Experience

Incepta Pharmaceuticals Ltd.

• Bangladesh
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Officer, Bio-analytical Section (Bioassay Team Leader), R&D Analytical, Biotech Plant

  • Jan 2023 - Present

  • Animal (Mice, Rat etc.), mammalian cell, ELISA and SPR based bioassay method development, troubleshooting, standardization, validation and transfer to QC of biotech products (Adalimumab, Rituximab, Trastuzumab, Bevacizumab, Ranibizumab, Denosumab, Etanercept, Interferon Alfa, FSH, Ulinastatin, Filgrastim, Pegfilgrastim, Erythropoietin, Pegylated Erythropoietin, Derbepoetin etc).• Bioanalytical method (qRT-PCR based Residual Host Cell DNA quantitation, Host Cell Protein (HCP) immunoassay (ELISA), Residual protein A, SDS PAGE, Western blot, Identification and Purity/Impurity Analysis based on HPLC and Capillary Electrophoresis etc) development, validation and transfer to QC.• Culture, characterization, banking (MCB & WCB) and management of cell lines related to bioassay (M-NFS-60, L929, Raji, HUV-EC-C, Primary HUVEC, BT474, RAW 264.7, UT-7, WEHI-13VAR, Vero, MDBK, WIL2-S, WISH, 3G6 etc).• Problem solving and review bioassay analysis/reports/note books/documents.• In process, finished and stability products analysis support (CE, HPLC, SDS-PAGE, Western Blot and UV based).• Preparation of common analytical documents (SOP/STP/SCA/Plan/Method Validation Protocol and Reports /Method Transfer Protocol and Reports).• Preparing and managing area specific SOPs & equipment SOPs, CER, URS, new cGMP documents as per requirement, periodic revision and get approval from corresponding department.• Handling Change Control, Document Change Control, OOS, Deviations, Failure Investigation, Risk Assessment related issues and implementing CAPAs.• Training, mentoring and coaching of laboratory analysts and method transfer training to other team members.• Ensuring that all equipments in Bioassay Laboratory are routinely calibrated and validated. Show less

• Officer, Bio-analytical Section (Bioassay Team Leader), R&D Analytical, Biotech Plant

  • Jan 2020 - Dec 2022

  • Acting as the scientific lead for bioassay method development, validation and transfer to QC.• Bioanalytical method development and validation (Host Cell DNA, Host Cell Protein, Molecular Weight (SDS-PAGE), Residual protein A, Western blot etc.) • Review/perform bioassays of samples for release and stability testing.• Management of bioassay cell lines, cell banking (MCB & WCB), culture and characterization.• Prepare and implement SOP/STP/CER/URS/Method Validation Protocol and Report/Method Transfer Protocol and Reports/ Logbook etc.• Maintaining inventory related to Bioassay and Cell Bank.• In process analysis support (HPLC and UV based).• Handling CCF, DCCF and implementing CAPAs.• Training, mentoring and coaching of laboratory analysts and method transfer training to other team members.• Ensuring that all equipments in Bioassay Laboratory are routinely calibrated and validated. Show less

• Officer (Upstream Development), R&D, Biotech Plant

  • Jul 2019 - Dec 2019

  • Maintaining the Upstream Development Bacterial area.• Upstream process development with Clone Development team.• Perform antibody (mAb for Cholkit) production process development from animal model (from Hybridoma cell culture to purification).• Participate in method development, validation for all Bioassays performed in R&D.• Perform and Report Bioassay analysis of R & D batches and stability samples of biotech products.• Participate in management of mammalian Cell Bank and all related works and preparation of documents related to Bioassay and Cell Bank.• Maintain reagent inventory related to upstream development, bioassay and antibody production process and mammalian Cell Bank• Area specific SOPs and logbook, equipment SOPs and logbook management. Show less