Experience

Venture Center (Official Account)

• India
• Venture Capital and Private Equity Principals
• 1 - 100 Employee

• Associate Manager

  • Dec 2021 - Present

  Bioassay team management to perform GLP studies at Center for biopharma analysis (CBA), Venture center. Training on OECD guidelines to carry out GLP studies with role of Study director. Prepare, review different study protocols, study reports, methods, SOPs, investigation related to change controls/deviations/LIRs and other related documents. Establish proof of concept/bioassay test procedure to carry out cell based assays/ELISAs for TNF alpha, CD-20 and HER2 target. (batch release, ADCC, CDC assays and ELISA's) Procurement of all the necessary reagents/kits to perform the assay along with cell culture related plasticware. Develop, qualify and validate bioassay methods suitable for characterization, release testing, and stability testing of Biopharmaceuticals Implement and support Quality Systems, ensure department compliance with GLP standards Purchase PLA software for statistical analysis and carryout qualification as IQ OQ and PQ. Follow up with yearly time table of instruments/equipment's calibration in co-ordination with engineering department/suitable vendors Show less



Enzene Biosciences Ltd

• India
• Biotechnology
• 400 - 500 Employee

• Assistant Manager

  • Jul 2021 - Nov 2021

  Team management to performed regular bio-similarity analysis of stability samples and performed batch release using cell-based assay and determine potency by parallel line analysis software (PLA3.0). Perform Method validation as per ICH guidelines and prepare reports such method validation reports (MVRs) and relevant SOPs, STPs and data record sheet. Implement and support Quality Systems, ensure department compliance with GMP standards.Prepared investigation reports for QMS (change control/deviations/lab incidence) activity. Prepare and review of Standard operating procedures for different products.Assay details:• cAMP release assay by Promega- cAMP GLO max kit.• Cell viability assay with CTG and Alamar blue dyes.•Cell dependent cytotoxicity (CDC) assays.• Invivogen cell based reporter assays Show less

• Senior Executive

  • Sep 2020 - Jul 2021

  Work profile is similar to that as Assistant Manager



Sai Life Sciences Ltd

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Research Associate

  • Jun 2019 - Sep 2020

  Perform 384 well plate based assay for NCEs characterizations Performed Ca flux assays using FLIPR Ca assays kits of Molecular devices using FLIPR Penta High-Throughput Cellular Screening System Performed HTRF assays to screen set of inhibitors for molecular characterization Basic taring and understanding of ECO 650 Acoustic Liquid Handlers Hands on expertise on lab automation and medium throughput based assays Perform 384 well plate based assay for NCEs characterizations Performed Ca flux assays using FLIPR Ca assays kits of Molecular devices using FLIPR Penta High-Throughput Cellular Screening System Performed HTRF assays to screen set of inhibitors for molecular characterization Basic taring and understanding of ECO 650 Acoustic Liquid Handlers Hands on expertise on lab automation and medium throughput based assays



Enzene Biosciences Ltd

• India
• Biotechnology
• 400 - 500 Employee

• Senior Executive

  • Apr 2018 - Jun 2019

  Developed and worked on 96 well plate: cell based assays to screen mAbs for bio-similarity analysis: 1. VEGF dependent proliferation assays, 2. TNF alpha neutralization assays, 3. cAMP accumulations assay glo-max assays-HTRF assays, 4. cGMP accumulation HTRF assays, 5. ADCC assays Worked on 4PL statistical models to generate analysis template for different methods in PLA software. Initiated Gen5 based statistical analysis for % relative potency calculation as an alternative approach to PLA analysis. Prepare MOA: Method of Analysis document, MQP/MQR: Method qualification protocol and report, Prepare method transfer document and BOM Show less



Lupin Limited. (Research Park),Pune

• India
• Biotechnology
• 100 - 200 Employee

• Research Associate

  • Dec 2015 - Apr 2018

  Work summary: • Developed and worked on FLIPER membrane potential assays for NCEs screening. • Developed stable cell lines clones expressing the target gene and performed assays in order to assess their functional response. • Worked at QC analytical lab as a qualified analyst for RP-HPLC, SEC-HPLC. • Optimized conditions for purification of active proteins for in vitro screening of assays. • Regular screening of NCEs and generation of DRC (Dose Response Curves) reports. • Routine testing of cell lines and stable clones for Mycoplasma contamination. • Performed need-based gene expression studies for biomarker analysis and clone characterization. Assay details: • FLIPER membrane potential assays by molecular devices kit. • His Protein purification by Ni-NTA and Ni TED resins. • Electroporation method for stable clone generation: Nucleofector 2b Device from Lonza. • RNA extraction cDNA synthesis for clone screening: Qiagen kits. • Mycoplasma testing by using MycoAlert™ Mycoplasma Detection Kit. • Gene expression studies were performed using Real-time PCR detection system from Bio-rad CFX96 touch Show less



Sai Life Sciences Ltd

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Research Assistant

  • Mar 2013 - Nov 2015

  Work summary: • Systematically optimized, validated and troubleshot biochemical and cell-based assays. • Worked on multiple projects for regular screening of NCEs. • Prepared accurate experimental records, followed by review and submission in accordance with the client deadlines. • Maintained good inter and intragroup coordination for integrated drug discovery projects. Assay details: • cAMP release assays by CISBIO kit. • Fluorescence polarization-based biochemical assay. • Ca2+ release assay by using molecular devices kit on Flex station. • SPA bead-based assay. Show less



National Centre For Cell Science

• Pune Area, India

• Project position - Junior Reseach Fellow

  • May 2011 - Feb 2013

  Title of the project: “Prognostic evaluation of the E-box binding transcription factors snail and slug in ovarian, breast, prostate and head and neck cancers” The study was focused on the key mechanistic process of cellular transformation viz. Epithelial to Mesenchymal transition (EMT). We carried out interdisciplinary research to derive molecular signature based on gene expression data and their further validation in cell line and animal models to identify EMT dependent and independent mechanism of metastases. Work summary: • Established matrigel based 3D-cell culture models for cell lines. • Optimization of immuno-fluorescence staining protocol for 2D and 3D cultures (Spheroids). • Develop expertise in the field of cell and molecular biology. • Carry out interdisciplinary research, work on gene expression data for functional annotation of genes and pathway analysis. • Perform cell cycle analysis, DNA damage and apoptosis profiling by FACS. • Develop good communication and data analysis skills. Show less



National Chemical Laboratories

• United States
• Chemical Manufacturing
• 1 - 100 Employee

• Junior Research Fellow

  • May 2010 - Apr 2011

  Title of the project: “Transglycation: a potential new mechanism for deglycation” Project work involved standardization of in vitro non-enzymatic glycation reaction for proteins viz. Insulin and BSA. Characterization of reaction products by fluorescence measurement, HPLC, LC-MS and MALDI TOF. Further testing of small molecules for their ability to carry out the process of transglycation. Name of the project investigator: Dr M. J. Kulkarni Title of the project: “Transglycation: a potential new mechanism for deglycation” Project work involved standardization of in vitro non-enzymatic glycation reaction for proteins viz. Insulin and BSA. Characterization of reaction products by fluorescence measurement, HPLC, LC-MS and MALDI TOF. Further testing of small molecules for their ability to carry out the process of transglycation. Name of the project investigator: Dr M. J. Kulkarni