In our organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen Vaccines.
Role DescriptionThe individual leads the DPD project team and represents the team in the CMC project team. The Technical Integrator coordinates 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.
Responsibilities- Represents the DPD department on the CMC project team, acting as a single point of contact for the CMC team leader - Leads a functional sub-team containing DPD representatives and Subject Matter Experts (SME) and is responsible for the planning and execution of DPD project deliverables - Develops the project strategy in consultation with the DPD department and CMC team in line with project targets, while ensuring alignment across the organization - Drives partnership and collaboration between the functions and ensures that the customer (internal & external) requirements are well understood by their teams and are used as main drivers for development - Responsible for budget preparation and alignment within DPD - Responsible for the generation of appropriate risk management scenarios - Responsible for ensuring that adequate technical review of regulatory submissions has taken place by the appropriate SME and ensures consistency in content across submissions.
Requirements- Education: MSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering. - Proven technical expertise in at least one of the functional areas (DS, DP 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. - A minimum of 5 years pharmaceutical industry experience, preferably in a biopharmaceutical drug development environment
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.