Biological Drug Development Specialist Consultant
Benson & Winch is searching for a Biological Drug Development Specialist Consultant to join our pharmaceutical client in their office
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.
• Excellent communication, negotiation and team player skills are required as there will be significant contacts with internal groups and external stakeholders. Project management skills is key
• Investigation failure, process improvement, waste reduction, cost reduction.
This description matches your profile and expectations?