As drug product development and manufacturing specialist you will support our late stage development/clinical projects, during the preparation for BLA submission and commercialisation.

This includes:

Development of biological product presentations and processes (from early to late stage) and participation in the transfer to GMP manufacturing / fill & finish sites (internal or external)
Coordination or contribution of a small matrix-type drug product project team within the drug development and manufacturing (DPDM) group, focused on supporting a late stage biological project
Representative for all related aspects of the project

You will more precisely contribute by:

Process development

Defining and executing work packages related to development of the drug product presentations and manufacturing process, fit-for-purpose for clinical development and subsequent commercialisation, and support filling preparations

Project management

Building the drug product (DP) strategic development plan
Conducting yearly resource forecasting based on defined work packages and assessing additional resource needs when project requirements change
Supporting the creation of the project budgets (CAPEX & OPEX) for the technical solutions teams (TST)
Developing the 5 year project plan for DP, in alignment with formulation and packaging teams
Overseeing all ongoing activities for the DPDM team members on project

Matrix team management

Coordinating, in matrix environment, a team of DP subject matter experts (SMEs) as required
Coordinating pre and post TST meetings with DP SMEs ensuring that all relevant project information is collated and shared at the TST and providing feedback to DP SMEs from the TST

Technical documentation

Being accountable for CMC documentation (reports, FMEA,...) as either author or reviewer

Communication

Communicating on DP strategy and status of plans to the TST
Communicating on overall project strategy from the TST to SMEs and DP and Biotech Clinical Manufacturing Sciences (BCMS) leadership teams
Timely escalation of risk/issues/deviations related to the development plans to the project and leadership teams, as required

Other

Lead and/or contributing to failure investigations and impact assessments of DP manufacturing processes at clinical and commercial fill & finish facilities (internal and external)