Raymond Ward

Experience

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  Ichor Medical Systems

  Jul 2002 - Jun 2004

  Surgical Laboratory Manager

  ► Managed tumor and vaccine research and experiments for a company with >$5-10MM in annual funding, performing over 2,000 surgeries on mice, rats, and rabbits, including cardiology, liver, spleen, lymphatic, and tumor excisions.► Directed all rabbit operations and experiments at a separate laboratory facility with an operating budget of $1MM, while performing molecular biology lab procedures, including blood work, DNA prep and spectrophotometry, and ELISA.

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  UC San Diego Health

  Jun 2004 - Oct 2022

  Chief Neonatal Respiratory Therapeutics Coordinator / Hospital Laboratory Technician IV Supervisor

  ► Led a GMP clinical laboratory in the development of respiratory distress therapy treatments and ventilation technologies with 15 research associates, 30 neonatal fellows, and 5 respiratory therapists, ensuring a 95% KPI achievement.► Oversaw a laboratories operating budget of $3MM annually, growing from $200K to increase the budget by 15x, increasing laboratory throughput and overall client demand while maintaining a 100% customer satisfaction rating.► Converted a research in-vivo bioactivity test to a new GMP in-vivo assay, optimizing the process through 3 revisions to increase capacity by 3x and increase assay throughput by 400%, increasing the profit margin by 2.5x.► Directed an FDA approved clinical Release and Stability testing facility within GMP/GLP guidelines to generate clinically linked efficacy data in support of FDA submissions, owning SOPs, change controls, deviations, and CAPAs. Show less

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  BIODATA INNOVATION SYSTEMS

  Jun 2008 - Oct 2022

  Director of Quality Assurance (2015 – Present)► Oversaw quality assurance for Molecular GPS Technologies, Inc. and six subsidiaries with annual revenue of over $21MM, successfully establishing and maintaining a Quality Management System for 2 manufacturing sites.► Led 7 teams of 35 quality assurance and control staff to support the development and manufacturing of 15 product lines and trained 12 staff in assay performance resulting in increasing testing throughput by 500%.► Spearheaded the ISO 13485:2016 implementation for the manufacture of the OviGenex CollOvine product line consisting of 11 different manufacturing processes and finished goods, valued at $5.5MM annually.► Executed over 167 investigations, deviations, and CAPA activities and processes to reduce error and increase overall process and product quality, decreasing deviations by 75% over 5 years and improving efficient review operations.► Established and documented an ISO 7 Class 10,000 clean room following 14644 standards, increasing operational efficiency by 50% while managing the supplier approval process of 53 QA approved supplies with audits and site visits.► Increased the quality system efficiency and throughput by >30% by converting a paper-based system to a hybrid electronic review and approval process while authoring 303 SOPs, 75 Test Methods, and other technical documentation.► Facilitated and authored the method transfer of a GMP in-vivo Bioactivity test from San Diego to Lee’s Pharmaceuticals in China, resulting in a cost reduction of release and stability assay testing by 80%, saving >$2.2MM annually. Show less Senior Manager of Quality Assurance (2008 – 2015)► Managed quality assurance with a team of 4 QA and 15 QC staff with a retention rate of 95%, while leading 5 ISO 9001 and 13485 audits with 100% certification success and zero observations needing remediation.► Designed a new optimized GMP in-vivo assay for respiratory lung compliance measurements, resulting in a 54% increase in release testing efficiency, a 30% reduction in per assay costs, and a 40% decrease in animal testing.► Partnered in the development of the Acoustic Respiratory Movement Sensor to wirelessly detect patient respiration, patient movement, and caretaker movement, with episodes of caretaker movement identified with 98% sensitivity.► Established and actively maintained a Quality Management System to support ISO certification, GMP manufacturing, and release and stability activities associated with 3 IND and NDA submissions for 2 sponsor companies.► Drafted and submitted a grant for “An Acoustic Respiratory Movement Sensor to Produce and Monitor SIMV in Infants” and was awarded $275K by the National Heart, Lung, and Blood Institute. Show less

  • Director Of Quality Assurance

    Jun 2008 - Oct 2022

  • Senior Manager of Quality Assurance

    Jun 2008 - Jun 2015
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  Biora Therapeutics

  Oct 2022 - now

  Provides leadership tor the Quality department and ensures the successful development, implementation and maintenance of all quality systems at Biora Therapeutics.Responsible for:► Quality Systems Management and overseeing daily activities performed by the Quality team.► Implementing and enhancing the MasterControl electronic quality management system.► Developing and implementing GMP systems and procedures including policies, SOP's, and work instructions.► Managing quality events, deviations, and CAPA programs and ensuring adequate cross functional investigation activities are performed and root causes are identified.► Leads internally and with suppliers on all validation activities required for combination medical device products.► Batch record review and releasing of drug product lots. Review of QC data, quality events, deviations, and NONCs.► Revamp the supplier qualification and management program. Ensuring that all suppliers are properly scored, risk assessments performed and ensuring supplier audits are current, reviewing audit reports and observations.► Directing the Quality operating budget and managing activities within approved budget.► Authoring Quality related sections of IND applications for medical device combination products.► Enhancing and directing the equipment calibration and qualification program.► Developing and implementing Biora's eTMF system for upcoming clinical trials.► Developing and implanting Biora's Design History File (DHF) and ensuring that design controls are followed and documented in the DHF properly. Show less Provides leadership tor the Quality department and ensures the successful development, implementation and maintenance of all quality systems at Biora Therapeutics.Responsible for:► Quality Systems Management and overseeing daily activities performed by the Quality team.► Implementing and enhancing the MasterControl electronic quality management system.► Developing and implementing GMP systems and procedures including policies, SOP's, and work instructions.► Managing quality events, deviations, and CAPA programs and ensuring adequate cross functional investigation activities are performed and root causes are identified.► Leads internally and with suppliers on all validation activities required for combination medical device products.► Batch record review and releasing of drug product lots. Review of QC data, quality events, deviations, and NONCs.► Revamp the supplier qualification and management program. Ensuring that all suppliers are properly scored, risk assessments performed and ensuring supplier audits are current, reviewing audit reports and observations.► Directing the Quality operating budget and managing activities within approved budget.► Authoring Quality related sections of IND applications for medical device combination products.► Enhancing and directing the equipment calibration and qualification program.► Developing and implementing Biora's eTMF system for upcoming clinical trials.► Developing and implanting Biora's Design History File (DHF) and ensuring that design controls are followed and documented in the DHF properly. Show less

  • Head of Quality, Senior Director of Quality Management

    Nov 2024 - now

  • Head of Quality, Director of Quality Management

    Oct 2022 - Nov 2024