Dir External Manufacturing Planning

Regeneron Pharmaceuticals • Valley, AL

22h • Onsite

About The Position

The Director of External Manufacturing Planning is accountable for global clinical and commercial manufacturing planning and scheduling, logistics coordination, and EM systems (i.e., ERP). This is a global leadership role with teams located in US and EU, primarily focused on delivering clinical and commercial medicines to all patients on-time and in-full. The Director builds and develops a global team of production schedulers that collaborates with CMOs as well as internal manufacturing operations, owns S&OP processes with strategic manufacturing partners and ensures manufacturing readiness milestones.

Requirements

• BS/BA in a scientific discipline
• 10 years of related experience in a biopharmaceutical cGMP environment
• 5 years management and/or leadership experience
• Equivalent combination of education and experience

Nice To Haves

• MSc/MBA

Responsibilities

• Accountable for the global External Manufacturing production planning and scheduling through external and internal manufacturing network.
• Serves as the senior person representing External Manufacturing in the IPS process.
• Utilizes manufacturing network to deliver all external production requirements, including, but not limited to, drug substance, drug product, device assembly and final package.
• Establishes and maintains a strategic plan for the External Manufacturing department in support of activity requested by the business, including supporting a business continuity plan to ensure continued external production during disruptive local or worldwide events.
• Develops and implements systems and reports that track and measure production readiness and supply metrics, component and WIP inventories meet defined safety stock targets, track the progression of every externally manufactured lot through release and ensure global capacity meets production requirements in the short and long terms for both clinical and commercial medicines.
• Leads the Logistics area to ensure material is shipped in a timely manner to meet finished goods delivery dates and/or downstream activities.
• Oversees the Requisition team that is responsible for ensuring all external production is financially secured with purchase orders.
• Builds and leads high performing production planning and scheduling teams that are well versed in external manufacturing processes, integrated in the Manufacturing and External Manufacturing Project teams and appropriately trained in all relevant systems and procedures.
• Partners with internal stakeholders to quickly assess supply constraints, communicate mitigation plans and ensure that production schedules are in alignment with IOPS priorities.
• Implements, owns and continuously improves the S&OP process with strategic CMO partners.
• Supports and collaborates with the External Manufacturing Project Management and Quality Assurance organizations to ensure accurate scheduling of manufacturing activities in support of technical transfers, process validations and CapEx project executions within the global External Manufacturing network.
• Establishes departmental and individual expectations, provides direction and balanced performance feedback, coaches, develops and challenge direct reports, upholds all company policies and serves as a leading example of Regeneron Way and IOPS Success Factors.
• Actively participates on departmental and site teams to improve and challenge processes, solve problems, initiate improvements, establish procedures, transfer new products or technologies, execute projects, etc.
• Ensures adequate resources are dedicated to correcting important or critical issues via personal involvement, delegated resources and/or appropriate escalation to internal and/or external management.
• Travel up to 25% (domestic and international), as required.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees