Anne Thomas

• Upstream technical lead
• Collaborated on DoE designs and experimental protocols for CPD and robustness studies for a perfusion process
• Managed GMP readiness at CMO for both fed-batch and perfusion processes
• Performed Person-in-Plant activities
• Led upstream subteam meetings
• Authored IND sections and supported regulatory submissions
• Monitored process performance and provided updates to internal and external teams
• Performed small scale cell culture assessments.

• Responsible for upstream process transfer to new CMO
• Responsible for coordinating and guiding small-scale model qualification and process characterization studies at CMO
• Responsible for expediated timelines to ensure PPQ readiness.

• Upstream technical lead
• Harvest development lead for process at CMO
• Authored and managed process transfer documents
• Collaborated with CMO on protocols and procedures for process characterization studies
• Managed and approved MBRs and PCS to ensure campaign readiness
• Monitored process performance and provided updates to internal teams
• Authored IND sections

• Led upstream process transfer for large scale cGMP manufacturing
• Generated and managed process transfer documents and batch records for process execution
• Key coordinator between client, process development, supply chain, manufacturing, and Quality Assurance
• Monitored process performance and generated campaign summaries
• Supported non-conformance (NC) closures.

Developed primary recovery and filtration processes

• Developed large scale centrifugation, acid precipitation, flocculation and extended microfiltration recovery processes
• Developed corresponding recovery clarification trains
• Developed cell culture media filtration trains
• Issued development reports

Performed upstream and recovery process transfers to clinical facilities

• Performed experiments for non-conformances and issued technical reports
• Issued campaign summaries.

• Assisted customer process transfers to cGMP manufacturing
• Supported manufacturing operations for airlift and perfusion cell culture processes
• Supported harvest recovery processes
• Identified and qualified critical raw materials
• Issued technical reports for both internal and external customers.