I’m looking for a Material Specialist for the leading Biopharmaceutical client in Leiden who can setup implementation and qualification of new raw materials, consumables, and excipients (materials).
The client is working on platform-based processes. For each of the different platforms the materials need to be assessed on effectivity-, critical characterization-, quality- and safety-attributes. Determining these attributes and setting up studies in cooperation with suppliers and internal stake holders is part of the job requested. Also changes in supplier of existing materials in platform can be assessed as part of this position. The 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.
The consultant will also have a role in introduction of new 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 need to be collected from manufacturers or suppliers of the materials.
- 5 years experience in pharma in GMP Operations or quality roles
- BSc / MSc in pharmacy or biochemistry
- Has been author or defender of regulatory filing documents in submissions or inspections
- Material chemistry knowledge
- Material Assay qualification
- Cell Culture media qualification
- Material life cycle management knowledge.
- New material Product impact assessment based on new excipient attributes
- New material Process impact assessment based on new excipient attributes
- Facilitation and project management for supplier qualification when applicable
- Material stability impact assessment based on stability studies, assessments and other available information
- Progression monitoring of excipient usage justification package for platform use
- 1 year
If you’re interested in the above description, please apply with your CV. For further information, please contact Daria Petrova at +31 (0)20 20 44 502 or by email at d.petrova @panda-int.com