MAHESH UKADE
Nashik
Summary
Dynamic scientist with over seven years of experience in cell-based assay development, biologics potency testing, and mammalian cell culture within GMP/GLP environments. Expertise in ADCC, CDC, immune functional assays, and cancer vaccine/immunotherapy programs has driven innovative advancements in the field. Proficient in process scale-up, technology transfer, and regulatory compliance while adept at troubleshooting complex issues and fostering team training. A strong advocate for cross-functional collaboration that enhances overall project outcomes and efficiency in biologics development initiatives.
Overview
8
8
years of professional experience
Work History
Scientist
Datar Cancer Genetic
01.2018 - Current
- Developed and maintained experimental protocols, SOPs, and technical documentation in compliance with GMP and regulatory standards.
- Maintained and optimized 15+ mammalian cell lines (adherent and suspension) as preclinical models for immunotherapy, biologics, and oncology drug discovery.
- Applied G-Rex 100M bioreactors and executed upstream mammalian cell culture processes (T-flasks, multilayer cell factories, suspension cultures) in cGMP cleanrooms, enabling reproducible high-density expansion for vaccine and biologics development.
- Developed, characterized, and scaled mammalian cell cultures from bench research to preclinical levels, ensuring reproducibility and compliance with regulatory guidelines.
- Performed validated potency assays for biologics (mAbs, vaccines), including antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and viability-based functional assays.
- Led immune functional assays by stimulating autologous PBMCs (T cells, NK cells) with tumor antigens and vaccine candidates to evaluate immune cytotoxicity, advancing personalized T-cell therapy research.
- Specialized in developing and validating in vitro cell-based assay protocols for biosimilars, cancer vaccine QC, and immunotherapy programs.
- Supported process scale-up and technology transfer by optimizing culture conditions for biologics production and cancer vaccine development.
- Trained and supervised junior scientists in aseptic techniques, assay execution, troubleshooting, and GMP documentation, improving team capability and compliance.
- Contributed to translational workflows by integrating potency assay data, immune functional results, and process optimization outcomes into regulatory packages and clinical readiness documentation.
- Reviewed and prepared Batch Manufacturing Records (BMRs) and associated documentation to ensure compliance with cGMP.
- Implemented and supported CAPA processes to address deviations and strengthen quality systems.
- Actively participated in change control management for process improvements, assay modifications, and protocol updates.
- Developed, revised, and trained team members on SOPs covering cell culture, assay execution, documentation, and GMP processes.
- Identified root causes, performed advanced troubleshooting, and implemented solutions to resolve critical assay and instrumentation challenges, improving reliability and throughput.
- Performed isolation of DNA/RNA and subcellular organelles, supporting molecular characterization and downstream analytical workflows.
- Conducted ELISA (IL-2, TNF-α).
- Executed microbial cell culture and handling techniques, applying aseptic practices for experimental reliability.
- Applied sterilization techniques to maintain contamination-free environments for mammalian and microbial cultures.
Education
M.Sc. - Biotechnology
K.T.H.M. College, Pune University
Nasik05.2018
B.Sc. - Biotechnology
K.T.H.M. College, Pune University
Nasik05.2016
Skills
- Laboratory Techniques:
- Mammalian cell culture (adherent & suspension)
- Cell line development & maintenance
- Cell-based assay development
- In vitro potency assays (ADCC, CDC, ELISA, cytotoxicity, viability)
- PBMC/T-cell/NK functional assays
- Upstream processing & scale-up
- Molecular biology: DNA/RNA/organelle isolation
- Biochemical & molecular assays
- Microbial culture & sterilization
- Equipment & Technology:
- Bioreactors: G-Rex
- Cell culture vessels: T-flasks, multilayer cell factories
- Instrumentation: Incucyte S3, EVOS M7000, Nanolive 3D Cell Explorer, Varioskan Lux, microplate readers, flow cytometers, PCR, CellInsight, ImageJ
- Regulatory & Quality:
- GMP & regulatory compliance (SOPs, BMR, CAPA, Change Control)
- Documentation & QA
- LIMS
- Data & Software:
- Data tools: Python, Excel, Word, PowerPoint
- Experimental design
Accomplishments
- Publication:
- Abstract PS4-36: Non-invasive evaluation of chemoresistance in breast cancers using circulating tumor associated cells February 2021.
- DOI: 10.1158/1538-7445.SABCS20-PS4-36.
- Project:
- Eco-friendly chitosan: An efficient material for effluent and water treatment.
- Technology Upskilling:
- Gained hands-on proficiency in Python for data analysis, AI/ML applications in automation of cell-based assay workflows, and integrating computational approaches with experimental oncology research.
Timeline
Scientist
Datar Cancer Genetic
01.2018 - Current
M.Sc. - Biotechnology
K.T.H.M. College, Pune University
B.Sc. - Biotechnology
K.T.H.M. College, Pune University