Senior Director Technical Services (SM API)-00000LQ3
Description
- Senior Director Technical Services (SM API)
Qualifications
- Master degree in Pharmaceutical Sciences, Engineering sciences, biological Sciences or a related discipline is required. An advanced degree/PhD is desirable.
- A Registered Pharmacist Certifications or any other engineering certifications can be an added value.
- Minimum of 15 years of experience in following domains: Drug Product Dosage Formulation / Process, Engineering, Manufacturing and Primary Packaging for small/large molecules development, including significant experience in process development and/or in manufacturing operations is required.
- Control Strategy and QBD experience is required.
- R/D Development experience for IND, NDA, BLA etc.
- Quality Assurance and Regulatory / Compliance for new product development.
- Business Unit Management.
- Ability to support the General Manager in all technical activities including validation, troubleshooting and maintaining technical expertise.
- Able to manage a various slate of activities.
- Ability to assess with independent view development strategy, process and execution, process robustness and ultimate fit to plant. Capable of providing actionable feedback to R/D development in timely and appropriate manner. Work well in R/D development teams including interaction with TLI and other senior R/D management, Capable to translate requirements to production floor for implementation and execution of Quality by Design and operational control strategies.
Travel / Location:
- Location: Belgium
- This position requires global travel of 25-40%, based on role and specific business goals
- Virtual Network interactions, utilizing available infrastructure to communicate with Key Partners and Stakeholders.
CBLD-BE
Primary Location:Europe/Middle East/Africa-Belgium
Organization: Janssen Pharmaceutica N.V. (7555)
Travel:Yes, 25 % of the Time
Job Function: Operations (Generalist)
Description
- Senior Director Technical Services (SM API)
Qualifications
- Master degree in Pharmaceutical Sciences, Engineering sciences, biological Sciences or a related discipline is required. An advanced degree/PhD is desirable.
- A Registered Pharmacist Certifications or any other engineering certifications can be an added value.
- Minimum of 15 years of experience in following domains: Drug Product Dosage Formulation / Process, Engineering, Manufacturing and Primary Packaging for small/large molecules development, including significant experience in process development and/or in manufacturing operations is required.
- Control Strategy and QBD experience is required.
- R/D Development experience for IND, NDA, BLA etc.
- Quality Assurance and Regulatory / Compliance for new product development.
- Business Unit Management.
- Ability to support the General Manager in all technical activities including validation, troubleshooting and maintaining technical expertise.
- Able to manage a various slate of activities.
- Ability to assess with independent view development strategy, process and execution, process robustness and ultimate fit to plant. Capable of providing actionable feedback to R/D development in timely and appropriate manner. Work well in R/D development teams including interaction with TLI and other senior R/D management, Capable to translate requirements to production floor for implementation and execution of Quality by Design and operational control strategies.
Travel / Location:
- Location: Belgium
- This position requires global travel of 25-40%, based on role and specific business goals
- Virtual Network interactions, utilizing available infrastructure to communicate with Key Partners and Stakeholders.
CBLD-BE
Primary Location:Europe/Middle East/Africa-Belgium
Organization: Janssen Pharmaceutica N.V. (7555)
Travel:Yes, 25 % of the Time
Job Function: Operations (Generalist)