Job Description
- Responsible for upstream manufacturing process support, data acquisition, and trending.
- To manage statistical analysis of manufacturing batches data using statistical software like Minitab, etc.
- Lead the upstream team in troubleshooting and process related deviation investigations activities to identify the root cause followed by providing an effective CAPA.
- Plan, evaluate and manage the technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing).
- To collaborate and communicate regularly with R&D teams in execution of experimental runs and any other scale down experiments to support manufacturing process changes/improvements.
- Planning and successful implementation of process changes in upstream manufacturing processes with relevant CFT consensus.
- Responsible for risk assessment, validation protocols, validation reports and facility fit assessment applicable for upstream processes.
- Review of technical documents i.e. manufacturing batch records, SOPs, study protocols, study reports and cleaning validation documents etc.
- Coach, mentor and train upstream team members in skill development.
Work Experience
8 - 15 years
Education
Masters in Biotechnology or Pharmaceutical Technology
Doctorate in Biotechnology or Pharmaceutical Technology
Competencies 
