Open Application API Small Technical Integrator-00000LO6
Description
BACKGROUND:
Worldwide, Janssen R&D focuses on five domains: neuroscience, cardiovascular diseases and metabolism, infectious diseases, immunology and oncology. Within these areas, the focus is on the research and development of vaccines and small and large molecules. Our campus is the largest R&D centre for small molecules within the entire Janssen group. It is the engine behind the continuous innovation at Janssen.
Researchers and laboratory workers with different nationalities work together on a daily basis to improve and innovate. The know-how on our campus - one of the leading R&D centers in the Janssen group and beyond - is also continually growing.
The department of API Small Molecule Development endeavors to develop chemical processes for drug candidates at all stages of development, including second-generation processes and improvement of existing commercial process. Due to the recent growth of our development pipeline, we are expanding our in house development group by hiring in a number of key strategic areas.
POSITION SUMMARY:
The Technical Integrator (Project Manager) will represent API Small Molecule Development on CMC teams, and interface with colleagues within the Pharmaceutical Development & Manufacturing Sciences department (= PDMS; e.g. analytical, drug product), Purchasing, Janssen Supply Chain (JSC), as well as relevant external partners; he/she will be accountable for all API-related project deliverables, including timely delivery of batches and all regulatory information according to API Small Molecule Development timelines and plans.
RESPONSIBILITIES:
• Ensure all filing and regulatory information is available and correct; represent functional area in meetings with regulatory authorities. Responsible for API control strategy, including spec setting, IPCs, criticality analysis, process parameters.
• Report and recommend to API Small Molecule Development management, when necessary, on project status, management of personnel and resources, budget, and other issues.
• Responsible for writing appropriate internal integrated reports and leading project reviews.
• Lead the API team on COGs, manufacturability (robustness), environment and safety evaluations.
• Responsible for transfer of processes to J&J plants or external partners.
• Responsible for post-approval support of the project.
• API Small Molecule Development representative for pre- and post-approval inspections.
Qualifications
- MS or PhD degree in Chemistry or Chemical Engineering.
- A minimum of 8 years of experience in a major pharmaceutical company, working in the area of chemical development.
- Good communication, organizing, and planning skills and ability to lead a team.
- Broad knowledge of process development, the regulatory environment, and the functioning of chemical plants.
- Ability to work in a complex, dynamic, global environment, and willingness to travel extensively when necessary.
COMPETENCIES – SOFT SKILLS
- Communicating – able to communicate upwards and across all levels of the organization; clearly expresses opinions and ideas, verbally and in writing and listens effectively.
- Leading collaboratively - able to build and inspire teams and motivate and mentor team members while credibly representing his/her organization towards PDMS, JSC, and external partners.
- Valuing diversity - treats people with respect and dignity.
- Managing expectations - able to set or manage appropriate goals from a wide variety of team members, management, and project teams while working to one common goal; works well across diverse functions and groups.
- Decision making – able to see the big picture and set the appropriate priorities while focusing on customer satisfaction and on-time completion of projects.
- Influencing & Negotiating – able to constructively manage and build on differences in opinion while remaining open to other’s ideas and leading to ultimate objectives.
- Problem solving – able to identify, analyze, and develop satisfying solutions, while being resilient and bouncing back quickly from disappointments and mistakes; learns and moves on quickly; has a continuous improvement mindset and a critical mind; sees new opportunities and is able to capitalize them.
- Resolving conflicts - remains open to other’s ideas and develops satisfying solutions or outcomes for the common goal.
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Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D
Description
BACKGROUND:
Worldwide, Janssen R&D focuses on five domains: neuroscience, cardiovascular diseases and metabolism, infectious diseases, immunology and oncology. Within these areas, the focus is on the research and development of vaccines and small and large molecules. Our campus is the largest R&D centre for small molecules within the entire Janssen group. It is the engine behind the continuous innovation at Janssen.
Researchers and laboratory workers with different nationalities work together on a daily basis to improve and innovate. The know-how on our campus - one of the leading R&D centers in the Janssen group and beyond - is also continually growing.
The department of API Small Molecule Development endeavors to develop chemical processes for drug candidates at all stages of development, including second-generation processes and improvement of existing commercial process. Due to the recent growth of our development pipeline, we are expanding our in house development group by hiring in a number of key strategic areas.
POSITION SUMMARY:
The Technical Integrator (Project Manager) will represent API Small Molecule Development on CMC teams, and interface with colleagues within the Pharmaceutical Development & Manufacturing Sciences department (= PDMS; e.g. analytical, drug product), Purchasing, Janssen Supply Chain (JSC), as well as relevant external partners; he/she will be accountable for all API-related project deliverables, including timely delivery of batches and all regulatory information according to API Small Molecule Development timelines and plans.
RESPONSIBILITIES:
• Ensure all filing and regulatory information is available and correct; represent functional area in meetings with regulatory authorities. Responsible for API control strategy, including spec setting, IPCs, criticality analysis, process parameters.
• Report and recommend to API Small Molecule Development management, when necessary, on project status, management of personnel and resources, budget, and other issues.
• Responsible for writing appropriate internal integrated reports and leading project reviews.
• Lead the API team on COGs, manufacturability (robustness), environment and safety evaluations.
• Responsible for transfer of processes to J&J plants or external partners.
• Responsible for post-approval support of the project.
• API Small Molecule Development representative for pre- and post-approval inspections.
Qualifications
- MS or PhD degree in Chemistry or Chemical Engineering.
- A minimum of 8 years of experience in a major pharmaceutical company, working in the area of chemical development.
- Good communication, organizing, and planning skills and ability to lead a team.
- Broad knowledge of process development, the regulatory environment, and the functioning of chemical plants.
- Ability to work in a complex, dynamic, global environment, and willingness to travel extensively when necessary.
COMPETENCIES – SOFT SKILLS
- Communicating – able to communicate upwards and across all levels of the organization; clearly expresses opinions and ideas, verbally and in writing and listens effectively.
- Leading collaboratively - able to build and inspire teams and motivate and mentor team members while credibly representing his/her organization towards PDMS, JSC, and external partners.
- Valuing diversity - treats people with respect and dignity.
- Managing expectations - able to set or manage appropriate goals from a wide variety of team members, management, and project teams while working to one common goal; works well across diverse functions and groups.
- Decision making – able to see the big picture and set the appropriate priorities while focusing on customer satisfaction and on-time completion of projects.
- Influencing & Negotiating – able to constructively manage and build on differences in opinion while remaining open to other’s ideas and leading to ultimate objectives.
- Problem solving – able to identify, analyze, and develop satisfying solutions, while being resilient and bouncing back quickly from disappointments and mistakes; learns and moves on quickly; has a continuous improvement mindset and a critical mind; sees new opportunities and is able to capitalize them.
- Resolving conflicts - remains open to other’s ideas and develops satisfying solutions or outcomes for the common goal.
-
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D