（Jeff) Jie Fu Chen Email & Phone Number

Singapore

Singapore

Newly established CDMO service provider specializing in Cell and Gene Therapy (CGT) product development and manufacturing:Validation Role:• Collaborate with cross-functional teams to ensure commissioning, qualification, and validation (CQV) activities align with overall business objectives.• Successfully led the implementation of an electronic Quality Management System (eQMS), enhancing efficiency and compliance.• Partner with Process Development (PD) and Research & Development (R&D) teams to finalize the Process Flow Design (PFD), ensuring seamless integration and scalability.Quality Assurance (QA) Role• Lead the QA team to maintain rigorous oversight, ensuring cGMP compliance and data integrity across all operations.• Serve as the Site Investigation Lead, conducting thorough investigations of quality issues in manufacturing and implementing effective CAPAs.• Develop and implement comprehensive QA/Validation SOPs, overseeing training programs, batch release processes, internal audit and change control systems.• Manage and mentor a team of two specialists, fostering professional growth and ensuring high performance.

Hsinchu County, Taiwan, Taiwan

Led the validation project and collaborated with cross-functional teams for a new drug product line setup, which involved:• Integrating advanced Cytiva-Vanrx fully automated robotic aseptic filling line equipment.• Developing the Vaporized Hydrogen Peroxide (VPHP) sterilization cycle and conducting Aseptic Process Simulation (Media Fill) for the new filling line.• Validating critical facility and utility systems such as Water for Injection (WFI) and gas systems.• Conduct validationfor for controlled environments, including cleanrooms and the warehouse.Ensuring Compliance and Technical Support:• Ensured processes complied with PIC/S GMP quality standards.• Provide support for product and equipment deviation investigations.• Conduct Site GMP Training for processes, equipment, protocols, and regulatory updates.• Manages and cultivates a team of three specialists, providing coaching and mentoring to foster professional development.

Hsinchu City, Taiwan, Taiwan

Responsible for Small-Molecule Antibiotic Drug (Lyophilized):• Validation Activities: Prepares and executes Validation Master Plans and protocols (IQ/OQ/PQ) for various validation activities including Process, Cleaning, Equipment, and Media Fill. • Compliance: Conducts gap analysis, quality risk assessments, annual product review (APR) and internal audit to ensures strict adherence to FDA regulations, cGMP standards, and Pfizer's robust quality systems.• Process Optimization: Identifies and implements improvements to reduce cycle times, optimize resources, and enhance operational efficiency while maintaining product quality.• Deviation Support: Technical support with cross-functional teams for product/ equipment deviation investigation.• Training: Develops and delivers training programs on aseptic processes, equipment, protocols, and regulatory updates.• Collaboration: Works closely with Engineering, and Production teams to support process scale-up.• Project Lead for site internal audit.

Keelung City, Taiwan, Taiwan

Responsible for Pharma Sterile Injectable (Isolator) drug products (Lyophilized):• Proficiency in aseptic practices and principles to ensure sterile manufacturing environments.• Expertise in maintaining and monitoring cleanrooms to meet regulatory standards (ISO Class requirements, cGMP).• Knowledge of sterilization and cleaning techniques such as steam-in-place (SIP), vaporized hydrogen peroxide (VHP), cleaning-in-place (CIP) and autoclaving.• Support validation and engineering teams to executing protocols for equipment qualification, Media Fill, process validation, cleaning validation to demonstrate capability and compliance.• Support QA teams for deviation investigation.

Taichung City, Taiwan