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Technical Integrator Drug Product Development

Vacaturenummer: A2100207
Janssen Vaccines & Prevention - Leiden (Nederland)

For our client, Janssen Vaccines & Prevention, we are looking for a Technical Integrator Drug Product Development.

Keywords

  • CMC;
  • Drug Product Development;
  • Project management;
  • Regulatory filing review process.


Profile
We are currently recruiting for a Technical Integrator Drug Product Development.
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.
You are able to provide scientific and technical information to a broad range of stake holders. 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 close together with the technical integrator team members, as well as the global vaccine development and supply chain organisation. Based on your solid scientific and (project/people) managerial background, you take the lead in strategic discussions, investment discussions and provide risk-based solutions.

Member CMC team:
  • Represent 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;
  • Ensure 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;
  • Present plans and development data in local and global internal and external meetings.
Drug Product project leader:
  • Lead 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;
  • Develop and update 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.


Who we're looking for
We are looking for a candidate with a Ph.D. and 4-10 years of pharmaceutical industry experience in a relevant discipline in biopharmaceutical sciences, engineering, biotechnology or analytical development.
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, you have experience with managing cross-functional (global) teams and working within a matrix environment. In addition, it is preferred that you have a demonstrated record of scientific or program managerial accomplishments directed towards the discovery, development and launch of (vaccine) drug products.
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. A scientific and technical background, in combination with project co-ordination and management are key for this position.  
Are you pro-active, flexible, and do you enjoy working in a matrix environment? The this might be the perfect position for you!


Company profile
Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing, and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern, such as Ebola and COVID-19.
In this organisation, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. They 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.



Department
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) organisation and collaborates with the clinical (supply) and commercial supply teams to define the storage and distribution network, and to generate in-use stability data.

Additional vacancy information
Reference:A2100207
Contract:Temporary contract with CLS Services
Education:PhD.
Employment terms:Salary: > 62500 EURO
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Project for at least 1 year
Publication date:30-9-2021
Location:View location with Google Maps
Contactperson:Claudia Erwich-Faaij
+31 (0)88 22 77 555

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