Mr. Halaby has over sixteen years of experience in programming, design, and qualification of biotechnology and pharmaceutical facilities ranging from clinical to full-scale production plants. Mr. Halaby’s particular focus is in cGMP manufacturing design, including process technology evaluation, capacity analysis and cGMP environmental classification, and operational analysis.
Dr. Reddy’s Labs – Vizag, India
New Advanced Aseptic Processing Facility
Aseptic SME and Concept Architect for a 45,000 SF greenfield Advanced Aseptic facility based on isolation technology. The project included fill/finish vials and syringes. The concept was based on the FDA objectives for segregation, integration, and automation and has become the basis for DRL’s focus on automation and included inspection and secondary packaging operations.
Project Manager/Process Lead - Site master planning and basis of design for a multi-building site supporting the manufacturing of products for distribution to US, EU, and Japan. This large volume (10-12 billion) OSD operation included handling of highly of potent [<1μg/m3].