For our client, Janssen Vaccines & Prevention, we are looking for a Manufacturing specialist.
The VPAD DPD FST group is looking for a consultant who can help documenting product and process impact assessments as part of material management project. The Adeno Janssen vaccine program is based on a platform process making use of pre-described excipients and manufacturing steps. Due to progress in development of the Ad26 Covid, RSV and HIV, the flexibility of the platform needs to be expanded by onboarding different suppliers of excipients or modifications to the manufacturing process of the API or it’s intermediates. Your primary function is documenting the assessments as agreed with the miscellaneous teams of stake holders, including the off-line collection of input from stake holders and subject matter experts. The resulting documents are upon finalisation used as source documents for regulatory filings and/or supportive documents to justification in controlled changes.
Pending development, you can also have a role in qualification of new raw 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 needs to be collected from manufacturers or suppliers of the materials.
Who we're looking for
We are looking for a professional with extensive experience with risk assessments in the field of (aseptic) manufacturing. You have experience within GMP and you have excellent communication skills.
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Education||:||HBO/BSc. WO/MSc. PhD.|
|Employment terms||:||Project for at least 6 months|
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.