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Technical Integrator Drug Substance Development
Requisition ID: 1805632745W
Janssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines to protect people worldwide from infectious diseases. We have built a dedicated, world-class, multi-functional team across a variety of disciplines to develop a promising vaccines pipeline. In Leiden, we have a workforce of 700 scientists and support staff. 45% of our employees has a nationality other than Dutch, with over 20 nationalities represented. We partner with many of the world’s leading experts, academic and clinical institutions and other pharmaceutical companies for the development of vaccines against, for example, Ebola and HIV.
In our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. We are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.
We are currently recruiting for a Technical Integrator Drug Substance Development
The Drug Substance Development (DSD) department consists of six teams that work closely together: Upstream process development, Downstream process development, Pilot Plant, Vaccine Launch Facility, Engineering/Validation/Maintenance and Technical Integrators. The DSD department develops the bulk drug substance production processes for clinical and commercial manufacturing, produces clinical trial materials, and oversees drug substance manufacturing at GMP facilities outside Janssen. The department is embedded in the broader Vaccine Process & Analytical Development (VPAD) organization and collaborates with other Janssen departments to perform process scale-up.
The individual leads a DSD project team and represents the team in the CMC project team. The Technical Integrator coordinates the departmental deliverables for 1-3 CMC projects in alignment with DSD line management as well as with other functional areas, like Analytical Development, Drug Product Development, Regulatory Affairs, Quality Assurance and Clinical Supply Chain.
- Represents the DSD department on the CMC project team, acting as a single point of contact for the CMC team leader
- Leads a functional sub-team containing DSD representatives and Subject Matter Experts (SME) and is responsible for the planning and execution of DSD project deliverables
- Develops the project strategy in consultation with the DSD 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 DSD
- Responsible for the generation of appropriate risk management scenarios
- Responsible for ensuring that adequate technical review of regulatory submissions is taking place by the appropriate SME and ensures consistency in content across submissions.
- Empowering team members to act with speed, agility, and accountability
- Managing interface with other groups
- Delivering of DSD project deliverables
- Adherence to functional strategies of the line
- Timely escalation of conflicts affecting ability to meet project deliverables
Education: PhD (preferred) or MSc in relevant discipline, like pharmaceutical sciences, engineering, (bio)chemistry or other life sciences.
Specific Knowledge: Proven technical expertise in Drug Substance process development, 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.
Experience: A minimum of 8 years pharmaceutical industry experience, preferably in a biopharmaceutical drug development environment.
Other: Positive, pro-active and supportive attitude. Ability to lead and develop multidisciplinary teams of professionals in a matrix environment. Stakeholder management skills. Project management skills. Role model for cross-departmental collaboration.
As an employee, you are our most valuable asset. We take your career seriously. As a member of a global team in an innovative environment, your development is key and is our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future.
Janssen Vaccines & Prevention BV (8852)