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News

Life Science - Manufacturing Specialist - Holland

  • Location

    Leiden, South Holland

  • Sector:

    Life Sciences

  • Job type:

    Temporary

  • Salary:

    Up to £0.00 per annum

  • Contact:

    Mark Pritty

  • Contact email:

    Mark.Pritty@talascendint.com

  • Job ref:

    BBBH92314_1605608962

  • Published:

    14 days ago

  • Expiry date:

    2020-12-17


Description:
Job title: Manufacturing specialist


Important experience needed:
- GMP knowledge and experience
- Aseptic manufacturing experience
- Experience with developing risk analyses

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 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. The primary function of the consultant is documenting 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.

Pending development, the consultant can also have a role in qualification of new raw materials for their 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.

Deliverables:

· New supplier Product impact assessment based on new excipient attributes

· New supplier 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

Education Required

University/Bachelors Degree or Equivalent

Job Function

R&D

Job Subfunction

R&D Engineering (R&D)

Work Experience

Generally Requires 4-6 Years Work Experience