Main responsibilities

• Coordination and sub-project management of industrialization projects for nanobody production
• Support the validation strategy for process implementation
• Support technical SMEs during on-site batch execution (tech batches, Eng runs, PPQ)
• Creation of GMP, regulatory, process, validation documentation in consultation with the relevant experts
• Regular communication with specialist departments and operations to implement project management objectives
• Creation of project documentation (e.g. schedules)
• Operate as a generalist for MSAT drug substance or as a specialist in drug substance operations
• Support process implementation projects, trouble shootings and best-practice exchanges

About you

Experience:

• Comprehensive hands-on experience in pharmaceutical operations in industry
• Experience in production and QA or QC
• Experience in project management in GMP environment (e.g. validation / technology transfer projects)
• Proven knowledge of GMP and regulatory affairs
• Experience in microbial drug substance manufacturing is beneficial

Main responsibilities

• Coordination and sub-project management of industrialization projects for nanobody production
• Support the validation strategy for process implementation
• Support technical SMEs during on-site batch execution (tech batches, Eng runs, PPQ)
• Creation of GMP, regulatory, process, validation documentation in consultation with the relevant experts
• Regular communication with specialist departments and operations to implement project management objectives
• Creation of project documentation (e.g. schedules)
• Operate as a generalist for MSAT drug substance or as a specialist in drug substance operations
• Support process implementation projects, trouble shootings and best-practice exchanges

About you

Experience:

• Comprehensive hands-on experience in pharmaceutical operations in industry
• Experience in production and QA or QC
• Experience in project management in GMP environment (e.g. validation / technology transfer projects)
• Proven knowledge of GMP and regulatory affairs
• Experience in microbial drug substance manufacturing is beneficial