PD Specialist – Viral Vector Process Development
Position Purpose
The PD Specialist is responsible for the technical ownership and execution of process development and technology transfer activities within a CDMO environment. The role focuses on development, optimization and implementation of manufacturing processes, with emphasis on retroviral vector platforms (gRV, LVV) and virology-driven approaches.
The position is suitable for candidates with experience in virology, molecular biology or viral vector research (academic or industrial) who are motivated to apply their expertise in a GMP and client-driven environment.
Key Activities and Responsibilities:
- Acts as technical owner of process development, optimization and technology transfer projects
- Cooperates in viral vector process development activities, including design, optimization and scale-up of manufacturing processes
- Applies virological knowledge (e.g. retroviral biology, producer cell systems, transfection strategies) in process design, interpretation and troubleshooting
- Drives development and optimization of upstream and downstream processes, including identification and resolution of process bottlenecks
- Supports process characterization, validation activities and GMP readiness
- Cooperates on technology transfer of processes into GMP manufacturing, including scale-up and implementation
- Closely collaborates with Manufacturing, QC, QA, PD/AD, Project management office and other stakeholders to ensure alignment and smooth execution of the projects
- Supports technical discussions with clients, data interpretation and presentations
- Supports process investigations and troubleshooting related to product quality and process performance
- Participates in preparation and revision of technical documentation (e.g., SOPs, batch records, development reports)
- Contributes to quality-related processes:
- Internal and external audits
- CAPA, deviations and change control
- Supports preparation of documentation for regulatory submissions (e.g. IND/IMPD sections)
- Collaborates with Business Development and Project Management Office on technical evaluation of opportunities and proposal preparation
- Participates in client interactions and may support business travel as needed
Position Purpose
The PD Specialist is responsible for the technical ownership and execution of process development and technology transfer activities within a CDMO environment. The role focuses on development, optimization and implementation of manufacturing processes, with emphasis on retroviral vector platforms (gRV, LVV) and virology-driven approaches.
The position is suitable for candidates with experience in virology, molecular biology or viral vector research (academic or industrial) who are motivated to apply their expertise in a GMP and client-driven environment.
Key Activities and Responsibilities:
- Acts as technical owner of process development, optimization and technology transfer projects
- Cooperates in viral vector process development activities, including design, optimization and scale-up of manufacturing processes
- Applies virological knowledge (e.g. retroviral biology, producer cell systems, transfection strategies) in process design, interpretation and troubleshooting
- Drives development and optimization of upstream and downstream processes, including identification and resolution of process bottlenecks
- Supports process characterization, validation activities and GMP readiness
- Cooperates on technology transfer of processes into GMP manufacturing, including scale-up and implementation
- Closely collaborates with Manufacturing, QC, QA, PD/AD, Project management office and other stakeholders to ensure alignment and smooth execution of the projects
- Supports technical discussions with clients, data interpretation and presentations
- Supports process investigations and troubleshooting related to product quality and process performance
- Participates in preparation and revision of technical documentation (e.g., SOPs, batch records, development reports)
- Contributes to quality-related processes:
- Internal and external audits
- CAPA, deviations and change control
- Supports preparation of documentation for regulatory submissions (e.g. IND/IMPD sections)
- Collaborates with Business Development and Project Management Office on technical evaluation of opportunities and proposal preparation
- Participates in client interactions and may support business travel as needed