For our client, a company in pharmaceuticals, we are looking for a Manufacturing Specialist based in Leiden.
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 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 the global Large Molecule Approved Material List. For this task materials need to be assessed according the regulatory criteria for excipients and where possible information need to be collected from manufacturers or suppliers of the materials.
- 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.
- MSc or BSc degree;
- Knowledge and experience with GMP;
- Experience with aseptic manufacturing;
- Experience with development and executing risk analysis.
What do we offer
- Contract via Kelly Services of 6 months (40 hours per week);
- Start date: asap;
- An international environment where you can learn a lot in challenging projects.
When interested please react through the application process with your English resume.
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Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.