Technical Integrator – Process Development-00000JD0
Omschrijving
BACKGROUND:
The department of API Small Molecule Development develops practical, efficient, safe and green 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 incumbent will represent API Small Molecule Development on CMC teams, and interface with colleagues within PDMS (e.g. analytical, drug product), Purchasing, Janssen Supply Chain, 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, impurity management, 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.
Kwalificaties
QUALIFICATIONS:
- MS or PhD degree in Chemistry or Chemical Engineering.
- A minimum of 8 years of experience in a large pharmaceutical company, working in the area of chemical development.
- Good communication, organizing, and planning skills and ability to lead and influence a team.
- Broad knowledge of process development, the regulatory environments, and the functioning of chemical plants.
- Ability to work in a complex, dynamic, global environment, and willingness to travel when necessary.
Primaire locatie: Europa/Midden-Oosten/Afrika-België-Antwerpen-Beerse
Organisatie: Janssen Pharmaceutica N.V. (7555)
Functie: R&D
Omschrijving
BACKGROUND:
The department of API Small Molecule Development develops practical, efficient, safe and green 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 incumbent will represent API Small Molecule Development on CMC teams, and interface with colleagues within PDMS (e.g. analytical, drug product), Purchasing, Janssen Supply Chain, 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, impurity management, 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.
Kwalificaties
QUALIFICATIONS:
- MS or PhD degree in Chemistry or Chemical Engineering.
- A minimum of 8 years of experience in a large pharmaceutical company, working in the area of chemical development.
- Good communication, organizing, and planning skills and ability to lead and influence a team.
- Broad knowledge of process development, the regulatory environments, and the functioning of chemical plants.
- Ability to work in a complex, dynamic, global environment, and willingness to travel when necessary.
Primaire locatie: Europa/Midden-Oosten/Afrika-België-Antwerpen-Beerse
Organisatie: Janssen Pharmaceutica N.V. (7555)
Functie: R&D