Sabika Rizvi

Led operational readiness and execution of large-scale capital projects for commercial manufacturing expansion, including cleanroom builds and technology transfers. Drove end-to-end readiness for new manufacturing spaces, coordinating timelines, resources, and stakeholder alignment to meet site capacity targets.

Led day-to-day CAR-T production activities for multiple manufacturing units under strict GMP regulations. Facilitated shift meetings, resolved floor-related issues, and ensured compliance across all operations. Partnered with Quality Assurance, Engineering, and Technical Teams for seamless production execution.

Directed daily production of personalized cell therapy for clinical and commercial requirements in a sterile cGMP environment. Led and supervised multiple units within CAR-T process operations, ensuring safe and compliant manufacturing according to cGMP requirements. Supported manufacturing investigations, authored/revised operational procedures, and managed change controls.

Ensured team adherence to standard operating procedures and maintained a high level of understanding of cell therapy processes, controls, and GMP requirements. Acted as a Subject Matter Expert with advanced proficiency in controlled area gowning and familiarity with cGMP/FDA regulated industry. Supported the development of manufacturing processes and drove continuous improvements and efficiencies

Trained in Cleanroom Operation, Aseptic Techniques, and handling bio-hazard materials for manufacturing tissue-based products. Followed standard operating procedures to ensure on-time production of high-quality products. Maintained strict aseptic technique within ISO Class aseptic cleanroom processing environment to prevent contamination.

Performed daily manufacturing for sterile bulk operations in a sterile pharmaceutical facility. Reconstituted bulk additives and prepared I.V. admixtures using proper aseptic procedures under the direction of a Registered Pharmacist. Operated automation robots, troubleshot equipment, and monitored employee training qualification schedules.

Consulted with insurance company representatives to complete claims processing, resolve concerns, and reconcile payments. Communicated with patients to collect information about prescriptions and medical conditions, or to arrange consultations with pharmacists. Processed incoming drug orders, entered and processed patient prescriptions, and communicated instructions about proper drug use and stora

Completed high school education, earning a diploma. Focused on general studies to build a foundational knowledge base.