Manager – Cell Therapy Supply Chain

Manager – Cell Therapy Supply Chain

Requirements

• ERP experience; preferably in SAP Extended Warehouse Management (EWM) transactions
• CGMP experience in the biotech industry; preferably Cell Therapy
• Demonstrated leadership capabilities and people management experience
• Proven experience in triage of events and execution of deviations, CAPA, and other workflows in the Quality Management System (QMS); preferably in Infinity
• Prior experience in kitting and delivery of raw materials and consumables to Manufacturing
• Prior experience in handling of cold chain biological materials; prior experience with cryogenic storage (LN2) is preferred
• Experience with health authorities (i.e., FDA) for audit support
• Experience and familiarity with electronic systems including SAP, and manufacturing execution systems (MES) including Syncade and DeltaV
• Safety and Quality mindset; proven ability to build a culture around these values and to communicate critical information clearly and in a timely manner to team and to leadership as needed
• Ability to independently determine business priority and direct resources to where the need is on the floor. This will require coordination with other managers and effective communication and assignment of work.
• Bachelor’s degree in a relevant science or engineering discipline. An advanced degree is a plus.
• 5+ years of experience in CGMP manufacturing within a biopharmaceutical or cell therapy manufacturing environment
• 3+ years of experience with direct reports required.
• Health Authority interaction and audit experience; experience with FDA is preferred
• Experience working in an ERP system; SAP EWM is preferred
• Experience with electronic manufacturing execution system (MES); DeltaV and Syncade are preferred
• Familiarity with operation in classified spaces (i.e. CNC and Grade 8)
• Experience with Quality Management Systems; Infinity is preferred
• Experience in following, revising, and creating controlled documentation in a document management system
• Experience with handling patient biological materials and understanding of Chain of Identity (COI)
• Experience with material operations (i.e., material delivery, replenishment, kitting)

Responsibilities

• Execute against scheduled activities and make decisions and allocate resources accordingly within and across departments.
• Provide management and oversight to floor operations team during second shift
• Perform and oversee the receipt and processing of incoming patient apheresis material with corresponding documentation in SAP and other electronic systems
• Perform and oversee the execution of the drug product put-away to final cryogenic storage location in SAP and other electronic systems
• Perform and oversee the packaging of final drug product into cryogenic shipper for shipment to patient with corresponding documentation in SAP and other electronic systems
• Perform and oversee execution of kit-building and material delivery to support manufacturing with corresponding documentation in SAP and other electronic systems
• Triage quality events with team and Quality Assurance to assess deviation requirement, impact, and forward processing decision; escalate as needed to drive resolution
• Ensure proper training for self and team against required unit operation-specific training curricula including SOP, policy, protocol, on-the-job training, health exam, etc.
• Manage implementation and maintenance of appropriate training curricula across team
• Maintain all operating spaces (suites, airlocks, corridors, workstations) in a clean and orderly manner per SOP and always ensure audit readiness. If deficiency is observed, the expectation is to take action to resolve or develop proposal to review with manager to implement solution.
• Lead by example and set expectation for Safety and Quality Culture; promote a mindset of ‘Right First Time’.
• Ensure your and your team’s adherence to all applicable policies, SOPs, and instructional documentation in accordance with BMS expectations
• Lead and manage the development of corrective and preventative actions, deviation responses, and investigations
• Identify opportunities for continuous improvement and drive efficiency in the process. Build business case and make proposal to streamline approval and implementation of the initiative.
• Make use of and promote the use of Tier meetings and other existing business processes to drive accountability, manage metrics, and cascade/escalate issues to and from your team
• Develop a mindset of continuous improvement within your team
• Hire, mentor, and develop exceptional people: Conduct performance reviews and identify opportunities for career growth for members of team as applicable
• Create an environment of teamwork, open communication, and a sense of urgency.
• Additional duties, tasks, and responsibilities as assigned by the Supply Chain department.

Preferred Qualifications

• Prior experience with cryogenic storage (LN2) is preferred
• Experience with health authorities (i.e., FDA) for audit support is preferred
• Experience with electronic manufacturing execution system (MES); DeltaV and Syncade are preferred
• Experience with Quality Management Systems; Infinity is preferred
• An advanced degree is a plus