Mina Youssef Email & Phone Number

Rtp, North Carolina

Participate in technical transfer of new processes into manufacturing . Prepare technical documents including batch records, formulation/solution/media records, item specifications, project reports, and engineering specifications.Participates in technical deviation investigations and collaborates with Operations, Technical and Quality Management to determine the impact of the event, determine root cause, identify corrective action and evaluate batch disposition. Assist with Bill of Material (BOM) generation for new process introductions as well as updating BOMs for introduced process modifications.Responsible for technical batch record and solution record review. Author Material Specifications in accordance with compendia requirements and meeting grade requirements for introduced process.Determination of solution volumes, working with vendor to generate solution packets, coordination of solution orders.Design and test chromatography equipment methods to ensure alignment with process design, batch record instructions and equipment functionality.Collect, organize, and analyze process data from engineering and manufacturing runs for presentation at project meetings.

Expert in protein purification operation including but not limited to Column Chromatography, different types of Filtration, Ex: Tangential Flow, Depth, and POD filtration, viral inactivation, and final formulation and filling operations•Strong project management experience, and Leads client’s process development, technology transfer and scale up into manufacturing. •Lead 5S project, process improvement and implementing new technologies and designs for lenient manufacturing process for drug products. •Create Document, material and equipment’s Change control requests, revise and improve controlled documents to follow the Good documentation practice.• Professional working with AKTA pilot, AKTA ready and AKTA process, along with creation of process methods and validation testing for all methods prior to execution.•Initiate Deviation reports, and CAPA if required, and communicate with QA department’s head and clients to address all comments and concern•Aseptic Handling and testing virus-based products while wearing adequate personal protective measures. • Advanced knowledge of Microsoft applications, especially Word and Excel and Other computer software skills including SAP, Trackwise and Documentum, Replicon, eLIMS.

Chicago, Il

• Construct, improve and invent new technology for Drug substance protein purification and scale up to cGMP (current good manufacturing practice).• Outstanding experience in laboratory analytical and characterization studies for vaccines, monoclonal antibodies and bio similar drug substances.

• Conduct Clinical trials, research and development of new drugs (Monoclonal antibodies) to treat Respiratory Syncytial Virus in premature babes.• Writes research and development protocols and optimize the manufacturing procedures in large scale cGMP Protein Purification Lab.

Baltimore, Md

• Conduct Interviews, full history and review patient’s past medical records. • Direct patient contact and great professional experience in multidisciplinary medical specialties. • Contact Johns Hopkins’s physicians to Schedule appointments for international patients who seek medical advice in multiple different medical, behavioral and surgical specialties.

Bachelor Of Science, Biology/ Biotechnology

Education record