Jose J. Cotto Ph.D. Email and Phone Number
Jose J. Cotto Ph.D. work email
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Jose J. Cotto Ph.D. personal email
Quality professional with proven experience in biopharmaceutical manufacturing operations, quality control, quality assurance, process development, technology transfer, and CMC regulatory compliance. Extensive experience in quality systems and their applications to manufacturing biological and small molecule products. Skilled in commercialization and working in cross-functional product teams to develop insightful strategies that increase top-line revenue and reduce cost of products.Areas of ExpertiseBiopharmaceutical Manufacturing | Regulatory Compliance | Quality Control | Cell & Gene Therapy | Product Commercialization | ATMP | Corrective and Preventative Action (CAPA) | Process Improvement | Technology Transfer | Regulatory Inspections (FDA, EMA, ANVISA, Cofepris, TGA, PMDA and Health Canada) | GMP | GCP | GDP
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Vice President Quality OperationsAtara Biotherapeutics Apr 2022 - PresentThousand Oaks, Ca, UsHead of Quality Operations at AtaraBio including; Quality oversight of Contract Manufacturing, Quality Control, Supplier Quality Management, Site Quality Assurance and Product Disposition
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Vice President Of Quality ControlAtara Biotherapeutics Dec 2020 - Apr 2022Thousand Oaks, Ca, UsResponsible for all Quality Control operations (internal and external)
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Executive Director - Global Quality Product Supply And DistributionKite Pharma Sep 2020 - Dec 2020Santa Monica, California, Us -
Executive Director-Quality Site HeadKite Pharma Jan 2020 - Dec 2020Santa Monica, California, UsProvide guidance to multiple Quality departments at the Urbana, MA site, including the Quality Management System (QMS), Quality Assurance, QC Microbiology, QC Analytical and Quality Engineering groups, to ensure compliance to all applicable FDA procedures, policies, and regulations. Direct involvement in the establishment of implementing global procedures and policies to ensure cGMP compliance at the site.
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PresidentIntelegenz, Llc May 2019 - Jan 2020Provide subject matter expertise and consulting services to the pharmaceutical industry in the areas of biologics and small molecules, Combination Products and Aseptic Processing.Assist clients on end to end inspection readiness program, including preparation and management of inspections, response to observations and the implementation of effective corrective actions.Focus on Quality System improvements with strong background on Quality Control, deviation and CAPA management, APR, Management review, Change Control, Disposition, Stability, Documentation and Data Integrity.
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Senior ConsultantAdalberto Ramirez And Associates, Llc Jan 2019 - Jul 2019Provide subject matter expertise and consulting services to the Biopharmaceutical industry
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Executive Director Quality Site HeadAmgen Oct 2016 - Dec 2018Thousand Oaks, Ca, UsProvide Quality oversight for all Development Supply Chain activities including the end to end clinical pipeline and commercial activities executed at the Amgen Thousand Oaks (ATO) campus. In addition, act as Quality business partner for the Process Development organization. -
Executive Director Cmc Commercialization Therapeutic Area HeadAmgen Oct 2014 - Oct 2016Thousand Oaks, Ca, UsGuided portfolio strategy development as Operations Therapeutic Area Head of the Bone, Nephrology, Inflammation, Cardiovascular and Neuroscience Franchises
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Executive Director Cmc Commercialization Global Operations LeaderAmgen Sep 2011 - Oct 2014Thousand Oaks, Ca, UsEstablished strategy to support product growth through Operations Life Cycle Management (LCM) initiatives. These resulted in the implementation of New Formulations, Re-usable devices and introducing the brand to Digital Media Solutions for Patients
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Executive Director QualityAmgen Sep 2007 - Sep 2011Thousand Oaks, Ca, UsDirected the Quality Control (QC) organization managing a $30 million budget and over 275 employees and contractors. Provided 24/7 analytical testing and sampling support to two bulk manufacturing plants and one fill and finish operation. Reduced testing cycle times while reducing operational cost by $5 million and consistently achieving over 95% release testing on time of Drug Product and Drug Substance.
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Roles Of Increasing Responsibility In QualityAmgen Jun 2001 - Sep 2007Thousand Oaks, Ca, Us
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Regulatory Specialist, New Product Introduction ManagerAbbott Diagnostics Business Jan 1998 - Jun 2001Abbott Park, Illinois, Us
Jose J. Cotto Ph.D. Skills
Jose J. Cotto Ph.D. Education Details
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Northwestern UniversityBiochemistry And Molecular Biology -
The University Of Texas At AustinBiochemical Engineering
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University Of Puerto Rico-CayeyGeneral
Frequently Asked Questions about Jose J. Cotto Ph.D.
What company does Jose J. Cotto Ph.D. work for?
Jose J. Cotto Ph.D. works for Atara Biotherapeutics
What is Jose J. Cotto Ph.D.'s role at the current company?
Jose J. Cotto Ph.D.'s current role is Vice President of Quality Operations at Atara Biotherapeutics.
What is Jose J. Cotto Ph.D.'s email address?
Jose J. Cotto Ph.D.'s email address is co****@****gen.com
What schools did Jose J. Cotto Ph.D. attend?
Jose J. Cotto Ph.D. attended Northwestern University, The University Of Texas At Austin, University Of Puerto Rico-Cayey.
What skills is Jose J. Cotto Ph.D. known for?
Jose J. Cotto Ph.D. has skills like Validation, Biopharmaceuticals, Biotechnology, Quality System, Fda, Aseptic Processing, Gmp, Lifesciences, Technology Transfer, Pharmaceutical Industry, Regulatory Affairs, Sop.
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