Qi Liu

About Qi Liu

Strategy and operations leader with 10+ years of experience in biopharmaceutical…

Experience

1. Senior Manager - Product Analytical Strategy Lead

   Bristol Myers Squibb

   Oct 2022 — Present

   Drive the analytical development strategy for drug product team, leading technical functional teams to deliver analytical milestones across multiple Cell Therapy programs.• Oversee analytical sections and collaborate with CMC functional teams to ensure successful regulatory submissions for clinical and commercial stage Cell Therapy programs in multiple countries.• Establish and author drug product release specification and justification of specification for clinical and commercial phase Cell Therapy programs.• Collaborate with Global Product Quality, site Quality, commercial QC, MSAT, and Process Development team to support GMP stability testing, change controls, product quality risk assessments, deviations, investigations, and CAPAs, ensuring compliance with cGMP standards.• Develop and maintain resource models and forecasting strategies for Cell Therapy programs, ensuring alignment with leadership team priorities and organizational goals.• Direct capacity planning, testing capabilities, and workload forecasting for the technical functional teams to support drug development and clinical activities.• Demonstrate expertise in project management, stakeholder engagement, and strategic planning, driving Book of Work development, resource allocation, efficiency improvements, lifecycle management, and project transitions.• Manage the Analytical Data Management team, overseeing data acquisition, verification, and report generation to support data-driven decision-making and regulatory submissions.

Education

• University of Iowa

  Master's Degree

  2012 — 2014

Skills

• Liquid Chromatography-Mass Spectrometry (Lc-Ms)
• Uv/Vis
• Analytical Chemistry
• Analytical Method Qualification
• Biochemistry
• Dna Extraction
• Reaction Kinetics
• Organic Synthesis
• Gc
• Fplc
• Recombinant Dna
• Esi-Ms
• Hplc
• Organic Chemistry
• Lc-Ms
• Protein Expression
• Chromatography
• Pcr
• Molecular Biology
• Bacterial Cell Culture
• Bacterial Transformation
• Protein Purification
• Enzyme Kinetics
• Chemistry
• Ir
• Protein Chemistry
• Dna Ligation
• Uv/Vis Spectroscopy
• High-Performance Liquid Chromatography (Hplc)
• Gmp
• Icp
• Anaerobic Protein Expression and Purification
• Method Transfer
• Microsoft Office
• Sds-Page
• Colormetric Assays