NPI Coordinator

The Netherlands, 1-year contract, 40h, Hybrid way of work 

Johnson & Johnson Worksense is responsible for finding, engaging, and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting an NPI Coordinator to join our contingent workforce in Janssen in Leiden for a 12-month contract. 

Reporting to Operations Manager, this position is responsible for representing operations on NPI tech transfer teams. The NPI Coordinator is responsible for delivery of the NPI process to the manufacturing site for NME’s, resupplies and phase changes of API and DP clinical materials per CMC timelines.  

Responsibilities

• Coordinate efforts among BTDS for delivery of GMP clinical materials.
• Investigate and resolve deviations raised within the manufacturing department, as needed
• Monitor and report process performance for supply chain and NPI tech transfers
• Partner with cross-functional colleagues to perform Process-Fit-to-Plant reviews of new programs
• Conduct Site Cross-Contamination Risk Assessments to identify and mitigate any risks prior to GMP manufacturing of clinical supplies
• Identify and implement continuous improvement projects to enhance the tech transfer process to scale appropriately to a higher volume output
• Prioritize and schedule activities to support business needs and to meet the requirements of the master production schedule.
• In collaboration with Operations and Quality, review and approve required GMP documentation for manufacturing production, when necessary.
•   Partner with the Global Planning organization in the planning of production schedules and capacity within the network.  Determine the impact of forecast changes on scheduling and cost.

To be successful in this role you have:

• A Master Degree in Life Sciences or Engineering is required combined with a proven work experience
• The ability to effectively apply project management tools to lead projects and programs. Knowledge of FPx is preferred.
• Experience in clinical or commercial manufacturing.
• Knowledge of cGMP’s and Agency requirements for biopharmaceutical manufacturing.
• Working knowledge of the following facility and site operations areas: facility design, HVAC, process utilities, room and equipment cleaning, and equipment qualification.
• Experience with the following API manufacturing processes: cell culture and harvest, viral inactivation, filtration, purification
•  Understanding of planning, material handling, manufacturing, and GMP compliance related to the manufacturing of biopharmaceuticals is required.

If you meet our requirements and are interested in hearing more about our NPI Coordinator role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!