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Manufacturing specialist

Vacaturenummer: A2000163
Janssen Vaccines & Prevention - Leiden (Nederland)

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.


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.

Company profile
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
Reference:A2000163
Contract:Temporary contract with CLS Services
Education:HBO/BSc. WO/MSc. PhD.
Employment terms:Project for at least 6 months
Publication date:29-10-2020
Location:View location with Google Maps
Contactperson:Claudia Erwich-Faaij
+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.