Dir External Manufacturing Planning

Regeneron Pharmaceuticals • Valley, AL

1d • Onsite

About The Position

We are currently looking to fill a Director of External Manufacturing (EM) Planning. 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 with the primary focus of delivering clinical and commercial medicines to all patients on-time and in-full. The Associate 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. A typical day in this role may include the following: Accountable for the global External Manufacturing production planning and scheduling through external and internal manufacturing network. 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. 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. Travel up to 25% (domestic and international), as required.

Requirements

• BS/BA in a scientific discipline
• 10 years of related experience in a biopharmaceutical cGMP environment
• 5 years management and/or leadership experience, or equivalent combination of education and experience.
• Demonstrated leader with expert knowledge of GMP production planning and scheduling processes for parenteral manufacturing, device assembly and finished label and package.
• Deep knowledge ERP systems (Oracle preferred).
• Knowledge of the challenges and lead times involved when transferring aseptic parenteral filling, device assembly and finish label & pack operations.
• Working knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, IMB, etc.).

Nice To Haves

• APICS, ISM, ASQ or SME professional certification preferred.
• Competencies in German, French and/or Spanish (oral and written) preferred.
• A MSc/MBA is a plus.

Responsibilities

• Accountable for the global External Manufacturing production planning and scheduling through external and internal manufacturing network.
• 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.
• 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.

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