Bassem Gayed Email & Phone Number

New York, Ny, Us

Summit, New Jersey, Us

Summit, New Jersey, Us

Summit, New Jersey, Us

Part of the Global Quality Operations Development QA supporting the CMC activities related to CAR-T Cell Therapy products filing globally. Work closely with cross functional teams globally both internally and externally with multiple CMOs to establish clinical supply chain readiness to support clinical trials and to prepare for the global commercial launch of CAR-T products.

Summit, New Jersey, Us

Member of the Manufacturing Services Team at the Phoenix Aseptic Manufacturing Site. Responsible for providing validation and technical services support including validation studies, technical investigations, CAPAs, change management and product quality complaints. Ultimately to ensure that the drug product meets cGMP’s, site compliance standards, industry standards and is in compliance with regulatory requirements. • Execute process performance qualification and perform data analysis.• Prepare validations protocols and summary reports.• Train multidiscipline team members on validation protocols.• Execute equipment validation including installation qualification, operational qualification and performance qualification.• Manage external vendors to execute on site qualifications of manufacturing equipment. • Provide technical support for execution of aseptic process simulation.• Serve as a validation representative for various project/investigational teams.• Lead technical investigations and writes complex investigation summary reports.• Prepare project schedules and lead multi-functional project teams.• Manage multi discipline project team to support increase in site manufacturing capacity. • Conduct research into industry standards and regulatory agencies guidelines and participate in efforts for internal process improvement.• Work with external vendors to establish technical requirements for manufacturing equipment and components.• Support manual and semi-automated visual inspection of finished drug product including defect identification, classification and trending.• Perform compounding/formulation and sterile filtration tasks of Nanoparticle Albumin bound Paclitaxel.• Perform aseptic operations tasks including operations in grade A space. • Support regulatory agencies audits.• Provide technical knowledge in support of regulatory filing.

Summit, New Jersey, Us

Global training manager responsible for establishing role based training for all GMP functions globally within Celgene• Lead Technical Trainer providing support to global GMP functions.• Perform “Train the Trainer” sessions for qualification of GMP trainers.• Consult with managers to design robust training program that meets their needs.• Apply role specific curricula design and gap analysis identifying departmental training needs.• Create and deploy global Curricula for Global Quality Systems. • Provide ongoing support to mangers for all training needs.• Develop training Metrics for GMP reporting to provide reports to Functional Area Management• LMS Super user and Celgene general administrator. • Provide systems support to all local and global staff and system administrators for LMS and DMS.• Provide system analysis support for global quality Systems to meet the global business needs.• Design global training material for newly implemented DMS and provide ongoing technical support.• Develop and perform annual GMP refresher training on variety of cGMP topics.• Participate in and manage Regulatory Agencies audits.

Showed conformational changes in the first transmembrane segment of P-type ATPase transporters family and studied the structural aspects of these enzymes’ function.• Incorporated a fluorescent unnatural amino acid into a functioning proton pump in yeast.• Gained extensive knowledge and expertise of fluorescence labeling for protein structure studies.• Developed and established technical protocols to improve expression and purification of membrane proteins in vivo using different expression systems.• Performed mutagenesis techniques, flow cytometry, electrophoresis, mass spectroscopy, IR, UV spectroscopy, electrophysiology, chromatography • Developed mathematical models of multiple states enzyme kinetics.• Expert in statistical analysis and data management.

Newark, Nj, Us

Contributed to studies involving the human visual system and carried out training sessions for new group members on the safety procedures and the use of laboratory instruments.• Adhered to government standards and IRB regulation explaining all benefits and potential risks to experimental subjects in order to obtain an informed consent.• Extensive experience with eye movement data collection and analysis from human subjects.• Performed functional MRI data collection and analysis for imaging of active brain centers in response to visual stimuli.• Expert on statistical analysis techniques for processing and analysis of experimental data• Teaching instructor for Biomedical Instrumentation graduate and undergraduate courses

Supported drug product release by completing quality control tests, including determination of API’s (Active Pharmaceutical Ingredients) content and degradation products, and in-vitro bioavailability• Expertise on the use of HPLC analysis• Performed tablet dissolution and disintegration test according to standard methods• Executed stability tests of tablets subjected to accelerated storage conditions• Determined characteristics of powder and operated the press to make tablets for QC testing

Doctor Of Philosophy - Phd, Biomedical Engineering

Bachelor Of Science - Bs, Biomedical Engineering

Associate Of Science - As, Biology