Ly Chen Email & Phone Number

- Lead CDMO and self-development projects at OEP group covering oral and injectable product- Oversee US submission progress, prepare CMC sections and monitor regulatory compliance- Provide transparent information in precisely and manage communication up, down and across organization.- Identify and manage risks with contingency plans and mitigating activities.- Efficiently oversee and manage a portfolio of 6 CDMO projects

台灣 臺北市 台北

South Taiwan

- Business Development Evaluate market opportunities, sales potentials and develop these leads into CRO project Negotiate contracts with external customers and prepare business proposals to efficiently respond to requests for project pricing, timeline information, etc. Act as primary liaison with client to build long term relationship and improve service satisfaction Attend trade shows to meet current and potential customers- Project Management Participate customer visit and lead presentations with prospective clients along with internal technical experts to demonstrate company expertise Develop client-specific project strategies to align with clinical status and customer needs Coordinate operation department to implement prospect manufacture schedule to initiate production on time and fulfill requirement from customers Hands on experiences on project in diverse clinical phase

Taoyuan, Taiwan

- Acts as primary liaison with client  Acts as lead contact for regional and or/project matters.  Understands/manages/satisfies customer contractual, organizational and relationship  Provide regular reporting on project metrics, status of deliverables and risks/ issues with the associated management plan to client.  Chairs and leads customer meetings. - Leads and directs cross-functional team leaders and third parties/vendors  Guides and supports team leads in prioritizing, trouble-shooting and contingency planning.  Communicate project specific priorities.  Liaise with functional leads/managers to optimize performance and utilization of project team members. - Manages project contractual deliverables  Supervise progress via metrics.  Monitors and ensures adherence to the contractual agreement (time, quality and deliverables).  Leads presentation of internal project status reviews and is accountable for action item follow up.  Proactively identifies, resolves/mitigates and escalates risks and/or issues. - Documentation and on-site Audit  Participate in site GMP audit by customers  Ensure adherence to company SOP, policies and guidelines at the project level.

Taoyuan, Taiwan

- Key person for project validation activities  Manage Process Validation Master Plan/ Reports, IOPQ protocol and reports. Execute semi-auto testing machine validation, assembly machine validation and Process validation activities.  Design and perform challenge tests and window finding for upper and lower limit.  Data collected and analysis  Deviation handling  Initiate deviation report and host meetings.  Cooperate with designer, QA, production expert to solve the deviation in a timely manner.  Conduct studies and experiments with materials, processes and recommend changes in procedures to improve quality.  Troubleshoot and work on Company matters and related Corrective and Preventative Actions. - GMP compliance documentation  Ensure proper documentation is completed to meet regulatory, customer, and quality system requirements.  Support GMP compliance efforts.

Taipei, Taiwan

- Responsible for technical transfer  Transfer production/ facility maintenance procedures, QC method and technical experiences from Taiwan site to China site.  Provide trainings to QC and operators - New project implement  Initiate BOM, working instructions and corresponding records for new project.  For approved R&D projects, initiate, implement, monitor, and manage to ensure project delivery within established cost, timelines, and quality guidelines set forth by the department heads.  Take charge in new products launch and ensure all launch related documentation and reports are prepared, reviewed, and approved before hands. - Production improvement  Identify, evaluate, and propose new procedures and new ideas at R&D  Provide direct support to RDD, QAD, BDD and MFD for preventive and corrective purposes - Participate in third party audit  Extensively involved in the ISO 13485, ISO 9001, and GMP (Taiwan FDA) certification and inspection (readiness and follow up).

Ph.D. Candidate, Biochemistry, Molecular Biology

Master’S Degree, Plant Physiology

Bachelor’S Degree, Forestry