Johnson & Johnson
Imagine your next role as an NPI Lead where in this team, you will be the department project lead and responsible for the introduction of new products into the Leiden lab, both for products manufactured in Leiden and elsewhere.
About the department
As a part of JSC QC Leiden situated at the Janssen Biologics Manufacturing site, the New Product Introduction (NPI) team is responsible for the coordination and introduction of new products into QC Leiden, from Phase 1 to Late Stage NPIs, supporting all testing laboratories in QC Leiden.
The NPI team ensures flawless NPI introduction meeting customer demands while ensuring the robustness and feasibility of a commercial lab are maintained. The NPI project leads are the multi-connector role that ensures alignment between customers, and local and global stakeholders.
roles and responsibilities
SPOC for all NPI activities, from Phase 1 to Late Stage NPIs throughout the CMC stage gates
Business case and budget estimations for NPIs requests
Project lead for NPI transfers, laboratory NPI capacity increase initiatives, and new technologies introduction (e.g. project management, leading the Leiden team, budget control, etc.)
Ensure the NPI testing plan is aligned with the platform testing strategy
Support the testing teams in aligning NPI volumes with testing capacity
Coordinating the analytical method transfer end-to-end
Raw materials qualification
Partner with local and global stakeholders (e.g. DPDS, PQM, Technical Operations, Operations, JSC QC sites, etc.)
Alignment of NPI global teams and department testing teams' needs and requirements to ensure flawless and on-time NPI introduction
Laboratory testing readiness
Ensure new products introduced have required the robustness and reliability of a commercial lab
Establish and improve standards for content and quality of NPI processes (change controls, method transfers, documentation, communication, etc.)
how to succeed
The ideal candidate will have:
Master/Bachelor's degree in Life Sciences, analytical chemistry, biochemistry, or comparable
At least 4 years of experience in a laboratory/pharmaceutical environment
Preferably project management experience
Experience with new product introduction.
Experience in analytical method transfers and/or raw materials qualifications
Knowledgeable about a wide range of large molecule analytical methods
Excellent communication skills (oral and written English)
Self-starter, initiative-rich, team player
Interpersonal skills and engaged in contact with personnel at all levels within the organization.
Shown to have excellent safety and GMP awareness and experience
A quality, compliance, and business-minded attitude
Flexible and agile, capable of handling multiple projects and changing priorities
Strategic thinking, balancing short and long-term priorities
This role offers a very competitive hourly rate & a supportive working environment. This contract will run initially for one year.
you are welcome here
Janssen is an innovative pharmaceutical company: we work every day on the frontline of health innovation. We can only meet this challenge because of our talented employees. Working at Janssen means that you get every opportunity to optimally develop your career.
about Janssen Biologics
Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen.
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email.
If you would like some additional information about the role please contact: email@example.com
Diversity, Equity & Inclusion
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 are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each 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”.