Jun Chen Email & Phone Number

We insist on pursuing excellence and constantly breaking through ourselves. We encourage innovative thinking, advocate teamwork, provide employees with broad development space, and jointly promote the continuous progress of the company. We attach importance to social responsibility. We promote the integration of AI into the medical field, accelerate the development of new drugs and clinical trials, quickly discover potential new drug candidates, analyze clinical trial data, optimize trial design, and improve trial efficiency. Accurately predict the efficacy, toxicity and other characteristics of compounds to help researchers design more effective and safer candidate drugs. This is conducive to improving the success rate and reducing ineffective attempts.

● Led Quality Operations organization in providing successful delivery of qualificationbatches and launch readiness across four new products. Hosted pre-approval inspectionand recovery from significant compliance challenges while also dealing with theuncertainty of site transformation and production ramp-down.● Developed site QA leaders to deliver improvements in areas of data integrity, qualityculture and GXP service provider oversight. Ensured clinical drug product facility wasinspection-ready to support a commercial launch.● Successfully partnered with site organizations to deliver the final commercial batches forproducts to enable closure of 3 commercial production buildings.

● Provided global support to contract manufacturing operations (CDMO) across smallmolecules and combination products.● Led transition of global CMO quality systems support to new Canadian site. Hired andonboarded new team and maintained business continuity.● Improved business and compliance performance by implementing a risk based qualityoversight program and by influencing global process changes in Complaint Managementand Annual Product Quality review.Task for implementation lead rotation: ● Led team to successful implementation of risk reduction measures across multipleproducts.● Influenced a broad range of technical operations functions to accelerate changes acrossthe areas of medical device development, excipients, analytics, and manufacturingprocesses.

Led site quality culture improvement as member of cross-functional team. Coached team indelivering an improved quality presence process covering aseptic operations, facilities, andsite operations.● Supported successful inspection status through hosting multiple internal audits anddeveloped staff for successful health authority inspections. Hosted training of FDA andCFDA inspectors in aseptic processing.● Initiated and supported leadership team efforts to improve quality professional developmentand developed drug product quality academy program

● Achieved reliability and quality improvements by launching plant right-first-time teams andTotal Productive Maintenance efforts.● Led site efforts to implement new corporate media fill and environmental quality standards.● Guided team to successful qualification of new lyophilized product

Leadership of Site Validation team covering large molecule manufacturing from cell banking through Drug Substance, Aseptic Drug Product and Packaging.● Completed re-organization of site validation execution teams, replacing smallertechnology-focused teams.● Drove efficiencies through validation grouping strategies, replacing testing with onlineconductivity measurement, and integration of validation testing into change controlprocess.● Improved strength of key validation programs by upgrading cleaning program. Co-authoredcorporate standard for systems qualification

Contract Validation Engineer supporting large molecule drug substance and drug product facility commissioning, qualification, and re-qualification activities. Generation of standard operating procedures for new facilities..

M.S. In Biological Sciences, Pharmacology，Biology

B.S. In Pharmaceutical Sciences, Pharmaceutical Engineering，Biostatistics