Johnson & Johnson Careers
Biopharmaceutics and PBPK modeling expert
Requisition ID: 1805691615W
Your key responsibilities:
- Development and validation of mechanistic absorption models (via GastroPlus, SimCyp, MatLab) to build an in-vitro in-vivo correlation, as well as to guide experimental designs and clinically relevant specifications for API and formulation.
- Design, execute and coordinate experimental work related to absorption modeling and bio-pharmaceutics in support of the selection and development of the appropriate drug delivery system for a multitude of formulation platforms and drug administration routes. This includes support for projects in early and late stage development.
- As a member of cross-functional project biopharm teams you contribute to the development and biopharmaceutical understanding of NME’s and their formulations
- You keep track of emerging regulatory expectations in the field of PBPK absorption modeling and biopharmaceutics. You define and execute plans to assure an optimal fit between these 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 PBPK absorption modelling, biopharmaceutics and CMC documentation to support both clinical and marketing applications
- You build and maintain strong relationship with key partners including Discovery Sciences, Preclinical, Clinical Pharmacology, Drug Product Development and Analytical Development.
- You contribute to building a strong biopharmaceutics team through collaboration, developing and coaching colleagues
- You will be part of a multidisciplinary team of scientists. Keep up to date with internal, external and regulatory innovations to strengthen the scientific expertise and maintain a world class standard in the area of PBPK absorption modeling and biopharmaceutics
Education & experience
- Master or Doctorate (Ph.D.) in Pharmaceutical Sciences, Bioinformatics, Engineering, Chemistry, Biology, or related science with relevant industrial experience in biopharmaceutics.
- Relevant hands on experience with mechanistic absorption modeling (GastroPlus/SimCyp) and in vitro biopharmaceutics (e.g. solubility, particle characterization, …) are highly preferred. Relevant experience in other modeling applications could be an asset.
- Sound knowledge of API physico-chemistry, drug absorption/disposition principles, formulation optimization, pharmacokinetics, and mechanistic design, or prepared to learn and get familiar with these principles.
- You are highly motivated, with excellent organizational, interpersonal, communication, and collaborative skills while demonstrating a high degree of personal accountability.
- As a highly effective team player you can work in a matrix organization to accomplish assigned tasks.
- Fluent English (both spoken and written) with excellent scientific writing skills.
- Dynamic, stress resistant, innovative and flexible.
Janssen Pharmaceutica N.V. (7555)