MSAT Process Specialist
Core
Execute and oversee process validation activities in downstream unit operations to support the transfer, scale-up, and continuous improvement of biopharmaceutical manufacturing processes.
Role type
MSAT Process Specialist (Downstream Manufacturing)
Builds
Biopharmaceutical medicines
Domain
Biopharmaceutical manufacturing / Downstream processing
Required skills
Downstream (purification) process expertise, Process scale-up, Technology transfer, Process validation, Root cause analysis, CAPA implementation, Process documentation (SOPs, protocols), Data analysis, Statistical tools, cGMP regulations knowledge
Preferred skills
Chemical Engineering or Biotechnology background, Cross-functional collaboration, Regulatory submission support
Technologies
Statistical tools, Data analysis software
Responsibilities
Execute and oversee process validation activities in downstream unit operations, Support the transfer of new manufacturing processes from R&D to manufacturing, Support root cause analysis for process deviations and implement CAPAs, Develop and revise process documentation including SOPs and validation reports, Provide technical support for troubleshooting and continuous process improvement, Collaborate with cross-functional teams including Manufacturing, Quality, Engineering, and R&D, Conduct data analysis and trending to monitor process performance
