Biopharmaceutics and PBPK modeling expert

Job description

Job Description

Requisition ID: 1805691615W

‘Caring for the world, one person at a time' ... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

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.

For our Pharmaceutical Sciences department, we are hiring a PBPK absorption modeling Expert in the Biopharmaceutics group, located in Beerse (Belgium).

As a scientific expert, your overall mission is to perform mechanistic absorption applying mathematical equations using in vitro and in vivo data as input. Our goal is to strengthen our knowledge of the biopharmaceutical properties of the drug substance and drug product candidates, ensuring optimal in vivo performance. Additional key elements of the function are: scientific curiosity, innovation, teamwork and networking.

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

Desired profile

Qualifications

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.

Competencies

·  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.

What's in it for you…?

“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Primary Location
Belgium-Antwerp-Beerse-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
R&D
Requisition ID
1805691615W