Manager Stability Outsourcing-00000N83
Description
Clinical Release and Stability (CRS) is a department of Pharmaceutical Development and Manufacturing Sciences, specifically of the Analytical Development organization.
The CRS department is responsible for:
• Clinical release and stability testing of Drug Substance (DS) and Drug Product (DP) for small molecules and large molecules covering Phase 1 through Phase 3
• DS and DP manufacturing process and product characterization support
• The stability process for small and large molecules in R&D
As a result of implementing our operating model, through which significant parts of our activities are executed by third parties, the following strategic position is created in our Beerse, Belgium organization:
Manager Stability Outsourcing
General scope of responsibilities
• Follow-up on the stability projects of our internal and external partnerships (WuXi, Higi, US, Europe, ...).
• Strategically manage and coordinate the optimal use of the external capacity and capability in support of the clinical release and stability deliverables in the area of small molecules.
• Act as a Single Point of Contact for our external development partners.
• Define the roles and responsibilities for testing, data interpreting, trending and reporting studies, within the contractual framework.
• Ensure GMP and compliance with regulatory requirements.
• Support the CRS project owners in their relationship and communication with external parties.
• Participate in the selection and review of contract laboratories, technical follow up of the services provided, and driving improvement through key performance indicators.
• Ensure continuous improvement and lean methodologies are integrated in the processes and systems.
Qualifications
• A minimum of Master’s degree in Chemistry, Pharmaceutical Sciences, Bio-engineering or equivalent through experience.
• A minimum of 5 years’ experience within the pharmaceutical industry.
• Experience in ‘small molecule’ chemistry, analytics and stability.
• Project management and problem solving skills.
• Ability to foster team productivity and cohesiveness and to work collaboratively in a global matrix environment.
• Customer focus and result driven.
• Efficient, flexible and dynamic.
• Excellent communication skills.
STEP-BE
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D
Description
Clinical Release and Stability (CRS) is a department of Pharmaceutical Development and Manufacturing Sciences, specifically of the Analytical Development organization.
The CRS department is responsible for:
• Clinical release and stability testing of Drug Substance (DS) and Drug Product (DP) for small molecules and large molecules covering Phase 1 through Phase 3
• DS and DP manufacturing process and product characterization support
• The stability process for small and large molecules in R&D
As a result of implementing our operating model, through which significant parts of our activities are executed by third parties, the following strategic position is created in our Beerse, Belgium organization:
Manager Stability Outsourcing
General scope of responsibilities
• Follow-up on the stability projects of our internal and external partnerships (WuXi, Higi, US, Europe, ...).
• Strategically manage and coordinate the optimal use of the external capacity and capability in support of the clinical release and stability deliverables in the area of small molecules.
• Act as a Single Point of Contact for our external development partners.
• Define the roles and responsibilities for testing, data interpreting, trending and reporting studies, within the contractual framework.
• Ensure GMP and compliance with regulatory requirements.
• Support the CRS project owners in their relationship and communication with external parties.
• Participate in the selection and review of contract laboratories, technical follow up of the services provided, and driving improvement through key performance indicators.
• Ensure continuous improvement and lean methodologies are integrated in the processes and systems.
Qualifications
• A minimum of Master’s degree in Chemistry, Pharmaceutical Sciences, Bio-engineering or equivalent through experience.
• A minimum of 5 years’ experience within the pharmaceutical industry.
• Experience in ‘small molecule’ chemistry, analytics and stability.
• Project management and problem solving skills.
• Ability to foster team productivity and cohesiveness and to work collaboratively in a global matrix environment.
• Customer focus and result driven.
• Efficient, flexible and dynamic.
• Excellent communication skills.
STEP-BE
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D