Fișier CV încărcat

Moscow, Russia | Visa/relocation support required

Analytical Chemist with experience in pharmaceutical QC and GMP-regulated laboratory work. Skilled in method transfer, validation, stability testing, and chromatographic analysis using HPLC & GC.

EDUCATION

NATIONAL RESEARCH TOMSK POLYTECHNIC UNIVERSITY
Master of Chemical Technology
2023-2025
Master's Thesis: Size-exclusion chromatography method validation for determination of molecular mass distribution in calcium nadroparin

NATIONAL RESEARCH TOMSK POLYTECHNIC UNIVERSITY
Bachelor of Chemical Technology
Graduated with honors
2019-2023

EXPERIENCE

R-Pharm, Moscow
Analytical Method Transfer and Validation Specialist
(QC, Chromatography)
Jul 2025 Present

• Supported analytical method validation and product registration for 10+ drug products using HPLC, GC, and KF titration in accordance with ICH guidelines.
• Performed method transfer from external R&D sites to the manufacturing site, compendial method verification, and statistical evaluation of validation characteristics.
• Conducted stability testing for 20+ pharmaceutical products, including cytotoxic, solid, and liquid dosage forms in accordance with WHO guideline.

Saint Petersburg Scientific Research Institute of Vaccines and Sera, Saint Petersburg
QC Chemist, Chromatographic Analysis
Jul 2024 Jul 2025

• Performed 90+ analyses per month of raw materials, intermediates (including proteins and polysaccharides), liquid drug products, and stability samples using HPLC and GC.
• Updated and optimized analytical procedures; supported method validation and successful method transfer across teams and sites.
• Investigated OOS/OOT results, designed follow-up experiments, and identified root causes to support quality improvement.
• Reviewed analytical data, performed calculations, and maintained laboratory documentation in compliance with ALCOA+, GMP, and compendial requirements.

Process Engineer, Manufacturing Technology Support Department
(Liquid Dosage Forms)
Aug 2023 - Jul 2024

• Developed and updated GMP-controlled documentation, including Manufacturing Instructions, SOPs, and process validation protocols, to support compliant manufacturing operations.
• Contributed to site readiness for a CECMED external audit and supported process validation activities, resulting in successful GMP certification.
• Managed quality-related manufacturing activities, including change controls, deviations, and risk assessments using FMECA methodology.
• Supported aseptic/controlled manufacturing operations in Grade C/D cleanrooms, including CIP/SIP, TFF, in-process controls, and batch documentation review.
• Trained production personnel and ensured compliance with GMP standards and internal procedures.

SKILLS

• Analytical Techniques: HPLC, GC, Karl Fischer titration, UV-Vis spectroscopy, pH testing, dissolution testing for solid dosage forms, uniformity of dosage units (UDU).
• Instrumentation: Waters Alliance, Waters Arc, Agilent 1260, Sintecon, Shimadzu LC-20 Prominence, Agilent 7890B, Shimadzu UV-1800.
• Languages: Russian (Native), English (B1, actively improving to B2). =