Manager-MSAT

As a Manufacturing Process Support Lead, you will be responsible for various tasks including but not limited to: - Leading the upstream manufacturing process support, data acquisition, and trending. - Managing statistical analysis of manufacturing batches data using statistical software like Minitab, etc. - Leading the upstream team in troubleshooting and process related deviation investigations activities to identify the root cause followed by providing an effective CAPA. - Planning, evaluating and managing the technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing). - Collaborating and communicating regularly with R&D teams in execution of experimental runs and any other scale down experiments to support manufacturing process changes/improvements. - Planning and successfully implementing process changes in upstream manufacturing processes with relevant CFT consensus. - Conducting risk assessment, validation protocols, validation reports and facility fit assessment applicable for upstream processes. - Reviewing technical documents i.e. manufacturing batch records, SOPs, study protocols, study reports and cleaning validation documents etc. - Coaching, mentoring and training upstream team members in skill development. **Qualifications required:** - Masters in Biotechnology or Pharmaceutical Technology - Doctorate in Biotechnology or Pharmaceutical Technology If there are any additional details about the company in the job description, please provide them for a comprehensive understanding of the role. As a Manufacturing Process Support Lead, you will be responsible for various tasks including but not limited to: - Leading the upstream manufacturing process support, data acquisition, and trending. - Managing statistical analysis of manufacturing batches data using statistical software like Minitab, etc. - Leading the upstream team in troubleshooting and process related deviation investigations activities to identify the root cause followed by providing an effective CAPA. - Planning, evaluating and managing the technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing). - Collaborating and communicating regularly with R&D teams in execution of experimental runs and any other scale down experiments to support manufacturing process changes/improvements. - Planning and successfully implementing process changes in upstream manufacturing processes with relevant CFT consensus. - Conducting risk assessment, validation protocols, validation reports and facility fit assessment applicable for upstream processes. - Reviewing technical documents i.e. manufacturing batch records, SOPs, study protocols, study reports and cleaning validation documents etc. - Coaching, mentoring and training upstream team members in skill development. **Qualifications required:** - Masters in Biotechnology or Pharmaceutical Technology - Doctorate in Biotechnology or Pharmaceutical Technology If there are any additional details about the company in the job description, please provide them for a comprehensive understanding of the role.