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NPI Co-ordinator - Manufacturing Process Specialist

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Job Description


WHO ARE WE?

The Johnson & Johnson (J&J) family of companies is globally active in Pharmaceuticals, Medical Devices and Consumer Health Care. We employ over 128,000 professionals in 60 countries, and they all have the same credo ‘Caring for the world, one person at a time’. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of billions of people.

Janssen Biologics (part of J&J pharmaceuticals) makes, acquires and markets unique biopharmaceutical medicines. We thereby build on our leading position in the development of monoclonal antibodies. Antibodies are substances that the body produces in response to bacteria, viruses or other foreign substances. The innovative products from Janssen Biologics focus on three major disease categories: cardiovascular and immunological disorders and cancer.
Janssen Biologics has built a dedicated and multi-functional, world-class team that develops a promising pipeline of products in numerous disciplines. Approximately1000 employees work in Leiden.

POSITION SUMMARY:

Reporting to Sr. Supervisor of the NPI team, this position is responsible for delivery of the NPI process for NMEs, resupplies and phase changes, mainly in plant 1, but support to plant 3. The NPI coördinator will support multiple project teams. NPI team is part of Operations Team F which also consists of supporting departments for operations. NPI Team will function as the bridge between project team, process- and equipment owners and operations shift to set-up the processes, technologies and practical implementation. We are recruiting for an enthusiastic candidate with project management skills for the NPI Coordinator role to complete our team for the implementation and governance of NPI introductions and improve this process. These activities include but are not limited to:

GENERAL ACTIVITIES:

· Establish, monitor and update the NPI process deliverables and milestones
· Oversee the NPI process, workcells and interdependencies between activities and disciplines for the tech transfer until shipment of the product
· Lead and be the communication point of contact for the availability and implementation of new materials (raw and disposables) within agreed timelines of NPI projects
· Good knowledge of the new material process from request, qualification until implementation on the shop floor.
· Support TLI in Core Team, Operations lead in extended teams and Plant 3 project teams, so all team members are delivering according NPI process.
· Communicate process status and forecast and interact with and obtain alignment
· Preparation and updating of weekly NPI update to Core Team and monthly update to MTs
· Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.

GENERAL SCOPE OF RESPONSIBILITIES:

· Lead by example and strive to perform to high standards at all times
· Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behavior in every activity.
· Carry out routine and non-routine tasks delegated by the Sr. Supervisor according to appropriate procedures, values and standards.
· Compliance with Manufacturing and general site procedures at all times.
· Completion of all documentation in compliance with site procedures and GDP.
· Prioritize and schedule activities to support business needs and to meet requirements of Clinical Master Production Schedule.
· Participate in and lead Cross-Functional teams as necessary.
· Generate and assist with generation, review and revision of Manufacturing documentation as necessary.

LEADERSHIP RESPONSIBILITIES / INDIVIDUAL CONTRIBUTION

· Report to Sr. Supervisor NPI Team.
· Communication skills and promote NPI projects
· Facilitate an environment of continuous improvement
· Facilitate an environment of open communication
· Lead Cross-Functional teams as necessary to support site goals.
· Collaboration and teamwork.
· Initiative and motivation.
· Share ideas and suggestions for improvement and encourage others to do the same.

ORGANISATIONAL INTERFACES:

Interface at (Team Leader, Manager and Director level) with all site departments, Operations and Maintenance.
Contact with Quality, Logistics, Operations, Technical Operations and Training departments. Contact with other Janssen sites.
Be conscious of internal customers to Manufacturing department and their requirements.

Qualifications
QUALIFICATIONS AND EXPERIENCE

ESSENTIAL

· A relevant qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering
· A minimal of HBO-degree
· Good knowledge of Project Management and tools, including principles of strategic planning, conflict resolution and stakeholder management
· Strong planning skills and keep track of oversight activities
· Affinity with MS Office and MS Project
· Ability to interact, influence and motivate experts from various disciplines in the organization

DESIRABLE:

· Postgraduate Qualification.
· Strong communication skills and a bridge builder / team player (tactful, easily approachable and approachable easily at various levels), also at Global Level (GTO, Global Planning, DPDS, procurement and ESIQ)
· Manufacturing experience within a GMP regulated environment and Biotechnology
· Experience of Microsoft Word, Excel, SharePoint and Outlook.

KEY COMPETENCIES REQUIRED:

· Excellent interpersonal skills
· Able to carry out several activities and projects in parallel
· Proactive and solution oriented
· Ability to operate as part of a team is critical.
· Customer focus.
· Innovative.
· Mechanical/Technical aptitude.
· Excellent communication skills both written and verbal.
· Attention to detail.
· Good problem-solving skills.
· Results and performance driven.
· Adaptable and flexible.


WHAT’S IN IT FOR YOU?

As an employee we consider you as our most valuable asset and we take your career seriously. You’ll be part of a global team in an innovative and international environment with room for personal and professional development. Through e-university, on the job training, various projects and programs, we ensure your personal growth by focusing on your talent. Our benefits make sure we care for you and your family now and in the future.

Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Biologics (7266)
Job Function
Engineering
Requisition ID
2005804639W