Chadd Criddle Email and Phone Number

Business leader at one of the largest independently owned and operated machine shops in the United States. C&K Departments/Divisions Include:• Nuclear – 10CFR50 Appendix B Nuclear Quality Program with Nuclear Repair (NR) Certificate of Authorization.• CNC Machining – low volume high quality customized manufacturing solutions including precision 4-Axis CNC milling (up to 30’ long) and CNC turning (up to 32’ diameter). 50 ton overhead crane capacity. • Rotating Equipment & Maintenance Machining – repair, overhauls, & upgrades of pumps, valves, turbines, compressors, blowers, fans, shafts, and centrifuges. Services include field machining, laser alignment, and vibration analysis. • Gear Manufacturing & Repair – repair of all O.E.M. gear boxes, precision gear grinding up to 2 meters in diameter, digital bore scope inspection, and design services. • Engineered Pumps – repair of all O.E.M. pumps, hydraulic re-rates, mechanical upgrades, and RC Failure analysis.• Valve Sales / Service – factory authorized distribution and repair with field service. Safety valves, line valves, actuation & instrumentation. Code Stamps: ASME “V” & “UV” and National Board “VR”. Leak detection and repair. • Engineering Services – Laser Tracker, Vibration Analysis, Failure Analysis, Reverse Engineering & Design. • Thermal Spray & Surface Finishing – dimensional restoration and protective coatings using combustion, electric arc, HVOF, and plasma thermal spray technologies. Cylindrical, Spherical, and Surface Grinding. • Welding & Fabrication – fabrication and repair, pressure vessels, and heat exchangers. Code Stamps: ASME “U” & “PP” and National Board “R”.

Areas of proficiency and achievement: o Expert understanding of closed-system bulk vaccine manufacturing business operations with over 13 years experience in biotechnology manufacturing and sterile product quality assurance. o Direct manufacturing supervision and personnel management with commitment to a safe and motivating workplace through employee engagement, development, and empowerment. o Resolution of complex mechanical and technical problems, risk analysis, and increased operational efficiency through right-first-time initiatives. Identification, standardization, and implementation of best practices.o End-to-end development bulk vaccine manufacturing systems: equipment and process automation design, process validation / verification, development of control procedures, personnel training, continuous process improvement, and external regulatory inspection preparedness.Senior investigator in newly chartered support team responsible for root cause analysis, assessment of product impact, and development of corrective / preventative actions – Alum/Buffer/Recombinant Yeast Purification Integrated Process Team.• Investigated complex mechanical, manufacturing, and product testing deviations. Mitigated potential impact to future product lots through active communication, real-time investigation, and development of robust Corrective Action / Preventative Actions (CAPAs).• Provided technical support to three separate capital projects including sterile process / equipment design, a capacity expansion project, and the migration of process automation controls from Provox DCS to Delta V.• Trained and provided guidance to personnel in newly chartered 24/7 Shop Floor Compliance initiative.

Technical expert for bulk vaccine antigen recovery / purification within Biotechnology Manufacturing organization. In addition to responsibilities listed below for Senior Manufacturing Facilitator, this position included the following:• Investigator for manufacturing related deviations (process, equipment, validation)• Primary manufacturing interface for tours and multi-national external regulatory inspections. • Capital project engineering lead for design of piping and process automation associated with two sterile bulk product tanks, a sterile filtration skid, and a bulk product dispensing station. Additionally, the project included design of point-of-use buffer sterile filtration skids, valve sequencing optimization, and enhanced process monitoring.

Lead supervisor responsible for the day to day GMP manufacturing operations occurring in the Recovery and Purification suites including scheduling, oversight, troubleshooting, and training / development of hourly technicians. • Achieved expert understanding of all process areas, including fermentation, purification and recovery, alum diluent, buffer and media preparation. • Technical lead for process improvements including media challenge re-design (process automation and batch record) as well as automation design for pressure testing of the micro-filtration skid and bulk product dispensing stations.• Manufacturing lead for CIP/SIP continuing validation studies. • Identified and implemented lean manufacturing initiatives including SOP re-design, work space re-design, and a sterile equipment inventory management system.

Release Coordinator (West Point Product Release) for raw materials, sterile product contact components, sterile injectibles and opthalmics; reviewed all testing, manufacturing documentation, and investigations prior to determining suitability for product release.

Supervisor (Alum / Buffer) and lead manufacturing investigator for deviations (process, equipment, validation, and environmental).

Technician responsible for manufacture of Alum Diluent, Buffers, Media, Fermentation of Recombinant Yeast, and running Sterile Supply area.