San Diego County, California, United States
Self-motivated and experienced Life Sciences/Manufacturing Professional with over 18 years of experience. Areas of expertise include: Aseptic process development Scale-up, validation, regulatory filing, and commercial launch Commercial manufacturing (in-house) Contract manufacturing oversight (International assignment) Major achievements include: Commercialization of 5x scaled aseptic manufacturing system including installation, commissioning, process development, validation, regulatory filing and approval, and commercial launch during 5 year international assignment Tech transfer of large-scale manufacturing system Primary contributor of Product by Process Patent Current position is a Director of Manufacturing at Pacira Biosciences located in San Diego, CA
Director Of Manufacturing Operations Oversee 200L manufacturing operations including large-scale aseptic bulk production at Pacira's San Diego, CA cGMP sterile products manufacturing facility. The 200L system’s anticipated capacity is >2.5 million vials/year, which represents over 50% of the global production capacity of EXPAREL®. Responsibilities include: Providing oversight and support for 200L skid installation in the San Diego Facility. Management of skid commissioning (IOQ), CIP/SIP/Bulk process development, and process and facility performance qualification (PQ). This includes the generation of registration material, successful media qualification (APS), Grade C EMPQ, and bulk process validation. Contribution to and review of the 200L prior approval submission (PAS) to the FDA focusing on all CMC sections. Management of a team of 8 bulk operators, 2 bulk supervisors, and a senior manager, supporting 24/7 manufacturing operations. Cross-functional coordination with facilities, engineering, quality assurance, quality control, microbiology, and supply operations. Management of raw material supply, quality events, plant maintenance, inventory management, and continuous improvement.
During international assignment to the UK spanning 5+ years, successfully scaled-up commercial EXPAREL manufacturing process and gained FDA approval for commercial production. Scope of international assignment was to provide oversight of equipment commissioning and validation, lead process development activities, generate Registration and Process Validation batches, participate in regulatory submissions, train manufacturing personnel, and provide oversight for continued commercial production at the CMO (Swindon, England). The new process (4.5x scale-up) includes several novel innovations which are included in U.S Patent 11,179,336 "Manufacturing of Bupivacaine Multivesicular Liposomes" , Hall, et al.