Scientist Process Development.
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 Scientist Process Development..
- Technology transfer
- Regulatory submission writing
- Project management
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. Would you like to be part of the team to contribute to this groundbreaking 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:
- Understand and provide input to define the technical content of the registration dossier, by guaranteeing availability of source documentation and data;
- Set-up, report and timely execute process development, characterization and validation activities, which can be done in-house or externally;
- Lead and participate in specialized committees, to ensure continuous improvement on departmental and project level;
- Establish and maintain a trustful and professional relationship with the stakeholders from departments within the company as well as with external partners.
Who we're looking for
For this role we are looking for PhD candidates with a background in biopharmaceutical sciences, biotechnology or related fields. You have proven experience in late-stage pharmaceutical development and GMP drug product manufacturing, including technology transfers. Experience with regulatory submission writing and/or technology transfer for drug product with a focus on vaccines is a must. You also have experience with project management.
You have excellent communication and interpersonal skills and like to work in a highly dynamic environment. .
Are you the Scientist we are looking for?
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 organization, 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.
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Salary: >59000
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555