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 Drug Product Development (DPD) department consists of the Formulation Development (FD) and the Fill/Finish Process (FFP) teams. The DPD department develops the bulk drug substance and drug product formulations, the aseptic compounding and fill/finish processes, and oversees DP manufacturing at fill/finish sites within and outside Janssen. The department is embedded in the broader Vaccine Process & Analytical Development (VPAD) organization and collaborates for instance with the clinical (supply) teams to define the storage and distribution network, and to generate in-use stability data.
You lead the 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.
Responsibilities• 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 is 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 • 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- PhD or MSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry, other life sciences, or engineering. - 5 years of 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, or Analytics), broad knowledge of the pharmaceutical industry and knowledge of functions involved in drug development/commercialization processes - GMP and regulatory process experience is required.
Other informationThis is a 6 month project for a maternity leave cover. You must be available for the 1st interview on the 8th or 10th of May.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.