Manufacturing specialist

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.

Deliverables:

• New supplier Product/Process impact assessment based on new excipient attributes;
• Material stability impact assessment based on stability studies, assessments and other available information;
• Progression monitoring of excipient usage justification package for Ad26 Platform use (potentially expanded to other platforms.