Omar Melendez
AstraZeneca
Sr. Director Facilities & Engineering
• OVERVIEW
o Omar currently works at AstraZeneca on the Rockville, MD in the Cell & Therapy facilities as Sr. Director of Facilities and Engineering. In his roles he is responsible for leadership and oversight for all aspects of plant operations to ensure effective and efficient operations of all equipment, systems, and site operations. In addition, he was accountable for aligning technology and innovation to the business strategy to meet business demands and needs.
• EDUCATION
o B.S. Mechanical Engineering, University of Puerto Rico, Mayaguez; School of Engineering
• PROFESSIONAL EXPERIENCE
o 25 years of industry experience, including expertise in Global Capital Projects (Biologics mAb DS Facilities, DP Fill & Finish, GMP Labs), Biologics, Corporate Capital Portfolio Management and Site Master Planning. He has extensive experience in Facility GMP Start up, Reliability Centered Maintenance Programs, Validation Master Plans, Requalification and Periodic Reviews. He has also worked in a number of therapeutic areas such as Oncology, Respiratory, Autoimmune and Infectious diseases as well as various modalities like Oral Solid Dosage, mAb’s, Vaccines, and Cell Therapy
• KEY HIGHLIGHTS:
o Managed a $150 million investment proposal for the Boulder Manufacturing Center Phase I, refurbishing 160K sqft. of real estate.
o Led the restructuring of the Engineering and Facilities Department, implementing performance targets for Maintenance and fostering staff commitment to superior quality and safety standards.
o Managed a $150 million budget and construction activities for the analytical laboratory building at Pfizer, including over 80,000 sq. ft. of laboratory space.
o Served as project manager for a $48 million budget to construct two facilities for the Pharmaceutical Development Center at Pfizer.
o Spearheaded a major aseptic manufacturing shutdown project, adhering to a strict schedule for 40 days with zero accidents on the field.
• COMPANIES WORK AT:
o Wyeth, TEVA, Pfizer, AstraZeneca, Kite & BioNTech
o Omar currently works at AstraZeneca on the Rockville, MD in the Cell & Therapy facilities as Sr. Director of Facilities and Engineering. In his roles he is responsible for leadership and oversight for all aspects of plant operations to ensure effective and efficient operations of all equipment, systems, and site operations. In addition, he was accountable for aligning technology and innovation to the business strategy to meet business demands and needs.
• EDUCATION
o B.S. Mechanical Engineering, University of Puerto Rico, Mayaguez; School of Engineering
• PROFESSIONAL EXPERIENCE
o 25 years of industry experience, including expertise in Global Capital Projects (Biologics mAb DS Facilities, DP Fill & Finish, GMP Labs), Biologics, Corporate Capital Portfolio Management and Site Master Planning. He has extensive experience in Facility GMP Start up, Reliability Centered Maintenance Programs, Validation Master Plans, Requalification and Periodic Reviews. He has also worked in a number of therapeutic areas such as Oncology, Respiratory, Autoimmune and Infectious diseases as well as various modalities like Oral Solid Dosage, mAb’s, Vaccines, and Cell Therapy
• KEY HIGHLIGHTS:
o Managed a $150 million investment proposal for the Boulder Manufacturing Center Phase I, refurbishing 160K sqft. of real estate.
o Led the restructuring of the Engineering and Facilities Department, implementing performance targets for Maintenance and fostering staff commitment to superior quality and safety standards.
o Managed a $150 million budget and construction activities for the analytical laboratory building at Pfizer, including over 80,000 sq. ft. of laboratory space.
o Served as project manager for a $48 million budget to construct two facilities for the Pharmaceutical Development Center at Pfizer.
o Spearheaded a major aseptic manufacturing shutdown project, adhering to a strict schedule for 40 days with zero accidents on the field.
• COMPANIES WORK AT:
o Wyeth, TEVA, Pfizer, AstraZeneca, Kite & BioNTech