Principal Scientist - Dissolution Sciences, Biopharmaceutics and Drug Product Performance-00000S57
Description
Pharmaceutical Materials Sciences is part of Drug Product Development, Pharmaceutical Development and Manufacturing Sciences-Drug Product Development (PDMS-DPD). The department is responsible for:
• Developability assessment of Discovery portfolio lead molecules
• Solid state form selection of the drug substance
• Definition of the drug product trajectory
• Characterization of Drug Substance and Drug Product
• Particle Characterization
• Raw materials characterization
• Dissolution and drug product performance optimization
In the Pharmaceutical Materials Sciences department in Beerse, Belgium, reporting into the head of the Dissolution Sciences group, there is currently a full-time opening for a
Principal Scientist
Dissolution Sciences, biopharmaceutics and drug product performance
The primary purpose of this role is to strengthen the team of Dissolution Sciences which is responsible to aid formulation design and optimization of small molecule products from an in vitro performance perspective, both for conventional and enabling technologies. In addition, the group is responsible to develop, validate and transfer QC dissolution methods, working closely with the QC labs during development as well as with the commercial sites. Besides focusing on method robustness and performance, the group is responsible to develop clinically relevant specifications for our drug products. Within this context, given the current trends from a regulatory and patient-centric perspective, a strong emphasis is placed on biorelevant in vitro testing to predict the relative bioavailability of candidate formulations, and to determine critical quality attributes relative to the API, the drug product manufacturing process and the raw materials used in the process.
Specific roles and responsibilities for this function are:
• To influence the design and optimization of our drug products, by actively contributing to cross-functional technical team meetings with project leaders and representatives from other departments such as formulation development, analytical development, pharmacokinetics, clinical pharmacology, quality assurance, regulatory etc, for specific new development projects and marketed products.
• To plan, perform and document laboratory experiments (dissolution and in vitro release testing) according to the current GMP requirements in function of developing complex formulations.
• To strengthen the dissolution sciences capability via novel analytical technologies (e.g. automation), as well as modeling the relationship between in vitro and in vivo performance (physiology based dissolution testing and pharmacokinetic modeling).
• To start and follow up activities internally and in collaboration with Contract Research Organizations (CROs) which also includes partnering with the quality, pharmaceutical development, procurement, and legal departments.
• To write and review technical protocols and reports, write parts of the Controls and Manufacturing part of regulatory submissions.
• To coordinate and perform technical method transfers to other laboratories / other sites. Assist in transfers or troubleshooting by giving support at the local testing site (world-wide).
• To represent the organization to the external environment, including regulatory authorities as well as the international scientific community
• To keep up to date with scientific publications and regulatory requirements and apply them to adjust or streamline development processes at the different development and commercialization sites, including Beerse (Belgium); Titusville (US); Mumbai (India); Gurabo (Puerto Rico) and Latina (Italy).
Qualifications
Qualifications:
• Doctorate in Pharmaceutical Sciences, Chemistry, Analytical Sciences or equal by relevant experience.
• University degree such as pharmacist, master chemistry or related.
• 7+ years in the pharmaceutical industry.
Your Profile:
• Good knowledge of pharmaceutical sciences relevant to the development of formulations and analytical chemistry, with plus point for pharmacokinetics and PBPK modelling.
• Experience with hands-on laboratory and modeling activities, more specifically with dissolution testing and/or HPLC/UPLC analysis in a GMP regulated environment, as well as the use of tools like GastroPlus.
• Good written and spoken communication in English for both reports as oral presentations; Knowledge of Dutch or the will to learn it. The ability to work in international teams and demonstrate leadership skills through an excellent communication;
• Experience with people development, coaching and mentoring;
• Team player, dynamic and results-oriented
• A strong ability to influence decisions, both at a project team level as well as at the level of devising strategies to strengthen the scientific direction of the department.
This function can be taken up immediately.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D
Description
Pharmaceutical Materials Sciences is part of Drug Product Development, Pharmaceutical Development and Manufacturing Sciences-Drug Product Development (PDMS-DPD). The department is responsible for:
• Developability assessment of Discovery portfolio lead molecules
• Solid state form selection of the drug substance
• Definition of the drug product trajectory
• Characterization of Drug Substance and Drug Product
• Particle Characterization
• Raw materials characterization
• Dissolution and drug product performance optimization
In the Pharmaceutical Materials Sciences department in Beerse, Belgium, reporting into the head of the Dissolution Sciences group, there is currently a full-time opening for a
Principal Scientist
Dissolution Sciences, biopharmaceutics and drug product performance
The primary purpose of this role is to strengthen the team of Dissolution Sciences which is responsible to aid formulation design and optimization of small molecule products from an in vitro performance perspective, both for conventional and enabling technologies. In addition, the group is responsible to develop, validate and transfer QC dissolution methods, working closely with the QC labs during development as well as with the commercial sites. Besides focusing on method robustness and performance, the group is responsible to develop clinically relevant specifications for our drug products. Within this context, given the current trends from a regulatory and patient-centric perspective, a strong emphasis is placed on biorelevant in vitro testing to predict the relative bioavailability of candidate formulations, and to determine critical quality attributes relative to the API, the drug product manufacturing process and the raw materials used in the process.
Specific roles and responsibilities for this function are:
• To influence the design and optimization of our drug products, by actively contributing to cross-functional technical team meetings with project leaders and representatives from other departments such as formulation development, analytical development, pharmacokinetics, clinical pharmacology, quality assurance, regulatory etc, for specific new development projects and marketed products.
• To plan, perform and document laboratory experiments (dissolution and in vitro release testing) according to the current GMP requirements in function of developing complex formulations.
• To strengthen the dissolution sciences capability via novel analytical technologies (e.g. automation), as well as modeling the relationship between in vitro and in vivo performance (physiology based dissolution testing and pharmacokinetic modeling).
• To start and follow up activities internally and in collaboration with Contract Research Organizations (CROs) which also includes partnering with the quality, pharmaceutical development, procurement, and legal departments.
• To write and review technical protocols and reports, write parts of the Controls and Manufacturing part of regulatory submissions.
• To coordinate and perform technical method transfers to other laboratories / other sites. Assist in transfers or troubleshooting by giving support at the local testing site (world-wide).
• To represent the organization to the external environment, including regulatory authorities as well as the international scientific community
• To keep up to date with scientific publications and regulatory requirements and apply them to adjust or streamline development processes at the different development and commercialization sites, including Beerse (Belgium); Titusville (US); Mumbai (India); Gurabo (Puerto Rico) and Latina (Italy).
Qualifications
Qualifications:
• Doctorate in Pharmaceutical Sciences, Chemistry, Analytical Sciences or equal by relevant experience.
• University degree such as pharmacist, master chemistry or related.
• 7+ years in the pharmaceutical industry.
Your Profile:
• Good knowledge of pharmaceutical sciences relevant to the development of formulations and analytical chemistry, with plus point for pharmacokinetics and PBPK modelling.
• Experience with hands-on laboratory and modeling activities, more specifically with dissolution testing and/or HPLC/UPLC analysis in a GMP regulated environment, as well as the use of tools like GastroPlus.
• Good written and spoken communication in English for both reports as oral presentations; Knowledge of Dutch or the will to learn it. The ability to work in international teams and demonstrate leadership skills through an excellent communication;
• Experience with people development, coaching and mentoring;
• Team player, dynamic and results-oriented
• A strong ability to influence decisions, both at a project team level as well as at the level of devising strategies to strengthen the scientific direction of the department.
This function can be taken up immediately.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D