Senior Vice President, CMC
Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company's current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL(r) (bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012. EXPAREL and two other products have utilized the Pacira proprietary product delivery technology DepoFoam(r), a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time.
Senior executive with over 25 years experience in research and drug product development, operational management, engineering and commercial pharmaceutical manufacturing. Excellent track record in achieving corporate goals in resource constrained environment by building strong and highly effective teams. Solid organizational skills resulting in increased productivity: built and reorganized departments to working parallel on new drug application preparation for the FDA, R&D support of NDA approval process, coupled with commercial manufacture of two products, construction of manufacturing facilities, process technical transfers and support of regulatory inspections. Strong leadership and cross-functional team management working relationships. Achievements •In record times developed sustained-release peptide product to clinical trial initiation stage. Clinical trial material was manufactured, IND was approved by the FDA and clinical trials started on time. •Managed NDA chemistry review process for new drug product by providing quickly and efficiently written responses to FDA and through teleconferences. NDA was approved. •Newly commissioned manufacturing system was qualified and validated for commercial aseptic manufacture of liposomal drug product. Product was launched for commercial distribution. •Reorganized Operations activities to focus on timely commercial products supply to US and ex-US customers •Oversaw several construction projects with each over $20M budget for manufacturing expansion with production equipment and automation. Project was completed on budget and with minimal delays. •Provided necessary support in company’s IPO. Company became public in Feb 2011. •Provided technical leadership in FDA and EMA manufacturing site inspections resulting in no major observations.
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