About Cristcot

We are in the business of addressing the problem within the problem. We focus on the details and connections that other, major pharma companies have left ignored for years. There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.

Job Summary:  

The Pharmaceutical Supply Chain Director will ensure supply continuity of all critical components and consumables required for the uninterrupted manufacturing of commercial and clinical pharmaceutical drug & medical device products in several cGMP manufacturing sites. Key focus areas include optimizing the global supply chain, maintaining approved suppliers/products for operations, demand/supply/capacity planning, sourcing, labeling, dispensing, inventory management, shipping, distribution, return/recall activities, and selection of drug supply-related vendors and depots. 

Primary Relationships:

• Within Cristcot, the Pharmaceutical Supply Chain Director will collaborate closely with Commercial, Manufacturing, Quality and support our cross-functional teams.
• Outside Cristcot, the Supply Chain Director will build strategic relationships with vendors.

Primary Job Responsibilities

The Pharmaceutical Supply Chain Director will have a deep understanding of supply chain networks, clinical regulations, serialization requirements, global import/export requirements, commercial regulations, timelines, end-to-end planning, and analytics to facilitate communications across a variety of functions to deliver cost-effective supply chain solutions while balancing multiple business objectives. The ideal candidate must be highly detail-oriented, organized, results driven, and passionate about driving high performance internally and externally to align with business objectives.

The Activities of the Supply Chain Director:

• Ensure uninterrupted supply of critical components and consumables to meet global manufacturing needs for commercial and clinical products
• Regularly evaluate and communicate risks and interruptions to the supply chain and proactively establish mitigations wherever necessary
• Partner closely with Commercial, Clinical, Manufacturing, and Leadership teams to establish and maintain robust supply/demand forecasts in alignment with core business goals
• 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
• 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
• Assume additional responsibilities supporting the broader CMC Development group, as needed

Skills and Qualifications:

• BS or MS degree in supply chain, science/engineering, production operations management, business, or related field with 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 experience/knowledge in forecasting, demand/supply planning, inventory management/ERP systems, clinical labeling, distribution, import/export, reverse logistics, CMC and GxP regulations.
• Experience in commercial supply chain required.
• Experience in small molecule required.
• Experience in topical is a plus.
• Supply Chain Management certification(s) (e.g., CSCP, CPIM, SCOR-P, CPM, etc.) are a plus.
• Familiarity with cGMPs, ICH regulations and industry standards for pharmaceutical manufacturing.
• 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.
• Excellent interpersonal, verbal, and written communication skills with the ability to work with uncertainty and to resolve conflict in a constructive manner.
• Must be self-motivated and comfortable in a fast-paced, demanding and dynamic work environment.
• Must be proficient in the Microsoft 365 environment
• Travel < 25%.