Robert Nichols
Director of Engineering, Maintenance, and Reliability, Azzur Group
Robert Nichols serves as Director of Engineering, Maintenance, and Reliability for Azzur Group, based out of the organization’s Los Angeles office. For more than 16 years, he helped Genentech build and operate biochemical manufacturing facilities in Vacaville, California. These two facilities (CCP1 and CCP2) remain the largest in existence today. As QA Validation Manager at BioMarin Pharmaceutical, Inc., he was responsible for maintaining the qualified state of three biochemical (CHO and E. Coli) facilities and one gene replacement therapy facility that spanned eight different products from clinical to commercial. Kite Pharma’s advanced medicinal products employed Robert’s talents as the Associate Director, Facilities, and Engineering at their CAR-T cell manufacturing facility in El Segundo, California where he served as Site Head of Validation and Facility Compliance. Robert now leads Azzur Group’s teams with thorough knowledge of Engineering, Validation, and Asset Lifecycle Management processes; Pharmaceutical Quality Systems’ Commissioning, Qualification, and Validation; Maintenance and Reliability; and Quality Risk Management. His extensive experience in the development of Engineering and Quality Manuals is instrumental to the support he provides to our clients. Robert is currently working with several Cell Therapy companies for either Site Expansion or initial Facility Qualification.
