Associate Scientist Product Design & Development - Belgium
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Global Drug Product Development is within the Pharmaceutical Development & Manufacturing Sciences (PDMS) 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 an Associate Scientist Product Design & Development
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.
- Execute experimental work to develop the formula/product/process. Design of experimental set up to be discussed with Subject Matter Experts (SME’s) and/or supervisor. After appropriate training, it is expected that the candidate performs small scale activities independently; while larger scale experiments are performed in team.
- Makes propositions and interprets the results of the experimental work, in consultation with SMEs.
- Contribute to a deep understanding of both the formulation (materials, drug properties, biopharmaceutical consideration) and manufacturing process (characterisation, robustness, scale-ability) to ensure a smooth transfer into the commercial organization. On the job training will be provided through interactions with scientists and SMEs within the department and within PDMS.
- Assemble/disassemble and use relevant pharmaceutical technology equipment, at both laboratory and large pilot scale. Acquires a good understanding of the working principles of the equipment and all process parameters.
- Evaluate the robustness of the solid dose formulation and process by measuring the appropriate In Process Controls (IPC’s) such as Granulometrics, Tablet hardness, disintegration time and using appropriate PAT and modeling tools.
- Experimental work occurs in compliance with regulatory requirements, GMP and PbOEL (Performance based occupational exposure level)
- Report experiments and results in Electronic Lab Notebooks and prepare technical reports of the experimental work. Experience with basic statistics and DoE methodology is a plus. Presents and defends the formulation strategy and technical results in scientific meetings/ reviews within PDMS
- Read appropriate literature as a learning opportunity in conjunction with SME’s.
Bachelor/Master degree in Pharmaceutical and Biological Technology, Pharmaceutical Sciences or Chemistry, or related subject with equivalent years of expertise in Pharmaceutical industry.
- relevant theoretical and practical hands-on knowledge and experience with technologies used in pharmaceutical formulation & process development (e.g. blending, wet granulation, roller compaction, spray drying, hot melt extrusion, tableting, film coating, continuous manufacturing)
- hands-on experience with IPC’s like granulometrics, tablet hardness, disintegration time, etc.
- 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
- a keen interest in practical work, scientific riguor and the ability to adapt and keep on learning new skills is required
- the preferred candidate has a background in pharmaceutical development, especially with expertise in oral solid dosage form development
Janssen Pharmaceutica N.V. (7555)