A self-motivated and dedicated Senior QC Leader with nineteen years of biopharma and analytical research and development experience in support of both small molecule and complex aseptic fill/finish Monoclonal antibody Mab (biologics) manufacturing. Experienced across several aspects of Product Quality, including: QC Laboratory leadership, technology method transfer and validation, drug stability, testing of raw materials including; in-process, intermediates and final product. Experience establishing test methods, specifications and writing SOP’s to match cGMP standards. Responsible for GMP training, leading audits and overall product compliance.

Associate Director @ Manage the qc functions for all cmos and cros From January 2014 to Present (2 years) Director @ From April 2013 to January 2014 (10 months) Sr Manager Quality Control @ Manage the chemistry, biochemistry and microbiology groups in support of raw materials, in-process, release, and stability testing for various monoclonal antibody products From March 2010 to April 2012 (2 years 2 months) Sr. Manager, Product Quality @ -Implement and oversee the Deviation and CAPA systems. -Manage the release and stability testing of clinical materials. -Manage the internal and external GXP auditing program. -Ensure that Contract Manufacture Organizations (CMO's) and Contract Research Organizations (CRO's) are in compliance with appropriate quality practices. -Manage the company document system. -Contribute to regulatory submissions. From January 2009 to May 2009 (5 months) Sr QC manager @ Oversaw the manufacturing and testing of Nuvelo products by CMO's and contract laboratories From 2008 to 2009 (1 year) Sr QC Manager @ • Set up and manage the Quality Control laboratories to support Technology Transfer. • Implement and support QC testing program. • Set up and manage Environmental Monitoring program. • Set up and manage the stability program for API and Drug Product. • Coordinate and schedule testing of raw materials, in-process, intermediates, and drug product to support biological manufacturing. • Coordinate and schedule all equipment qualification activities for the QC group • Oversee and manage the method validation activities for stability and release testing methods. • Review and approve discrepancies and Investigations. • Prepare and manage departmental budgets. • Responsible for protocol review and approval for analytical methods, equipment, instrumentation, and utilities. • Participate in IND writing and review. • Participate in CMC writing and review. • Participate in CMO oversight during product fills. From July 2005 to November 2007 (2 years 5 months) QC supervisor @ Manage the Quality Control functions for a commercial stage company. From 1999 to 2002 (3 years) Research Associate @ From 1992 to 1997 (5 years)

BS, Chemistry @ University of California, Riverside From 1986 to 1991 Martin Coronel is skilled in: Biotechnology, Quality System, ELISA, Quality Assurance, Sop, Pharmaceutical Industry, 21 CFR Part 11, Monoclonal Antibodies, Chromatography, LIMS, Microbiology