Manager/Sr. Manager of Cell Therapy Logistics
Position
My client is seeking a Manager/Sr. Manager of Cell Therapy Logistics to join the Clinical Supply Chain team. This is a new role within the company. The incumbent will be instrumental in its creation. This individual will be responsible for all aspects of the planning and execution of logistics functions for clinical Cell Therapy programs. This position reports to the Director, Clinical Supply Chain. The role requires the ability to manage multiple activities simultaneously, balancing priorities, ability to work with ambiguity, and significant attention to detail.
This individual will be involved in work central to the companies strategic goals. They will apply existing technical skills, learn new skills, and play a role in the development of the programs and help grow the company.
This position is primarily responsible for managing the critical, time-sensitive aspects of Cell Therapy Logistics. Responsibilities include: working with Clinical Operations and Transport Vendors for shipping tumor samples to manufacturing sites from Clinical Sites, and return of Drug Product from manufacturing sites to Clinical Sites; coordination with CMC of the timing of manufacturing at production facilities; management of storage, and logistics vendors; inventory management of select Clinical Supplies at depots and sites; and, returns and destruction.
- Participate in cross-functional team meetings internally and externally
- Create and maintain a tracking process to ensure drug product traceability and chain of custody between clinical and manufacturing sites
- Work with Clinical Operations/Sites to schedule pick up of Tumor Sample from Clinical/Manufacturing Sites
- Work with Manufacturing/Vendors to ensure a slot for Production of Cell Therapy Drug Product, and select Clinical Supplies
- Collaborate with team members to resolve constraints or delays to mitigate potential risks
- Collaboration with QA to investigate exceptions in storage and logistics activities
- Support the writing and revision of supply chain-related SOP
- Participate in vendor selection
- Accountable for process discrepancies
- Facilitate technical troubleshooting when necessary, participate in investigations, and escalate as appropriate
- Other duties as assigned
Required Qualifications
- 5+ years of related work experience
- Experience with Cell therapy and gene therapies
- Good understanding of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements (EMA, TGA)
- Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements
- Work experience in a supply chain, planning, or manufacturing role
- Ability to effectively plan, prioritize, execute, follow up, and anticipate challenges
- Experience managing complex schedules and priorities in dynamic environments
- Ability to work, influence, and gain consensus across multiple functions (Manufacturing, Regulatory, Quality, and Clinical)
- Ability to operate and thrive in a fast-paced, start-up environment
- Expertise in the use of MS Excel, Office, and PowerPoint
- Excellent interpersonal, verbal, and written communication skills
- Self-motivated, build trust easily and operates with integrity and ethics
- Occasional travel
Bonus Qualifications
- Experience in Global Cell Therapy Trials
- Experience in Packaging & Labeling
- Adept at developing visual management tools to provide status updates on organizational performance
Fit within Culture and Values
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view