J&J Family of Companies Bioanalytical Project Manager in Beerse, Belgium
‘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 centre 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.
The bioanalytical department at the Janssen Research and Development site in Belgium provides analytical support and expertise for the development of small molecule drugs and peptides. The group is responsible for the absolute quantification by LC-MS/MS of drugs and their metabolites in biological samples from animal and human studies. Sample analysis is conducted in the internal lab in Beerse as well as outsourced to external providers.
We are looking for a (Senior) Bioanalytical Project Manager (location: Beerse, Belgium)
Serve as the technical bioanalytical expert for the different projects that you will be managing at all stages of drug development (in internal lab and at contract labs)
Liaise with the different disciplines involved in the development of new drugs: Drug Discovery, Pharmacokinetics, Metabolism, Toxicology, Pharmaceutical Sciences and Clinical Development
Be closely involved in the development of new LC-MS/MS assays for your projects, in collaboration with the internal assay development team or contract labs.
Monitor, review and troubleshoot the scientific performance of the different LC-MS/MS assays for your projects, ensuring regulatory compliance, in the internal lab and at contract labs
Interact with technical experts at external contract labs for assay transfer, validation and sample analysis for outsourced studies
Provide bioanalytical input in regulatory filing documents and respond to questions from worldwide regulatory agencies (EMA, FDA, Health Canada, Anvisa…)
Keep up to date on new bioanalytical technologies and future trends and bring innovation to the bioanalytical team
Contribute to branding the department by authoring scientific peer reviewed papers and presenting at relevant conferences
Education & experience
PhD in Chemistry or Pharmaceutical Sciences with at least 5 years of industry experience in the field of bioanalysis
Experience in developing and troubleshooting bioanalytical assays
Industry experience in managing multiple bioanalytical projects and interacting with regulatory authorities
Good knowledge of bioanalytical regulatory guidelines (GLP, GCP) from worldwide agencies (EMA, FDA, …)
Able to manage multiple projects in parallel with aggressive timelines
Good communicator, both orally and in writing
Good interpersonal skills
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.
Janssen Pharmaceutica N.V. (7555)