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Global professional leader with over 29 years of Biotech and Pharmaceutical experience with expertise in Quality Assurance, Quality Control, Aseptic Processing, Engineering and Technical OperationsSummary of Qualifications• Strategic hands on leadership of Quality Assurance, Quality Engineering, and Facilities Operations• Leading and hands-on interaction with global regulatory agency audits, internal and external audits• Quality lot release, annual product reviews, compliance trending, metrics, data review and training• Full range of GxP; GMP, GLP, GDP and GCP• US and International regulatory compliance, ICH and ISO standards• Regulatory Submission: Common Technical Documents, INDs, BLAs • Compliance Risk Analysis and Risk Management, Change Management, Supplier Control, Quality Control, Stability, Terminal Sterilization, Shipping, Labeling and Distribution• Project Management across multiple layers, departments and personnel. • Qualification of equipment, systems, facilities, production processes, process optimization and technical transfer• Quality system remediation and gap assessments to corporate and board of health standards• Pharmaceutical and Biotechnology subject matter expertise in Aseptic processing, Lyophilization, Sterilization, and Depyrogenation processes• Process knowledge in Aseptic Sterile Filling of vials and syringes, Packaging, Bioprocessing, Purification, Conjugation, Formulation, and Human Tissue Production. • Process deviation support, resolution, CAPA, complaints and risk analysis • Management of third party manufacturing and engineering firms• Consent Decree remediation of qualification programs, equipment, facilities and processes• Strategic Planning, Quality Objectives, Results focused and Goal Setting• Product knowledge: large and small molecule production, cephalosporin’s, vaccines, mRNA, monoclonal antibodies
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Vice President Life Sciences BiotechnologyDynamixe, Inc. Aug 2023 - PresentNew York, New York, Us -
Vice President Of Validation (Quality Engineering) And Quality OperationsCheerland Biotechnology Jul 2022 - Aug 2023Shenzhen, Cn -
Senior Director Quality Assurance Center Quality EngineeringSamsung Biologics Apr 2019 - Jul 2022Yeonsu-Gu, Incheon, KrSr. Director Head of Quality Center Quality Engineering >80 FTEs• Site Quality Leadership for CMO, CDO, CRO, DS and DP areas. • International Regulatory Inspections, Client Interaction, and Internal Audits• Inspection readiness, GMP remediation, and facility expansion • Process capabilities, product tech transfer and continuous quality improvements• Quality Engineering accountabilities include equipment, utility, computer systems, sterilization, cleaning, production processes, process optimization, product transfer and environmental qualification of facilities• Quality strategy, objectives, budget management and goal setting. • Client interface throughout product life cycle. • New product launches, tech transfer, project management, and regulatory submissions• Business Development and new partnership interaction• Employee development, training, coaching and mentoring -
Director Quality Engineering And Quality ControlMimedx Jun 2017 - Mar 2019Marietta, Georgia, UsSr. Director Quality Engineering and Quality Control • Management of Quality Engineering and Quality Control Personnel • Change management, Supplier Control, Auditing, Complaints • GMP remediation, facility expansion and growth• Calibration and Maintenance • Stability, Label control and Shipping • Quality Control operations internally and external• Terminal Sterilization by gamma and e-beam• Tissue Donor eligibility, tissue processing, medical device research • Process capabilities, gap remediation and process improvements • Regulatory assessments and BLA submissions• Hosting regulatory inspections and leading inspection readiness activities -
Pharmaceutical Quality And Engineering ConsultantAdvent Engineering Services, Inc. Feb 2013 - May 2017San Ramon, California, UsPharmaceutical Quality and Engineering Consultant• Management of Engineering and Quality personnel • Consent Decree and Compliance Remediation Projects• Facility and Equipment Upgrade projects consisting of Design, Planning, Scheduling, Qualification activities and Project Closure Verification• Verification accountabilities include equipment, utility, computer systems, sterilization, cleaning, production processes, process optimization, product transfer and environmental qualification of facilities• Client Site Sterilization Subject Manger Expertise support• Project Management and Qualification of automated insulin inspection systems• Project Management and Qualification of new Clinical Trail Manufacturing Facility.• Clients: Genzyme, Sanofi Pasteur, Novartis, Novo Nordisk -
Site Engineering And Maintenance Associate DirectorPfizer Jul 2001 - Jan 2013New York, New York, UsAseptic Biotech Facility Specializing in Vaccines• Engineering accountabilities include equipment, utility, computer systems, sterilization, cleaning, production process, process optimization, product transfer and environmental qualification of facilities• Consent Decree remediation; created the validation program and validation SOPs, remediated process hold times, process validation, process mixing, process monitoring, created cleaning monitoring program, created clean hold times, SIP and sterile hold times, and re-qualification program• Responsible for the day to day investigation and troubleshooting of Utilities, Equipment, Computer, Fermentation, Conjugation, and Purification processes in a Quality minded matrix environment• Ensuring compliance through re-qualification programs, continuous facility upgrades, reliability maintenance programs, internal and external audits• SOP creation and remediation to corporate and board of health standards• Batch record creation and review• Site Lead for the corporate Integrated Facilities Management Program utilizing Johnson Controls, Inc. for cost savings• Lead for Site Master Planning for facilities, assets, decommissioning and product exit• Direct supervision of up to a maximum of 23 technical employees and over a 100 contingent workers -
Senior Project Quality Assurance ManagerMonsanto Jul 1998 - Jul 2001St. Louis, Missouri, UsSterile Biotech Drug Manufacturing Facility• Provided engineering and qualification input to A&E firm for all process areas during design of new facility • Planned and coordinated commissioning, startup and validation activities• Verification of equipment and processes of Fermentation, Purification, Aseptic Formulation, Filling and Packaging• Responsible for the review and approval of over 350 protocols, developed maintenance and validation system SOPs • Trained engineers, operators, and other plant personnel on validation and cGMP
Ray Cox Skills
Ray Cox Education Details
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North Carolina State University - College Of ManagementManagement And Engineering -
Duke UniversityOrganizational Leadership
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Sandhills Community CollegeEngineering
Frequently Asked Questions about Ray Cox
What company does Ray Cox work for?
Ray Cox works for Dynamixe, Inc.
What is Ray Cox's role at the current company?
Ray Cox's current role is Vice President Life Sciences.
What is Ray Cox's email address?
Ray Cox's email address is ra****@****ung.com
What is Ray Cox's direct phone number?
Ray Cox's direct phone number is +192554*****
What schools did Ray Cox attend?
Ray Cox attended North Carolina State University - College Of Management, Duke University, Sandhills Community College.
What skills is Ray Cox known for?
Ray Cox has skills like Validation, 21 Cfr Part 11, Fda, Change Control, Gmp, Capa, Pharmaceutical Industry, Biotechnology, V&v, Computer System Validation, Technology Transfer, Management.
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