CLS Services

Gepubliceerd: 1 month ago

Senior Scientist Formulation Development

Leiden
Gepubliceerd: 1 month ago
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CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Vaccines & Prevention, we are searching for a Senior Scientist Formulation Development.

Company profile
Janssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. The teams focus on the discovery, development, manufacture and marketing of vaccines to protect people worldwide from infectious diseases. They have built a dedicated, world-class, multi-functional team across a variety of disciplines to develop a promising vaccines pipeline. In Leiden, they have a workforce of 700 scientists and support staff. 45% of their employees has a nationality other than Dutch, with over 20 nationalities represented. They 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 their organization, entrepreneurial people are working in a dynamic culture in which innovation and a #39;can do#39; state of mind are of crucial importance. They 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.

Department
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.

Job description
Are you that enthusiastic and proactive candidate who has experience in project management? And are you ready for a challenging role as senior scientist formulation?
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.

Key Responsibilities:

  • Set-up, execute and report studies to deliver project objectives;
  • Present the outcome internally (project team meetings and functional reviews) and externally (scientific publications, conferences and meetings with KOL’s);
  • Summarise the outcome of the studies into regulatory documents and present to governance regulatory bodies;
  • Advance the scientific understanding, set out the formulation and filing strategy and to build external partnerships;
  • Create Intellectual Property;
  • Investigate quality incidents from the end to end clinical supply;
  • Review scientific work and mentor other scientists.


Who we're looking for
The ideal candidate has PhD in a relevant discipline, like biotechnology, pharmaceutical sciences or (bio)chemistry and at least 5 years of industry experience in a biologics or vaccine development company. MSc. candidates with at least 10 years of industry experience will also be considerd.
You must 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. Familiarity with stability studies is a plus and working knowledge of assays, quality systems (GMP) and regulatory guidelines and expectations is mandatory.
Experience with filing a number of patents is a plus.

Additional vacancy information
Reference: A2000019
Contract: Temporary contract with CLS Services
Education: PhD.
WO/MSc.
Terms: After 6 months direct contract with J&J. Full time preferred, 32 hours discussable. It is acceptable to work from home 1 day per week but must be on-site 4 days minimum.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555

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