Associate Director, Supply Chain

Associate Director, Supply Chain (Nucleus Radio Pharma Inc. (Rochester, MN)):
Assists in the development and execution of Nucleus’ supply chain strategy aligned to Nucleus’ corporate goals and regulatory requirements (21 CFR Part 211/212, DOT, IATA);
Drives supply chain readiness for client-specific technology transfer, scale up and product launch;
Oversees the sourcing strategy that supports Nucleus’ operational activities including isotopes, production and analytical equipment, packaging and GMP-grade raw materials;
Identifies and evaluates potential new suppliers in the industry to support the growth objectives of the organization;
Manage relationships with suppliers and logistics partners ensuring quality, reliability and cost-effectiveness.;
Collaborates closely with QA in the qualification of new suppliers and the management of existing critical suppliers;
Establishes and evaluates supplier performance through periodic review of key performance metrics (KPI’s);
Collaborates with QA department with the initiation of Supplier Corrective Action Requests (SCAR’s) and vendor responses;
Assists in the negotiation of key supplier agreements and manages contract renewals with established vendors;
Oversees the inventory management program in both a GMP and non-GMP environment;
Implements and maintains best practices in inventory management (i.e. FIFO, lot traceability, re-supply thresholds) to minimize waste and ensure product availability;
Collaborates closely with Manufacturing team to ensure adequate and timely supply of raw materials, including short shelf-life isotopes;
Acts as the main point-of-contact for all logistics relating to delivery of finished product from all Nucleus facilities;
Collaborate closely with QA, Manufacturing and R&D to ensure timely, efficient and cost-effective Supply Chain support;
Acts as the primary liaison between Operations and Supply Chain teams to align demand forecasting with supply chain capabilities;
Develops and implements risk-management procedures to mitigate the risk of product shortages, stockouts; and Manages the effective distribution of work across the team and ensures the backlog of purchase requests meet established targets. In order to complete the above-mentioned tasks, the following skills and experience are required:
Experience working with 21 CFR Part 211;
Experience working with FDA, EMA DOT/IATA regulations;
Experience sourcing GMP-grade raw materials, consumables and primary packaging components;
Experience managing supply chain limitations for finished Drug Products;
Experience supporting vendor qualifications in alignment with internal procedures;

Experience with ERP systems Oracle, SAP;

Experience with BOM and item master management in GMP environments;
Experiencing interfacing with multiple departments to understand procurement needs;
Stakeholder engagement and communication experience;

Experience with safety stock planning, cycle counts, supplier redundancy and mitigation of supplier disruptions;

Experience with just-in-time (JIT) supply chain models and vendor-managed inventory (VMI) models;

Experience with cost analysis and price variance tracking;

Experience with quality management processes such as SOP drafting and review, change controls, corrective and preventative actions (CAPAs) and supplier corrective action requests (SCARs); and

Experience with documentation practices in alignment with cGDP’s. Requires a Master's degree or foreign equivalent in Supply Chain Management, Supply Chain Analytics, Business Analytics, or a closely related field, and at least one year of experience as a Supply Chain Manager or related occupation. In the alternative, the employer will accept a Bachelor's degree and five years of experience in the above-mentioned field and occupation.

Domestic travel required: 20% - Philadelphia, PA (Nucleus facility) and assorted critical vendors throughout the United States. Option to work from home may be available (1 day a week). Standard company benefits. Salary: $,000/year. Please send C.V. to  #LI-DNI