SRI KIRANMAI NANDURU

Accomplished laboratory operations manager and quality management representative with 9+ years of progressive experience in biotechnology, specializing in immunohistochemistry, FISH, and regulatory compliance. Expert in leading cross-functional teams, implementing quality management systems (ISO 13485:2016), and driving operational excellence. Successfully managed multiple regulatory audits and developed 400+ products. Skilled in software workflow design and digital transformation of laboratory operations in a startup environment.

• MDSAP – Medical Device Single Audit Program
• ISO 13485:2016 – Quality Management System
• ISO 14971:2019 – Application of Risk Management to Medical Devices

• Received "Pinnacle Performer" award from PathnSitu Biotechnologies for exceptional work performance
• Achieved "On Time Every Time" award for consistent punctuality
• Received appreciation from auditors and management for effective complaint handling and problem-solving skills
• Established product shelf-life studies department, completing initiative within 18 months
• Secured 1st place in M.Tech at School of Biotechnology, JNT University
• Achieved 74th rank in PGECET - 2013
• Won 1st place at national-level paper presentation on GMO crops (GITS2k11)
• 1st rank holder in M.Tech (Biotechnology), JNTU Kakinada (08/2015)
• National paper presentation winner (GMO crops) and 74th rank in PGECET 2013.

• "Evaluation of programmed cell death ligand 1 expression in a contemporary cohort of penile squamous cell carcinoma and its correlation with clinicopathologic and survival parameters" - American Society for Clinical Pathology
• "Transducing-like enhancer of split (TLE-1): Promiscuous Staining Patterns in Soft Tissue and Other Neoplasms" - USCAP, 2017 (Poster Presentation)

• Poster presenter, USCAP 2017 (TLE-1 in soft tissue tumors)
• Presenter, World Congress on Biotechnology, 2011
• Contributor at national-level events on histology, bioinformatics, and biochemical engineering
• Participated in R-based data analysis and cybercrime workshops
• 45-day internship, KCP Sugar & Industries Corporation Ltd (Distillery Unit), Andhra Pradesh, 2012
• Visited BIOCON, Indo-American Hybrid Seeds, and CFTRI for industrial exposure, 2011
• Delivered over 10 technical presentations at CME and medical gatherings on immunohistochemistry and FISH techniques

• Project on gene validation in mycotoxin synthesis, University of Hyderabad, 2014-15
• Techno-economic feasibility study on PHA copolymer, GITAM University, 2012-13

Professional Projects

• Led software team in "Business software development" within the organization
• Documented 400+ products (reagents and instruments) in licensing processes
• Coordinated and participated in workshops conducted by the organization
• Contributed to development of organizational software applications
• Established dedicated department for product shelf-life studies, completing initiative within 18 months
• Successfully managed multiple audits including ISO 13485 and CDSCO Medical device audits

Research Projects

• "Detection and validation of highly conserved pathogen-specific genes with a putative role in mycotoxin synthesis using genome-wide in-silico approach" - University of Hyderabad (2014-2015)
• "Techno-economic feasibility studies for the large-scale production of PHA copolymer from marine vibrio sp by using palm oil under aerobic-anaerobic fermentation process" - GITAM University (2012-2013)

Industrial Experience

• 45-day Industrial Training on "Production of alcohol (distillery unit)" - KCP Sugar and Industries Corporation Ltd (2012)
• Industry visits to BIOCON, INDO-AMERICAN HYBRID SEEDS, and CFTRI (2011)