CDMO Materials Management Senior Specialist

Lantheus BrandSpringfield, NJ
Onsite

About The Position

The Materials Management Senior Specialist is responsible for overseeing the accuracy, control, reconciliation, and reporting of inventory across radiopharmaceutical development, manufacturing, quality control, warehouse, and distribution operations. This role ensures that GMP materials, radioactive materials, APIs, precursors, reagents, components, finished radiopharmaceutical products, cold kits, labels, and consumables are received, stored, counted, replenished, transferred, and reconciled in accordance with cGMP, GDP, radiation safety, DSCSA, DOT/IATA, company procedures, and applicable regulatory requirements.

Requirements

  • Bachelor’s degree in supply chain, Logistics, Business, Life Sciences, Engineering, or a related discipline preferred; equivalent experience may be considered.
  • Minimum of 5–8 years of experience in inventory control, warehouse operations, supply chain, materials management, or logistics within a regulated pharmaceutical, biotechnology, radiopharmaceutical, nuclear pharmacy, medical device, or GMP manufacturing environment.
  • Prior lead or supervisory experience preferred, including coaching employees, assigning work, resolving issues, and supporting performance expectations.
  • Strong understanding of cGMP, GDP, material traceability, lot control, expiration management, quarantine controls, inventory reconciliation, and audit readiness.
  • Experience handling or supporting temperature-sensitive, short shelf-life, hazardous, or radioactive materials is strongly preferred.
  • Working knowledge of ERP, WMS, inventory, or manufacturing systems such as SAP, PETra, Oracle, Microsoft Dynamics, Blue Mountain, Qualio, or similar platforms.
  • Familiarity with DSCSA, DOT/IATA hazardous materials shipping, radiation safety practices, and controlled distribution environments preferred.
  • Demonstrated ability to investigate inventory discrepancies, identify root causes, implement corrective actions, and improve process controls.
  • Strong communication, organization, analytical, problem-solving, and cross-functional collaboration skills.
  • Ability to work in a fast-paced, time-sensitive environment where product availability, patient impact, compliance, and shipment timing are critical.

Nice To Haves

  • Outstanding verbal and written communication skills are necessary with proven strong leadership skills.
  • Goal-oriented self-starter with an acute attention to detail.
  • Must be team-oriented, able to work independently and proactively, and able to multitask.
  • Lead others by building consensus.
  • Well-grounded in drug development with extraordinary leadership competencies and the strategic business perspective needed to bring products forward and to maximize their commercial value.

Responsibilities

  • Lead day-to-day inventory control activities for GMP and non-GMP materials, including receiving support, put-away verification, stock movement, cycle counting, physical inventory, and reconciliation between physical inventory and inventory management systems.
  • Maintain accurate inventory records for raw materials, excipients, APIs, radionuclides, precursors, reagents, components, labels, packaging materials, finished goods, kits, PPE, cleaning supplies, and other controlled materials.
  • Ensure inventory transactions are completed accurately and timely in applicable systems such as PETra, SAP, ERP, WMS, eQMS, or other site inventory platforms.
  • Manage inventory controls for temperature-sensitive, time-sensitive, short shelf-life, and radioactive materials, including lot, expiration, calibration, activity, storage condition, and chain-of-custody requirements.
  • Coordinate routine cycle counts, quarterly physical counts, variance investigations, and inventory reconciliations; document discrepancies and drive timely resolution with Supply Chain, QA, QC, Manufacturing, Finance, and Warehouse teams.
  • Establish and monitor inventory levels, reorder points, safety stock, expiry controls, and replenishment plans to support uninterrupted manufacturing, QC testing, clinical supply, commercial distribution, and customer commitments.
  • Support quarantine, release, hold, rejected, expired, returned, recalled, damaged, or suspect product processes in partnership with Quality Assurance and Regulatory/Compliance teams.
  • Ensure compliance with cGMP, GDP, DSCSA, PDMA, applicable state licensing expectations, DOT/IATA hazardous materials requirements, radiation safety procedures, and internal SOPs.
  • Partner with Procurement and Planning to prevent stockouts, excess and obsolete inventory, material shortages, and avoidable production or shipment delays.
  • Develop, maintain, and improve SOPs, work instructions, checklists, training materials, and inventory control processes.
  • Support internal audits, customer audits, regulatory inspections, and management reviews by providing inventory reports, reconciliation evidence, deviation support, and corrective action updates.
  • Lead or support deviations, CAPAs, change controls, investigations, and process improvement initiatives related to inventory accuracy, material traceability, system controls, and warehouse compliance.
  • Prepare and communicate inventory metrics, aging reports, expiry risk reports, material availability updates, inventory valuation support, and operational readiness dashboards for leadership and cross-functional stakeholders.
  • Train, coach, and provide daily direction to inventory control specialists, warehouse associates, or cross-functional users involved in inventory transactions and material handling.
  • Serve as primary point of contact for business development and operational needs for existing and prospective CDMO clients.
  • Prepare work orders for execution with existing and prospective customers.
  • Cross-functionally support all operational teams in the CDMO including manufacturing, MSAT, QC, and QC among others.
  • Lead and manage CDMO vendor relationships, including establishment of Master Service Agreements and service contracts.

Benefits

  • Comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
  • Life and disability benefits
  • Pre-tax accounts
  • 401(k) with company contribution
  • Generous time off package including paid vacation, holidays, sick days, and paid parental leave.
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