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.
Senior Director, Head of External Operations, GEO 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. Come join our team and make a meaningful impact on patients’ lives. The role of Snr. Director, Head of External Operations, GEO will provide leadership for all manufacturing and packaging operations which take place in Contract Manufacturing locations globally to support BioMarin’s clinical pipeline and commercial product portfolio. The core focus of the role is to ensure timely delivery of quality commercial and clinical product to support patient supply from our CMO network. Our CMO operations span multiple sites (approx. 20) and multiple technology platforms namely, Biologic Drug Substance, Synthetic Drug Substance, Oral Solid Dose, Sterile Drug Product, Combination Products, and Packaging. The successful candidate will provide leadership to a global team of Managers with responsibility for operational management and oversight of the CMOs and other key suppliers within the BioMarin network. The position reports directly to the Vice President of Global External Operations. The successful candidate will be tasked with leading the implementation, standardisation, and enhancement of a number of global Process Teams consisting of cross functional representation with members from QA, Supply Chain, MSAT, Operations, and other key functions. These cross functional teams have accountability to deliver approved commercial product from our global network of Clinical and Commercial CMOs to support over $2bn of revenue across 8 commercial products with significant planned future growth. Additionally, this role will have accountability for the delivery of released product to support our exciting clinical pipeline (e.g., Make-Assess-Release and Ready – Run – Release processes). The Snr. Director, Head of External Operations will be a member of the GEO Leadership Team (GEO LT) where they will have shared accountability for managing the global external supply business, setting our vision and developing and delivering our strategic roadmap. This role will also be a key member of other governance bodies within TOPS and across BioMarin. Primary Activities:
- Ensure delivery of quality product on time from our CMO network to support clinical and commercial supply plans, proactively resolving issues that escalate from Process Teams (Make – Assess – Release and Ready – Run – Release processes).
- Partner with MSAT, External Quality, and Partner Management team to oversee & support product launch programs, tech transfers, technical changes, labelling updates, etc.
- Manage the trades offs & risks between longer-term strategic programs & day-to-day supply activities.
- Develop the Operations model supporting the teams as they look to standardise work, eliminate waste and focus on cross functional working relationships to ensure product supply.
- Recruit, onboard, & train operations professionals to ensure the team has the appropriate experience & capabilities to provide oversight across the E2E pharmaceutical value chain.
- Manage career development & succession planning for external operations teams.
- Manage CMO performance and develop the CMO relationship through routine cycle of Business Review Meetings (BRMs), Quality Review Meetings (QRM), and Joint Steering Committee (JSCs