1 year contract, full time, with minimum 1 year extension
Prinicipal Scientist, Drug Product Process Design and Development based either near London or Brussels
Biologics Drug Product Development specialist supporting a late stage project for the preparation of commercialisation.
Co-ordinating a small matrix project team within the Biological Pharmaceutical Sciences (BPhS) department focussed on supporting a late stage project.
Representing BPhS as the Technical Solutions Team Representative for all related aspects of the project.
Project Management accountabilities:
- building of the drug product (DP) and packaging strategic development plan
- conducting yearly resource forecasting based on defined workpackages and assessing additional resource needs when project requirements change
- support the building of the CAPEX & OPEX budget for the TST
- develop the 5 Year project plan for DP & packaging development
- track all ongoing activities for the BPhS team members on the project
Manage a matrix team:
- Manage the BPhS team (Subject Matter Experts (SMEs)) & resources as a matrix team
- co-ordinate pre- and post- TST meetings with BPhS SMEs - ensuring that all relevant project information is collated and shared at the TST and providing feedback to BPhS SMEs from the TST
- accountable for CMC documentation as either author or reviewer
- communication of BPhS strategy and status of plans to the TST and communication of overall project strategy from the TST to BPhS SMEs and BPhS Leadership Team (BPhSLT)
- timely escalation of deviations / issues related to the development plans to the TST and BPhSLT as required
Minimum 10 years' experience in biologics drug product development and steriles manufacturing within the biopharmaceutical industry is required.
An understanding of the issues and challenges of taking products from late stage development into commercialisation.
Good knowledge and technical experience in parenteral liquid drug product development and cGMP manufacturing under aspetic conditions would be required.
Good technical knowledge of sterile DP development covering DP 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.
Expertise in supporting the required drug product activities for the manufacture and development of cGMP material and timely delivery of activities to internal and external partners.
Development of the strategic plan for DP and packaging activities.
Resource forecasting for identifed workpackages.
Managing small BPhS team of SMEs on a late stage project.