Associate Director, External Partner Management - Global External Operations
BioMarin Pharmaceutical Inc.About the role
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.
Associate Director, External Partner Management - Global External Operations
The role of Associate Director, External Partner Management will have responsibility for partnership enablement with all contract manufacturing organizations (CMOs) that support BioMarin’s clinical pipeline and commercial product portfolio. The core focus of the role is to develop & foster relationships with CMOs to enable seamless supply of products. Our CMO operations span multiple sites and multiple technology platforms namely, Biologic Drug Substance, Synthetic Drug Substance, Oral Solid Dose, Sterile Drug Product, Combination Products, and Packaging. The Associate Director, External Partner Management (EPM) is accountable for overall relationship management and operational oversight of one or more contract manufacturing organizations (CMOs) or contract development manufacturing organizations (CDMOs) used in the manufacture of materials and products. A primary focus is leadership of matrix teams that interface closely with the external manufacturing network and internal stakeholders, to ensure flawless execution of the product supply. The EPM acts as a manufacturing site lead and is accountable for the overall performance of the team and activities under their responsibility. Furthermore, the Associate Director, EPM is accountable for ensuring that external partners, CMOs, CDMOs, meet BioMarin’s long term strategic growth requirements. The Associate Director, EPM will sit as part of External Partner Management Organization, reporting through the Sr. Director of External Partner Management in Global External Operations.Primary Activities:
- Accountable for overall CMO partnership / relationship management activities including day-to-day supply / supporting escalations management, driving alignment between internal & external stakeholders
- Accountable for ensuring long-term strategic plan & objectives are considered & addressed in the CMO selection, contract development, and long-term partnership commitments
- Partners with external operation & external quality to deliver quality product on time from our CMO network to support clinical and commercial supply plans, proactively resolving issues that escalate from Process Teams
- Has a deep understanding of overall CMO performance and develop the CMO relationship through routine cycle of Business Review Meetings (BRMs), Quality Review Meetings (QRM), and Joint Steering Committee (JSCs) Meetings as well as ad hoc visits as needed
- Lead the CMO selection process by evaluating CMO capabilities against applicable manufacturing, quality and compliance requirements and needs of BioMarin – both operational capabilities & strategic objectives
- Partner with Global Supply Chain to develop and maintain CMO Network Strategies which will ensure capacity is in place for long term product supply
- Accountable for long term strategic agenda at CMOs and support development of strategic partnerships with CMOs
- Develop detailed un
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