CLS Services

Gepubliceerd: 14 days ago

New Product Introduction Coordinator

Leiden
Gepubliceerd: 14 days ago
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CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Biologics B.V., we are searching for a New Product Introduction Coordinator.

Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.



Job description
Are you a strong communicator and a bridge builder? Are you looking for a new challenge where you can use your experience in a biotechnology or pharmaceutical manufacturing environment? We are looking for a team player with excellent communication skills on different levels.
In your role as Co-ordinator, you are responsible for delivery of the New Product Introduction (NPI) process for New Molecular Entities (NMEs), resupplies and phase changes in several plants. The NPI coördinator will support multiple project teams. The NPI team is part of the Operations Team which also consists of supporting departments for operations, and functions as the bridge between project team, process- and equipment owners and operations shift to set-up the processes, technologies and practical implementation.
Activities and Responsibilites:

  • 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;
  • Gain knowledge of the new material process from request, qualification until implementation on the shop floor;
  • Support Technical Launch Integrator (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 manager teams;
  • Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and Environment Health and Safety (EHS) requirements;
  • 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;
  • Stakeholder management.


Who we're looking for
We are looking for a candidate with a BSc (HBO) or MSc degree in Microbiology, Biochemistry, Pharmacy, Biotechnology or Engineering with some manufacturing experience within a GMP regulated environment. Working experience in a biotechnology environment is considered as a plus. You have strong planning and/or coordination skills and are able to keep track of oversight activities. Additionally, you are able to explain new processes to stakeholders and an advocate to adhere to them.
We are looking for a candidte who has (working) knowledge of Project Management and tools and experience with MS Office tools, particularly MS Project.
You are able to manage conflict through to resolution and able to interact, influence and motivate experts from various disciplines in the organization.
Are you the strong communicative team player we are looking for?

Additional vacancy information
Reference: A2000037
Contract: Temporary contract with CLS Services
Education: HBO/BSc.
WO/MSc.
Terms: Position for at least one year, longer term possibilities possible. Full time preferred, 32 hours discussable. English is required, Dutch considered a strong plus.
Contactperson: Aniek Vugts
Phone: +31 (0)88 22 77 555

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Vacature details

Fulltime / parttime

Opleiding

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