Johnson & Johnson Loopbaan
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Drug Product Development Technical Integrator (Project Manager)
Requisition ID: 1700207728W
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.
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 Product Development (m/f)
The 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.
The 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.
- 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.
- Empowering team members to act with speed, agility, and accountability
- Managing interface with other groups
- Delivering of DPD project deliverables
- Metrics on HR, Finance, Quality & EHS
- Adequacy of functional strategies as shown in DPD’s ability to handle the CMC product portfolio
- General leadership within DPD group
Education: PhD (preferred) or MSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering.
Specific Knowledge: 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.
Experience: A minimum of 5 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)