Associate Director - CMC Supply Chain

Position Overview

The Associate Director, CMC Supply Chain will lead and grow a supply chain team responsible for ensuring supply continuity of all critical components and consumables required for the uninterrupted manufacturing of commercial and clinical radiopharmaceutical drug products across a worldwide network of cGMP manufacturing sites.

Responsibilities

• Ensure uninterrupted supply of critical components and consumables to meet global manufacturing needs for commercial and clinical products
• Develop and maintain supply chain partnerships with internal and external stakeholders
• Explore opportunities for innovation, efficiency and creativity within the radiopharmaceutical supply chain
• Evaluate and communicate risks and interruptions to the supply chain and proactively establish mitigations wherever necessary
• Create a sense of excitement within the team, which includes ensuring opportunities for growth and development, sharing industry knowledge when appropriate, building positive relationships within the supply chain team, and hiring/building the team as needed
• Manage financial planning and budget forecasting activities associated with the supply chain function; perform invoice reconciliation, ensure functional area adherence to budget
• Prepare and present supply chain updates at regular internal work group and team meetings; support the preparation of presentation materials for senior leadership, when required
• Partner closely with Commercial, Clinical, Manufacturing, and Leadership teams to establish and maintain robust supply/demand forecasts
• Build, deploy, and maintain tools for cross-functional tracking and communication of approved suppliers, products, and components
• Review technical and regulatory documentation to ensure accuracy, consistency, and currency of all critical components/key consumables
• Support management and closure of product investigations associated with critical components/key consumables including authoring and reviewing investigation documents and risk assessments
• Track component recalls/retrievals and communicate cross-functionally as necessary
• Identify alternative component sources; manage associated change control process where needed

Basic Requirements

• Earned Bachelor's degree in supply chain, science/engineering, production operations management, business, or related field
• 5+ years of experience in a supply chain function within a pharmaceutical environment
• 2+ years of CMC experience in the biotechnology or pharmaceutical development industries
• Strong supply management expertise, including a combination of experiences with forecasting, demand/supply planning, IRT systems, inventory management/ERP systems, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and/or GxP regulations
• Excellent interpersonal, verbal, and written communication skills
• Previous experience building and maintaining relationships with key internal and external stakeholders
• Ability to work with uncertainty and shifting priorities, and to resolve conflict in a constructive manner
• Self-motivated and comfortable in a fast-paced, demanding and dynamic work environment
• Proficient in the Microsoft 365 environment

Additional Preferences

• Earned Master's degree in a relevant field
• Proven ability to lead and grow high functioning teams
• Familiarity with cGMPs as well as US, European, Japanese, Chinese, and ICH regulations and industry standards for pharmaceutical manufacturing
• Previous project management or project leadership experience
• Experience within a CMC/cGMP role in the radiopharmaceutical industry
• Familiarity with collaborative project management tools such as Microsoft Project, Smartsheet, Monday, Jira, etc.
• Solid understanding of pharmaceutical manufacturing and release within a cGMP environment
• Supply Chain Management certification(s) (e.g., CSCP, CPIM, SCOR-P, CPM, etc.)