Principal Scientist Formulation Development Vaccines

The organisation

The Corona pandemic has a huge impact on public life and the world economy. At Janssen Vaccines & Prevention, part of Johnson & Johnson, we are developing a vaccine against this fast-spreading disease. Would you like to be part of our team of professionals, contribute to this groundbreaking development and bring Corona to a halt? 

Janssen Vaccines & Prevention, formerly Crucell, is 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 the Janssen organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. To strengthen the team, Janssen is continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value.

The position 

For the Drug Product Development department (DPD) in Leiden, we are exclusively recruiting for a Principal Scientist Formulation Development Vaccines. The DPD department consists of a young and dynamic team of 40 people responsible for the late stage development of their vaccines until market launch. This is done in close collaboration with Analytical Development, Clinical and Regulatory affairs and the Quality department. 

Tasks & responsibilities

As a principal scientist you define the vaccine formulation development strategy based on the market trends, company strategy and competitive environment. You will work in multi-disciplinary project teams on the formulation and primary packaging development of several vaccines, amongst which Corona. You will oversee the studies to evaluate the robustness, stability and compatibility with process and packaging materials and take risk-based decisions. The outcome of the studies forms the basis for the regulatory dossier, which health authorities use to approve clinical trials and finally market authorization. 

You take the lead in solving complex technical problems, mentor other scientists, collaborate across all levels of the enterprise and build external partnerships. The scientific results are translated into (platform) process improvements. You are the senior author in the preparation of presentations, documents for regulatory filing, patents and scientific publications and represent the company in discussions with regulatory bodies.

Candidate profile 

To be successful as a Principal Scientist Formulation Development Vaccines you must hold a PhD degree or equivalent with a minimum of 10 years of pharmaceutical industry experience. You have experience in all facets of product development from the development of a stable formulation and choice of primary packaging around a new molecular entity, submission of the regulatory dossiers towards MAA/BLA/IND, until the post launch market support. Furthermore you gained experience with working according to quality (GMP) and regulatory guidelines. When you have knowledge of stability studies or filing patents, it will be considered as a plus. As a person you are a team player with excellent communication skills in both Dutch and English. You are pro-active, flexible, creative and have strong scientific and quality mindset.

The offer 

You’ll be offered a contract directly at our client Johnson & Johnson. They offer a broad range of benefits and a competitive salary. They take your career seriously. Through e-university, on the job training, various projects and programs, they ensure your personal growth.

Interested?

If you're interested in this role, click the link below to forward an up-to-date copy of your CV.