Dedicated professional with extensive experience in CAR-T Cell Therapy, particularly within controlled environments that demand precision and adherence to strict regulatory standards. My expertise spans across key areas such as cleanroom practices, cleanroom behaviors, environmental monitoring, aseptic technique, troubleshooting existing issues, preventive routine inspections, responding to emergencies and cGMP, ensuring the highest level of quality and compliance in every aspect of the production process. Possessing a strong track record of effectively managing multiple priorities and maintaining a positive attitude, I consistently demonstrate organization and reliability. I am proactive in assuming additional responsibilities to ensure team goals are achieved.
Manufacture human blood derived components per Standard Operating Procedures in controlled, cGMP cleanroom environments through the execution of cell culture, harvest, and cryopreservation. Achieve full training and qualification in all aspects of assigned processes, developing a comprehensive technical understanding of project-specific procedures and requirements. Engage in continuous learning to deepen technical knowledge and enhance process efficiency. Accurately weigh and measure in-process materials, ensuring proper quantities are added or removed during production stages to maintain consistency and quality. Maintain strict adherence to production schedules, optimizing internal production logistics for timely and efficient manufacturing. Record production data and information in a clear, concise format, adhering to Good Documentation Practices (GDPs) to ensure compliance and traceability. Work collaboratively in a team-based, cross-functional environment to complete production tasks as required by the schedule. Actively participate as a motivated and team-conscious individual, contributing to a positive work environment and achieving collective goals.
Performed tube/frame assembly, filling, labeling and pouching operations consistent with Roche quality standards. Followed all department work instructions, SOPs, OSHA safety regulations. Executed all manufacturing activities in accordance with cGMP/cGDP/cGLP guidelines. Executed SAP and electronic batch record transactions to ensure all components meet requirements pertaining to lot numbers, expiration dates, intermediates, reconciliations. Monitored laboratory supply inventory, replenishes lab supplies as needed.
Delivered and developed lesson plans by using broad range of teaching techniques and strategies. Evaluated student progress using standardized tests, quizzes, and oral assessments to modify teaching strategies as needed. Improved learning outcomes with implementation of differentiated instruction strategies tailored to individual student needs.
Distinguished Performance Award in TESOL, Long Island University, New York 2015.
Certificate of Appreciation, Secretary of Education, Turkey 2007
Medine Sahin, Manager, MSS Cryo Value Stream Operations, Bristol Myers Squibb, Summit, NJ 07901
(862)296-7057
More references available upon request.