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Drug Product Development Scientific Integrator
Requisition ID: 1805631823W
Janssen R&D, a member of Johnson & Johnson's Family of Companies, is recruiting a Senior / Principal Scientist - Drug Product Development Scientific Integrator, based in any of these locations: Beerse, Belgium. The Pay Grade Level for this position is: 30 / 31.
Janssen Research & Development area 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 Senior / Principal Scientist Scientific Integrator is the DPD (Drug Product Development) representative and single point of contact on the CMC new product development teams.
The Senior / Principal Scientist leads a sub team of DPD scientists including Oral Solid Dosage Development, Parenterals & Liquids, Pharmaceutical and Material Sciences, Primary Container & Device, integrating DPD activities so that deliverables are being met balancing cost/time/quality. Specifically, the Scientific Integrator (SI) will provide scientific technical leadership, ensuring the focus on scientific excellence is maintained within the DPD/CMC teams.
Main responsibilities include:
- This role will be focused on defining the DP development strategy across phases (E2E and LCM), through in depth understanding of the compound properties and TPP, aligned with DPD function, CMC and CDT team.
- Driving the project advancement (pre-NME - TOO) in partnership with DPD functions, CMC lead, CDT functions (preclinical and clinical), JSC while ensuring scientific standards are met
- Overseeing the planning and execution of DPD project deliverables
- Delivering clinical and commercial robust formulations and manufacturing processes, meeting manufacturing performance, cost needs, in line with QbD/DTV principles
- The scientific integrator will overview the project as core member of the CMC team, with key interactions with API and analytical integrators, clinicians, technical groups, external consultants and vendors as well as portfolio management functions
- The scientific integrator will also connect to and collaborate with other functions/partners such as QA, JSC, GTS, RA, PD&S, QS.
- Leading and providing technical leadership to a team of DPD scientists including OSD, PLG, DPD Engineering, PS, PCD, CSC engineers, ensuring the focus on scientific excellence is maintained within the DPD/CMC teams
- Leading the BioPharm team, composed of CMC, clinical, preclinical, regulatory, toxicology and/or other relevant functions to ensure correct formulation selection in view of the required PK profile, to determine bridging strategies, to define clinically relevant controls and ultimately correct specs.
- Responsible to have a full product and process technical/scientific understanding.
- Responsible for and driving the Level 1 Governance Review for the assigned projects.
- Managing the DP risk register and defines mitigation plans. He/she will ensure rapid identification and resolution of problems.
- A Masters Degree or PhD in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with five to ten (5 - 10) years of experience is required or the equivalent training/experience
- Demonstrated competency and experience in drug product development within the pharmaceutical industry is required. Demonstrated high level of technical understanding.
- Demonstrated leadership in providing integration of activities and delivering information across multifunctional groups and sites is required.
- Demonstrated experience in scale up of manufacturing processes and technical transfer of projects into commercial manufacturing.
- Drug Product Development experience that a span early through late is preferred.
- This position is based in Beerse, Belgium and may require up to 15% international and domestic travel.
Janssen Pharmaceutica N.V. (7555)