Packaging and Device Scientist
Role Summary
The Devices & Delivery Systems Science group is accountable for the development and validation of the methods and technologies to support the development as well as the characterization of the primary, secondary packaging and devices.
This position aims at:
• leading and delivering the development of the methods and technologies supporting the projects
• capturing and reporting the scientific knowledge about the development of methods and technologies to support all the activities of pipeline devices and delivery systems, including primary and secondary packaging components.
• contributing to the identification and implementation of new technologies, tools and the development and validation strategies
• ensuring the activities requested are achieved in agreement with the project needs and the customers and coordinating the work with the lab technicians
• analyzing the studies data, sharing and presenting conclusions and recommendations to the project team
• Coordinating the activities with different internal functions/stakeholders or external partners to achieve the goals in due time
• contributing to the regulatory and GxP documentations when appropriate
Your responsibilities
• People management:
o Supervision of the daily bench activities and distribute/organize workload
o Ensure appropriate and efficient allocation of resources and expertise in order to meet the agreed milestones of the projects.
• Active collaboration to the evaluation of fit between available resources and forecasted workload
• To build a harmonized and consistent scientific strategy to support the development of technologies for medical devices and delivery systems
• Transfer to the manufacturing unit and troubleshooting of the commercial activities
• Identify, Evaluate & Coordinate the scientific efforts supporting the development of Devices, Delivery Systems and Packaging
o Promote and lead innovative approaches and design of future Patient Solutions
o Support innovative technology platforms to allow a fast and agile support to all relevant company stakeholders
o To maintain and develop scientific expertise through scientific literature, meetings or continuing education opportunities.
o To identify creative and efficient solutions for IP protection of the combination product
• (co)authoring the study protocol, coordinating and/or running the lab experiments, analyzing and reporting the results.
• Performing the data check in the Electronic Lab Notebook and in the Source documents when appropriate to ensure the data integrity
• Communicating the study conclusions and presenting the results at the appropriate audience (e.g. technical meetings, project meetings, etc)
• Networking with the external experts and potential partners in order to both evaluate and potentially develop new technical solutions.
• The development and validation of packaging- and device-related test methods is a part of the scope of this role and also contributes to the strategy for the selection and characterization for materials, including primary packaging systems, materials coming in contact with products like ancillaries (i.e. Infusion sets, syringes, etc.) & process manufacturing accessories (i.e. tubing, filters, etc.)
• Ensures the compliance to the adequate quality systems to support all the activities
• Project management :
o To plan, allocate resources, define tasks and implement the optimal sourcing strategy to ensure a seamless progress of the projects and to meet the milestones
o To collaborate and provide the appropriate support to customers within the organization to ensure successful therapeutic or non-therapeutic projects
Profile
o Master’s degree in Engineering or scientific areas
o Knowledge of the HS&E processes and procedures
o Project leadership skills including planning, monitoring, issue resolution, risk mitigation, decision making and reporting
o Ability to lead and influence people in a complex matrix environment
o Excellent interpersonal, verbal, and written communication skills
o Proactive and flexible to solve problems and to continuously improve business processes
o Detailed understanding of regulatory and GxP quality constraints
o Demonstrated capacity to work in a matrix organization in different technical areas.
o Be able to find technical solutions and activate all appropriate internal /external experts to solve
Our offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Caroline at [email protected]
