Senior Scientist, Drug Product Development
Locations: Beerse, Belgium
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Requisition ID: 1905717880W
The overall mission of the role is to strengthen the formulation and process development capabilities for oral solid dosage forms. Key elements of the role are: end -to-end formulation & process development, innovation, customer focus, teamwork, managing regulatory topics for pharmaceutical development, international networking and building up the scientific knowledge/expertise.
More specific responsibilities for the job holder consist of the following
* Formulation and process development of drug product including performing experimental work, designing and executing DOE's
* Daily follow-up of the scientific work
* Develop the internal knowledge around drug release expertise through partnerships/collaboration with academia, specialized drug delivery companies and suppliers
* Design, execute and coordinate the set-up of lab experiments and development of characterization methods
* Follow-up literature (scientific and patent) in order to create new development opportunities for Pharmaceutical Development
* Reach out to preclinical, clinical PK, tox and marketing in order to find opportunities for better drug development
* Monitor progress and quality of development work, and take appropriate actions
* Write and review reports and scientific articles
* Use his/her global network in order to set up collaborations with external partners and follow-up on Pharmaceutical Development, Legal, Procurement, IP, and on other CM&C aspects
* Ensure overall compliance with regulatory requirements, GMP and PbOEL (Performance based occupational exposure level)
* Develop Best Practices / Decision trees / Development Plans, Material characterization and selection to support drug product development.
* Develop the internal critical mass of expertise through partnerships/collaboration with academia and suppliers
* Formulation and process development supporting activities including: experimental support, designing DOE's, interpretation of data and preparation of clinical DP. Explore and implement new formulation and process best practices for DP formulations. Expand knowledge through collaboration and partnerships with academia.
* Protocol and report writing and reviewing. Literature follow-up.
* Consolidation of data, preparation and actively participation in DPD and other scientific meetings
* Ensuring of being compliant with regulatory requirements, GMP, pilot plant-, quality- and safety-guidelines, SOP instructions, 5S and departmental best practices.
Required Minimum Education:
Ph.D. in Biological, Physical or Pharmaceutical Sciences or Engineer with equivalent years of expertise in Pharmaceutical industry.
Required Years of Related Experience:
+ 2-10 years
Required Knowledge, Skills and Abilities:
* expertise in formulation and process development of solid dosage forms in conventional (wet granulation, dry granulation, direct compression) as well as enabling (spray drying, bead coating, melt extrusion, nanosizing, lipid based drug delivery,…) technologies for development of oral dosage forms
* experience with technology transfer to manufacturing and marketed product support for solid pharmaceuticals.
* 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.
* ability to work well within teams and provide leadership through effective communication skills.
* experience with implementation of state-of-the-art technologies and principles in the development of robust and marketable modified release oral solid dosage forms.
* the preferred candidate will have stayed abreast of the pharmaceutical development field; participated in industry workshops, attended scientific meetings, and monitored relevant scientific literature.
* demonstrate a high degree of personal accountability
* demonstrate the ability to deliver under pressure
* drive and energy to make the role a success
Janssen Pharmaceutica N.V. (7555)