Ryan Cox
Fuquay-Varina,NC
Summary
Highly effective Operations Leader with over nineteen years of progressive experience in the purification of human plasma-derived therapeutics, as well as multiple fermentation and chemical manufacturing processes. Proven record of collaborative work with all levels of the organization to ensure a high level of engagement and productivity. Track record of exceeding goals and deadlines throughout career in a wide variety of environments.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Senior Director, Manufacturing Operations
Amyris, Inc
04.2021 - Current
- Responsible for the scale-up and commercialization of a novel, fermentation-derived alternative to shark squalene for vaccine formulation
- Served as a manufacturing SME in a Joint Venture for the development of an SA-RNA Covid-19 vaccine for early stage clinical trials
- Leveraged years of experience in the pharmaceutical industry to implement best practices and elevate the knowledge base at Amyris in regards to cGMP requirements
- Led US manufacturing activities of multiple molecules in the beauty products and flavors and fragrances sectors
- Manufacturing responsibilities included a chemical production site with approximately 40 employees, as well as oversite of multiple Contract Manufacturing Organizations in the US
- Accountable for the resource allocation and operational budgets for all US manufacturing activities.
Operational Services Director, Bulk Manufacturing
CSL Behring
08.2020 - 04.2021
- Responsible for managing and directing all activities required to support the operational needs of Manufacturing in the Bulk Mfg value stream
- Responsible for leading an Operational Subject Matter Expert group to manage and improve operational services including: process change management, issue/deviation resolution, continuous improvement, training, and transfer of newly developed processes including process improvements to support manufacturing growth and efficiency
- Accountable for the resource allocation and operational budgets of the operational services group aligned to the manufacturing organizations goals and objectives
- Manages and delivers cross-functional manufacturing projects to improve safety, productivity, quality, and customer satisfaction and/or reduce risk with particular focus on change controls, risk assessments, deviations, CAPAs and audits
- Supports future production capacity and capability expansion programs by contributing expertise and resources in specific operational service processes and disciplines
- Champions efforts to identify best demonstrated process methods/practices and ensures harmonization of manufacturing practices with global operations standards.
Strategic Improvements Lead
CSL Behring
09.2018 - 08.2020
- Provided dedicated leadership for short, medium and longer-term activities and plans for a key CSL commercial product
- Lead a cross functional team to develop and implement, in collaboration with manufacturing, improvements to the process
- Key deliverables were productivity, yield and robustness improvements
- Facilitated debottlenecking of the manufacturing process to increase capacity, operational efficiency and to reduce costs
- Reviewed assessments of repeat deviations and product losses and worked with teams to implement engineering solutions in place of administrative controls
- Assessed and prioritized based on current business needs improvements/best practice opportunities for the product, and selected those opportunities that provided meaningful benefits to the company and patients
- Drove efficiency improvements and cost reductions in production
- Aligned the strategies with the longer term needs of the company
- Provided expert technical leadership for the product
- Lead a search for a CMO to perform drug product filling and lyophilization for the product
- Identified partner, assisted in execution of agreements, and drove technology transfer to the CMO.
Director, Bulk Manufacturing
CSL Behring
01.2014 - 09.2018
- Responsible for an organization of 200+ employees
- Ensured departments were operating in compliance with cGMP, including equipment/facility upkeep and timely completion of corrective actions
- Ensured departments met the production plan, including yield and throughput
- Provided direction, support, and prioritization for process / facility improvements, coordinating with support groups as necessary
- Formulated succession plan for manufacturing departments and ensure proper staff development
- Developed and implemented procedures to ensure all products are manufactured in facilities and with equipment meeting all regulatory requirements
- Planned for optimum utilization of manpower, equipment, and materials through effective production control techniques
- Compiled, analyzed and published production reports on a monthly basis
- Led project teams for process improvements and product expansion
- Served as lead for the initial implementation of Autonomous Management at the site as part of a continuous improvement program.
Manager, Clinical Manufacturing
CSL Behring
11.2011 - 01.2014
- Ensured cGMP compliance in the operation of clinical manufacturing areas
- Applied applicable levels of GMP requirements based on the phase of clinical manufacturing
- Facilitated technical transfer of clinical scale production to commercial scale manufacturing
- Maintained validated cGMP status of clinical manufacturing facilities
- Performed qualification of processes, equipment, and facilities as required
- Acted as the Clinical Manufacturing Lead by collaborating with Manufacturing, Research and Development, and other departments to lead clinical manufacturing projects
- Supervised scientific staff conducting cGMP clinical manufacturing of therapeutics and/or APIs.
Process Scientist, Bulk Manufacturing
CSL Behring
02.2008 - 11.2011
- Completed multiple process improvement and cycle-time reduction projects
- Developed manufacturing procedures and SOP’s
- Worked closely with members of various departments including Validation, Engineering, Quality, Purchasing, and R&D
- Obtained Six Sigma Green Belt certification
- Trained in risk management utilizing FMEA
- Recognized as a subject matter expert for the manufacturing process
- Tracked several yield and quality attributes and provided monthly reports to senior management
- Gave multiple presentations to large groups related to the manufacturing process.
Scientist I, Adjuvant Manufacturing
CSL Behring
01.2006 - 02.2008
- Lead the transfer and development of a small-scale process for the manufacture of an adjuvant for use in clinical trials
- Gained experience in preparative HPLC, sterile filtration, and UF/DF
- Worked closely with management to develop manufacturing schedules and capacity analyses
- Developed strong working relationships with members of different departments, including Validation and Engineering
- Given the lead role in a 16X scale-up of the process
- Worked with engineers to qualify systems, develop a process flow, and troubleshoot technical issues.
Associate Scientist, Technical Operations
CSL Behring
02.2005 - 01.2006
- Experience with down-scale qualification for material replacement/process modification
- Worked with cold alcohol human plasma fractionation – particularly steps involving filtrations
- Developed protocols and reports related to each step in the material qualification process.
Education
Bachelor of Science - Biology
Eastern Illinois University
Charleston, IL12.2004
Skills
- Operational leadership
- GMP
- Deviation investigation
- Protein purification methodologies
- Collaboration
- Technology Transfer
- Continuous improvement
- Lean Six Sigma
- Operational Excellence
- Regulatory agency interactions
- Change Management
- Process Scale-up
Education Certifications
- Bachelor of Science in Biology, Eastern Illinois University, Charleston, IL
- Lean Six Sigma Green Belt, STAT-A-MATRIX
Volunteer Experience
St. George School District #258, School Board Secretary, 09/2016, 06/2023
Certification
Lean Six Sigma Green Belt
Timeline
Senior Director, Manufacturing Operations
Amyris, Inc
04.2021 - Current
Operational Services Director, Bulk Manufacturing
CSL Behring
08.2020 - 04.2021
Strategic Improvements Lead
CSL Behring
09.2018 - 08.2020
Director, Bulk Manufacturing
CSL Behring
01.2014 - 09.2018
Manager, Clinical Manufacturing
CSL Behring
11.2011 - 01.2014
Process Scientist, Bulk Manufacturing
CSL Behring
02.2008 - 11.2011
Scientist I, Adjuvant Manufacturing
CSL Behring
01.2006 - 02.2008
Associate Scientist, Technical Operations
CSL Behring
02.2005 - 01.2006
Bachelor of Science - Biology
Eastern Illinois University
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