Amzad Hossain Email and Phone Number

● Designing and executing development and feasibility trials to fully define or refine new or existing product formulation and process from benchtop/pilot through launch phase. ● Providing technical support and ensure cost effective and robust manufacturing processes for various unit operations including blending, compression, coating, encapsulation, and novel technologies within the R&D and pilot set up.● Performing analysis of process execution, recommend opportunities for improvement with efficiency and risk mitigation.● Acting as a liaison between R&D and other cross-functional teams to ensure scale ups, pilots and work instructions meet established operational requirements.● Working with R&D/Quality to adjust specifications as needed to help meet production needs.● Developing appropriate experimental designs, analyze, and interpret data to drive technical understanding, meet project targets and make recommendations that drive efficiency, learnings and manage risk.● Building strong working relationships with cross functional partners to enable collaboration.● Identifying, procure and set-up R&D lab equipment to establish/enhance core development capabilities.● Completing development reports for feasibility and process evaluation studies, pilot trials, and product development summaries, makes presentations for projects at key development milestones.● Provides training to the development team as required.● Managing multiple projects with a high degree of complexity.

● Conducting formulation and process development activities from hands-on internal laboratory work through commercialization. ● Developing as a technical professional, to provide leadership and solutions solving problems oral solid drug product manufacturing, for unit operations including but not limited to encapsulation, blending, milling, granulation, drying, compression and coating.Assumes personal responsibility and ownership for team goals and priorities● Developing appropriate experimental designs● Coordinating and executing benchtop, pilot, manufacturing scale-up and verification batches. Providing technical and scientific input, support and assistance to other technical disciplines.●Maintaining accurate records of all development projects. Preparing technical documents relevant to area of responsibility such as SOP's, MBRs, raw material and product specifications, technical reports, lab book documentation and technology transfer documentations.● Preparing stability, consumer, and clinical samples. Also preparing, reviewing, and/or approving stability protocols. Monitoring, evaluating and summarizing the results of stability studies● Gather and analyze relevant formulation data and make recommendations on finalformula specs● Utilizing proper formulation development protocols to ensure consumer centric product islaunched● Properly communicate project details and experimental designs to technician●Participating in cross site team meetings to support contract manufacturers and to identify and resolve potential issues● Provides for the development of new products as guided by development pipelines,timelines, and project details to maintain and build Megafood’s competitive advantage● Supporting production runs at Manufacturing sites.● Improving workflow by studying process flowcharts, recommending modifications in workflow, work stations and products, developing new procedures, recommending equipment modifications and purchases.

• Effectively managing all technical aspects of the product development process from pre-formulation to commercialization, utilizing standard best practices and procedures with hands on formulation, scale up and commercialization support.• Improving current products, addressing manufacturing issues, evaluating new and alternative raw materials, reformulating existing products.• Effectively interfacing with Operations, Brand, Regulatory Affairs and other cross-functional disciplines to accomplish project goals.• Preparing stability, consumer, and clinical samples. Also preparing, reviewing, and/or approving stability protocols. Monitoring, evaluating and summarizing the results of stability studies.• Improving workflow by studying process flowcharts, recommending modifications in work flow, work stations and products, developing new procedures, recommending equipment modifications and purchases.• Performing continuous improvement for formulations and process of the existing products to minimize operations downtime, maximizing throughput and quality of final products, providing technical improvement projects and analyzing formulas for reformulation. Creating rework procedures and preparing Master Batch Records (MBR’s).• Coordinating and executing benchtop, pilot, manufacturing scale-up and verification batches. Providing technical and scientific input, support and assistance to other technical disciplines.• Maintaining accurate records of all development projects. Preparing technical documents relevant to area of responsibility such as SOP's, electronic master batch records, raw material and product specifications, technical reports, lab book documentation and technology transfer documentations.

• Independently develops formulations for a variety of oral solid dosage and delivery forms.• Prepares stability, consumer, and clinical samples. Prepares, reviews, and/or approves stability protocols. Monitors, evaluates and summarizes the results of stability studies.• Improves work flow by studying process flowcharts, recommending modifications in work flow, work stations and products, developing new procedures, recommending equipment modifications and purchases• Performs process improvement projects and analyzes formulas for reformulation. Creates rework procedures and prepares Master Batch Records.• Assists manufacturing with processing and thru-put goals by using statistical analysis programs for overall product improvement. For assigned manufacturing responsibilities, provides technical support to Operations by establishing the requirements for batch manufacturing and overseeing the execution of any required studies.• Trains others in developing new products; conducts appropriate experiments and instructs in the proper use of laboratory and manufacturing equipment.• Responsible for coordination and execution of benchtop, pilot, manufacturing scale-up and verification batches. Provides technical and scientific input, support and assistance to other technical disciplines.• Maintains accurate records of all development projects. Prepares technical documents relevant to area of responsibility such as SOP's, electronic master batch records, raw material and product specifications, technical reports, lab book documentation and technology transfer documentations.• Maintains awareness of current developments in the functional discipline. Develops a network of outside contacts such as vendors, consultants, educators and appropriate continuing education courses.• Interfaces with other operating units within and outside the department. Presents ideas and suggestions for new products, product or process improvements and improved laboratory operations.

•To perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. • Troubleshoot and resolve process related issues • Initiate and document minor deviations • Execution of critical and routine production operations • Perform Batch Record, Log Book and Form Prep requests • Enter data in the Laboratory Information Management System (LIMS) • Record data into log books • Review log book data • Sample preparation and testing • Propose document revisions • Initiating work orders & assembly and disassembly of process equipment • Perform scheduled cleaning of equipment • Perform standardization of equipment • Support change over activities • Execution of equipment and process qualifications as well as validation • Meet and maintain training requirements • Develop and maintain personal development plan • Provide annual performance self assessment on development plan

• Assist with identification of best vehicles for administration of neuroactive steroids to rodents via oral, subcutaneous and intraperitoneal routes of administration. • Assist with in vivo electrophysiological recordings of neural network activity from freely behaving rodents.• Operate and maintain lab equipment, clean, prepare solutions and lab reagents.

• Investigated manufacturing related problems in tablets like capping, lamination, sticking, chipping, mottling etc. and sought opportunities to improve yield and quality.• Performed root-cause analysis in product failures and implement appropriate Corrective Actions/Preventive Actions (CAPA) to remove production constraints and improve product quality as required.• Process optimization and waste elimination by following the lean six sigma techniques.• Maintained accurate records of all development projects, create and execute experimental design utilizing Design of Experiments (DOE) techniques.• Collaborated with the engineering team to adjust and modify production equipments like Rapid Mix Granulator (RMG), Fluid Bed Dryer (FBD), Oscillator, Blender, Compression and Coating Machines & Ensured that machines/equipment are regularly maintained and calibrated for their highest performance. • Lead and support technology transfer activities; guide product and process development activities, working closely with different stages of manufacturing processes like granulation, blending, compression and coating to deliver successful processes for production into the commercial environment.• Prepared technical documents relevant to area of responsibility such as SOP’s/protocols, BMR’s, raw materials and product specifications, log book documentation, scale-up and technology transfer documentations.• Trained, developed and counseled employees to develop a high performing team and monitored production output and costs by evaluating procedures and resources to lessen costs. • Ensured implementation of quality policies at every stage of production according to cGMP by following BMR and kept data of batch records by using SAP software.