Ryan Mingcay Email & Phone Number

Canada

Reykjavík, Capital Region, Iceland

 Shift lead in downstream operations for production of biosimilar Bulk Drug Substance (monoclonal antibody) products. Worked closely with Managers to ensure performance metrics are achieved for downstream operation (production schedule, Batch Records, Deviation closures and Operators trainings) Specialized in downstream equipment such as Pall Cadence VI, BioSMB Process Continuous Chromatoghraphy, Pall Allegro MVP Advanced (Viral Inactivation), GE AktaProcess Chromatography Skids… Show more  Shift lead in downstream operations for production of biosimilar Bulk Drug Substance (monoclonal antibody) products. Worked closely with Managers to ensure performance metrics are achieved for downstream operation (production schedule, Batch Records, Deviation closures and Operators trainings) Specialized in downstream equipment such as Pall Cadence VI, BioSMB Process Continuous Chromatoghraphy, Pall Allegro MVP Advanced (Viral Inactivation), GE AktaProcess Chromatography Skids, Pall MVP Basic (Nano filtration), Pall Allegro CS1000 Single-Use Tangential Flow Filtration System, Parker Bulk Dispensing Unit, HOF Freeze/Thaw Unit and CYTIVA Systems (XDuo Mixers, Harvest/NFF Skids, AKTA Bioprocess 1 inch skid and AKTA readyflux XL). Subject matter expert (SME) for downstream operations (Chromatography, Viral Inactivation, Nano Filtration, UFDF, Bulk Filling, Freezing). Actively involved in troubleshooting issues. Support Pre-Approval Inspection (PAI) and Regulatory agencies such as EMA and FDA. Collaborated with MSAT and Validation Team for execution of equipment qualification and cleaning validation. Supports Technology transfer of processes to large manufacturing scale. Support initiation of Change control, Document Change Control and Deviation. Proactively initiated continuous improvement contributes to trending and evaluating process data, proposing, and implementing cGMP and business improvement initiatives in downstream operation. Show less

Singapore

 Specialized in Single Use Technologies (SUT) for downstream equipment and materials. Part of first fully licensed biomanufacturing facility in Singapore. Supports the execution of 3.5days run rate in downstream operation for production of Bulk Drug Substance (human monoclonal antibody). Experts in Downstream set-up and operation such as Protein A affinity chromatography, Viral Inactivation, Cation exchange chromatography, Hydrophobic interaction chromatography, Anion Exchange… Show more  Specialized in Single Use Technologies (SUT) for downstream equipment and materials. Part of first fully licensed biomanufacturing facility in Singapore. Supports the execution of 3.5days run rate in downstream operation for production of Bulk Drug Substance (human monoclonal antibody). Experts in Downstream set-up and operation such as Protein A affinity chromatography, Viral Inactivation, Cation exchange chromatography, Hydrophobic interaction chromatography, Anion Exchange Chromatography (AEX), Viral Filtration, Ultrafiltration/ Diafiltration and Bulk Fill. Trainer and conduct analytical analysis of in-process sampling for protein concentration, pH, conductivity, endotoxin, turbidity using downstream instruments such as SOLO VPE, pH meter GE TOC Siever and Endosafe Portable Test System. Proactively monitor and analyze critical process parameters for downstream processes. Collaborate with Product Development team and contributes to the successful execution of various new product technology transfer, Process Performance Qualification (PPQ) runs for a multiproduct milestone and successful regulatory (BLA and FDA) approval. Trained in electronic Batch Records (Werum PAS-X MES), Delta V, SAP, Maximo and LIMS. Participated in execution and coordination of downstream equipment cleaning validation activities. Supports and improves KANBAN and 6S for downstream area. Show less

35 Tuas South Avenue 6, Singapore 637377

 Section Lead deputy role in Upstream operation to adhere 3.5days run rate. Leading 10 biotechnologists, ensures implementing of GMP practices, executing production schedule and actively collaborated with MSAT, QA and Management Hands-on in Cell Culture (CHO cell line) operation from Thawing, Passaging, Media Preparation, Fermentation and Primary Recovery.  Trainer in Aseptic technique and preparation of stainless-steel bioreactors for large-scale mammalian cell culture production… Show more  Section Lead deputy role in Upstream operation to adhere 3.5days run rate. Leading 10 biotechnologists, ensures implementing of GMP practices, executing production schedule and actively collaborated with MSAT, QA and Management Hands-on in Cell Culture (CHO cell line) operation from Thawing, Passaging, Media Preparation, Fermentation and Primary Recovery.  Trainer in Aseptic technique and preparation of stainless-steel bioreactors for large-scale mammalian cell culture production. Suite capacity from 4 x 200L to 4 x 20,000 liters Bioreactors. Execute and analyze assay testing for daily in-process sampling using various assay instruments.  Executing commissioning and validation protocols for CIP and SIP equipment. Maintain and update Upstream Standard Operating Procedures (SOPs), Logbook and Batch Records and ensures Good Document Practices effectively. Monitors Critical process parameters and troubleshoot process abnormalities. Support Deviation investigation and CAPA closures. Experienced in PWCS (Plant Wide Control System - DELTA V), QC LIMS and SAP Supports EHS audit, Customer and Regulatory Audits. Implemented various projects to improve equipment cleaning effectiveness, KANBAN improvement and reduction of EHS incident. Show less

