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An energetic, quality driven individual with initiative and extensive hands-on cGMP Quality experience serving the life sciences and pharmaceutical communities in the areas of Quality Assurance, Quality Control, Pharmaceutical Manufacturing Operations, Contract Manufacturing, Validation, Stability, Raw Materials, and building/implementing Quality Systems. Management responsibilities within pharmaceutical and CMO companies include lab management, auditing (internal & external), product release, documentation review, investigations, establishing specifications, QC testing, working with biologics (cells/viruses), drug substance/drug product, implementing/executing validations, raw material control and stability.
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Director Of QualityCellipont Bioservices Sep 2021 - Dec 2023The Woodlands, Texas, UsManaging Quality Assurance/Quality Control Operations for CDMO cell based Biopharma company. GMP cell therapy manufacturing in support of human clinical development. Working with clients in expansion of indications for human treatment and regulated drug development. -
Director Of QualityVetstem, Inc. Jul 2019 - Sep 2021Poway, California, UsManaging Quality Assurance/Quality Control Operations for CDMO cell based Biopharma company. GMP cell therapy manufacturing in support of human clinical trails. Working with subsidiary (Personalized Stem Cells Inc.) in expansion of indications for human treatment and regulated drug development to include early stage IND filings. Oversight of Quality for materials and products to include phase III drug development for canine. -
Sr Manager QualityVetstem, Inc. Feb 2019 - Jul 2019Poway, California, UsManaging Quality for CMO cell based Biopharma industry. GMP manufacturing in support of human clinical trails.
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Quality Assurance ManagerCaps - B. Braun Medical Aug 2014 - Jan 2019Bethlehem, Pa, UsResponsible for planning, organizing and directing activities related to cGMP Quality within a sterile injectable production facility for QA & QC. Support Quality Department to ensure cGMP regulations are upheld and the timely completion of projects/tasks are completed. Also, responsible for the development and implementation of quality related programs to maximize efficiencies of staff, testing and budgetary resources to support the company goals while complying with GMP and regulatory requirements. Oversee the implementation/ start-up/ growth of the site specific Quality Assurance systems to include the control/ review of product release and laboratory testing with continuous quality improvements to assure that products and processes meet company and regulatory requirements.Responsible for staffing, training and development of 18 direct reports working within QA & QC (Quality Assurance, Microbiology and Chemistry) on three shifts. This includes training and working within ISO classified cleanroom environmentsProvide technical assistance and direction to the other functional groups. Interface with FDA and other regulatory agencies during audits, field complaint investigations, customer audits and technical interchanges to present the company's quality bases..Develop, direct and implement validation programs to establish and maintain a satisfactory level of compliance with regulatory requirements. This includes managing the analytical and microbiological testing within the facility.Supervises the implementation of internal audit program to determine any deficiencies in the Operations as they relate to current GMP regulations.Directs the investigation of deviations in operations resulting in out of specifications & abnormal operation rejections. Resolves nature of the cause, impact, and disposition and ensures corrective/preventative actions are executed. Work with Electronic quality systems to track, control and improve quality. -
Director Of Quality ControlAmerican Peptide Company, Inc. Sep 2003 - Aug 2014Oversee and Directed the Quality Control Laboratory, Validations, Raw Materials, Environmental Monitoring and Stability within the CMO production facility of various regulatory stages of products manufactured. Interface with FDA regulatory agency during audits and interactions. Host numerous customer cGMP audits on a monthly basis
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Quality Control ScientistMedigene, Inc. Jan 2001 - Mar 2003DeManaged stability and validations for viral based assays. Developed assays. -
Quality Control ManagerImmune Response Corporation Jun 1992 - Dec 2001Managed Quality Control Operations for our west coast facility that included Biologic Product Manufacturing & Release, Environmental Monitoring, Microbiology, Assay Development, Validations, Stability, and Raw Materials control for various biological material products to include Peptide, Viral and cell based Gene therapy activities/projects. Supported operations for the east coast facility, to include setting up aseptic cleanroom activities for cell based viral injectable production. Key participant in regulatory audits by FDA and other regulatory agencies.Accomplishments include: -Initiated & executed investigations/projects and write reports for the FDA to remove clinical hold. -Write/execute validation protocols and reports for biological assays.-Setup and design GMP Quality Control Laboratory that included tissue culture, analytical and microbiology operations.-Setup aseptic cleanroom activities for commercial scale operations.
Scott Caton Skills
Scott Caton Education Details
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San Diego State UniversityBiology (Emphasis In Microbiology); Minor: Chemistry -
St Augustine
Frequently Asked Questions about Scott Caton
What is Scott Caton's role at the current company?
Scott Caton's current role is Director of Quality | GMP, Quality Assurance, Biopharma.
What is Scott Caton's email address?
Scott Caton's email address is sc****@****tem.com
What is Scott Caton's direct phone number?
Scott Caton's direct phone number is +176053*****
What schools did Scott Caton attend?
Scott Caton attended San Diego State University, St Augustine.
What are some of Scott Caton's interests?
Scott Caton has interest in Collecting Coins, Cooking, Electronics, Home Improvement, Reading, Crafts, Stamp Collecting, Gourmet Cooking, Sports, Woodwork.
What skills is Scott Caton known for?
Scott Caton has skills like Gmp, Validation, Analytical Chemistry, Fda, Biotechnology, Quality Assurance, Quality Control, Pharmaceutical Industry, Glp, Change Control, Quality Auditing, V&v.
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