Operations Manager – Global External Operations

🔥 10 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

👻 Ghost score 10%

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BioMarin Pharmaceutical Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2020-05

Healthcare • Biotechnology • Pharmaceuticals

BioMarin Pharmaceutical Inc. is a leading global biotechnology company dedicated to transforming genetic discoveries into innovative medicines. Founded in 1997, the company has developed eight marketed products that address life-threatening genetic and lysosomal storage disorders such as achondroplasia and severe hemophilia A. BioMarin is also heavily invested in research and development, with a robust pipeline of investigational medicines at various clinical trial stages. The company's mission revolves around improving patient care by leveraging scientific expertise to understand the underlying causes of these conditions. BioMarin is committed to inclusivity and patient advocacy, engaging closely with communities to enhance care and quality of life for those with rare conditions.

📋 Description

• Manage day-to-day activities at one or more Contract Manufacturing Organizations (CMOs) • Execute production plans with CMOs to deliver uninterrupted clinical and commercial product supply • Manage CMO meeting schedules with cross-functional colleagues • Identify supply constraints and negotiate or resolve issues with CMOs • Manage operational escalations and communications within the process team/GEO site • Collaborate with cross-functional teams to ensure uninterrupted product supply • Perform root cause analysis and implement corrective actions • Manage material movement between CMO sites with internal partners • Attend CMO sites to monitor production campaigns and develop knowledge of manufacturing processes and systems • Maintain visual metrics/dashboards overseeing GEO business • Coordinate evaluations of process changes, change requests, and deviations • Facilitate communications between CMOs, BioMarin manufacturing, and other departments • Lead or participate in technology transfers, product launches, and validation activities • Contribute to formal systems and procedures for CMO selection • Implement control systems within budget and reduce cost of goods • Ensure CMO compliance with cGMPs with Corporate Compliance and Quality departments • Support CMO contracts and negotiations with procurement and EPM teams • Represent assigned products, CMOs, and GEO Operations at relevant meetings • Establish GEO processes and project templates for ORP management as required • Conduct operational gap analyses for new CMOs and lead mitigation plans • Ensure transition of operations from PPQ/launch into commercial process teams • Lead site exit projects as required

🎯 Requirements

• Minimum requirement of 5 years leadership experience in Operations, Supply Chain or Quality • BS/BA degree in life sciences, business, or supply chain management • Excellent understanding of processes/unit operations • Demonstrated ability to lead/manage cross-functional, multi-disciplinary teams • Ability to guide and support cross-functional teams in resolving short-term issues and achieving sustained long-term performance • Proven effective decision-making ability • High initiative, influencing, coaching, and organizational skills • Experience working and managing in a regulated GXP environment • Strong stakeholder and relationship management experience • Experience with CAPA, FMEA, and RCA tools in a highly regulated manufacturing environment desired • Excellent organizational, written, verbal communication, and commercial acumen • Experience in supply planning or inventory management