This website uses cookies to improve your user experience. Continuing to browse this website will be seen as your consent to us for placing cookies on your computer and using those cookies.
More information can be found in the Cookies-section of our Privacy Policy.
OK

Biological Drug Development Specialist Consultant

Brussels, Belgium

Benson & Winch is searching for a Biological Drug Development Specialist Consultant to join our pharmaceutical client in their office

Your responsibilities

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
Technical Documentation:
- accountable for CMC documentation as either author or reviewer
Communication:
- 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

Your profile

Experience :
• 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.

Specific skills:
• 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

Problem Solving:
• Investigation failure, process improvement, waste reduction, cost reduction.

This description matches your profile and expectations?

Jobs Overview