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.

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.

• Process Leadership & Integration:
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• 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:
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• 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:
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• 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:
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• 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:
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• 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:
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• 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.