Yun Lu

WORK HISTORY

EDUCATION

SKILLS

ABOUT YUN LU

Accomplished scientist with over 10 years of experience in R&D, cGLP, and cGMP pharmaceutical environments, with a strong emphasis on the bioanalytical field. Expert in designing and executing complex analytical strategies to support drug development, process optimization, and regulatory compliance. Proven leader with 7+ years of matrix team management experience, effectively guiding multi-functional teams to achieve critical organizational milestones. Adept at collaborating with cross-functional leads to design and implement development strategies, facilitate CMC decision-making processes, and oversee regulatory submissions, including FIH IND/INDa/IMPD filings.Highly skilled in a wide array of analytical techniques, including HPLC/UPLC, ELISA, CE, iCIEF and compendial assays, with hands-on experience in method development, transfer, and validation. A strong team player, committed to mentoring junior scientists and fostering collaborative team environments.Experienced in collaborating with CDMOs, CLTs, and CROs to ensure the successful execution of analytical and CMC strategies, with the ability to adapt to changing priorities and meet rigorous timelines. Possesses strong program management and leadership skills, coupled with excellent communication and troubleshooting abilities, making a significant impact on drug discovery, formulation development, and product characterization.