Saibal Chanda

• Developed Azapeptide-based Ubiquitin Probes for Cysteine Enzymes involved in Ubiquitin and Ubiquitin-like Proteins Signal Pathway.
• Developed Fluorogenic Substrates for assessing activities of Deubiquitinases and Ub-like Protein specific Proteases.
• Drug Discovery for E1, E2, E3 and Deubiquitinases and role of the Ubiquitin System in health and diseases.
• Development of Peptide-based Inhibitors for HIV.

Trastuzumab Emtansine, Etanercept, Pembrolizumab, Tocilizumab, Ipilimumab, Plasmodium vivax duffy binding protein, and Follicle Stimulating Hormone.

• Performed Physico-Chemical Characterization and Quality Control of therapeutic mAbs and proteins across Drug Substance (DS), Drug Product (DP), and Fill-Finished Product (FP) stages.
• Performed Analytical Method Validation and executed Technology Transfers to ensure compliance. Review of Analytical Data, Preparation and Review of Method Validation, Tech-transfer Protocol & Report.
• Executed Comprehensive Characterization Studies to evaluate the Purity and Stability (Real-time, Accelerated/Stress condition) of therapeutic mAbs.
• Implementation of QMS: Fish-bone tool, 5-Whys, Preparation and Review of Laboratory Incidents, Deviation reports, Out-of-Specification (OOS), Out of Trend (OOT), Change Control, CAPA
• Drafted and reviewed Standard Operating Procedures (SOPs) and Standard Testing Procedures (STPs) for laboratory operations.
• Trained new personnel in Laboratory Procedures, Safety Protocols, Instrument Operation, and relevant Software Applications under cGMP regulations.

Rituximab, Bevacizumab, Trastuzumab, Adalimumab, Filgrastim, PegFilgrastim, Darbepoetin-alpha

• Collaborated with management on developing strategic plans for achieving business goals.
• Executed cGMP Biochemical and Chromatographic Characterizations of Biotherapeutics across Drug Substances (DS), Drug Products (DP) stages.
• Performed Technology Transfer and Analytical Method Validation.
• Performed Physico-Chemical Characterizations of therapeutics during Clinical Trials and Product Launch Campaigns.
• Real-time and Accelerated Stability Studies and Characterization of mAbs at DS, DP, and FP Stages.
• Implementation of QMS Compliance, Regulatory Affairs, and Audit Support