Material Safety Expert

Conteúdo do emprego

Make your mark for patients.We’re here because we want to build the future and transform patients’ lives for the better.At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?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, BelgiumAt 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 applyWe 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 meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.About Us.UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.Curious to know more? Please visit our website www.ucb.com .UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.