Technical Integrator Drug Product Development
This biopharmaceutical company is committed to developing first-in-class vaccines for some of the world’s most life-threatening infectious diseases such as Ebola, RSV and HIV.
You lead the Drug Product Development (DPD) project team and represent the team in the CMC project team. You coordinate the departmental deliverables for 2-3 CMC projects in alignment with DPD line management as well as with other functional areas, like Analytical Development, Drug Substance Development, Regulatory Affairs, Quality Assurance and Clinical Supply Chain.
- Represent the DPD department on the CMC project team, acting as a single point of contact for the CMC team leader
- Lead a functional sub-team containing DPD representatives and Subject Matter Experts (SME) and be responsible for the planning and execution of DPD project deliverables
- Develop the project strategy in consultation with the DPD department and CMC team in line with project targets, while ensuring alignment across the organization
- Drive partnership and collaboration between the functions and ensure that the customer (internal & external) requirements are well understood by their teams and are used as main drivers for development
- Be responsible for budget preparation and alignment within DPD
- Be responsible for the generation of appropriate risk management scenarios
- Be responsible for ensuring that adequate technical reviews of regulatory submissions have taken place by the appropriate SME and ensure consistency in content across submissions.
- PhD (preferred) or MSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering.
- A minimum of 5 years pharmaceutical industry experience, preferably in a biopharmaceutical drug development environment
- Proven technical expertise in at least one of the functional areas (Drug Substance, Drug Product and Analytics), broad knowledge of the pharmaceutical industry and knowledge of functions involved in drug development/commercialization process, GMP and regulatory process experience is required. Experience with vaccines is preferred.