For our client, Janssen Vaccines & Prevention, we are looking for a Material Specialist.ProfileJanssen vaccines & prevention is working on platform-based processes. For each of the different platforms the materials need to be assessed on effectivity-, critical characterization-, quality- and safety-attributes. Determining these attributes and setting up studies in cooperation with suppliers and internal stake holders is part of the job requested. Also changes in supplier of existing materials in platform can be assessed as part of this position. As Material Specialist you document the assessments as agreed with the miscellaneous teams of stakeholders including the offline collection of input from stakeholders and subject matter experts. The resulting documents are upon finalization used as source documents for regulatory filings and/or supportive documents to justification in controlled changes.
- BSc. or Msc.
- Raw materials
- Regulatory filing documents
You will also have a role in introduction of new materials for the global Janssen Large Molecule Approved Material List. For this task materials need to be assessed according the Janssen and regulatory criteria for excipients and where possible information need to be collected from manufacturers or suppliers of the materials.
Who we're looking forThe VPAD DPD FST group is looking for a candidate who can setup implementation and qualification of new raw materials, consumables, and excipients (materials). Therefore, we are looking for a candidate with a BSc. or MSc. background in pharmacy or biochemistry and 5 years experience in pharma, in GMP Operations or quality roles. You have been author or defender of regulatory filing documents in submissions or inspections. Knowledge of material chemistry, material Assay qualification, Cell Culture media qualification or Material life cycle management knowledge are strong advantages.Company profileJanssen 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.
- New material Product impact assessment based on new excipient attributes;
- New material Process impact assessment based on new excipient attributes;
- Facilitation and project management for supplier qualification when applicable;
- Material stability impact assessment based on stability studies, assessments and other available information;
- Progression monitoring of excipient usage justification package for platform use.
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
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Salary: >41000|
Days of leave: 25 + 11
See here our other employment terms for this vacancy
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|+31 (0)88 22 77 555|