Johnson & Johnson

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Senior Scientist COVID

Job Description

Janssen Vaccines & Prevention, previously Crucell, 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 and antibodies to protect people worldwide from infectious diseases.

In our 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 we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.

Department:

The Clinical Immunology department is responsible for the immunological evaluation of vaccine candidates in clinical trials. In close collaboration with the Biomarker group and clinical development group, the clinical immunology department executes the immuno strategies and ensures the development, and validation of the required immunological assays as well as clinical sample analysis and data reporting. Typical assays to determine the immunogenicity of vaccines are the antibody ELISA, T cell ELISpot, Intracellular Cytokine Staining, and virus neutralization assays. The clinical immunology department offers Janssen Vaccines with services in Scientific and operational excellence, with high standards of quality and compliance.

Job Description:

The main responsibility of the Senior Scientist will b to guarantee the correct design and execution of experiments for the development and validation of immunological assays to be used in the analysis of samples from clinical trials for multiple programs within time and budget. The initial focus will be on assays in support of our Coronavirus program. The activities of the Sr. Scientist must be executed, documented and reported according to Good Clinical Laboratory Practice (GCLP) quality requirements.

The Senior Scientist will be responsible for the scientific quality of the analysis of clinical trial samples, as well as long term life cycle of the methods he/she is the expert on. To that effect, the Senior Scientist needs to consider the long-term strategies of the project and align his plans accordingly. He/ She also needs to understand well regulatory expectations and guidelines, and how this may impact implementation of technical strategies.

For outsourcing activities, the Senior scientist is responsible for making sure the technical/scientific assessment and selection of candidate partners, as well as for monitoring of the scientific quality of the outsourced activities, are performed.

Next being an assay subject matter expert, the senior scientist is also expected to coach and advice other scientists on their projects, and work closely with the Project lead.

The required activities must be executed, documented and reported according to Good Clinical Laboratory Practice (GCLP) quality requirements.

Qualifications
The right candidate has:
  • Solid, hands-on experience in bio-assay development, qualification and validation according to regulatory standards with at least >5 years’ experience in Pharma/ Biotech setting.
  • Hands on experience with ELISA, Virus neutralization assays and other immuno-assays will be required.
  • Ability to support the technical aspect of vendor management and participate in technical visit.
  • A PhD or Master's degree (with relevant working experience)
  • Experience in clinical development of vaccines or large molecules; early and late phase trials experience will be a great advantage.
  • Has experience contributing to regulatory submissions.
  • Experience in working under quality standards such as GCLP, GLP, GCP or GMP.
  • Experience with vendor management/ outsourcing
  • Excellent communication skills (both verbal and writing), fluent in English.
  • Experience in Stakeholder Management
Competences:The right candidate is:
  • Quality minded and flexible.
  • Able to remain calm and positive under pressure.
  • A team player with soft skills, able to motivate and empower others.
  • A well-rounded leader, who can make decision, think strategically and communicate clearly/ diplomatically with stakeholders.
  • Able to lead multiples complex projects and work with partners to prioritize and find the right balance between supply vs demand.
  • Independent thinker, and not afraid to challenge the status quo to find efficiencies.
Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Vaccines & Prevention BV (8852)
Job Function
R&D
Requisition ID
2005808393W