Sotheara Ith Email & Phone Number

Lake Forest, Illinois, United States

Skokie, Illinois, United States

Supports plant start-up activities such as authoring process related documents (batch records, and SOP’s) for downstream processes. Supports technology transfer of the processes from development stage to GMP scale and optimize the processesfor robustness.

Greater Chicago Area

• Authored technical documents such as historical batch report, process description, process control strategy, process failure mode and effects analysis (PFMEA), validation master plan, sampling plan, validation.
• Collaborated with CDMO to implement process changes to optimize a robust process
• Managed production activities at CDMO as needed to meet business needs
• Coordinated with CDMO for material shipments to testing labs/other CDMO
• Person-in-plant (PIP) to oversee tech transfer and PPQ batches
• Led AAV process risk assessment for DOE studies

Libertyville, Illinois, United States

• Managed a team of seven Bioprocess Engineers- Responsible for sterile filtration, sterile fill, visual inspection, labeling, and packaging- Assigned/scheduled tasks to engineers and ensured tasks are performed in a.
• Reviewed executed batch records, protocols, logbooks, etc
• Wrote/Initiated deviations, CAPAs, and change controls
• Supported Zolgensma launches for Japan, EU, Brazil, Israel, Canada, Taiwan, and Argentina
• Implemented 5S pillars into manufacturing processes for cost savings, lean process and time efficiency
• Identified as an SME for the fill-finish processes in audits for HPRA, and Ministry of Health of the Russian Federation

Libertyville, Illinois

• Executed Bosch filling machine batch reporting validation
• Executed TFF and Ultracentrifugation studies to support deviation closure
• Worked with vendors to create assemblies/manifolds to close processes
• Identified as an SME for the fill-finish processes in audits for HPRA, FDA, and PMDA
• Initiated Change Controls/CAPAs to optimize process improvements
• Optimized downstream and fill-finish sampling plans to increase 4% theoretical yield

• Authored startup batch records, SOPs, and validation protocols
• Equipment validation: SAT (Site Acceptance Test), IQ/OQ on Bosch Filler, Spectrum TFF system,Millipore TFF skid, Millipore Chromatography skid, Pall TFF Skid, Beckman Coulter Ultracentrifuge
• Perform smoke studies for Filling suite
• Successfully brought unclassified Fill suite to ISO 5/6 classification
• Tech transfer downstream process from CDMO to internal manufacturing
• Process performance qualification runs for downstream and drug product processes

Chicago, IL

• Drug Product manufacturing: buffer preparation, sterilization of sterile filling parts, sterile filtration, filling of vials and syringes, visual inspection, and packaging
• Drug Substance manufacturing: -Upstream: Cell bank, Cell Expansion (flasks to wave bag to bioreactor), Cell High Pressure Homogenizer (cell lysis), Cell Harvesting -Downstream: Clarification of harvested cells.
• Reviewed executed documents: batch records, protocols, and logbooks
• Updated batch records/SOPs, initiated deviations/CAPAs/work orders
• Led tech transfer of the fill-finish process to CMO