Overview

At New York Blood Center Enterprises (NYBCe), one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse communities, further our lifesaving strategic goals in a rapidly changing environment, and expand our impact on the local, national, and global communities we serve.

Responsibilities

The Director, Supply Chain and Logistics is responsible for building out a Supply Chain team, will implement, optimize, or maintain Supply Chain relevant GMP systems, procedures, and documents. He/She is responsible for managing all supply chain operations including procurement of all GMP materials, oversight of materials management operations and the vein-to-vein logistics of shipping and receiving cell therapy starting material and drug product.

Reports to: Senior Director GMP Cell & Gene Manufacturing and Louisville Site Head

Responsibilities:

• Work with other CCS colleagues to stay informed about emerging technologies and best practices in cell sourcing and supply chain management.
• Explore and implement innovative techniques to enhance operational capabilities.
• Responsible for overseeing all activities within the Supply Chain function.
• Direct Supply Chain operations conducted within facility in a manner that assures reproducibility and compliance with GxP regulation, including 21CFR Parts 11, 210, 211, 312, 600 and 1271.
• Train and mentor GMP Supply Chain personnel to develop a strong team of highly skilled professionals responsible for procurement, materials management, and logistics.
• Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and functions.
• Responsible for implementing and maintaining a material control strategy.
• Identify potential capacity and mitigate risks for operational effectiveness.
• Manage the logistics and supply chain activities to ensure optimal processing for customer orders.
• Reduce costs throughout the supply chain.
• Play significant role in interviewing, hiring, and training Supply Chain staff.
• Accountable for developing/optimizing, implementing Supply Chain systems, documentation, and procedures.
• Responsible for the oversight of any Supply Chain related validation studies. Including but not limited to shipping validations.
• Accountable for developing, implementing, maintaining, and tracking Supply Chain related key performance indicators (KPIs).
• Ensure all training requirements are up to date for personnel performing operations in the facility.
• Accountable for performing investigations, CAPA implementation and continuous improvement of production SOP’s.
• Key stakeholder in developing vendor relations, negotiating and managing supply agreements.
• Accountable for timely processing of Purchase Orders and Invoices.
• Maintain materials management and warehouse areas in accordance with GxP requirements and company SOP’s.
• Develop and maintain procedures and documentation for material receipt, quarantine, release/reject and destruction.
• Develop and oversee systems for GMP material picking and kitting.
• Develop, implement and maintain a system for GMP material specifications.
• Accountable for maintaining inventory levels sufficient for cell therapy manufacturing.
• Implementing centralized control and reporting of material inventory.
• Responsible for managing an electronic inventory system for GMP materials.
• Establishing, implementing and maintaining a business continuity plan.
• Oversee systems developed to ensure product Chain-of-Identity (COI).
• Ensure on time shipments of cell therapy products.

Qualifications

Education:Master’s degree or equivalent job experience in biologic sciences with 8 years of experience in cell therapy.

Experience:10 years of experience in cell therapy.Previous experience leading and managing logistics of shipping fresh and cryopreserved patient-specific cell products within a cGMP/cGTP compliant system.

Location:

Louisville, KY

Travel:

Up yo 10%

Knowledge:

Understanding of applicable regulations and standards for processing of cellular therapy products for Phase I, II, and III trials (GMP, GTP, AABB, FACT)

Extensive experience in GMP cleanroom operations and GMP warehouses

Knowledge of cell therapy manufacturing and handling of fresh and cryopreserved cells

Experience with electronic systems (ERP and QMS)

Skills&Abilities:

Strong leadership skills with ability to motivate staff members and develop a culture of operational excellence.

Strong technical writing skills, including preparation of validation and qualification documents and batch records.

Demonstrated ability to effectively manage performance, set and prioritize departmental goals.

Excellent time management and organizational skills and demonstrated ability to manage multiple projects and meet deadlines.

Ability to handle confidential information and maintain confidentiality. 

For applicants who will perform this position in New York City or Westchester County, the proposed hiring range $185,000.00p/yr. For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant’s skills, job-related knowledge, and experience.