Bassem Azizeh Email & Phone Number

Menlo Park, CA, US

• Project Team Lead: Took over the Project Team Lead of the group until completion (supervised 17 consultants).
• Laboratory Controls and Data Integrity Assessment. FDA remediation and Forensic data analysis (CDS and Non CDS), chromatographic and non chromatographic analyses; discover, extract and analyze patterns of fraudulent.
• Maintaining and assuring the accuracy and consistency of data over life cycle during Data Integrity Review.
• Review batch records, API releases, stability studies, Investigations, Deviations, Out-of-Specifications, Validation Protocols and Reports for New Drug Application (ANDA).
• Establishing, applying and reviewing critical quality attributes during the product development lifecycle.

Bubendorf, CH

• Oversee day-to-day tasks in a QC Lab Operations cGMP environment (APIs release, IPC and final products, managed stability program, testing &releasing incoming raw materials, quality systems, water & environmental.
• Qualification, transfer methods, and validation of Bioidentity / Bioassay methodology for generic peptides using USP / EP monographs
• Represent the QC Laboratory during customer visits, cGMP audits and during regulatory agency inspections
• Guide direct reports that include Director, Managers, Project Manager, and Scientists of the Quality Control Laboratory and evaluate their capabilities and abilities to meet business needs
• Provide analytical, technical and chemical expertise (Peptides and Oligonucleotides), microbiological support, and quality systems compliance for non-conformance investigations, manage CAPAs, root cause, OOSs, OOTs.
• Maintain Subject Matter Expert (SME) title to all analytical methodology and all lab operations activities. Mass spectrometry, HPLC, UPLC, ELISA assays, GC, GC/MS, SEC, UV-VIS, CD, ICP-MS/OES, KF, SDS-PAGE, PCR.

Fullerton, CA, US

• Develop and oversee management of Quality Control operation plans, schedule and budget.
• Support of lot release packets, raw materials testing and identification, stability study testing and enrollments and all analytical method validation.
• Liaison between CancerVax Corporation and Contract Laboratories.
• Responsible for stability study tracking, enrollment, and execution per ICH guidelines.
• Responsible for the Analytical Master Validation Plan, review, approve and execution. Support / complete (compendial) assay validation according to plan. Review and approve Standard Operating Procedures (SOPs).
• Set up new facility for Cell Proliferation/Tissue Culture lab in support QC Labs and due to expansion of QC area/space.

Irvine, CA, US

Tucson, Arizona, US

Norman, Oklahoma, US

Ph.D., Chemistry

M.S, Biochemistry

Bachelor’S Degree, Chemistry/Biology