Sr. Manager, Clinical Supply Chain Ops

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.

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Cork, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

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.

About the Opportunity:We are seeking an experienced and driven Senior Manager of Clinical Supply Chain Operations to collaborate on the end-to-end clinical supply chain execution across our global study portfolio. This individual will play a critical role in program management, forecasting, scenario planning, and risk mitigation to ensure timely and uninterrupted availability of clinical trial materials (CTM). The ideal candidate is both strategic and hands-on, with strong cross-functional collaboration skills and a deep understanding of the clinical development lifecycle. This is an exciting opportunity to contribute to a growing organization by applying best-in-class planning principles, digital technologies, and operational excellence.

Key Responsibilities

Clinical Supply Chain Operational Execution:

· End-to-end global clinical supply operations management, including but not limited to timelines to ensure alignment overall clinical development, manufacturing, pack and label, logistics, inventory, reconciliation, and IRT, maintaining Clinical Supply Plan up to date.· Translate clinical protocols into integrated demand forecasts and risk-adjusted supply plans across regions.· Support long-range planning, scenario modeling, and financial forecasting to ensure uninterrupted supply and potentially identify cost efficiency.· Provide input to Interactive Response Technology (IRT) system design, testing. Maintain system to support supply tracking and randomization.· Monitor and track manufacturing timelines and ensure alignment with clinical supply needs.· Responsible for inventory management at patient level to ensure zero out of stock situations.· Partner with key stakeholders to understand details of clinical study design, planning and execution, such as examples below (but not limited to) :o GEO (Global External Operations) to monitor and understanding status of manufacturing operations (DS, DP and FG), storage and distributiono GSO (Global Study Operations) to understand study milestones, upcoming visits, site inventory, and ensure supply continuityo CSC Planning to provide demand and understand supply forecasting

Program Management and Cross Functional Collaboration

· Lead Clinical Supply Chain (CSC) operations at the study and program level, including budget and timeline development and adherence.· Serve as the primary CSC representative in cross-functional governance forums.· Collaborate with internal and external stakeholders to align supply strategy with development, regulatory, and operational needs.· Influence program-level decisions to optimize timelines, patient access, and budget compliance.

Operational Excellence, Quality Compliance and Digital:· Ensure compliance with global GxP, ICH, and regional regulatory requirements in clinical supply operations.· Support regulatory filings and inspections as a subject matter expert; lead TMF preparation for investigational product supply.· Drive SOP development, process improvements, and audit readiness to enhance operational scalability.· Lead digital transformation initiatives including forecasting tools, dashboards, and AI-driven analytics to improve resilience and sustainability.Other duties as assigned

Must have: Minimum Requirements:· Bachelor’s degree in a science-related field; advanced degree preferred· 8+ years of experience in clinical supply chain, planning, or operations within the biotech/pharma industry· Proven ability to lead cross-functional teams, influence stakeholders, and manage complex supply planning scenarios.· Experience with digital planning tools (e.g., SAP, Tableau).· Experience using the Smart Supplies Forecasting tool is preferred.· Strong understanding of GxP, ICH, and regulatory requirements governing clinical supply activities· Strong understanding of technical drug development is advantageous

Nice to have:- Rare disease therapeutics clinical development

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.