Lijun Duan

Biography

Associate Director Company Name BioDuro Dates Employed Mar 2016 – Present Employment Duration 1 yr 7 mos Senior Group Leader Company Name PPD Dates Employed Sep 2005 – Feb 2016 Employment Duration 10 yrs 6 mos Location Madison, Wisconsin Area Led and developed a team providing analytical method development and validation services to clients in pharmaceutical industry. Coached and developed direct reports and performed performance review. Prepared and reviewed business bids and proposals. Allocated, scheduled and managed laboratory resources for group's project activities and update project status and revenue projections biweekly. Followed up the progress of projects and re-prioritized resources to ensure to meet the financial goals. Reviewed and approved study protocols, project status reports, final study reports, final methods and other project related technical documents. Reviewed and approved laboratory investigations, deviations, QA/QC facility and data audits. Interacted with clients regularly: Responded to client questions and requests; Led technical meetings with clients and made recommendations to client on technical and compliance issue. Prepared and implemented SOPs and guidance documents. Participated in bi-annual SOP review & change process. Identify process issues and lead process improvement initiatives in the E&L department. Regularly communicated to the team quality related issues and items for improvement through biweekly meeting and one to one meetings with each individual. Conducted analytical method development and Validation for the analysis or characterization of drug products, active pharmaceutical ingredients, raw materials, impurities, residuals using HPLC-UV, HPLC-CAD, HPLC-ELSD, GC/MS, LC/MS, LC/MS/MS.etc. Troubleshot method and instrument issues.

Research Interest

Pharmaceutical Science