Primary Packaging Management Projects & LCM

仕事内容

Make your mark for patients

We are looking for a Primary Packaging Projects & LCM Lead able to provide guidance for innovation, new product development and life cycle management to join us in our global Primary Packaging Management team.

About The Role

This position leads the primary packaging and direct drug contact medical devices projects within the “Primary Packaging Management” organization globally. It includes the primary packaging technical, scientific and regulatory knowledge and leadership around the design, development, industrialization and life cycle management activities of all UCB primary packaging components and systems.

The scope is global, including new chemical entities, new biological entities and gene therapy from a drug product and a drug substance primary packaging and direct drug contact medical devices perspective.

Who Will You Work With

You will join an international high skills team having a common passion, an agile mindset and an unique spirit. You will closely interact with Medical Devices, RA, QA, Procurement, Operations, etc. teams.

What Will You Do

• Be responsible of the primary packaging systems and direct drug contact medical devices innovation and new products development projects
• Coordinate the primary packaging systems life cycle & sustaining activities
• Benchmark the competitors pharmaceuticals primary packaging systems
• Assess the primary packaging materials, components and systems
• Planning, implementation and documentation to maintain and set up the systems (processes, resources, equipment) of the organizational unit
• Where applicable: maintenance of and responsibility for the SOP processes assigned to the unit and direct sub-processes thereof
• Ensure that the applicable internal rules (Standard Operating Instructions, SOP) and the applicable national and international laws, regulations and directives are observed

Interested? For this role we’re looking for the following education, experience and skills

• Master’s Degree or PhD in materials science, physics or equivalent
• Minimum of 5-10 years track record in the pharmaceutical/biologics/medical primary packaging industry. Operational GMP or quality experience would be a distinct advantage
• Proven track record in project management
• Knowledge of Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Directive) and evolving regulatory expectations in the field of primary packaging raw materials, components and systems
• Global primary packaging suppliers’ knowledge
• Pharmaceutical business experience and familiarity with competitive landscape of primary packaging development process, regulatory requirements
• Experience in global projects, ideally with USA or EU operational experience
• Experience in intellectual property management
• HS&E processes and procedure
• Leading and influencing cross-functional and matrix projects teams
• Management of external relationships
• Forward-looking vision to anticipate challenges and opportunities in the evolving healthcare environment and its impact on future customer (patient, payer, physician, regulator) needs
• 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

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.