The Drug Product Development (DPD) department consists of 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.
The FST group is involved as of developability assessments of new compounds and responsible for early formulation development, up to and including Tox and phase1/2a clinical studies. In addition, responsibilities include the evaluation of novel technologies as well as formulation improvements for life cycle management of our next generation of vaccines.
You will provide (applied) physics expertise, physical modelling and drive complex data analysis in active vaccine drug product development projects. You will participate in investigational teams to help identify root causes and implement solutions and provide alternative approaches or perspectives during problem solving and solution implementation. You will complement the existing drug product development expertise by identifying blind spots or unforeseen risks and proactively identify problems or issues where an applied physics/mathematical analysis would be beneficial. You will also write study plans, reports and presentations to stakeholders as appropriate.
Simplifies complex problems while keeping the relevant parameters
Runs physical modelling using COMSOL or/and similar programs
Designs, executes, and leads complex studies to reach the project targets. Accountable for accompanying documentation such as Study Plans and Reports, compliance to GRP and adheres to timelines and budget.
Imbeds elements of machine learning into existing programs and process flows
Complex data analysis
Accountable for proper recording of information and collection of the data and for review of experimental results and presenting key-messages to the broader organization.
Lead and participate in cross-departmental technology and investigation teams.
Discusses problems and presents plans and data in local and global internal and external scientific meetings and conferences.
Challenges the status-quo; leads and adapts to change, continuously improve.
Value creation. Is responsible for innovation, conception of new ideas. Creates Intellectual Property. Is insight-driven to uncover unmet needs.
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, and inclusion are fundamental to our success.
Key Performance Indicators
Delivers assigned project deliverables with high quality, within budget and timelines.
Able to think and challenge beyond own expertise area.
Able to simplify complex problems while keeping the relevant parameters
Takes quick action driven by scientific curiosity.
Education: Master degree in physics and/or PhD in a relevant discipline in applied physics (PhD can be replaced by 5 years of experience in relevant industry).
Experience: Experience in Thermal physics/thermodynamics, Thermal conductivity, Fluidics/fluid dynamics, and COMSOL. Expertise in physical and numerical modelling/simulation. At least 1 year industry experience.
Other: Pro-active, flexible, and enjoys working in a team. Creativity and out-of-the-box mindset are key for this position.Primary Location