Associate Director, Warehousing & Distribution

Lead warehousing and distribution operations for the Rockville Manufacturing Center (RMC), ensuring reliable material flow for cell therapy manufacturing and protecting product quality, patient supply, Chain of Identity (COI) and Chain of Custody (COC). Accountable for quality, safety, cost and delivery performance in compliance with Good Distribution Practice (GDP), current Good Manufacturing Practices (cGMP), Safety, Health and Environment (SHE), financial controls and applicable regulatory requirements. Provide strategic and operational leadership for warehouse teams, build and develop the organization as RMC ramps up, serve as the escalation point, and drive continuous improvement, digital adoption and value for the business.

Typical Accountabilities

• Define and execute the RMC warehousing and distribution strategy, operating model and priorities, translating manufacturing and supply objectives into business plans, budgets, capacity and technology plans, resources, performance expectations and site-specific goals.

• Build and lead the warehousing organization as RMC ramps up, including organization design, workforce and shift planning, recruitment, onboarding and training, qualification, capability development, performance management, succession planning and leadership of employees and people leaders. Establish clear roles, decision rights, escalation pathways, shift-handover expectations, and leader standard work to ensure consistent execution across shifts.

• Ensure end-to-end warehouse activities, including goods receipt, storage, status control, material sampling coordination, cycle counting, internal movement, picking, packing and dispatch, are executed safely, compliantly, on time and in full to support cell therapy manufacturing and patient supply. Collaborate closely with the Gaithersburg Manufacturing Warehouse (GMW) to maintain material availability, inventory alignment and reliable replenishment of consumables and raw materials to RMC.

• Establish robust governance for inventory accuracy, material status, traceability, segregation, Chain of Identity (COI), Chain of Custody (COC), reconciliation and discrepancy investigation, including controls for temperature-sensitive, hazardous, restricted, obsolete, expired, rejected, returned or quarantined materials.

• Ensure compliant, inspection-ready warehouse operations through effective SOPs, standard work, validated systems, data integrity, documentation, deviations, investigations, CAPAs, change controls, quality risk assessments, audit actions, recall support and disposition or destruction processes in partnership with Quality.

• Monitor and improve safety, quality, service, delivery, cost, capacity, productivity, and inventory; lead Tier meetings and daily management routines, use data to resolve issues, and optimize warehouse processes using Lean Six Sigma tools and TPM practices.

• Manage risks to materials, cell therapy products and patient supply, maintaining business continuity and emergency-response readiness; act as the senior escalation and decision point for complex warehousing, transportation, delivery, collection, COI/COC and distribution issues.

• Lead effective use of warehouse management, enterprise resource planning, electronic quality, reporting and analytics tools, ensuring accurate transactions, appropriate access controls and validated processes while maintaining safe, clean and organized facilities.

• Build effective relationships across RMC and the broader network; influence decisions without direct authority, provide feedback on supplier and logistics-partner performance, and represent warehousing in production planning, material-readiness reviews, site changes, new-product introductions, capital projects, shutdown and restart planning, and network logistics initiatives.

Qualifications and Skills

• Essential: Degree-level qualification or equivalent relevant experience; extensive people-leadership experience in warehousing, distribution or logistics within a regulated manufacturing environment; demonstrated ability to build organizations, lead through ramp-up and develop employees and people leaders; strong working knowledge of GDP, cGMP, SHE, corporate governance, risk management, compliance, inventory control and warehouse management systems; experience supporting regulatory inspections, quality investigations, CAPAs and change controls; demonstrated experience in budget, capacity and resource management, operational performance management, stakeholder influence and complex issue resolution; strong written and verbal communication skills and demonstrated ability to use data to make operational and investment decisions.

• Desirable: Master’s-level or relevant professional qualification in supply chain, logistics, warehousing or a related discipline; experience in cell therapy, biopharmaceutical or other complex patient-specific supply chains; knowledge of Chain of Identity (COI), Chain of Custody (COC), cold-chain logistics and special material-handling controls; experience designing and improving logistics processes, managing transportation relationships, implementing or validating digital warehouse systems, and applying Lean Six Sigma tools and TPM.

Key Internal and External Relationships

• Internal: RMC Manufacturing and Process Execution teams; Gaithersburg Manufacturing Warehouse (GMW); Quality and Quality Control; Supply Chain and Planning; Clinical or patient-supply interfaces, as applicable; Engineering and Facilities; Safety, Health and Environment; Finance; Procurement; Digital and Information Technology; Human Resources; Patient Operation; and site and network operations functions.

• External: suppliers, couriers, manufacturers, transportation and cold-chain partners, equipment and technology providers, and applicable local or regional regulatory authorities.

The annual base pay for this position ranges from $117,377.60 - $176,066.40 USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.