiple stakeholders' needs. Proficient in MS Office: Word, Excel, Outlook, PowerPoint, MS Project, etc. Education and experience A degree in engineering or science with relevant experience in the biotech/pharmaceutical field. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Qualified Person (QP) - Shanbally, Cork - Hybrid Role The Qualified Person (QP) is responsible for fulfilling QP responsibilities in relation to batch release of commercial and clinical product, in accordance with the requirements of 2001/83/EC, 2001/20/EC, Annex 16 and Annex 13 requirements as applicable. The QP ensures all products certified have been manufactured in accordance with the requirements of its marketing authorisation/ CTA and are in compliance with cGMP requirements. Provide technical expertise for all QA and compliance topics /issues relating to manufacturing and product supply of drug product and finished goods. Routinely monitoring the company's operations to ensure compliance with site licenses and Good Manufacturing Practice bringing any critical and major deficiencies to the attention of the Head of Quality Assurance. Participate in management reviews of process performance, product quality and of the quality management system in order to identify and action opportunities for continual improvement. Participates in cross functional teams as the Quality/Qualified Person representative. Reviews and approves Product Quality Reviews Experience/ Skills: Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing. Biologics manufacturing experience highly desirable Experience in Sterile Manufacturing and/or Clinical Trials Regulations highly desirable High level technical skills including analytical, auditing, pharmaceutical manufacturing, and regulatory inspection management. Technical writing skills required. Expertise in GxP and global regulatory requirements Excellent training/mentoring experience Excellent oral and written communication skills Competent problem solving, risk assessment and impact analysis abilities. Requirements: QP Qualification with at least 5 years of Quality experience in an EU licensed facility in a relevant functional area. Qualified Person status achieved with min 3-5 years of relevant work experience acting as Qualified Person named on a Manufacturing and Importation Authorisation (MIA/ IMP MIA) Aseptic / Sterile Drug Product manufacturing experience desirable Experience with IMP's (Investigational Medicinal Products) desirable Experience with participation in regulatory inspections, presenting or defending departmental functions in audits or regulatory inspections. Understanding and familiarity with European/ FDA regulatory requirements, guidelines, and expectations. Ability to comprehend technical information related to equipment, processes, and regulatory expectations. Maintain knowledge up to date with respect to the current Good Manufacturing Practices (cGMP), technologies and quality systems for the products they certify We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Recruiter/ Talent Advisor - Cork (Hybrid) 4 Month Contract Reporting to the Principal Talent Advisor, the Recruiter deals with business leaders, hiring managers and other HR colleagues to engage and recruit top talent across Europe. You will individually manage a portfolio of openings, focusing on exceeding client's expectations and ensuring a positive candidate experience. You will apply strong technical expertise (such as strategic sourcing, candidate and client management, data analysis, and project management) in implementing the solutions to find top talent. Experience and Skills 8+ years of progressively responsible Talent Acquisition/ Recruitment experience is required Biotech or pharmaceutical experience is highly desired In-house recruitment experience strongly preferred Experience of managing full 360 degree recruitment process for R&D and Commercial role highly desirable Outstanding client service, problem solving, and project management skills Strong influencing and negotiating skills Demonstrated success in managing a high volume of requisitions within a rapidly changing, fluid, innovative culture Strong technical expertise in direct sourcing techniques History of consistently meeting or exceeding quantitative goals A strong understanding of compensation guidelines, legal implications in hiring, and an understanding of relocation and immigration processes Experience utilizing Applicant Tracking Systems; Jobvite preferred Strong Microsoft Office skills Education Bachelor's Degree in Human Resources, Business, Life Science or equivalent work experience. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
