(Senior) Fill/Finish Process Development Specialist (Yacht Life Sciences)

Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. This ranges from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern such as Ebola and COVID-19.

In their organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. We are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.

Yacht Life Sciences has a vacancy for a (Senior) Fill/Finish Process Development Specialist 

The Fill Finish Process Development Specialist is one of the key contributors in the process development activities from technology transfer to the manufacturing site until manufacturing of process verification/validation batches to be introduced in the global market. You will be part of a dynamic and accomplished team and are responsible for:

• the setup, reporting and timely execution of process development, characterization and validation activities. These activities can be done in-house or externally.
• Managing and challenging the various stages of the project by:
• preparing and periodically updating project plans;
• reporting periodically and escalating when needed;
• judging when and what (external) knowledge should be sourced in during the development stages and manage accordingly.
• establishing and maintaining a trustful and professional relationship with the different stakeholders from other departments within the company as well as with external partners;
• the technical content of the registration dossier, by guaranteeing availability of source documentation and raw data;
• leading and/or participating in specialized committees, as appropriate to ensure continuous improvement on departmental and project level.

• MSc/ BSc in pharmaceutical sciences or other relevant disciplines (i.e., pharmacy, (bio)chemistry or other life sciences or engineering)
• At least 5-year experience (10 year for Senior position) in vaccine and/or large molecule process development and GMP drug product manufacturing is required
• Experience with writing regulatory filings
• Experience with technology transfers and outsourcing is an advantage
• Proficient English both on paper and verbally is a must
• This position may require traveling and staying abroad for up to 1 week

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 full-time secondment contract for 1 year (extension is anticipated).

Start date: as soon as possible.

We will offer a competitive benefit package in line with the seniority of the position. 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 to become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers, you will be able to follow courses and training via our Yacht Academy in order to keep your knowledge and skills up-to-date, i.e. boosting your career through personal and scientific growth.