Iurii (Yurii) NIKITIN
Bellevue,USA
Summary
Experienced Biotech Manufacturing Specialist with 6+ years in biomanufacturing operations, including 3+ years in clinical cell therapy, across GMP-regulated environments. Proven expertise in technical transfers, deviation resolution, aseptic techniques, and continuous process improvements. Skilled in downstream processing and CAR-T Cell Therapy and in cross-functional collaboration with MSAT, QA, and QC. Experienced in using software platforms for GMP such as Syncade MES, Delta V, Labware LIMS, Oracle, and SAP. Adept at executing and optimizing manufacturing workflows with strict adherence to GDP, GMP, and safety standards. Self-motivated with minimal supervision, attention to detail, communicative and initiative team leader, trainer.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Downstream Manufacturing Associate II
Just-Evotec
Redmond, WA
09.2024 - Current
- Lead execution of downstream operations: Column chromatography (Capture/Polishing), Viral Inactivation, Ultrafiltration/Diafiltration, BioSMB skid
- Supported and led validation projects, ensuring compliance with regulatory standards and enhancing operational effectiveness
- Investigated non-conformance and deviation issues, implementing CAPA to ensure compliance.
- Actively support technology transfers and implement continuous process improvements
- Drafted, reviewed, and revised SOPs and MBRs, ensuring adherence to regulatory compliance and maintaining operational accuracy
- Investigate and resolve deviations, collaborating with MSAT, QA, and QC
- Conduct equipment calibration, sampling, and sensor verification to ensure process in control state.
- Function as team lead and trainer, supporting onboarding and departmental coordination
Manufacturing Associate II – Cell Therapy Operations
Bristol Myers Squibb
Bothell, WA
05.2021 - 08.2024
- Performed and proficient in CAR-T cell therapy manufacturing selection of CD8/CD4 cells using CliniMACS and Sepax equipment.
- Conducted aseptic manual formulation in the biosafety cabinet (BSC) following gowning procedures in ISO 5/7 environments for media, buffers, and viral packs.
- Performed media preparation using Automated Media Production System (AMPS) in ISO-8 environment
- Conducted environmental, personal, and in-process sampling utilizing LabWare LIMS to ensure compliance with safety standards.
- Experienced in performing cell counter using flow cytometry principle
- Contributed to facility setup, commissioning, and validation of equipment following 5S principles
- Led continuous development initiatives for CliniMACS operations, enhancing safety, quality, compliance, and efficiency
- Collaborated with cross-functional teams to address non-conformances and operational issues, ensuring adherence to quality standards
- Conducted training for new associates and regularly reviewed SOPs and batch records (ALCOA+)
Maintenance Technician
Coca-Cola
Bellevue, WA
05.2016 - 05.2021
- Conducted preventive maintenance to maintain machine performance and ensure safety
- Diagnosed mechanical and electrical issues to enhance equipment reliability and minimize downtime
- Collaborated with technical teams to implement system upgrades and streamline troubleshooting protocols
Chemical Development and Validation, Engineer II
OJSC SPE Krasnoznamenetc
Saint-Petersburg, Russia
07.2009 - 11.2015
- Designed, optimized, and validated chemical processes, ensuring quality through pH, titration, and spectrometry testing
- Supervised manufacturing operations to maintain adherence to quality, chemical, and safety standards
- Evaluated equipment and procedures for regulatory compliance, enhancing safety and performance
- Developed and maintained safety procedures, SOPs, and compliance documentation
Education
Associate of Applied Science - Molecular Science Technician
Bellevue College
Bellevue, WA06-2020
Bachelor of Science - Organic Chemistry
Chuvash State University
Russia06-2008
Skills
- Aseptic Techniques (ISO5/7/8/9)
- GMP/GDP Compliance
- Manufacturing Batch Records (MBR)
- Deviation investigations
- Root Cause analysis
- Tech transfer
- CAR-T Therapy
- Chromatography
- CliniMACS operations
- Sepax operations
- MES (Syncade)
- Delta V
- SAP
- Equipment troubleshooting
- Oracle
- Labware LIMS
- Technical Operations Support
- Equipment Troubleshooting & Calibration
- SOP Development
- Audit Preparedness
- Training
- Cross-Functional Collaboration (QA/QC/MSAT)
- Audit Preparedness
Certification
Microsoft Office Specialist: Office PowerPoint 2016
Timeline
Downstream Manufacturing Associate II
Just-Evotec
09.2024 - Current
Manufacturing Associate II – Cell Therapy Operations
Bristol Myers Squibb
05.2021 - 08.2024
Maintenance Technician
Coca-Cola
05.2016 - 05.2021
Chemical Development and Validation, Engineer II
OJSC SPE Krasnoznamenetc
07.2009 - 11.2015
Associate of Applied Science - Molecular Science Technician
Bellevue College
Bachelor of Science - Organic Chemistry
Chuvash State University