Mohammad Shamsul Islam

I am an analytical chemist and want to develop me to serve the people.

Current Job Responsibilities 

• Lead for bio- similar product development: Characterization, method validation, cleaning validation, process validation, in-process analysis and stability study of Biotech API and formulated products. 
• Conducting Bio-similarity study of new developed bio-similar products to assure its identity, purity and potency against reference products.
• Review method validation, cleaning validation, process validation, source approval and stability study plans and reports to assure the requirements of biotech API/ formulated products during the development.
• Design experiments toward troubleshooting/optimization of existing analytical methods when necessary.
• Assure accurate and timely testing and reporting all results, issuing technical reports which include certification and validation data.
• Provide guidance on analytical investigations of abnormal results.
• Work in collaboration with other departments, e.g. Process, Formulations, Regulatory Affairs, Production, Supply Chain, etc., to support timely new product development and submissions.
• Participate in evaluation and development of new personnel.

Achievement:

• Completed characterization of many biotech products (Pegfilgrastim, Filgrastim, Erythropoetin, Pegylated Erythropoetin, Darbepoetin, Adalimimab, Rituximab, Trastuzumab, Denosumab, Pertuzumab, Bevacizumab, Interferon, Ranibizumab, Semaglutide, Liraglutide, Human Insulin, Insulin Aspart, Insulin Glargine, Insulin Degludec etc.) using various promising analytical methods during the API development and establishment of drug formulation.
• Successfully performed bio-similarity study of Pegfilgrastim, Filgrastim, Erythropoetin, Adalimumab, Trastuzumab etc. against respective reference products.
• Achieved experience of performing method validation, cleaning validation and stability study of existing API and finished products in Incepta Pharmaceuticals Ltd.
• Acquired practical knowledge of analytical and process instruments like Preparative HPLC, HPLC, FT-IR, AAS, UV-spectrophotometer, SDS-PAGE, ELISA Plate Reader, Fluorescence Plate Reader, Akta Pilot, Rotary evaporator and so on.
• Faced DGDA audit for Pegfilgrastim (first bio-similar API in Bangladesh) and filgrastim from R&D analytical part and got approval.
• Faced audit of Helvetic Biopharma (Bio-pharmaceutical company based in Ticino, Switzerland) from R&D analytical part for Pegfilgrastim Bulk and got approval.
• Experienced on the first time lunching of products in local market and alternative source development of exiting products.
• Successfully organized, updated and prepared the DGDA related documents from analytical view.
   

Academic Records