Leon Li Email & Phone Number

United States

Wuxi, Jiangsu, Cn

Paris, France, Fr

Build a highly functional QC team. Support CMC activities of multiple Phase1,II and III pipeline products using mRNA platform;Responsible for establishing the QC GMP laboratory and operational systems at the Sanofi Waltham site, including instrument IQ/OQ/PQ, SOPs, laboratory operations system, sample and reference/reagent management, shipping, etc.Ensure all GMP testing is conducted in accordance with SOPs, compendia, approved methods, and policies and procedures of Sanofi and regulatory agencies.Provide oversight and guidance to internal and CROs GMP contract testing labs including but not limited to technical transfer, method qualification and validation as well as routine GMP testing (in process, lot release and stability testing, and reference standard maintenance and qualification). Ensures a science-driven, phase appropriate, and risk-based quality control strategies to support development projects.Support the portfolio of clinical development to ensure timely delivery of clinical supplies and will assemble, review and trend release, IPC, and stability data, generating reports as necessary to support specification and expiry setting.Participate in regulatory agency inspections, and assists in observational resolutions, as needed. Author/Review of relevant sections of IND/BLA

Tokyo, Jp

Oversight and effectively manage Takeda contract test laboratories and contract manufacturing organization utilized from release and on-going stability testing for multiple Takeda products.Interpretation of data trends for both release and stability, life cycle of methods and other technical support as required.Lead deviation and OOT/OOS investigations with strong understanding of compliance and cGMP's, strong scientific judgment and leadership in decision making.Identify and remediate Analytical, compliance, and efficiency gaps.Lead external critical materials and reference standard management and coordination of sample management activities.Provide accurate and timely updates of group activities to International Quality and US Technical Operations management with a focus on compliance, cycle times, cost management, and productivity.

Waltham, Ma, Us

• Lead planning and operation of QC release, and stability testing performed externally at contract laboratory organizations (e.g. Eurofins, PPD, KBI and Lonza). Ensure timelines are met for release and stability testing of product;• Ensure compliance and support of company Standards, Practices, and SOPs as well as ICH and FDA guidelines; • Lead and support Quality operations including deviation management, OOS/lab investigation, CAPA, Change control and procedure/document changes at CLOs ;• Support department budget planning, Manage MSA, QTA, facilitate SOW, PO generation and invoice management;• Actively support global BLA filing, PAI and other internal/external inspections, addressed questions and requests from FDA/PMDA and other agencies; • Manage critical reagents, assay control and reference standard;• Support CoA issuance via LIMS;

Paris, France, Fr

Group lead for the Analytical Life Cycle Management Working Group supporting the life-cycle management activities. Lead group to deliver method assessments, remediation strategy, and remediation priorities within timelines. Supported multiple internal/external regulatory inspections. Supported various FDA requests.Participate in the Specification Development Team and closely monitor progress in order to fulfill the commitment to various regulatory agencies (e.g. FDA, Health Canada, etc.). Led QC Science & Technology group and actively participate in Deviation and Laboratory Investigations (with Trackwise) and provide technical guidance to the QC Chemistry department. Assist in determining the root cause of OOS/OOT. Assist in determining CAPA and lead implementation team.Led the transfer of the QC Chemistry laboratory by participating in gap analysis, risk assessment, review/approve Change Control, transfer proposal/plan, and individual transfer protocol.Responsible for quality section for the periodical product review (PPR)Work as the department Empower subject matter expert. Propose and help implement changes to ensure compliance and system performance.

Lawrence Township, Nj, Us

Work as a team lead of a group of Analysts in a start-up facility. Played key role in Quality Control Analytical lab to support STAT testing .Supported and coordinated equipment qualification.Drove tech transfer activities and in process testing activitiesLed team successfully troubleshoots for different instruments and methods.Played a Lead role in OOS and major lab investigation and actively coordinate with QA/ Manufacture group towards resolution of comprehensive issues.Drove the electronic method conversion for multiple HPLC/UPLC methods, Support method qualifications.

Us

Supervised the analytical testing of in-process testing, bulk drug product, stability samples, and raw materials. Participated in the departments OOS investigations, non-conformance investigations, and corrective/preventive actions. Perform review of quarterly Invalid assay reports.Actively used technical expertise to improved methods and procedures to reduce laboratory errors.Lead the biochemistry group operations performing multiple QC methods and ensure lab operations and lab personnel meet cGMP requirements/compliance.Perform product complaint assessments. Participate on cross functional/cross site teams to include method or equipment transfer/validation activities.Satisfactorily facilitated inspections from multiple agencies including FDA, EMA, Health Canada, MHLW and KFDA.

Us

Supported commercial production of ERBITUX®.provide compliant analytical support for in-process testing, drug substance/drug product release.Wrote and execute validation protocols and reports for ERBITUX® and development product testing, tech transfer and Qualification per FDA/ICH guidelines.Participated in the implementation of a networked environment for HPLC systems and executed the associated validation activities for Empower. Participate in method development, revision, investigation and served as a technical resource to QC department. Participated in setting up new QC analytics Laboratory. Exhibited strong teamwork and communication skills.

Princeton, Nj, Us

Doctoral Research, Biochemistry

Ms, Bioengineering And Biomedical Engineering