Process Engineering design & support biologics drug manufacturing.
- Provide scientific/technical support, expertise, and guidance to commercial manufacturing at Company Manufacturing/Partner/CMO sites including process monitoring, change assessment, and continuous improvement that result in safe, high quality products and continuously improving processes.
- Provide technical leadership in process-related investigations. Anticipate, respond to, and permanently resolve issues that arise during production. Provide on-the-floor technical support if required.
- Review production data and manufacturing processes. Lead process monitoring and continued process verification activities.
- Generate conclusions based on data analysis and prepare presentations and reports to clearly communicate outcomes.
- Partner with external and internal functions to identify, prioritize, transfer, implement, validate, and file product/process life cycle improvements.
- Define relevant operational/technical standards and best practices for manufacturing sites.
- Degree(s) in Engineering, Biological Sciences or equivalent.
- BSc with 5+ industry years or Masters with 3+ industry years.
- Understand key elements of unit operations in a GMP manufacturing environment.
- Understand core concepts in biotechnology or pharmaceutical industry