Hsin-Ying Lin
Manager, Project Management at TaiMed Biologics Inc- Claim this Profile
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Madarin Native or bilingual proficiency
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English Full professional proficiency
Topline Score
Bio
Credentials
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Clinical Research Training Program Certification
Foundation of Medical Professionals Alliance in Taiwan (FMPAT)Oct, 2015- Sep, 2024 -
Project Management Professional (PMP)
Project Management InstituteMar, 2018- Sep, 2024
Experience
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Manager, Project Management
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Jan 2022 - Present
• Manage contract manufacturing organization (CMO) projects on the commercialized product. Activities include commercial logistics, commercial campaign readiness, and coordinating project-related communications.• Manage in-house R&D project. Activities include budget estimate, development and manufacturing timeline control, and facilitating cross-functional collaboration.• Manage administrative activities including operational budget allocation, expense monitoring, cost control, and asset management since 2018.• SAP SD and MM module major user since 2017.• Oversee procurement activities since 2020.
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Associate Manager, Project Management
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Jul 2020 - Jan 2022
• Managed contract manufacturing organization (CMO) projects. Activities include process validation and pre-commercialized manufacturing.• Prepared for drug facility cGMP readiness.
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Senior Specialist, Project Management
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Jan 2019 - Jun 2020
• Set up a new branch with SMEs from different areas. Activities include internal control system setup, asset management, budget control, and SAP system build-up.• Developed and monitored timeline for protein drug facility GMP/GDP qualification, including manufacturing, utility qualification, and warehouse readiness.• Managed validation activities, tech transfer, method transfer, and supply chain management executed by Contract Manufacturing Organization (CMO).
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Specialist, Project Management
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Apr 2018 - Dec 2018
• Managed facility construction project timeline and budget.• Assisted the Manufacturing and QC Department with equipment procurement, delivery, and qualification tasks.• Contract negotiation and supplier management.
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Associate, Clinical Operations
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Sep 2015 - Mar 2018
[Clinical Operations]• Monitored the progress of clinical trials.• Clinical drug logistics and management.[New Protein Drug Facility Construction Project]• Facility conceptual, basic, and detail design phase.• Protein drug production process development.• SWOT analysis of equipment suppliers and choose the ones that fit the facility design most.• Procured equipment and contract negotiation with equipment suppliers.
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Taipei Medical University Hospital
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Taiwan
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Hospitals and Health Care
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1 - 100 Employee
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International Healthcare Coordinator
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Jun 2014 - Jul 2015
• Coordinated international affairs• Planned training courses for exchange medical experts• Conducted projects on JCI (Joint Commission International) Accreditation• Processed affairs of the Swaziland medical mission team • Coordinated international affairs• Planned training courses for exchange medical experts• Conducted projects on JCI (Joint Commission International) Accreditation• Processed affairs of the Swaziland medical mission team
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Practicum
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Feb 2014 - Apr 2014
• Performed statistical analysis on Behavioral Risk Factor Surveillance Systems (BRFSS)• Researched on the relationship between mental health and social demographics • Performed statistical analysis on Behavioral Risk Factor Surveillance Systems (BRFSS)• Researched on the relationship between mental health and social demographics
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Education
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2012 - 2014
University of South Carolina-Columbia
Master's Degree, Health Services Policy and Management -
2006 - 2010
Taipei Medical University
Bachelor of Science (BS), Public Health
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