Naganath Swami Mandi

Dynamic individual with hands-on experience in cell line development and process development and talent for navigating challenges. Brings strong problem-solving skills and proactive approach to new tasks. Known for adaptability, creativity, and results-oriented mindset.

Committed to making meaningful contributions and advancing organizational goals. Developed cell lines for four biosimilar mAbs with productivity in the range of 2 - 3.5 g/L. Scaled-up at 2 L and 5 L scales and process optimization for bioreactor studies to achieve the high cell count and high productivity.

Successful expression of Fab molecule in periplasmic space in E. Coli and considered for product development. Several research papers published in peer-reviewed journals (National and International).

GM – BIOTECHNOLOGY at Jodas Expoim Pvt. Ltd. (2025-06 – 2025-09)

• Responsible for operations of upstream (including cell line development) and downstream activities
• Supervising purchase and manpower management

GM, HEAD - PROCESS DEVELOPMENT at Veeda Clinical Research Ltd. (2023-09 – 2025-01)

• Responsible for driving the process business including cell line development, upstream process and downstream process development
• Designed ISO Class 7 clean room for mammalian work
• Website content creation
• Meeting clients, presentation and proposal preparation

DGM, HEAD - BIOANALYTICAL SERVICES DEPARTMENT at Bioneeds India Private Ltd. (2021-04 – 2023-08)

GLP compliance facility to conduct regulatory submission studies.

• Clients/Sponsors communication for proposals, scientific discussions and update on the progress of the projects
• Team management and assigning teams to the studies
• Training teams with respective SOPs
• SOP drafting, reviewing and training for the team
• Study Director for immunogenicity assays; ADA assays; NAb assays
• Working on regulatory compliances of facilities and studies
• Active role in DGCI approval for clinical sample analysis

DGM, HEAD - PRODUCT DEVELOPMENT at Amthera Life Sciences Pvt. Ltd. (2018-07 – 2021-03)

• Cell line development for biosimilar manufacturing in CHO cell line [dhfr system]
• Successfully developed recombinant CHO cell lines for four mAbs and tested their suitability at 2 L scale in bioreactors
• Developed the recombinant cell line for human blood coagulation factor VIII for a BIRAC funded project
• Successfully set up and run 2 L & 5 L bioreactors
• Potency testing of the biosimilar products by ligand binding assays along with Reference drug product
• Cell line characterization for stability, gene expression and gene copy numbers
• Preparation of documents and filing of applications for obtaining necessary approvals from Govt. agencies [RCGM]

AGM & HEAD, CELL LINE DEVELOPMENT/UPSTREAM DEPARTMENT at Bioneeds India Pvt. Ltd. (2016-01 – 2018-06)

• Cell line development for biosimilar manufacturing in CHO system using a CQA based approach
• Establishment of facility biopharma [biosimilars] product development
• Study on the products, products identification, sequences identification and verification, Study design for cell line development and upstream process development
• Capex preparation; instrument evaluation; team management

RESEARCH SCIENTIST & SR. RESEARCH SCIENTIST at Lupin Limited (2007-05 – 2015-12)

• Cloning and expression of biomolecules of therapeutic importance in mammalian, E. coli and P. pastoris
• Recombinant cell line development for mAb production in CHO cells
• Cell lines for recombinant human Reteplase and human Enterokinase molecules in P. pastoris
• Identified a novel molecule lethal to E. coli and antidote for it and working towards the development of antibiotic free vector for the cloning and expression of biotherapeutics
• Construction of vector for hyper expression of recombinant molecules
• Identified a tag for E. coli system for imparting solubility to biotherapeutics
• Preparation of documents and filing of applications for obtaining necessary approvals from Govt. agencies

SR. SCIENTIFIC OFFICER at Panacea Biotec Limited (2005-12 – 2007-04)

• Responsible for protocol development for validation of methods, development of recombinant vaccines for Varicella virus
• Cloned and expressed vaccine candidate from Varicella virus genomic DNA in E Coli and carried-out its partial purification for the development recombinant vaccine
• Maintained cell line and virus cultivation for the above gene amplification
• SDS-PAGE and Western blot protocols development for characterization of recombinant biomolecules

SENIOR RESEARCH ASSOCIATE at Bhopal Memorial Hospital and Research Center (2004-02 – 2005-11)

• Responsible for establishment of molecular biology, cell culture and radioactive laboratories
• Genomic DNA isolation from cancer cells and performing inter-SSR PCR

Ph.D. in Cloning, sequencing, and expression of selected region(s) of BVDV virus genome and Mucosal disease susceptibility – Indian Veterinary Research Institute (IVRI) (2004-01)

M.V.Sc. in Biochemical characterization of gelatin-binding fragment of bovine plasma Fibronectin – Indian Veterinary Research Institute (IVRI) (2000-01)

B.V.Sc. & AH – Veterinary College, Bidar (1998-01)