Janssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines to protect people worldwide from infectious diseases. We have built a dedicated, world-class, multi-functional team across a variety of disciplines to develop a promising vaccines pipeline. In Leiden, we have a workforce of 700 scientists and support staff. 45% of our employees has a nationality other than Dutch, with over 20 nationalities represented. We partner with many of the world’s leading experts, academic and clinical institutions and other pharmaceutical companies for the development of vaccines against, for example, Ebola and HIV.
In our 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.
We are currently recruiting for a Senior Scientist in Formulation Development
You will be responsible for the late stage development of the Drug Product (formulation and primary packaging). You will execute studies to evaluate robustness of the product during realistic conditions regarding transport, handling and use in the supply chain. In addition, you will perform studies to assess stability as well as compatibility with processes and packaging materials. These activities are conducted in close collaboration with experts from process and analytical development, clinical operations and regulatory affairs. The outcome of the studies will be used to support process and distribution parameters in the whole supply chain. Furthermore, they form the basis for the regulatory dossier, which health authorities use to approve clinical trials and finally market authorization.
As a senior scientist you define the vaccine formulation development strategy based on the market trends, company strategy and competitive environment. You take the lead in scientific discussions in which you focus on risk-based solutions. You translate scientific results into (platform) process improvements and lead the continuous improvement. You review scientific work, mentor other scientists, collaborate across all levels of the enterprise and build external partnerships.You will be a member of the Formulation Development team, which is a section of the Drug Product Development (DPD) department. The other sections are Formulation Science & Technology, Fill/Finish Process, Fill/Finish Manufacturing and the Technical Integrators. The Technical Integrators lead projects teams where you will be a member of. Each project team develops the bulk drug substance, the drug product formulation, the aseptic compounding, fill / finish process and oversees manufacturing at sites within and outside Janssen for the development of a vaccine for a specific infectious disease.
- To set-up, execute and report studies to deliver project objectives
- To present the outcome internally (project team meetings and functional reviews) and externally (scientific publications, conferences and meetings with KOL’s)
- To summarise the outcome of the studies into regulatory documents and present to governance regulatory bodies
- To advance the scientific understanding, set out the formulation and filing strategy and to build external partnerships
- To create Intellectual Property
- To investigate quality incidents from the end to end clinical supply
- To review scientific work and to mentor other scientists
- Delivers assigned project deliverables with high quality, within budget and timelines
- The strength of the IP portfolio to build a competitive advantage
- Demonstrates the J&J leadership imperatives
- Meets personal growth objectives
Education and experience: PhD in a relevant discipline, like biotechnology, pharmaceutical sciences or (bio)chemistry complemented with at least 5 years of industry experience in a biologics or vaccine development company. Alternatively, a master’s degree in these disciplines complemented with at least 10 years of industry experience. This experience should include all facets of product development f rom 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.
Familiarity with stability studies is a prerequisite, as is a working knowledge of assays, quality systems (GMP) and regulatory guidelines and expectations. Has filed a number of patents.
Other: Pro-active, flexible, creative and challenges the status quo. Team player with excellent communication, interpersonal and project management skills. Has a strong scientific and quality mindset.
As an employee, you are our most valuable asset. We take your career seriously. As a member of a global team in an innovative environment, your development is key and is our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future.
Janssen Vaccines & Prevention BV (8852)