Johnson & Johnson Careers
Requisition ID: 1905751746W
Based at our European Site in Belgium, (Beerse) we have a vacancy for a Scientist in Biopharmaceutics in the Pharmaceutical Sciences department.
As a scientific expert in Biopharmaceutics, your overall mission is to design, execute and coordinate in silico and in vitro experiments to strengthen our knowledge of the physicochemical and biopharmaceutical properties of the API and drug product, ensuring optimal in vivo performance. This will involve projects from Early through late Development. Added key elements of the function are: innovation, customer focus, teamwork including cross R&D, networking and expanding our scientific knowledge and expertise.
- Design, program and execute experimental work related to Biopharmaceutics in support of the selection and development of the API and /or drug product.
- Support the design and execution of the overall project biopharmaceutics strategy encompassing
- Biopharmaceutical profiling (e.g. solubility, dissolution, stability, drug delivery system selection)
- API and drug product physico-chemical characterization (e.g. in silico, in vitro and in vivo product performance considerations) in function of targeted PK profile, route of administration and drug delivery system.
- Implementation of drug absorption and disposition modeling techniques (e.g. GastroPlus, SimCyp, MatLab) to build mechanistic absorption models, as well as to guide experimental designs and specifications for API and formulation properties.
- As a member of the project biopharm teams contribute to the development and biopharmaceutic understanding of APIs and their formulations
- Keep track of emerging regulatory expectations in the field of biopharmaceutics, including the setting of clinically relevant controls/specifications. Define and execute plans to assure an optimal fit between regulatory expectations and the Janssen small molecule portfolio by applying a fit-for-purpose mindset and building on well balanced investments in biopharm.
- Writing and reviewing reports, including relevant documentation to support both clinical and marketing applications
- Build and maintain strong relationships with key stakeholders including Discovery Sciences, Preclinical DMPK, Non-Clinical Safety, Clinical Pharmacology, Regulatory Affairs, API, Drug Product Development and Analytical Development.
- Work in a multidisciplinary team of scientists. Keep up to date with scientific innovations, to ensure that Pharmaceutical Sciences continues to perform as a world class team in the area of biopharmaceutics.
- Master or Doctorate (Ph.D.) in Pharmaceutical Sciences, Chemistry, Biology, Engineering or related science with relevant industrial experience in biopharmaceutics.
- Relevant hands on experience with modeling of drug absorption and disposition (Gastroplus/Simcyp) and in vitro biopharmaceutics (e.g. solubility, particle characterization, …), or prepared to build this experience
- Sound knowledge of API physico-chemistry, drug absorption/disposition principles, formulation optimization, pharmacokinetics, and mechanistic design.
- Highly motivated, with excellent organizational, interpersonal, communication, and collaborative skills while demonstrating a high degree of personal accountability.
- Highly effective team player who can work in a matrix organization to accomplish assigned tasks.
- Fluent English (both spoken and written) with excellent scientific writing skills.
- Team player, dynamic, stress resistant, innovative and flexible.
Janssen Pharmaceutica N.V. (7555)