Wanlin Sun

- Supported CTMs to execute and manage the oncology trials in collaboration with CROs and Central Lab for a variety of activities, including site and vendor selection, study start-up, trial conduct, IP and lab supply, etc -Collaborated with the CTMs to review study-related documentation and shared the responsibility of drafting the study-related documents - Acted as the Veeva eTMF owner to lead the completion of eTMF implementation and documents migration as well as oversight and management of internal and external use of Veeva eTMF - Managed and coordinated with Central Lab to supply lab materials and have them delivered in a timely manner to the sites for different study countries - Planed and managed Investigational Product (IP) supply through working with Pharma Service Vendor in terms of packaging, labeling, and shipping to support all trials that are conducted in different countries - Collaborated with cross-functional teams facilitate the progress of drug development and clinical studies in compliance with GCP and regulatory guidelines

- Management, oversight, and coordination of assigned Companion Diagnostics studies in terms of immuno-oncology as well as maintenance of corresponding documentation in accordance with customer expectation and in compliance with regulatory requirement - Monitored the progress of CDx studies to ensure the successful delivery of all operations within timeline as well as management of project budget and billable activities - Prepared, coordinated, hosted and participated in the diagnostic clients visits in terms of SQV, SIV, IMV, and COV per study plan - Identified and resolved the case report forms (CRF) through collaboration with function teams which are labs, PM and DM teams - Prepared and submitted IRB application - Review of CDx SOW to facilitate the progress of study and database setup - Acted as the liaison between the diagnostic clients and internal function teams - Assisted in the global management of diagnostic services and lab operation processes harmonization for global consistancy of the Dx program across different testing sites

 Set up the analytical lab with variety of physical and chemical testing techniques as well as completion of the instrument qualifications in terms of IQ, OQ and PQ.  Established extractable & leachable lab testing capability for material characterization of polypropylene, polyethylene, polycarbonate, PVC and EVA, etc.  Lead, plan, manage and conduct study design and development activities related to chemical testing, extractables & leachables evaluation, biological evaluation and corresponding analytical support per project plan  Generated project plans/strategies and regularly review priorities to maintain focus and achieve objectives per project plan to meet the timeline  Possess a deep understanding of local, regional, and global consensus standards which include USP, ISO, and ICH, etc. and FDA, CFDA and EMEA guidelines in terms of extractables & leachables and biocompatibility study requirements  Generated workflow of toxicological assessment based on the extractable & leachable and biological evaluation testing outcome to make sure the material is safety for intended use as medical grade  Employed evaluation principles to conduct risk assessment of material qualification for pharmaceutical packaging and medical device in accordance with regulatory requirements  Wrote study protocols, validation protocols, validation reports, study reports, technical reports, investigations, and documents for regulatory submission  Provided leadership for various operational tasks within the laboratory including utilization and maintenance of modern analytical instrumentation such as GC/MS, LC/MS, HPLC, NMR, GC and ICP-MS, etc.  Performed lab work in accordance with cGMP, SOPs and safety regulations with 5S concept  Worked closely with design, development, quality assurance, regulatory and lab teams to facilitate the progress of corresponding projects

• Set up a startup lab as well as maintaining and ordering lab supplies and consumables Identified and quantified drugs of abuse through urinalysis by using LC-MSMS analytical instrumentation with knowledge of toxicology in high-complexity clinical lab • Followed the forensic toxicology standard practice to perform the instrument method validation that meets the COLA inspection requirement • Maintained the instrument and solved the problem from troubleshooting • Performed proficiency testing and reported to the American Proficiency Institute as the same manner as the patient specimens • Trained new lab assistant