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Scientist Drug Product Process Development

Drug product development GMP regulatory submission tech transfer

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Vaccines & Prevention we are searching for a Scientist Drug Product Process Development.

Keywords
  • Ph.D.
  • Late stage pharmaceutical development
  • GMP drug product manufacturing
  • Regulatory submission writing
  • Tech transfer

Would you like to be part of a team to contribute to groundbreaking drug product development and bring life threatening diseases to a halt?
In this position, you will be working in an outstanding team to develop fill/finish processes and technology transfer of innovative vaccines. Your main responsibilities are:
  • Establish and maintain a trustful and professional relationship with the stake holders from departments within the company as well as with external partners;
  • Understand and provide input to define the technical content of the registration dossier, by guaranteeing availability of source documentation and data;
  • Setup, report and timely execute process development, characterisation and validation activities, which can be done in-house or externally;
  • Lead and participate in specialised committees, to ensure continuous improvement on departmental and project level.

Profile

The ideal candidate has a Ph.D. in biopharmaceutical sciences or biotechnology and experience in late-stage pharmaceutical development and GMP drug product manufacturing. We are looking for someone who has experience with regulatory submission writing and/or technology transfer for drug product (focus on vaccines). Are you passionate about drug product development, do you have a critical and creative mindset and excellent interpersonal skills? Then we are looking for you!

Benefits

Salary: >4360
Days of leave: 25 + 11
See here our other employment terms for this vacancy

Company profile

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. These range 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 this organisation, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' 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.

The Process Development group within the Drug Product Development department is responsible for early- and late-stage process development activities in drug product manufacturing. The developed manufacturing processes are transferred to external GMP production facilities to produce clinical batches as well as for scaled-up process validation/verification and commercial manufacturing. This is done in close collaboration with both internal and external partners.

Contact

Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.
Location Leiden
Scientist Drug Product Process Development

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