Cheng Han-Ni, Ms, Ipmp - E/Acc Email & Phone Number

Shanghai, China

As PMO Manager at Tri-I Biotech (Shanghai) Inc, my responsibilities include project and program management, strategic planning, and ensuring successful project execution aligned with organizational goals. I work closely with various teams, including sales, technical, development, validation, quality, and operations.In my role, I have established a project monitoring and management baseline from scratch, allowing for effective tracking and control of project progress. By fostering… Show more As PMO Manager at Tri-I Biotech (Shanghai) Inc, my responsibilities include project and program management, strategic planning, and ensuring successful project execution aligned with organizational goals. I work closely with various teams, including sales, technical, development, validation, quality, and operations.In my role, I have established a project monitoring and management baseline from scratch, allowing for effective tracking and control of project progress. By fostering knowledge sharing through KPI planning and training initiatives, I have improved project deliverable quality and accelerated service delivery. I have also developed project management tools to visualize project status and create risk-action plans to address potential challenges proactively.As a solution provider, I support business development and pre-sales activities, identifying potential risks and business opportunities. I actively contribute to pipeline expansion and M&A efforts, successfully transferring and building delivery chains/platforms. Additionally, I create and develop new solutions while providing internal coaching on Computer System Validation (CSV) experiences.Coaching internal project teams in communication skills, Work Breakdown Structure (WBS) techniques, Statement of Work (SOW) modification, and project closure is another crucial aspect of my role. Through effective leadership, I have expanded the PMO team and effectively led a team of three members.Prior to my role as PMO Manager, I served as a Project/Program Manager at Tri-I Biotech (Shanghai) Inc. During that time, I successfully completed over 33 projects related to eQMS implementation and CSV. I was also involved in business process management and gap analysis activities.My experience has equipped me with a comprehensive understanding of project management, a proven track record of successful project delivery, and the ability to drive organizational growth and operational excellence. Show less

Shanghai City, China

REPORT TO THE DEPUTY GENERAL MANAGER Multi-systems Integration Business Architecture Design and solutions *with MES, PLM, ERP, OA and relative master data /operation management systems  Completed 14 projects in eQMS* implantation (with integration) & keep several projects on-going Creating communication tooling between end users & tech. team Tasks shifting and SOW with a compliance and flexible CVS strategy (solution)*eQMS: Honeywell-Sparta TrackWise & TrackWise… Show more REPORT TO THE DEPUTY GENERAL MANAGER Multi-systems Integration Business Architecture Design and solutions *with MES, PLM, ERP, OA and relative master data /operation management systems  Completed 14 projects in eQMS* implantation (with integration) & keep several projects on-going Creating communication tooling between end users & tech. team Tasks shifting and SOW with a compliance and flexible CVS strategy (solution)*eQMS: Honeywell-Sparta TrackWise & TrackWise Digital (QDT), Opentext Documentum, UL ComplianceWire, Labware & relative integration solutions Show less

Auckland, New Zealand

REPORT TO THE VICE PRESIDENT OF R&D Coordinating Consistency Evaluation 6 projects* in NMPA & sorting situation in a short time  On-site project management service & key account relationship Creating kit tooling list for specific project*Cephradine, Calcium Dobesilate capsules, Carbidopa &Levodopa, Metoprolol Succinate, Rabeprazole, Tadalafil

Hsinchu County/City, Taiwan

REPORT TO THE Director OF QAScope: From trail to post-commercialOTC, non-sterile solid drug/sterile injection for chemical or biopharma matters*improving closed-on-time in 3 months (from 30% to 95%)*push long-term improving and monitoring CAPA plans for repeat deviations-environmental monitoring for microbial issues-adequate criteria study for injection process1. Deviation Leader: investigation direction maker, report reviewer & summary report2. Deviation… Show more REPORT TO THE Director OF QAScope: From trail to post-commercialOTC, non-sterile solid drug/sterile injection for chemical or biopharma matters*improving closed-on-time in 3 months (from 30% to 95%)*push long-term improving and monitoring CAPA plans for repeat deviations-environmental monitoring for microbial issues-adequate criteria study for injection process1. Deviation Leader: investigation direction maker, report reviewer & summary report2. Deviation timeline management 3. Coordinator for internal investigation and CAPA system shifting4. Support Change Request initiation/(closure)reviewer5. Support business for closed-on-time and compliance GMP.6. Support internal quality auditing and translation.7. Support client service for quality requirement Show less

