New Product Introduction

il y a 2 semaines

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

**Make your mark for patients**

We are looking for a **NPI Expert** who is a dynamic team player to join us in our **Internal Manufacturing** Department, based in **Braine-l’Alleud**, **Belgium.**

**About the role**

**As a NPI Expert you are the Field Representative for NPI (New Product Introduction) activities and the main contact for knowledge management across projects.**

**Who you’ll work with**:

- Leslie Noon as your Manager.
- A lot of internal stakeholders from departments part of Internal Manufacturing (Braine Technical Operations), Development and Third Party.

**What you’ll do**:

- To develop & maintain a close collaboration with UCB community (Development Partner, Industrial Leader, Quality, Production) to facilitate and accelerate manufacturing processes transfers into the Sterile Manufacturing Plant.
- To largely contribute at Feasibility and Risk analysis associated with the process scaling-up and/or transfers.
- To review and approve all documentation, required to start scaling-up and manufacturing activities up to the validation of the processes, including qualification steps and documents to support the submission.
- To provide the necessary support to answer questions from authorities, whether in writing or during inspections.
- To manage the material & consumables requirements, as well as equipment: define specification with the project team, coordinate the supply till release and to coordinate all manufacturing activities for delivering on time.
- To ensure all manufacturing and operating documents are available at the handover of the project and the team is trained.
- To coordinate the review and release of GMP development & validation batches.
- To coordinate the review and make the disposition of the technical development batches.
- To coordinate/lead weekly project meetings with appropriate participants, to ensure proper project management (scheduling, problem solving, action log,.)
- To ensure reporting and escalate the risks & issues related to your projects to the management.
- To ensure the follow-up of the projects in the system defined by the governance, maintain schedule and budget.
- To lead investigations, manage deviations and implement CAPA in case of process issue.
- To act as change leader for activities required by the projects you are in charge of.
- To suggest and elaborate optimization of operational & organizational processes to gain in efficiency and maximize output.
- To contribute actively to the NPI community to grow project & process competencies within Braine Technical Operations.

**I**nterested? For this role we’re looking for the following** **education, experience** **and **skills**
- Master’s degree as Bioengineer, Process Engineer, Mechanical Engineer, Chemical Engineer, Industrial Pharmacist, Chemist, Biologist or equivalent by experience.
- Strong practical experience in **Project Management**.
- Strongly safety minded and knowledgeable of **industry safety standards**.
- Good knowledge of **GMP** requirements for sterile product development & manufacturing.
- Knowledge in aseptic manufacturing practices: bulk filling, aseptic filling or visual inspection is a plus.

Soft skills:

- **
Communication skills**: to foster collaboration with internal customer and support departments with an excellent teamwork mindset.
- ** Problem solving**: to have an out-of-the box approach with an eye for innovation.
- ** Dynamism**: to work in a highly matrixed environment.
- ** Multitasking**: to prioritize and organize daily tasks to meet deadlines.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

**Why work for us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

**Learn more** about sustainability at UCB and how it is integrated into our business approach.

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/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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