Primary Packaging Projects
Vor 4 Tagen
**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 **Primary Packaging Management team**, we are looking for a talented individual to fill the position of**: Primary Packaging Projects & LCM Lead** based preferably in **Braine l’Alleud, Belgium** or in **Bulle, Switzerland**
**You will contribute by**:
Leading the primary packaging systems globally and the ancillaries development and life cycle management projects within the global “Primary Packaging Management” organization.
This includes the primary packaging and ancillaries technical, scientific and regulatory knowledge and leadership around the design, development, industrialization and UCB global (internal & external) life cycle management strategy and coordination.
The scope is global and includes new chemical and biological entities, from a drug product and a drug substance primary packaging perspective.
**Interested? For this position you’ll need the following** **education, experience** **and** skills**:
**Education and Experience**
- Material science or physics or equivalent engineer
- Knowledge of Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Directive) and evolving regulatory expectations in the field of primary packaging systems and medical devices
- Proven track record in project management
- Pharmaceutical business experience and familiarity with competitive landscape of pharmaceuticals primary packaging and ancillaries development process, regulatory requirements, and market access
- Experience leading internal and external project teams
- Experience in global projects, ideally with USA or EU operational experience
- Experience in evaluating external projects and technologies
- Experience in budget management
- Experience in intellectual property management
- HS&E processes and procedures
**Knowledge/Expertise/Skills**
- Minimum of 5-10 years working in the pharmaceutical/biologics/medical primary packaging industry. Quality management experience would be a distinct advantage
- Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements, USP, Ph.Eur. and JP standards, Food-contact legislations
- Project Management certification will be a distinct advantage
- Management and leadership skills (ability to lead, motivate, inspire, resolve conflict, etc)
- Demonstrate ability to independently analyze data and information and assess the risks to draw conclusions and make effective decisions and actions within area of expertise, with an extensive quality experience
- Develop (innovative) solutions through judgment and reasoning leveraged from extensive quality experience and help others solve problems in a creative and practical way through development of solutions from innovative problem solving activities
- Providing guidance for improvements, corrective and preventive actions related to processes
- The jobholder must communicate internally (including cross-functional technical and matrix teams) and externally. They must be able to communicate complex technical data to non-specialist audiences from diverse backgrounds (e.g. briefing and persuading management, external partners).
**Professional and Personal Attributes**
**Language skills**
Spoken and written English proficiency is required
French proficiency is desirable
**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 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.
**About us.**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around
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