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Principal Scientist OSD

Senior/Principal Scientist OSD

Locations: Beerse, Belgium
Functions: R&D
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Job Description

Requisition ID: 1905762962W

Global Small Molecule Drug Product Development is within the Discovery, Product Development & Supply (DPDS) organization of Pharmaceutical Companies of Johnson and Johnson responsible for the development of Pharmaceutical Dosage Forms. Development centers are located in the US, Asia and Europe.
For the location in Europe (Belgium, Beerse) there is a vacancy for a
Senior/Principal Scientist Oral Solids Development with general expertise in Pharmaceutical Technologies and specialized expertise in Oral Local/Targeted GI delivery of Small Molecules and Biologics.
The overall mission is to strengthen the capabilities for oral solid dosage forms.
Key elements of success are innovation, customer focus, teamwork, international networking and building up the scientific knowledge/expertise.
Specific responsibilities:
* Design formulation and process development activities in the area of solid dosage development with broader focus on oral local GI drug delivery, oral delivery of biologics, and/or oral targeted delivery.
* Write and review characterization reports and protocols, as well as contribute and update of Current Best Practices as applicable.
* Follow-up literature (scientific and patent) in order to create new development opportunities for Pharmaceutical Development
* Ensure overall compliance with regulatory requirements, GMP and environmental health and safety.
Ph.D. Degree in Pharmaceutical Sciences or Industrial Pharmacy, Bio-engineering, Chemical Engineering, or experienced Master in the Same Relevant Areas.
Ideally, you have at least 5 - 10 years of experience or equivalent with a demonstrated competency and experience in drug product development within the pharmaceutical industry or academically, mainly in the field of oral solid dosage form development with special focus on oral local/targeted GI delivery.
Specific Requirements
* You have a broad, end-to-end expertise in formulation and process development for solid dosage forms, i.e. scientific and technical expertise in conventional and enabling pharmaceutical technologies with special attention on formulation and processing to obtain a localized or targeted delivery of the API in the GI tract.
* Hands on experience of working on different conventional and enabling technologies mentioned in above point.
* Experience with scale up and technology transfer to pilot scale and commercial manufacturing of the different manufacturing processes, including setting up DOE's, applying scale up process modelling methodologies, mechanistically understanding the influence of the critical process parameters on the final product characteristics, statistics etc is desirable.
* Experience with implementation of state-of-the-art technologies and principles in the development of robust and marketable dosage forms, determining critical quality attributes, critical parameters and critical material attributes is desirable.
* Experience working within GMP requirements, implementing and maintaining high quality standards for all aspects of the work conducted including adherence to regulatory GMP, departmental, and safety guidelines.
* Track record in writing skills, scientific papers, development reports, protocols, etc.
* You are able to build up a broad network within Janssen (strong link with pharmacology (PK/PD), therapeutic areas, discovery sciences, etc) as well as externally, academics, CRO's, etc.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Primary Location
Janssen Pharmaceutica N.V. (7555)
Job Function
Requisition ID

Principal Scientist OSD

Permanent contract
R&D Engineer