Shafiul Alam Sikder

Experience

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  North South University

  Jan 2008 - Jan 2009

  Teaching Assistant

  1. Lectures on specific topic related to pharmaceutical technology and pharmaceutical engineering.2. Taking Laboratory classes of pharmaceutical technology and pharmaceutical engineering3. preparing class notes and lecture notes on Pharmaceutical technology, pharmaceutical engineering and biochemistry.4. Arranging class exams as well as tutorial test, exam report completion and result publication.5. Conduct all necessary job related to exam controller

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  Beacon Pharmaceuticals PLC

  Oct 2008 - Sept 2009

  Senior Officer, Product Development

   Undertake compilation of product development works. Prepare lab trial batches of new products. Prepare pilot batches and validation batches of new products. Conduct stability study of new products. Prepare all Necessary documents relevant to Product Development. Formulation of new products. Prepare recipe and annexure of new products.

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  RAK Pharmaceuticals Pvt. limited

  Oct 2009 - Sept 2011

  Officer, Product and Process Developmenrt

   Develop formulation of new product. Develop and prepare lab trial batch, Pilot batch and Validation batches of new product. Conduct all necessary steps to prepare validation batches and transferring new products to production. Prepare all validation documents e.g. Validation plan, Sampling plan, Validation protocol, Manufacturing Instruction and Validation assessment report etc. Prepare all necessary documents of PPD e.g. BMR, BPR, Recipe, Annexure and Dossier. Operation and maintenance of all machinery used in the PPD Pilot Plant. Design and requisition of all packaging materials of new product. Conduct Pre formulation study and Stress study of new products. Conduct all necessary tests of developed product (initial tests) prior to storage for stability. Conduct stability study of new products. Reformulation and revalidation of products for cost minimization and reduce time consumption. Maintain and execute PPD inventory of raw materials and excipients. Prepare and conduct all SOP and SOP training relevant to PPD as necessary. Undertake all necessities of Contract manufacturing batches. Show less

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  Labaid Pharmaceuticals Limited

  Sept 2011 - Apr 2017

  Senior Executive, Product Development

   Preparation and implementation of Validation Master Plan (VMP) and Departmental Validation Plan (DMVP). Ensure all qualification activity and documentation and find out limits of Worst Case Condition. Preformulation studies and Formulation development of new products. Defining all Critical Process Parameters (CPP) in qualification and development phase and finalization of workable limits. Development and execution of Process Analytical Technology (PAT) and Design Space in development phase. Conduct Risk Analysis (RA) based on Critical Process Parameters on individual product base. To conduct Accelerated and Long time stability study of all products. To compile all documents of Product Master File. Preparation of all necessary documents of product development and process validation. Development of all necessary packing materials. To Conduct Prospective Process validation of all the new products. Time to time reevaluation of Process Validation. Design and execution of machine accessories (Die & Punch, Blister Change parts, Utensils etc). Preparation of all necessary documents corresponding to Regulatory affairs. Preparation of machine URS and Qualification documents for relevant machineries. Reformulation of existing products when necessary. Preparation of all necessary protocols for product development and stability study. Preparation of all SOPs and provide training to corresponding departments as well as operators. Source selection and finalization for active materials according to APIC guideline. Show less

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  Beacon Pharmaceuticals PLC

  Apr 2017 - Sept 2023

  Assistant Manager, Research Development

  1. Preformulation activities of New Products2. Development of New Products 3. Development of Analytical Methods 4. Process Validation 5. Reformulation of Existing Products 6. Analytical Method Validation 7. Development of Research & Development Laboratory 8. Qualification of R&D Equipment 9. Facility Validation 10. Documentation related to R&D and Regulatory Activities11. Stability Study and Shelf Life Determination 12. Trial & Pilot batch Preparation 13. Departmental SOP Preparation and Training 14. Direct Costing, Productivity & Conversion cost analysis and reduction. Show less

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  Labaid Pharmaceuticals Limited

  Jan 2021 - now

  Quality Assurance Manager