NL - Technical Integrator Drug Product Development

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

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 are located in Leiden, the Netherlands.

We are currently recruiting for a Technical Integrator Drug Product Development!

Located in Leiden, the Netherlands and 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:

• Drug product development and vaccine deployment expert(ise)
• Functional strategist
• Project manager / project leader

He/she is working as CMC core-team member representing DPD in global multi-disciplinary project teams. He/she leads DPD sub-team(s) consisting of various scientific and technical experts and manages the project deliverables in an efficient manner. The technical integrator is able to provide scientific and technical information to broad range of stakeholders. You will present 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 close together with the technical integrator team members, as well as the global vaccine 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. In your role, it is expected that you demonstrate strong leadership with excellent interpersonal and project management skills. You have a critical attitude and a strong scientific and quality approach.

Key responsibilities:

Member CMC team

• Represents DPD functional area in the (global) CMC team(s) delivering on the vaccine products within Janssen Infectious Disease therapeutic area, from preclinical, tox, early development to late development and launch.
• Lead all drug product development aspects within the CMC team(s) and act as single point of contact for CMC Leader and functional line managers.
• Ensures alignment and endorsement of CMC strategy with the DPD department.
• Responsible for generation of appropriate risk management, mitigations and solutions.
• Represent DPD in meetings with health authorities.
• Responsible for DP sections of regulatory submissions by ensuring 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.
• Presents plans and development data in local and global internal and external meetings.

Drug Product project leader

• Leads the DPD cross-functional sub-team(s) with subject matter experts (e.g. formulation development, process development, fill finish manufacturing, technical operations, QA, AD) to develop high quality vaccine drug products.
• Develops and updates the DPD project strategy.
• 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 to launch.
• Responsible for the co-ordination 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.
• Co-ordination of activities related to the regulatory filing review process within the sub teams and functional management and ensuring consistency in content.

Member Technical Integrator team

• Participation as member of the drug product technical integrator team.
• Identify common improvements (lessons learned) and implement learnings as part of “best practices”. Leverage of expertise gained in other projects (re-useable know how).
• Expert owner in a specific focus area, on which regular training of fellow technical integrators will be expected. Example of focus areas: i) functional planning, ii) stage gates, iii) regulatory filings, iv) project management methodologies, v) investigational product preparation instructions, vi) combination products, vii) transfer into development, viii) transfer of project ownership to supply chain, ix) lifecycle management.

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 lead changes..
• Facilitation of decision making process and ability to decide

Qualifications

• PhD or masters degree is preferred in a relevant discipline in biopharmaceutical sciences, engineering, biotechnology or analytical development.
• Fluent in English.
• When PhD, with at least 4+ years pharmaceutical industry experience, with strong business background and good communication skills, preferably obtained within a biopharmaceutical drug development environment.
• Without PhD, 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 and working within a matrix environment.
• 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.
• 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.

EXTRA INFORMATION:

• You will work on-site in Leiden.
• This is a contracting position, with the possibility of an extension after the end date. You will receive a contract via our partner YACHT. They can offer you a contract for the duration of the assignment at J&J, a one year contract or a freelance contract (ZZP).