22 Ang Mo Kio Industrial Park 2, Singapore 569506

 Engineer in BGA (Ball Grid Arrays) Equipment Engineering to provide overall maintenance support for production operation. Hired as pioneering team to set-up the Preventive Maintenance and Equipment Engineering at BGA Department. Supports product ramp-up and product transfer from Japan to Singapore.  Supervised Associate Engineer in their daily shift activities. Responsible for equipment qualification, improvement project and preventive maintenance for Transfer /… Show more  Engineer in BGA (Ball Grid Arrays) Equipment Engineering to provide overall maintenance support for production operation. Hired as pioneering team to set-up the Preventive Maintenance and Equipment Engineering at BGA Department. Supports product ramp-up and product transfer from Japan to Singapore.  Supervised Associate Engineer in their daily shift activities. Responsible for equipment qualification, improvement project and preventive maintenance for Transfer / Compression Molding (TOWA), Laser Marking (HANMI Rofin Sinar & EO Technics), Heatsink Attach and Post Mold Cure ovens (ESPEC). Liaising with Vendor for equipment innovation and spare parts management Planning and Management of Periodic Maintenance for Automated Equipment, Mold Tooling, Conversion kit and Equipment Spare Parts. Study and plan TPM (Total Productive Maintenance) and MTBF (Mean Time Between Failure) for machine performance improvement. Implement cost saving programs by process optimization that minimize material wastage, by sourcing-out an economical supplier and qualification of alternate material source. Show less

No. 37, Hsin-Tai Rd. Chu Pei Hsin-Chu, 302, Taiwan R.O.C.

 Support production in meeting output and “Quality & Reliability” (Q&R) through technical service in resolving product/equipment issues Perform periodic preventive maintenance to ensure consistent performance with high degree of production and reliability. Perform the daily set up, conversion and troubleshooting in ATE and Wafer Prober such as TEL and TSK.  Assign as Equipment Engineer in Manufacturing Assembly for production of Mixed Signal Devices such as PDIP, PLCC, SOJ… Show more  Support production in meeting output and “Quality & Reliability” (Q&R) through technical service in resolving product/equipment issues Perform periodic preventive maintenance to ensure consistent performance with high degree of production and reliability. Perform the daily set up, conversion and troubleshooting in ATE and Wafer Prober such as TEL and TSK.  Assign as Equipment Engineer in Manufacturing Assembly for production of Mixed Signal Devices such as PDIP, PLCC, SOJ, SOP, QFP, LQFP, TQFP, and TSOP. Support Mold project improvement to improve machine efficiency and package quality issues Perform equipment movement and Mechanical/Electrical hookup. Performed set-up conversion and major troubleshooting on Pre-heaters, Auto-loaders, Hydraulic Mold Press (KK & JI CHENG) and Automold machines (TOWA, DAICHI, GPM). Monitor Mold tools and spare parts and perform assemble and disassemble of mold tool. Show less

119 North Science Ave. Special Economic Processing Zone

 Assigned as Maintenance Supervisor to oversee the Technician’s daily activities and line deployment Perform TPM and Process improvement to resolves product issues in BGA from MOLD (ASA & FICO MARKII), MARKING (EO Technics & Dongyang Rofin Laser Head), BALL ATTACH (Poongsan & Vanguard) and SINGULATION Punch (HANMI). Performed equipment tooling modification and innovation for continuous yield improvement. Performed buy-off of newly acquired Mold Machines, Mold Tool and System… Show more  Assigned as Maintenance Supervisor to oversee the Technician’s daily activities and line deployment Perform TPM and Process improvement to resolves product issues in BGA from MOLD (ASA & FICO MARKII), MARKING (EO Technics & Dongyang Rofin Laser Head), BALL ATTACH (Poongsan & Vanguard) and SINGULATION Punch (HANMI). Performed equipment tooling modification and innovation for continuous yield improvement. Performed buy-off of newly acquired Mold Machines, Mold Tool and System Conversion Kit.  Generate Equipment FMEA, DOE and MTBA/MTBF for Quality, Productivity, Yield and Maintenance Cost Improvement programs. Assists in the monitoring, maintenance and review of equipment performance records such as Equipment History, Equipment Trouble Records, Equipment PM Records, TCMs and SPC Records. Show less

119 North Science Ave. Special Economic Processing Zone

• Practiced On-The-Job Training and hired by the company as one of their Mold Technician based from the Training Competency Evaluation they made.

Bachelor’S Degree, Bachelor Of Science In Mechanical Engineering

Associate’S Degree, Mechanical Technology