Starsha Walker

• Operate and monitor equipment for bulk biopharmaceutical manufacturing processes, ensuring adherence to standard operating procedures (SOPs) and good manufacturing practices (GMP).
• Collaborate with cross-functional teams to troubleshoot process deviations, equipment issues, and quality concerns, contributing to continuous process improvement efforts.
• Maintain accurate documentation of production activities, batch records, and equipment logbooks to ensure compliance with regulatory requirements and quality standards.
• Conduct precise sampling of pharmaceutical materials and products, ensuring meticulous labeling, documentation, and storage to uphold sample integrity and regulatory compliance.

Obtained complete training on 37 process tasks related to COVID drug substance production, such as cell harvest, expansion and infection processes. Acted as a significant member of the Upstream operations team that successfully accomplished 3 PPQ batches resulting in 30 million vaccine doses worth approximately $300 million. Oversaw the operation of two autoclaves ensuring material sterilization, performing equipment and analytical checks, maintaining compliance with cGMP standards and addressing housekeeping, GDP, 5S and process safety concerns.

• Lyophilization Technician.
• Performed sampling, in-process testing, inoculation, and batching of the cell culture for the CDS2 vaccine via Unicorn Software on Wave 25 Bioreactor.
• Performed 1 cell count determination and viability and 2(p.) and chemical/metabolic concentrations via Vi-Cell blu and Nova Flex Metabolic Analyzer, machineries specifically.
• Performed and logged daily, weekly, monthly, quarterly, and biannually decontamination, as required, on PAS-X MES to maintain a steady clean state for vaccine manufacture.
• Provided timely delivery of samples and other materials to appropriate locations laboratories via GLIMS, coordinating with Quality and Logistics as required.
• Participated in 5S cell suite

• Performed packaging and shipping tasks in a cGMP environment
• Operated process equipment in accordance with protocols
• Utilized an extruder to process material for producing cell membranes for batteries
• Subject Matter Expert in unit operations, product testing and quality assurance
• Accomplished daily tasks with minimal supervision.