Hassan K. Awada

About Hassan K. Awada

As a Leader in Scientific Services, I excel in strategic decision-making, risk…

Experience

1. Biocompatibility Manager, Sr Principal Scientist

   Cardinal Health

   Oct 2021 — Present

   In-depth knowledge of medical device regulations and ISO 10993 series. • Performs secondary review and approval of biological evaluation plans and reports, biocompatibility risk assessments, summaries, and memorandums. • Determines potential regulatory risks associated with proposed biocompatibility test strategy. • Supports interactions with regulatory bodies related to biocompatibility of a product and submissions. • Participates in client discussions regarding products/projects as required. • Generates and reviews gap assessments, as assigned, for the relevant updated versions of the ISO 10993 parts and other standards. • May participate in building external relationships and influencing emerging regulatory/industry standards. • Participates in developing departmental fiscal year budget. • Develops internal biocompatibility policies and standard operating procedures (SOPs). • Conducts periodic review of team’s policies, procedures, and work instructions, and initiate changes as needed. • Maintain current knowledge of relevant QSRs, ISO standards, and other regulatory requirements related to biocompatibility to ensure compliance in all research, data collection and reporting activities. • Assists in developing biocompatibility training programs. • Manages internal team members and supports their development plans, career growth, and goal achievements. • Leads and/or assists in resource allocation, project assignments, and appropriately prioritizing assignments to meet project timelines • Supports and collaborates closely with the operations team and other divisions to create efficient technology tools and platforms, processes, and internal policies. • Drives improvement practices and processes, to deliver consistency. • Supports root-cause investigations, non-conformances, and corrective action and preventive action (CAPA) plans, where required. • Participates in audit preparation and acts as SME in audits situations as required.

Skills

• Positron Emission Tomography
• Histology
• Biotechnology
• Vascular and Cardiac Regeneration
• Small Animal Models
• Pharmacology
• Signal Processing
• Matlab
• Scanning Electron Microscopy
• Zymography
• Microscopy
• Small Animal Imaging
• Project Management
• Radiolabeling
• Cell Culture
• Gpc
• Ftir
• Biomedical Engineering
• Imagej
• Elisa
• Rheometry
• Microsoft Office
• Urodynamics
• Clarizen
• Data Analysis
• Graphpad Prism
• Nuclear Magnetic Resonance (Nmr)
• Animal Studies
• Angiogenesis
• Tissue Engineering
• Minitab
• Biomechanics
• Mentoring
• Presentation Skills
• Western Blotting
• Biomaterials
• Endnote
• Cryosectioning
• Spine Biomechanics
• Drug Delivery