Supply Execution Specialist CAR-T
Locations: Beerse, Belgium
Functions: Clinical Supplies
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Requisition ID: 1905712142W
The Clinical Supplies organization is responsible for the end-to-end supply chain management of clinical supplies aligned with the needs of each therapeutic area. The Supply Execution Specialist (SES) is specifically responsible for supporting clinical materials and processes for new modalities at contract manufactures and internal sites. This includes but is not limited to the shipping and tracking of CAR-T clinical materials from the clinic to the manufacturing site and back to the clinic. The SES coordinates available production slots at the CAR-T manufacturing site with the collection of patient samples at the clinic and has responsibility for ensuring the maintenance of patient identity (Chain-of-Custody and Chain-of-Identity) as each sample moves through the supply chain.
Responsibilities of the Role:
* Coordinate the development of robust supply chains to ensure the manufacturing and delivery of clinical supplies per CMC timelines.
* Develop knowledge of the supply chain and compliance requirements to support new modalities.
* Conduct investigations and identify corrective / preventative actions for supply chain issues.
* Develop strong internal collaborations across CSC and with key stakeholders.
* Participate in CMC sub-teams and cross-functional meetings as needed.
* Utilize business tools to manage metrics that track on-time delivery and supply chain performance.
* Identify opportunities to lower costs or improve existing business processes.
* Monitor actual spend vs budget.
CAR-T Program Responsibilities:
* Support the manual tracking of Chain of Custody / Chain of Identity for patient samples.
* Engage in development of a Chain of Custody / Chain of Identity IT system.
* Support the logistics for shipping CAR-T materials to / from clinical sites.
* Help set up shipping instructions and SOP's for manufacturing and clinical supplies.
* Partner with GCDO and CAR-T manufacturing sites in the coordination of apheresis and production schedules.
* Conduct training at each clinical site and be present for the pack-out of FPI samples at each site.
* Ensure labels and other packaging components are provided for each subject.
* Align with JSC on procedures to be followed for clinical and commercial operations.
* A Bachelor's Degree in Supply Chain, Life Sciences or Engineering is required. A minimum of a BS with 2 years or an MS with 1 year of experience.
* Prior experience working in a clinical or commercial supply chain is required.
* Knowledge of cGMP's and Agency requirements for biopharmaceutical manufacturing is required.
* Ability to effectively apply project management tools to lead projects and programs is required. Knowledge of FPx is preferred.
* Understanding of planning, material handling, manufacturing, and GMP-compliance related to the manufacturing of biopharmaceuticals is required.
* Strong project management skills
* Good communication and influencing skills
* Big picture orientation with attention to detail
* Ability to collaborate internally and work in a matrix environment
* Ability to work in a multi-cultural environment
* Results oriented
This position is located in the EU (Beerse) and may require up to 20% travel.
Janssen Pharmaceutica N.V. (7555)