Nantou County, Taiwan

Report to the site head, APEC PM Director, GLOBAL Artwork VPNew Product Launch （global supply chain support)- Being on Time Product Serialization SME & Packaging Specialist *System set up from 0% → 100% (from dot to net)*Improving Efficiency from 1 month → 3days (pass 4 working stations at least)*Right First Time from 80% → 100% (no return or scrap)*Trackable from 0% → 100% (core members on track)- Manage the overall process and governance of artwork of… Show more Report to the site head, APEC PM Director, GLOBAL Artwork VPNew Product Launch （global supply chain support)- Being on Time Product Serialization SME & Packaging Specialist *System set up from 0% → 100% (from dot to net)*Improving Efficiency from 1 month → 3days (pass 4 working stations at least)*Right First Time from 80% → 100% (no return or scrap)*Trackable from 0% → 100% (core members on track)- Manage the overall process and governance of artwork of Specification, PBR content, and operation about Client Serialization Requirements and GMP compliance-Set up the internal operation process, overlap global process and serialization agreement (Local Lv1-Lv3, Global Lv4-Lv5)- Coordinate with the artwork design team, global SCM team, global RA team and local technical team for compliance GMP and serialized operation. GS1 Barcode Management Specialist*System set up from 0% → 100% (from dot to net)*Qualification from 0% → 100% (operation available)*Right First Time from 80% → 100% (unknow to know well)- Induction and provide GTIN encoding for aggregation (or non-aggregation) from Global Policy- Provide training and lead members to operate with S&OPs - Provide continuous enhancement and review of GTIN (with serialization set up) S&OP for operation SAP HANA MM&PM SME & FG/PKM/artwork Master Data Management*System set up from 0% → 100% (from dot to net)*Team up from 0% → 100% (seed to whole dept.)*Right First Time from 80% → 100% (no major deviations)-Manage the overall process and governance of master data creation and maintenance to ensure consistency across the corporation for all Master and Reference data-Manage the data requirements for the implementation of new locations and new products-Audit data quality of all master and reference data across all locations and coordinate resulting data cleansing activities-Provide continuous enhancement and review of MDM matching rules, data quality, and validation processes Show less

Nantou County, Taiwan

*Improving Efficiency: 4wks → 2wks (relative documents preparation)*On time: 60% → 95% (actual/expected)*Team up: 00% → 100% (seed to whole dept.) Serialization importing assist with logistical concepts and training  Team leader of Assets management calibration management with Blue mountain  internal site (production) system management and administration writer CapEx project manager (equipment major or scale up) Business process modeling SAP HANA… Show more *Improving Efficiency: 4wks → 2wks (relative documents preparation)*On time: 60% → 95% (actual/expected)*Team up: 00% → 100% (seed to whole dept.) Serialization importing assist with logistical concepts and training  Team leader of Assets management calibration management with Blue mountain  internal site (production) system management and administration writer CapEx project manager (equipment major or scale up) Business process modeling SAP HANA MM&PM SMEsequipment and.Computer system validation Leading a 4-person group Show less

Nantou County, Taiwan

 FDA/EMA/PMDA/TFDA plant tour and be audited-PIC/S GMP compliance. Oral form process deviation & process improving leader - sustained (coated) tablet/capsule and soft capsule Tablet PTP, Alu/Alu, bottle packaging Importing SAP- Manufacturing MTD SME (on-going, since kickoff-present, approximately 1y project) Importing QUMAS system finished and keep following trouble shooting (end user) GMP facility: Maintain and improve Project management: leader and team up.… Show more  FDA/EMA/PMDA/TFDA plant tour and be audited-PIC/S GMP compliance. Oral form process deviation & process improving leader - sustained (coated) tablet/capsule and soft capsule Tablet PTP, Alu/Alu, bottle packaging Importing SAP- Manufacturing MTD SME (on-going, since kickoff-present, approximately 1y project) Importing QUMAS system finished and keep following trouble shooting (end user) GMP facility: Maintain and improve Project management: leader and team up. Improving cleaning system (estimation of one detergent estimation done, various are on-going with validations) Risk Management: Failure Mode and Effects Analysis (FMEA) & Root Cause Analysis (RCA) - replying and be audited author. Validation design/ plant study design and execution  Global quality improving program team Show less

Taipei City, Taiwan

It donated by Terry Kuo, who are the CEO of Hon-Hai. I wrote a CLike proposal and expected captital. CLike would provide a high-relative preclinical assay ( high-barrier service) for individual medical.CLike brief BP here >> http://www.slideshare.net/ChengHanNi/c-like-business-model-20160901-update1. Products Research & Development2. Clinical Trials 3. Patent Map4. Marketing 5. Operational and financial planning6. Company operation (business… Show more It donated by Terry Kuo, who are the CEO of Hon-Hai. I wrote a CLike proposal and expected captital. CLike would provide a high-relative preclinical assay ( high-barrier service) for individual medical.CLike brief BP here >> http://www.slideshare.net/ChengHanNi/c-like-business-model-20160901-update1. Products Research & Development2. Clinical Trials 3. Patent Map4. Marketing 5. Operational and financial planning6. Company operation (business operation)7.Focus on healthcare8.Business model pattern setup and validation9.Road-show 10.Business development Show less

Tainan City, Taiwan

 The Second author of JSR- Exendin-4, a glucagon-like peptide-1 analogue, accelerates diabetic wound healing. 2016 Protocol set up and experiment design Decreasing least 80% laboratory animal management cost Operating animal models-ICCUA writing/applying/qualification Molecular biology assay: including parameter testing, data collection and analysis IRB qualification

Taichung City, Taiwan

Being served as teaching assistant in course of Animal Reproduction in Summer 2009-2012.-Individually in reproductive tracts -team work in vivo production (IVP:IVM,IVA,IVF)-stem cell culture (maintain/differentiation/scale up)-embryonic stemcell differentiation and system build up

Master Of Business Administration - Mba, Project Management

Master Of Science - Ms, Biology Technician/Biotechnology Laboratory Technician

Activities and Societies: Co-guided with National Cheng Kung University Medical College The Second author of JSR- Exendin-4.