Winna Yang
Singapore
Summary
Senior Manufacturing Manager with 8 years experience in aseptic drug product manufacturing, process validation, and technology transfer within biopharmaceutical environments.
Proven expertise in aseptic filling and lyophilization, with track record in equipment qualification, contamination control strategy, and end-to-end technology transfer.
Skilled in CPP/CQA definition, control strategy development, and process risk management (FMEA/HAZOP). Recognized for leading complex technical problem-solving, enabling robust process validation, and ensuring compliance with EU GMP Annex 1 and FDA aseptic guidance.
Overview
8
8
years of professional experience
Work History
Senior Manager, DP Aseptic Manufacturing
Wuxi XDC Singapore Pte. Ltd.
Singapore
08.2025 - Current
- Provide technical leadership and oversight for aseptic drug product manufacturing, with current focus on equipment qualification (OQ/PQ), aseptic process simulation design, and contamination control to ensure GMP readiness.
- Act as a subject-matter expert (SME) in aseptic processing, partnering with Validation, Engineering, and Quality teams to ensure robust execution of qualification activities and alignment with regulatory expectations.
- Lead and influence key activities including:
- Equipment qualification (OQ/PQ) for aseptic processing systems (filling line, isolator VHP, lyophilizer, CIP/SIP), providing protocol review, technical oversight, and decision-making during execution
- Aseptic process simulation (APS/media fill) design, including intervention definition, risk assessment, and support of worst-case scenario development
- Contamination control strategy, including intervention optimization, airflow visualization (smoke studies), and Environmental Monitoring Risk Assessment (EMRA) using BioPhorum principles
- Technical troubleshooting and deviation management, leading resolution of issues encountered during qualification and applying structured root cause analysis and CAPA
- Building and leading a high-performing aseptic manufacturing team, including 24 direct reports across filling and lyophilization, coaching for operational excellence, and developing team capability to support GMP operations
- Drive cross-functional collaboration to align on validation strategy, resolve technical challenges, and ensure operational readiness for aseptic manufacturing.
Technical Operations Engineer
MSD Singapore (Pharm & API)
Singapore
09.2026 - 07.2026
- Provided technical engineering support across the pharmaceutical product lifecycle, building strong foundational expertise in process understanding, qualification, and continuous process verification within GMP manufacturing.
- Supported a wide range of activities including new product introduction, production capacity expansion, process qualification, deviation investigations, and continued process verification (CPV), while driving data-driven improvements in process performance and product quality.
- Key Contributions & Achievements
- Supported process development, scale-up, and qualification for commercial products, including supporting granulation process development and qualification runs for Janumet to enable volume ramp-up.
- Led continuous improvement initiatives to enhance operational efficiency, including:
- Reduction of granulation and cleaning turnaround time
- Harmonization of cleaning monitoring approaches across manufacturing units
- Conducted and led complex deviation investigations, including stability-related issues for Asmanex, applying structured root cause analysis and implementing effective CAPAs
- Led process qualification and change implementation, including lactose micronization process changes to enable alternate raw material sourcing
- Established proactive process monitoring and analysis frameworks, strengthening continued process verification and process robustness
- Supported technology transfer activities for API manufacturing, including process assessment and qualification runs for Sugammadex, and post-qualification lifecycle activities (change control, documentation updates)
- Contributed to cleaning validation and monitoring, ensuring compliance with GMP requirements and consistency across manufacturing processes
Manufacturing and Tech Transfer Project Manager
Thermo Fisher Biopharma Service Pte. Ltd.
Singapore
06.2022 - 08.2025
- Technology Transfer & Project Management
- Drafted technology transfer plans and led planning and execution of tech transfers from internal sites and external clients (CDMO environment), performing fit-gap assessments of equipment and process readiness and enabling effective cross-site knowledge transfer.
- Designed and implemented single-use materials and components for use in single-use systems, ensuring compatibility, sterility assurance, and suitability for aseptic processing.
- Supported APS/media fill process simulation and intervention planning to ensure aseptic process robustness.
- Contributed to control strategy and process risk assessments (FMEA) to ensure operational readiness.
- Project Management & Cross-Functional Leadership
- Led cross-functional projects including new sterile filling line qualification and Singapore Digital Line digital twin/AR/VR training initiatives.
