The Role:

Reporting to the Senior Director, Global Supply Chain and Logistics, this position is responsible for integrated clinical and commercial product planning. The Associate Director, Supply Chain Product Planning, partners with the clinical supply chain, commercial supply chain, CMC-project management, CMC-QA, and CMO project core teams to obtain forecasts, which the Associate Director will then use to generate/update the master production schedule across multiple, global, external CMOs. This role also monitors global stock levels, sets safety stock guidelines, tracks expirations, and allocates bulk materials.

Key Responsibilities:

• Develop and maintain the combined clinical and commercial forecasts within the supply chain management system (SCMS) planning and inventory management tool based on actual demands and future projection inputs from clinical and commercial teams.
• Translate clinical trial enrollment schedules and commercial sales forecasts into the master production plan for drug substance, drug product, drug/device combination products, clinical finished goods, and commercial finished goods.
• Allocate drug substance batches to clinical versus commercial end use, considering Regulatory-driven material requirements.
• Build and maintain item/material masters within SCMS tool.
• Contribute supply chain input into cross-functional CD&OP/S&OP processes.
• Provide supply plan requests to CMO core teams at vendor-specific frequency and integrate endorsed manufacturing schedules into master production plan within the SCMS.
• Generate and communicate bulk material allocations and associated finished goods production plans to clinical and commercial supply colleagues to support operational execution of finished good batch production at packaging and labeling vendors.
• Establish safety stock guidelines for materials across the global supply chain, project future inventory positions, and prevent overstocking or stockouts for clinical and commercial materials.
• Monitor global stock levels, safety stock, and expiration dates.
• Respond to dynamic clinical and commercial projections by developing/comparing various scenarios and determine/communicate the associated impact across end-to-end materials.
• Partner with finance to determine the budget impact of various planning scenarios.
• Identify supply bottlenecks, manage lead times, and maintain operational continuity under strict GxP rules.
• Support commercial launch readiness activities.

Requirements:

• Bachelor's degree in biotechnology, life sciences, supply chain, business, engineering or another relevant field.
• 7+ years of relevant biopharmaceutical industry experience.
• 3+ years in production planning, inventory control, or demand forecasting for both clinical and commercial materials within the biotech, pharmaceutical, or regulated life sciences sectors.
• Experience using multiple systems for planning, forecasting, inventory management and ERP processes.
• Excellent understanding of manufacturing processes for drug substance, drug product, drug/device combination products, clinical finished goods, and commercial finished goods.
• Very good understanding of cGMP and Regulatory requirements as it pertains to material releases, country requirements, etc.
• Strong computer skills including MS Office, Excel, SharePoint, etc.
• Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results.
• Demonstrate strong communication & problem-solving, excellent organization skills.
• Strong capability to build relationships across the organization and externally.
• Technical, operational, and business-oriented mindset capable of analyzing and resolving complex, multifaceted issues through solid problem-solving skills.
• Ability to think outside of the box and challenge the status quo.
• Natural entrepreneurial spirit with unrelenting dedication to delivering results.
• Desire to work in a fast-paced, dynamic, and innovative environment.
• Natural collaborator who enjoys working on a cross-functional team.
• Strong working knowledge of cGMP and GDP requirements.
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  Work Environment:
  
• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (10-20%)