Yacht Life Sciences has a vacancy for a NPI Coordinator at Janssen Biologics / Johnson & Johnson, situated in Leiden, the Netherlands.
The BCPO Biologics MAKE department is responsible for the production of Biologics API (Active Pharmaceutical Ingredient) and DP (Drug Product) clinical supplies at 3rd party contract manufacturers (CMO’s), BTDS internal sites and Janssen Supply Chain (JSC) internal sites. 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.
Objectives & Responsibility
Tech Transfer Coordination
- Setup and lead project kick-off meetings, weekly workcells, and other tech transfer meetings, as necessary, to coordinate efforts among BTDS for delivery of GMP clinical materials.
- Participate in / lead cross-functional conferences with BTDS stakeholders
- Investigate and resolve deviations raised within the manufacturing department, as needed
- Monitoring and reporting of process performance for supply chain and NPI tech transfers
- Partner with cross-functional colleagues to perform Process-Fit-to-Plant reviews of new programs, as required.
- Conduct Site Cross-Contamination Risk Assessments to identify and mitigate any risks prior to GMP manufacturing of clinical supplies, as required.
- Identify and implement continuous improvement projects to enhance the tech transfer process to scale appropriately to a higher volume output.
Site Manufacturing Support
- Act as the single point of contact (SPOC) between CMC and CSC teams / members and the Site Operations team, regarding tech transfer and GMP DS clinical supplies updates.
- Prioritize and schedule activities to support business needs and to meet requirements of the master production schedule.
- In collaboration with Operations and Quality, review and approve required GMP documentation for manufacturing production, when necessary.
Clinical Supply Chain and Cross-Functional project support
- Partner with site operations BCPO and BTDS colleagues to ensure on-time, end-to-end supply chain delivery of GMP API clinical supplies
- 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.
- Participate in CMC subteams and cross-functional meetings, as required, to provide sourcing, operational and supply chain expertise.
- A minimum of Master Degree in the Life Sciences/ Microbiology/Biochemistry/Biotechnology or Engineering is required.
- A minimum of MSc. degree with 5+ years of experience is preferred, or a PhD degree with 3 years of experience.
- Ability to effectively apply project management tools to lead projects and programs is required. Knowledge of FPx is preferred.
- Experience in clinical or commercial manufacturing is required.
- Knowledge of cGMP’s and Agency requirements for biopharmaceutical manufacturing is required.
- Working knowledge of the following facility and site operations areas are required: facility design, HVC, process utilities, room and equipment cleaning, and equipment qualification.
- Experience with the following API manufacturing processes is required: 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.
- Critical thinking
- Independent or a fast learner and hands-on
- Accurate/precise and able to understand what is doing and why
Terms of employment
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.
This concerns a secondment contract for 1 year via Yacht with an initial assignment at Janssen Biologics. Salary is based on work experience (salary between 2900 and 4400 euro gross per 4-week period).
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
About the company
Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.
In their organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team, they are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.
Janssen's work in the Netherlands covers almost everything involved in making medicines and vaccines: from research to disease prevention and from the development of new medicines to their production and marketing. They do this at four different locations. Janssen Biologics, one of their sites in Leiden, produces complex biological medicines and vaccines.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.