Experienced Manufacturing Associate with a background in GMP-regulated environments, contributing to technology transfer, scale-up processes, and continuous improvement initiatives. Proficient in supporting CAPA and deviation work to ensure compliance and enhance operational efficiency. Currently pursuing a degree in Mechanical Engineering and holding certifications in Project Management, AI Development, and Data Analytics. Skilled in training and mentoring team members, fostering operational excellence and organizational growth. Dedicated to improving processes, contributing to team success, and continuously learning within organizations that value quality, collaboration, and
innovation.
• Directed precision-focused Activation, and Cryopreservation operations,
consistently enhancing operational efficiency and process output.
• Led aseptic processing in ISO 5 Biosafety Cabinets, advanced cell expansion using
Xuri Bioreactors, and cell washing with Sepax C-Pro equipment, ensuring scalability
and consistency.
• Performed accurate and reliable cell viability assessments with the Cellometer,
supporting robust quality control measures.
• Strictly adhered to Cleanroom protocols, maintaining compliance with company
benchmarks and regulatory requirements.
• Managed manufacturing operations in full alignment with cGMP and FDA
regulations, prioritizing safety, quality and consistency.
• Analyzed and resolved deviations through Infinity, ensuring CAPA implementation
and compliance with internal and external standards.
• Utilized key software platforms, including Infinity, MES, EMES, CeLabs, Oracle,
Veeva, and BMRAM, to optimize data integrity and streamline operations.
• Provided mentorship and assisting in training to new team members, fostering operations
excellence and supporting technology transfer initiatives.
• Ensure aseptic conditions, cleanroom integrity, and compliance with regulatory
standards