Johnson & Johnson

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Originele vacaturetekst

DP Technical Integrator

Job Description

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 the central points. 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.

We are currently recruiting for a

Technical Integrator Drug Product Development

reporting directly to Head of Technical Integrators

The Drug Product Development (DPD) department consists of close to 100 colleagues spread between five teams that work closely together: Formulation Development (FD), Process Development (PD), Manufacturing (Mfg), Formulation Science & Technology (FST), and Technical Integrators (TI). 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 with the clinical (supply) and commercial supply teams to define the storage and distribution network, and to generate in-use stability data.

Job description

The role of the Drug Product Technical Integrator is divided into three main categories: i) drug product expert(ise), ii) strategist, iii) project leader. He/she is working as a core-team member representing DPD in global multi-disciplinary CMC project teams developing innovative transformational vaccines (e.g. COVID, HIV, RSV, influenza, Ebola, ExPEC, Staph. Aureus) with the potential to have a direct impact on global health. He/she leads a DPD sub-team(s) consisting of various functional experts and manages the DP project deliverables in an efficient manner. He/she is able to provide scientific and technical information to a broad range of stakeholders.

You will present the outcome of studies to local and global governance bodies and drive the short and long-term strategies benefiting our current and future vaccine portfolio. You will work closely together with local team members from DPD and the broader global development and supply chain organization. Based on your solid scientific and (project/people) managerial background, you take the lead in strategic discussions, investment discussions and provide risk-based solutions.

Key responsibilities

  • Represents DPD functional area in the (global) CMC team(s), acting as a single point of contact for the CMC Leader (CMC-L) and functional line manager(s).
  • Leads the DPD (cross)functional sub-team containing Subject Matter Experts (SME); plan and execute project deliverables to the desired cost (according to the project budget) and quality level during all CMC stage-gate phases (from preclinical, early development to late development and launch).
  • Develops the DPD functional strategy ensuring leverage of expertise gained in other projects (re-useable know-how) and with focus on the end product and customer.
  • Ensures alignment and endorsement of CMC strategy within the DPD organization.
  • Drives partnership and collaboration between functions and ensures that the customer (internal & external) requirements are well understood by their teams and are used as main development drivers.
  • Lead sub-team supporting the tech transfer teams to multiple fill-finish manufacturing sites in close collaboration with other functions, such as analytical development, drug substance development, quality, regulatory, technical operations and supply chain.
  • Responsible for the coordination of all sub-team activities required to support the governance model (e.g. DPD functional review, VPAD cross-departmental scientific-technical review, and CMC-council), including active tracking and monitoring of stage-gate deliverables and integration of those deliverables into the functional project team
  • Responsible for the generation of appropriate risk management scenarios
  • Responsible for DP sections of the regulatory submission by ensuring that adequate technical content review of module 3 of IND/IMPD/BLA/MAA has taken place by either the appropriate expert or alternatively by (co)authoring several (sub)sections. Coordination of activities related to the review process within the sub-teams and ensuring consistency in content. Representing DPD in meetings with health authorities.
  • Discusses problems and presents plans and data in local and global internal and external meetings and conferences.
  • Accountable for proper recording of information and for review of experimental results and presenting key-messages to the broader organization.
  • Challenges the status-quo; leads and adapts to change, continuously improve.
  • Demonstration of strong leadership, interpersonal and project management skills. Importantly, you have a critical attitude and a strong scientific and quality approach. We value an ethical and safe environment, as described in our Credo, where trust, diversity, equity and inclusion are fundamental to our success.

Key Performance Indicators

  • Shapes, creates and delivers assigned DP project deliverables with high quality, within budget and timelines
  • Leadership of drug product team(s) for one or more programs
  • Timely management and escalation of risks affecting project deliverables
  • Able to think and challenge beyond own expertise area in a constructive way
  • Takes quick action driven by scientific curiosity and strategic insights
  • Excel in communication and influencing key stakeholders
  • Flexibility and adaptive to change.
  • Facilitation of decision making
Qualifications

Specific professional/technical requirements

Education:Ph.D. is preferred (not mandatory) in a relevant discipline in biopharmaceutical sciences, engineering, biotechnology or analytical development.

Languages: English

Experience: When Ph.D., with at least 4+ years pharmaceutical industry experience, with a strong business background and good communication skills, preferably obtained within a biopharmaceutical drug development environment. Without Ph.D., a proven track record in the pharmaceutical industry is required. Familiarity with one or more of the following aspects of product development is a prerequisite: (vaccine) formulation, process and product, CMC regulatory filings, and transition from clinical to commercial supply. Preferably, the candidate has experience of managing cross-functional (global) teams. In addition, it is preferred that the candidate has a demonstrated record of scientific or program managerial accomplishments directed towards the discovery, development and launch of (vaccine) drug products.

Other: Pro-active, flexible, and enjoys working in a matrix environment. Scientific and technical background, in combination with project coordination and management, are key for this position.

What’s in it for you …?

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.

Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Vaccines & Prevention BV (8852)
Job Function
R&D
Requisition ID
2105899597W
Type vacature:
Intern

Vaardigheden

  • Er is geen minimale opleiding vereist