Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology conditions.
Do you have at least 10 years experience in biologics drug product development ?
Don't hesitate to contact me : firstname.lastname@example.org
The Biologics Drug Product Development specialist will support the late stage project for the preparation of commercialisation:
- building of the drug product (DP) and packaging strategic development plan
- conducting yearly resource forecasting
- support the building of the CAPEX & OPEX budget
- develop the 5 Years project plan
- track all ongoing activities for the Biological Pharmaceuticals Sciences department
- manage the team & resources as a matrix team
- coordinate meetings with the team - ensuring that all relevant project information is collated and shared
- accountable for CMC documentation
- communication of the strategy and status of plan
- timely escalation and deviations
- Minimum 10 years experience in biologics drug product development and steriles manufacturing within the biopharmaceutical industry
- An understanding of the issue and challenges of taking product from late stage development into comercialisation
- Good knowledge and technical experience in parenteral liquid drug product development and cGMP manufacturing under aseptic conditions would be required
- Good technical knowledge of sterile development covering drug product components, process transfer, scale and optimization
- Knowledge in primary and secondary packaging
- Good knowledge of cGMP and regulatory requirements
- Knowledge of analytical, preformulation and formulation development
- Understanding of biologicals drug product manufacturing process and scale-up
We offer an attractive salary with extra-legal advantages :
A rate as freelance is also possible.