Janssen Pharmaceutica NV, a member of Johnson & Johnson's Family of Companies, is recruiting a Principal Scientist - Drug Product Technical Integrator, based in Beerse, Belgium.
Janssen develops treatments that improve the health and lifestyles of people worldwide.
R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. The Principal Scientist Drug Product Technical Integrator is the DPD (Drug Product Development) representative and single point of contact on the CMC new product development teams.
The Principal Scientist leads a team of DPD scientists including Packaging Development and Engineering, Pharmaceutical and Characterization Sciences, Oral Solid Dosage Development, Parenterals & Liquids, Drug Delivery & Device Development, and Material Sciences integrating DPD activities so that deliverables are being met balancing cost/time/quality. Specifically, the Principal Scientist Technical Integrator (TI) is responsible for: developing the global DPD strategy and plan per product, in line with the overall strategy and plan as outlined by the CMC team. The successful candidate will ensure alignment and endorsement of this strategy within the DPD function. Driving the Target Product Profile (TPP)-CMC agreement & deliverables in partnership with the CMC team leader, the Supply Chain, Marketing and the Compound Development Team (CDT). Delivering the clinical and commercial formulations & manufacturing processes, meeting the manufacturing performance, cost and process robustness needs, in line with Quality by Design (QbD) principles. Managing the planning and execution of DPD project deliverables and coordinating project transfer along the project continuum. Coordination of all dossier writing activities within DPD and optimizing the DPD development methodology, making use of standard technology platforms, accelerating development timelines, and streamlining the technical transfer process. The scope of the integrator function is 'End-to-End' and applies to all DPD, chemical and biological projects and products, either developed and/or manufactured within Janssen or externally. The Principal Scientist Technical Integrator is a core member of the CMC team, with key interactions with the API and Analytical Integrators, clinicians, technical groups, external vendors and partners as well as the Portfolio Management Functions. He/She will lead a DPD cross-functional team of scientific experts that will cover all responsibilities of the DPD organization and will work with the senior functional leaders of Drug Product Development and the CMC Leader.