Annapurna Akella

Qc Associate Scientist @Novartis

Morris Plains, NJ, US

As a Quality Control Associate Scientist, I take part in the production and release of Cell and Gene Therapy (CGT) products, especially Chimeric Antigen Receptor T-Cell (CAR-T) therapies, the latter being one of the most promising and oncological treatment and regenerative medicine applications. My duties include a variety of analytical and bioassay testing to monitor the quality, safety, and consistency of the product throughout its manufacturing cycle. My daily work includes PCR, Endotoxin, and Sterility testing, Flow Cytometry, interpretations, and reporting, which are all done under GMP and regulatory standards. These are all very important techniques for checking the performance, quality, and microbiological safety of the product. Working very closely with cross-functional teams like manufacturing, quality assurance, and analytical development, I help in conducting the in-process, release, and stability testing for both clinical and commercial batches. I make sure that our work is aligned with the corporate and regulatory requirements through active involvement in method qualification, validation activities, data trending, deviation investigations, and CAPA implementation.Moreover, I am involved in assuring strong documentation practices, analyzing data, and offering help to the QC laboratory\'s continuous improvement initiatives to increase both operational efficiency and data integrity. Besides, I took part in the internal and external audits, where I provided necessary documentation, answered the auditor\'s queries, and made sure that the quality and regulatory compliance standards were followed. This experience has given me a thorough understanding of cellular therapy workflows, aseptic techniques, and the strict analytical controls that are needed for the successful release of life-saving biological products.

Vishnu Institute of Pharmaceutical Education and Research

Bachelor of Pharmacy - BPharm

Northeastern University

Master of Science - MS