Xi Zhan
Associate Director at Bristol Myers Squibb
- Role
- Associate Director at Bristol-Myers Squibb
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
Experience
Associate Director
Apr 2024 — Present
Lead a team under MS & T for biologics cryogenics and single-use system. Serve as a key technical SME in CMC teams to support 20+ Tech Transfers and commercial manufacturing. Develop and implement cutting-edge technologies for freezing, thawing and shipping biologics across network. Assess and qualify consumables used in drug substance (DS) and drug product (DP) processes.2. Collaborate with Process Development, Manufacturing, MS & T, Analytical Development, QA, Regulatory Affairs, and Supply Chain to ensure robust CMC execution. Develop and implement process control strategies, PPQ readiness, and life-cycle management plans in alignment with regulatory expectations.3. Author, review, and approve technical documentation including validation protocols/reports, change impact assessments, risk assessments, and regulatory submission content.4. Own the change control activities for the implementation of changes of process, material and in-process controls.5. Oversee external manufacturing CMO activities on process implementation, deviation investigations, change management, and continuous improvement.6. Support regulatory filings and health authority interactions (IND, BLA, HA inquiries) by contributing to quality and process sections and responding to regulatory questions.7. Streamline and drive the improvement of global strategies for DS freezing/thawing/shipping, consumable extractable and leachable and qualification to enable reliable external and internal manufacturing.8. Manage and mentor a team of scientists and engineers, driving prioritization, execution discipline, and operating rigor across a growing portfolio.
Education
Tsinghua University
Bachelor's degree, Chemical Engineering
2006 — 2010
University of Washington
Doctor of Philosophy (Ph.D.), Chemical Engineering
2010 — 2014
Skills
- Formulation Development
- Lyophilization
- Flow Cytometry
- Microscopy
- Matlab
- Bioassay Development
- Confocal Microscopy
- Nanoparticles
- Vaccine Development
- Data Analysis
- Cell Culture
- Research
- Molecular Biology
- Fluorescence Microscopy
- Cryo-Em
- Elisa
- Chemical Engineering
- Protein Purification
- Tem
- Characterization
- Nanotechnology
- Vaccines
- Imagej
- Dls
- Biochemistry
- Scanning Electron Microscopy
- Dsc
- Immunology
- Assay Development
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