Material Safety Expert

Il y a 2 mois

Brainel'Alleud, Belgique UCB S.A. Temps plein

**Make your mark for patients**

To strengthen our **Devices, Packaging, and Wearable Technologies team**, we are looking for a high caliber, self-motivated, **Packaging and Device Material Safety Expert** based in **Braine l’Alleud, Belgium**

**At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.**

**You like to work in an** **environment **where you will be**:

- Driving the Materials Safety expertise in the department, by defining and implementing the Extractables-Leachables strategy and the Materials of Contact Safety assessment
- Providing the scientific knowledge, the external network and the leadership around the strategy design, implementation and maintenance of all internal policies and guidances associated with Extractables/Leachables and Materials of Contact Safety assessment strategies.
- Identifying, Evaluating & Coordinating the scientific efforts supporting the development of those strategies
- Setting up the contract with the appropriate external partners and following the activities in relation with the E/L and safety assessment
- Liaising with the internal stakeholders involved in the Material Safety (engineering and non clinical safety departments)
- 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 according to the project milestones
- Contributing to the regulatory and GxP documentations when appropriate
- Contributing 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.)
- (co)authoring the study protocol, coordinating the work, analyzing and reporting the results.
- Communicating the study conclusions and presenting the results at the appropriate audience (e.g. technical meetings, project meetings, etc)
- Managing the technical and scientific team to support the activities effectively and efficiently and act as a coach to team members
- Planning, allocating resources, defining tasks and implementing the optimal sourcing strategy to ensure a seamless progress of the projects and to meet the milestones
- Ensuring the compliance to the adequate quality systems to support all these activities
- Be planning, allocating resources, defining tasks and implementing the optimal sourcing strategy to ensure a seamless progress of the projects and to meet the milestones

**Interested? For this position you’ll need the following** **education, experience** **and** skills**:

- Project leadership skills including planning, monitoring, issue resolution, risk mitigation, decision making and reporting
- Knowledge of the HS&E processes and procedures
- Project leadership skills including planning, monitoring
- Ability to lead and influence people in a complex matrix environment;
- Excellent interpersonal, verbal, and written communication skills
- Proactive and flexible to solve problems and to continuously improve business processes.
- Detailed understanding of regulatory and GxP quality constraints regarding the material safety, biocompatibility and extractables/leachables (Pharmacopeias, ICH, ISO, USP)
- Demonstrated capacity to work in a matrix organization in different technical areas.
- Be able to find technical solutions and activate all appropriate internal /external experts to solve the issue
- Must be able to independently manage scientific tasks in order to meet deadlines within given constraints in resources, e.g. headcount, equipment, time, etc.
- Written and oral presentation skills (English)

**Why you should apply**

We can offer you an informal and open working environment that does not lock scientists into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams and with world-renown academic investigators. Opportunity to grow both as a drug hunter and leader through participation in project teams and our career/personal development programs.

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meani

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