Scientist Product Design & Development-00000NAL
Description
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: innovation, customer focus, teamwork, managing regulatory topics for pharmaceutical development, international networking and building up the scientific knowledge/expertise.
Specific responsibilities of the role related to continuous manufacturing of Drug Product are:
- Support equipment selection process – Design of continuous line – IQ/OQ/PQ/FAT
- Selection and implementation of PAT tools, for process understanding and control
- Support modeling activities for process understanding and monitoring, resulting in an end to end process control strategy
- Develop Best Practice / Decision trees / Development Plans for continuous manufacturing platforms: blending, wet granulation, dry granulation, direct compression and in a later phase coating
- Material characterization and selection to support continuous manufacturing
- Design and perform DOEs on continuous processes to define/optimize final continuous manufacturing line configuration
- Design and perform DOEs on excipients/compositions to define new platform formulations
- Support the process of change and requirements with regard to new filings with continuous processing
- Ensure compliance with regulatory requirements, GMP and PbOEL (Performance based occupational exposure level)
- Support process technical transfers
- Monitor progress and quality of development work, and take appropriate actions
- Write and review reports and articles
- Develop the internal critical mass of expertise through partnerships/collaboration with academia and suppliers
- 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
- Support the process of change with regard to QA/QC systems and appropriate proactive conversations with regulatory agencies
- Follow-up literature (scientific and patent) in order to create new development opportunities for Pharmaceutical Development
- Reach out to PK, Preclinical, Tox and Marketing in order to find opportunities for better drug development
Qualifications
Qualifications:
- Ph.D. in Biological, Physical or Pharmaceutical Sciences or engineer with equivalent years of expertise in Pharmaceutical industry.
Assets:
- Expertise in formulation and process development for solid dosage forms
- Experience with technology transfer to manufacturing and marketed product support for solid pharmaceuticals.
- Experience working within GMP environment, 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 oral solid dosage forms.
- The preferred candidate has been participated in industry workshops, attended scientific meetings, and monitored relevant scientific literature.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D
Description
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: innovation, customer focus, teamwork, managing regulatory topics for pharmaceutical development, international networking and building up the scientific knowledge/expertise.
Specific responsibilities of the role related to continuous manufacturing of Drug Product are:
- Support equipment selection process – Design of continuous line – IQ/OQ/PQ/FAT
- Selection and implementation of PAT tools, for process understanding and control
- Support modeling activities for process understanding and monitoring, resulting in an end to end process control strategy
- Develop Best Practice / Decision trees / Development Plans for continuous manufacturing platforms: blending, wet granulation, dry granulation, direct compression and in a later phase coating
- Material characterization and selection to support continuous manufacturing
- Design and perform DOEs on continuous processes to define/optimize final continuous manufacturing line configuration
- Design and perform DOEs on excipients/compositions to define new platform formulations
- Support the process of change and requirements with regard to new filings with continuous processing
- Ensure compliance with regulatory requirements, GMP and PbOEL (Performance based occupational exposure level)
- Support process technical transfers
- Monitor progress and quality of development work, and take appropriate actions
- Write and review reports and articles
- Develop the internal critical mass of expertise through partnerships/collaboration with academia and suppliers
- 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
- Support the process of change with regard to QA/QC systems and appropriate proactive conversations with regulatory agencies
- Follow-up literature (scientific and patent) in order to create new development opportunities for Pharmaceutical Development
- Reach out to PK, Preclinical, Tox and Marketing in order to find opportunities for better drug development
Qualifications
Qualifications:
- Ph.D. in Biological, Physical or Pharmaceutical Sciences or engineer with equivalent years of expertise in Pharmaceutical industry.
Assets:
- Expertise in formulation and process development for solid dosage forms
- Experience with technology transfer to manufacturing and marketed product support for solid pharmaceuticals.
- Experience working within GMP environment, 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 oral solid dosage forms.
- The preferred candidate has been participated in industry workshops, attended scientific meetings, and monitored relevant scientific literature.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D