Chen Zhang Email & Phone Number

Philadelphia, Pa, Us

Philadelphia, Pa, Us

Wilmington, Massachusetts, Us

Philadelphia, Pa, Us

• Acted as senior technical representative on cross-functional team, aligning analytical project strategies, improving project timelines and resource optimization.• Implemented phase-appropriate validation strategies for early and late-phase programs, ensuring regulatory compliance and timeline adherence.• Conducted method bridging, implementation, and specifications for commercial programs.• Led HPLC and CE-SDS method development, optimization, validation, and transfer.• Oversaw analytical method validation, transfer, and GMP testing at external Contract Testing Laboratories (CTL), ensuring GMP compliance.• Authored and reviewed over 20 method validation/transfer protocols and reports.• Provided technical support and troubleshooting for internal and external GMP testing, resolving technical issues and ensured continuous QC operations.• Authored over 20 SOPs, change controls, deviations, OOS/OOT investigations and CAPAs, ensuring compliance and on-time closure.• Supported process comparability studies and statistical trend analysis. • Managed reference standard and critical reagent qualifications, as well as stability studies.• Served as the analytical SME during internal audits and regulatory inspections.• Assisted with implementation of new instruments, applications, and processes in GMP laboratories, improving operational efficiency.• Mentored and trained junior scientists, fostering a more skilled and capable team.

Paris, France, Fr

• Managed method transfer project with over 20 analytical methods to CDMO to support mRNA vaccine technology transfer, ensuring seamless integration and adherence to project timelines.• Authored the analytical section for an IND regulatory submission.• Implemented platform method strategy and managed platform method validation at CTL. • Led mRNA method development and optimization for GMP testing, enhancing method accuracy and reducing testing variability.

Wilmington, Nc, Us

• Managed client project as technical project manager.

Wilmington, Nc, Us

• Managed client project as technical project manager.• Coordinated client audit and vendor visits. • Performed HPLC, icIEF, CE method development, transfer, qualification and validation. • Prepared protocol and report for method development, transfer, qualification and validation. • Participated new instrument IQ OQ PQ and SOP written. • Served as an investigator for technology and instrumentation troubleshooting.• Authored deviation, investigation and root cause analysis.• Conducted statistical analysis for data trend review. • Reviewed GMP documentation and data for qualification and validation.• Tutored and trained junior scientists.

Wilmington, Nc, Us

• Performed release, stability and in-process biopharmaceutical sample testing for multiple clients. • Authored certificate of analysis for sample testing.• Performed HPLC, UV/Vis method development, transfer, qualification and validation.

Chicago, Il, Us

• Prepared process development and design package for defined projects.• Developed process flow diagram (PFD) and piping and instrumentation diagram (P&ID).• Assisted in scale-up process design for manufacturing expansion.• Coordinated new product development and commercialization process. • Represented in project meeting with cross-functional teams to ensure timely completion of deliverables.

Chicago, Illinois, Us

• Experience with mammalian cell culture• Produced and purified protein using affinity chromatography• Performed polymer synthesis and characterization with hands-on experience on polyethylene glycol (PEG), polyurethane, polydimethylsiloxane (PDMS) and polyacrylamide• Developed PEG polymers tethered bioactive protein and scaffolds using PEGylation technology• Performed protein stability and degradation study using SDS-PAGE, western blot and spectroscopy • Conducted experimental design and statistical data analysis• Mentored over 10 graduate and undergraduate students on original research involving biomaterials• Presented studies in group meeting and scientific conference• Coordinated hazardous chemical and biological waste disposal

Chicago, Illinois, Us

• Synthesized metallic nanoparticles and nanorods using wet colloidal chemistry• Characterized nanomaterials using UV-Visible spectroscopy, dynamic light scattering and atomic force microscopy• Developed and Characterized nanoparticle surface modification using FTIR• Monitored and simulated metallic nanorods formation mechanism and reaction kinetics

Chicago, Illinois, Us

• Assisted teaching in Transport Phenomena, Bioprocess Engineering and Biomaterials for 3 semesters.• Facilitated learning and improved performance by tutoring students individually and in small groups.

Phd, Chemical Engineering

Master'S Degree, Chemical Engineering

Bachelor'S Degree, Chemical Engineering