Biotech and Agricultural Medical and Healthcare Other Science and Tech
1 - 2 Years
Principal Scientist Dissolution Sciences
‘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 Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development center develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions
Our core activities are focused around the development of solid oral formulations such as tablets and capsules for poorly soluble drugs for immediate, modified or targeted release, and suspensions for oral or parenteral use.
The Dissolution Sciences team is part of Analytical Development (AD) in Small Molecule Pharmaceutical Development (SMPD). The Dissolution Sciences team is responsible for characterizing and understanding the in vitro release of different formulations to support drug product development, for developing and transferring dissolution methods to ensure the quality of the product, and for troubleshooting and investigating unexpected or deviating drug product behavior. The team is also responsible for developing biorelevant in vitro tests to predict the in vivo relative bioavailability of candidate formulations in function of their composition, excipients and manufacturing process.
The position will be executed out of Beerse site in Belgium.
As a Dissolution Scientific Support Leader, the successful candidate will design and lead the dissolution method development strategy to support the development of a selected number of molecules and their corresponding novel dosage forms, and lead the biopharmaceutical assessment strategy towards predicting in vivo exposure and obtaining biorelevant methods and specifications.
(S)he will represent the Dissolution Sciences team in cross-functional matrix environment including formulation development, pharmaceutical sciences, clinical pharmacology, quality assurance and regulatory.
(S)he will act as a scientific coach to younger scientists within a broader team. (S)he will also be responsible for writing and reviewing technical and scientific documents in support of scientific discussions, product filings as well as for Health Authority interactions.
Finally, (s)he will stay at the forefront of the scientific and regulatory trends in Dissolution Sciences through literature and participation to conferences and workshops and lead initiatives to optimize the current working practices and introduce the latest innovations in dissolution sciences in terms of in vitro technology and in silico tools.
Education & experience
PhD in Pharmaceutical Sciences, Biopharmaceutics, Chemistry or related.
10 years or more experience in the pharmaceutical industry in the filed of dissolution and drug product development.
Competencies & Knowledge
Pharmaceutical sciences relevant to the development of small molecule formulations, analytical chemistry, compliance and GMP.
Health authority regulations towards dissolution method development, biowaivers, IVIVC, SUPAC for the largest markets (EMA, FDA, ICH). Health authority interactions for technical questions, pre-NDA or EMA scientific consulting meetings, and site inspections.
Writing scientific reports and dissolution related parts of the NDA/MAA file.
Dissolution method development, validation and transfer; trouble shooting, problem solving.
Working with external CROs and academic partners.
Good presentation skills and the ability to be influential in global scientific meetings.
Fast learner with scientific curiosity, self-steering, pro-active, creative.
Ability to work together as one team in a global environment and coach or lead other scientists.
Good written and spoken communication in English. Knowledge of Dutch or willing to learn the basics.
Belgium-Antwerp-Beerse- Other Locations
France, United Kingdom-England, Netherlands, Italy, Germany, Spain Organization
Janssen Pharmaceutica N.V. (7555) Job Function
R&D Requisition ID
Open Positions from Johnson & Johnson Family of Companies