- Partnered with Supply Chain and IT teams to deploy SAP for GMP manufacturing.
- Provided weekly project updates (4-UP) to senior leaders and facilitated After Action Reviews (AARs) to identify process and team improvements.
- Oversaw equipment qualification (CQ/PQ) and process validation, providing technical review, guidance, and issue resolution.
- Operational Readiness & Continuous Improvement
- Built a high-performing aseptic manufacturing team with direct management of 24 direct reports; coached and mentored staff to drive GMP readiness and operational excellence.
- Implemented lean manufacturing practices: tier standard work, consumable management (Kanban), 5S, and production standard work.
- Participated in budget planning, cost control, and supplier optimization, achieving controlled consumable spending below budget.
- Cross-Cultural & Global Collaboration
- Collaborated with EU and US colleagues on knowledge transfer and Augmented Execution System (AES) digital initiatives.
- Attended internal benchmark visits to other global sites to incorporate best practices.
- Talent Management & Leadership
- Conducted performance coaching, one-on-one feedback, and team development, leading change initiatives to strengthen team structure and capability.
- Recognized for driving key plant start-up milestones, receiving awards for outstanding site contributions.
Operations Technical Lead and DP Manufacturing Manager
MSD Singapore (Biotech)
Singapore
08.2018 - 06.2022
- Operations Technical Lead (Sterile Drug Product)
- Acted as technical lead for process robustness, quality systems, and inspection readiness
- Led Deviation Management & Utilities Alarm Management workstreams; achieved zero audit observations
- Certified Root Cause Investigator; coached teams on structured problem-solving
- Supported PPQ and APS (media fill) readiness and execution
- Led continuous improvement initiatives to enhance microbial control and environmental cleanliness
- Streamlined SOPs across production suites, improving consistency post-upgrade
- Manufacturing Manager (Aseptic Filling & Lyophilization)
- Promoted to lead aseptic manufacturing operations and NPI (New Product Introduction) workstream
- Provided business owner approval for project documentation and process implementation
- Participated in HAZOP and led operational safety risk assessments
- Defined roles and aligned teams to deliver project milestones and validation readiness
- Coached operations teams to support aseptic validation and GMP manufacturing
- Delivered commercial production campaigns with 100% schedule adherence
- Supported upgrade of critical sterilization equipment, improving system reliability
Education
Master in Business Administration - General Management
Nanyang Business School (Nanyang Technological University)
Singapore08.2024
Bachelor of Engineering - Chemical and Biomolecular Engineering
Nanyang Technological University
Singapore06.2015
Skills
- Aseptic Manufacturing
- Environmental Monitoring Risk Assessment
- Intervention Design
- Intervention Risk Assessment
- Aseptic Process Simulation Design
- Single Use Technology and Design
- Sterile Fill-Finish (Aseptic Fill and Lyo)
- Coaching
- Technology Transfer
- Production Planning
- Change Management
- Audit and Inspection
- Continuous Improvement
- Troubleshooting and problem resolution
- Air Flow Visualization Study
- Cross-functional collaboration
- Budget oversight
- Cross-functional team coordination
Interests
Hiking - Enjoy exploring nature and outdoor environments, Badminton - Regularly play to maintain health and fitness
Hiking - Enjoy exploring nature and outdoor environments
Hiking - Enjoy exploring nature and outdoor environments
Badminton – Maintain an active lifestyle through regular play
Languages
English
Bilingual or Proficient (C2)
Chinese (Mandarin)
Intermediate (B1)
Indonesian
Intermediate (B1)
French
Beginner (A1)
German
Beginner (A1)
Timeline
Technical Operations Engineer
MSD Singapore (Pharm & API)
09.2026 - 07.2026
Senior Manager, DP Aseptic Manufacturing
Wuxi XDC Singapore Pte. Ltd.
08.2025 - Current
Manufacturing and Tech Transfer Project Manager
Thermo Fisher Biopharma Service Pte. Ltd.
06.2022 - 08.2025
Operations Technical Lead and DP Manufacturing Manager
MSD Singapore (Biotech)
08.2018 - 06.2022
Bachelor of Engineering - Chemical and Biomolecular Engineering
Nanyang Technological University
Master in Business Administration - General Management
Nanyang Business School (Nanyang Technological University)