Zhiying Ho

6 years experience in Biopharma (upstream, downstream analytics)

Past year experience in startup facility with validation work 

Passionate working in non-routine, startup environment

Handled from URS, to DIA, ERES, CSV testing

Production Supervisor at Esco Aster Pte Ltd                                                           JUN 2022-Current

• Demonstrated flexibility, capability and interest in supporting various roles during operations startup- Commissioning & Qualification, production planning, Automation & Engineering, Training
• Authored User Requirement Specifications for analytical, cell banking to Cell Culture equipment
• Internally discussed with production team to procure equipment based on URS
• Assessed various equipment (ancillary, analytical and operational equipment) for System Classification for Qualification and successfully routed for Quality and department approval
•  In-charge of Data Integrity and/or Electronics Records & Signature assessment for critical equipment/systems identified for Environmental Monitoring Process Qualification- example autoclave, passthrough box, fridge & freezers, isolators, incubator, Tulip
• Actively liaised with CQV consultant and internal equipment/system owners to finalize assessment for site operations startup
• Initiated format revision for electronic DIA and ERES forms to aid form traceability and user documentation, further updated contents to reflect CFR Part 21 upon discussion and agreement with QA 
• Authored and successfully routed System Configuration Specifications documents for Drug Substance equipment- Rapid Decontamination System, Cell Processing Isolator, BDS Isolator, 200L Incubator + CelCradle X Bioreactor
• Further revised SCS documents upon CSV testing from protocol execution and CSV exception forms
• Authored internal GMP Installation Qualification and Operational Qualification documents, understood the requirements from the SME and team, achieved document approval on Veeva
• Arranged and participated in vendor and internal IQOQ for various equipment identified for cleanroom and HSA qualification, including CSV testing
• Reviewed and provided feedback on production draft SOPs (gowning, cleaning of classified areas, material movement and sanitization, aseptic technique for cleanroom qualification) and performance qualification document for isolators
• Authored SOPs for operation startup (analytics, access control, BSC operation, cell banking), successfully routed on Veeva
• Worked closely with technical operations lead to set up controlled area access to the cleanroom
• Participated in technology transfer (Retrovirus run) to transfer from Product Development to MFG
• Actively engaged with PD for engineering runs and continuously reviewed and improved for MFG fitness
• Reviewed process batch records for MFG
• Participated in alignment discussions to setup Tulip as part of electronic inventory and process order management for the site
• Led meetings with IT and Automation to setup data backup and archival for critical equipment in the site, drove CAPA to realise the operational workflow together with required supporting documents
• Arranged, drove and heavily involved in vendor FAT and SAT for Drug Substance equipment in the cleanroom- RDS, Incubator, Isolators
• Readily engaged with vendors to troubleshoot, address punchlist and exceptions for successfully FAT and SAT closure, including programming
• Maintained excellent relationship with the team and cross-functional- kept QC associates engaged to support production and validation activities during EMPQ downtime, influenced CQV associates to transfer to production team for IOQ execution and engineering run, trained to handover GMP CSV document writing and management to Automation staff

Senior Manufacturing Associate at Amgen Singapore Manufacturing                 JUN 2016-JUN 2022

• Functional area lead for cell culture team since 2020, extended influence to manage team of 10 associates
• Set team training plans to rapidly achieve goals in evolving manufacturing environment
• Actively prepared manufacturing floor for inspection readiness, participated in Gemba walk with senior leadership team, and in virtual audits
• Championed daily operations meeting, cross functional Continuous Improvement using digital platform (Webex, Spotfire, Smartsheet, Microsoft Teams) to drive alignment
• Led deviation triage initiative with support functions (IS, Automation, F&E, Quality), including deviation re-classified to Major
• Revised and owned Risk Assessment (RA) documents on Amgen Controlled Document Management System (CDOCS): LFH & BSC operation, parts washer, warming cabinet & shaker incubator, single-use bag installation & handling
• Designed upstream leak response protocol to respond to SIUSE technology failures: inoculum prep (hood work), productions bioreactors, flocculation harvest
• Represented MFG on yield improvement initiative with support functions (Process Owner, Product Development, System Owner), covered actions and operational concerns
• Selected instructor for Instructor Led Training (ILT), prepared training materials for new hires on MoF (Manufacturing of Future) cell culture sampling and analytics, MoF small scale and bioreactor operations, inventory management
• Reviewed Standardized Work Guide (SWG) and streamlined operations: real-time sampling, single-use bag operations, Alternating Tangential Filtration (ATF) preparation
• Identified improvement opportunities on current pre-Job Briefing (PJB), drove and re-introduced PJB onto the floor
• Oversaw and handheld team through advancement and/or digitalisation transformation- finite schedule into smart scheduling, Electronic Batch Record (EBR), Product Changeover (PCO) and New Product Introduction (NPI), increased operational run-rate, direct Smartsheet for Supply Quality Management (SQM), electronic Kanban
• Executed and ensured success of engineering run (Aimovig, Soliris), Not For Human Use (NHU) run (Prolia high concentration, Biosimilar), Process Performance Qualification (PPQ) runs (Biosimilars)
• Executed and supported completion of validation activities (media/buffer hold time, cleaning validation for parts washer and manual clean), aligned workflow for execution of NPI cleaning validation
• Identified qualified trainer for Grade 5, environmental monitoring (EM), Single-Use Bioreactors (SUBs) installation and handling, MoF probes, ATF technology, upstream and downstream analytics (UPLC, TOC Analyzer, TOC swabbing, endotoxin)
• Oversaw and communicated team on non-routine activities (contamination response, SUB to SUB transfer), represented MFG in contamination investigation

Research Assistant at KK Women’s and Children’s Hospital                              AUG 2015-FEB 2016

• Genotyped over 700 Perinatal Depression samples for Restriction Fragment Length Polymorphism (RFLP) in ESR1 marker
• Designed primers on samples using Sanger sequencing validation software
• Extracted and purified DNA from patient blood samples for downstream applications
• Supported housekeeping, equipment maintenance and procurement activities subjected to stringent audit checks
• Negotiated and managed contract with external vendors, and worked closely with clinical nurses and research coordinators
• Documented all results, lab activities and paperwork according to strict clinical guidelines

Nanyang Technological University                                                                           AUG 2011-JUN 2015

Bachelor of Sciences in Biological Sciences (Honours)                                         (Graduated August 2015)

• Awarded distinction in relevant coursework: Biochemistry I, Biochemistry II, Advanced Biochemistry, Immunology, Physiology, Current Topics in Muscle Biology and Neuromuscular Diseases, Microbiology, Environmental Microbiology, Principles of Genetics, Advanced Molecular Genetics and Forensic Science
• Selected for NTU’s distinguished Undergraduate Research Experience on Campus (URECA) programme in 2013 and completed a semi-independent study at Lee Kong Chian (LKC) School of Medicine
• Selected for NTU’s Global Education and Mobility (GEM) Explorer Programme in 2013, enrolled in top choice McGill University of Quebec, Canada, studying stimulating courses in Faculty of Science

National Junior College                                                                                                             2007-2009  

• GCE A-Level: 2 As including Mathematics H1 and Art H2
• Graduated with exemplary results from MOE’s Art Elective Programme (AEP), including Art H3 

Cedar Girls’ Secondary School                                                                                                 2003-2006     

• GCE O-Level: 7 distinctions including Biology, Chemistry, Physics, Mathematics, Mandarin Chinese, Art & Design
• Received MOE’s Edusave Scholarship from good conduct and academic performance